The Journal of Arthroplasty 33 (2018) 2627e2630

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The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Other

A Higher Altitude Is an Independent Risk Factor for Venous

Thromboembolisms After Total Hip Arthroplasty
Dhanur Damodar, MD a, Chester J. Donnally III, MD a, Jonathan I. Sheu, MD c,
Tsun Y. Law, MBA, MD b, Martin W. Roche, MD b, Victor H. Hernandez, MD a, *
a
Department of Orthopedic Surgery, University of Miami Hospital, Miami, Florida
b
Department of Orthopedic Surgery, Holy Cross Hospital, Orthopedic Research Institute, Fort Lauderdale, Florida
c
Department of Education, University of Miami Leonard M. Miller School of Medicine, Miami, Florida

a r t i c l e i n f o a b s t r a c t

Article history: Background: High altitudes lead to physiological changes that may predispose to venous thromboem-
Received 26 January 2018 bolisms (VTEs) including deep vein thrombosis and pulmonary embolism (PE). No prior study has
Received in revised form evaluated if there is also a higher risk of VTEs for total hip arthroplasties (THAs) performed at higher
22 February 2018
elevations. The purpose of this retrospective study was to identify if undergoing THA at a higher altitude
Accepted 17 March 2018
Available online 27 March 2018
center (>4000 feet above sea level) is an independent risk factor for a postoperative VTE.
Methods: A thorough evaluation of the Pearl Diver Database was performed for patients undergoing
THAs from 2005 to 2014. Using International Classification of Diseases Ninth Edition facilitated in
Keywords:
altitude
ascertaining patients who underwent THA. Using the ZIP codes of the hospitals where the procedure
elevation occurred, we separated our groups into high-altitude (>4000 ft) and low-altitude (<100 ft) groups.
deep vein thrombosis Results: In the first 30 postoperative days, patients undergoing THA at a higher altitude experienced a
pulmonary embolism significantly higher rate of PEs (odds ratio, 1.74; P ¼ .003) when compared to similar patients at lower
total hip arthroplasty altitudes. This trend was also present for PE (odds ratio, 1.59; P < .001) at 90 days postoperatively.
Conclusion: THAs performed at higher altitudes (>4000 feet) have a higher rate of acute postoperative
PEs in the first 30 days and also 90 days postoperatively when compared to matched patients receiving
the same surgery at a lower altitude (<100 feet). THA patients at high altitude should be counseled on
these increased risks; however, owing to retrospective nature and confounders, prospective studies are
necessary to explore this outcome in more detail.
© 2018 Published by Elsevier Inc.

After most orthopedic surgery, chemical prophylaxis is a

One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.045.
Funding: The authors, their immediate family, and any research foundation with
which they are affiliated did not receive any financial payments or other benefits
from any commercial entity related to the subject of this article.
All authors significantly contributed to the document and have reviewed the final
manuscript. This study was a retrospective chart review. For this type of study,
formal consent is not required. This manuscript and all associated authors are
familiar with and agree to the Committee on Publication Ethics (COPE).
* Reprint requests: Victor H. Hernandez, MD, Department of Orthopedics, Uni-
versity of Miami Hospital, 1400 NW 12th Avenue, Miami, FL 33136.
mainstay of the anticoagulation protocol. For patients undergoing
total hip arthroplasty (THA) and total knee arthroplasty (TKA),
postoperative venous thromboembolism (VTE) is associated with
high morbidity and mortality. In total joint arthroplasty (TJA), VTE
is a comprehensively studied postoperative complication [1].
Studies have shown 3%-4% readmission rates after THA and TKA
due to VTE [2]. Based on revised guidelines in 2011, the American
Academy of Orthopedic Surgeons recommends that all patients
undergoing elective THA and TKA receive deep vein thrombosis
(DVT) prophylaxis postoperatively [3]. In 2012, the American Col-
lege of Chest Physicians published new guidelines recommending
that THA and TKA patients receive VTE prophylaxis for at least 10-
14 days. The guidelines also state that prophylaxis may be extended
for up to 35 days [4]. The type of VTE prophylaxis and duration of
treatment, however, appear to be more surgeon dependent.

https://doi.org/10.1016/j.arth.2018.03.045
0883-5403/© 2018 Published by Elsevier Inc.
2628 D. Damodar et al. / The Journal of Arthroplasty 33 (2018) 2627e2630
An additional practice of most TJA surgeons is to try and limit
the modifiable risk factors for VTE, such as smoking, elevated body
mass index (BMI >30), as well as to encourage early ambulation.
One risk factor for postoperative VTEs that has been demonstrated
in other orthopedic procedures is altitude, with the thought pro-
cess that higher altitudes may predispose patients to an increased
risk of VTEs. While this has been evaluated for postoperative or-
thopedic patients undergoing acute air travel, the influence of
altitude has never been explored in TJA patients [5].
Higher altitudes lead to physiologic changes that may predis-
pose to VTE including DVT and pulmonary embolism (PE). Several
studies have demonstrated an increase in factors contributing to
Virchow's triad (hypercoagulability, venous stasis, and vessel wall
injury) at high altitudes [6e8]. Prior studies have noted increased
rates of VTE in patients undergoing arthroscopic knee and shoulder
surgery at high elevation centers (>4000 feet) compared with low
elevation centers (<100 feet) [9e11]. No study has evaluated if
there is also a higher risk of VTEs for THA procedures performed at
higher elevations compared to lower elevations.
The purpose of this study was to compare the rates of DVT and
PEs in patients undergoing THA at low-altitude centers compared
to those at higher altitude centers. Through this, we are able to
determine if altitude is a potentially modifiable risk factor for VTEs
following these procedures. Our hypothesis is that patients un-
dergoing THA at higher altitudes will have higher incidence of VTEs
than patients at lower altitudes.
Materials and Methods
A retrospective study was done using the national provider
database by the name of Pearl Diver (Pearl Diver Technologies, Inc.,
Fort Wayne, IN) which is compliant with the Health Insurance
Portability and Accountability Act. Pearl Diver is a publicly available
database which holds the records of over 23 million patients. Our
study looked at the Medicare provider for our population, from the
years of 2005 to 2014. Using the International Classification of
Diseases, Ninth Edition (ICD-9) codes facilitated in ascertaining our
population.
Patients who underwent primary THA from the years of 2005 to
2014 were identified using the ICD-9 procedure code ICD-9-P-81.51.
Patients were stratified into 2 groups. Those who had the procedure
in areas with an altitude >4000 feet were defined as the “high-
altitude group,” and the control group which had the procedure at
<100 feet were defined as the “low-altitude group”. Five-digit zip
codes provided through the Zip Code Database (Datasheet LLC,
Hopewell Junction, NY) provided the geographic locations of the US
mainland with respect to altitude (Fig. 1). An assumption was made
that zip code of procedure was the same as zip code of recuperation
Fig. 1. Geographic altitude (feet) of the mainland United States.
for these patients. After our inclusion criteria were defined, our
exclusion criteria included those patients with a prior history of
DVT and/or PE. Additional exclusion criteria excluded those pa-
tients with a prior history of hypercoagulable state and patients
with any unspecified coagulation defect. There is no evidence in the
literature to suggest that surgeons at high altitudes use more
frequent Doppler screening or more rigorous prophylaxis; however,
this possibility cannot be excluded.
Using Boolean operations, the patients in the high-altitude
group were match controlled with the patients in the low-
altitude group. Patients were also matched based on comorbid-
ities, which are known to lead to thromboembolic events, including
BMI >30, tobacco use, hypertension, diabetes, and hyperlipidemia.
The matching process is done 1:1 based on age, sex, and 5
comorbidities known to be associated with increased risk of post-
operative VTE: obesity (BMI 30), tobacco use, hypertension,
diabetes mellitus, and hyperlipidemia. Rates of DVT and PE were
assessed in both groups within 30 days and 90 days of the afore-
mentioned procedures. Descriptive and statistical analysis was
performed using the programming language R (University of
Auckland, New Zealand). Statistical analysis included calculating
odds ratios (ORs) and 95% confidence intervals via binary logistic
regression. Risk ratios (RRs) were calculated from odds ratios and
event prevalence in the low-altitude group. Number needed to
harm (NNH) was calculated from event incidence in both groups.
Statistical significance was defined as P < .05.
Results
A total of 206,115 THA patients met all inclusion criteria before
breakdown by zip code. A total of 42,780 THA patients had their
procedures performed at an altitude of greater than or equal to
4000 feet and formed the high-altitude study group, and 163,335
THA patients had their procedures performed at an altitude of less
than or equal to 100 feet and formed the low-altitude study group.
Of these, 87,033 THA age- and gender-matched patients (Table 1)
were identified for inclusion in this study.
For patients undergoing THA, the overall VTE rate within 30
days was 0.28%; the overall DVT rate within 30 days was 0.28%, and
the overall PE rate within the same time frame was 0.15%. Within 90
days, the overall VTE rate rose to 0.60%; the overall DVT rate within
90 days rose to 0.60% and the overall PE rate within the same time
frame rose to 0.41%.
Within the first 30 days, the PE rate in patients undergoing THA
at higher altitudes was significantly higher (OR 1.74; P ¼ .003) when
compared to similar patients at lower altitudes. This was also true
for the PE rate (OR 1.60; P < .001) at 90 days postoperatively (Figs. 2
and 3, Table 2). The risk of PEs was elevated at both 30 (RR 1.74) and
90 days (RR 1.59) postoperatively. The NNH for a PE at 30 days was
1250; the NNH for a PE at 90 days was 526.3. The incidence of DVT
and overall VTE did not increase significantly from low to high
altitude for either 30 or 90 days after primary surgery.
Discussion
In this study, we found Medicare patients undergoing THA were
1.74 and 1.60 times more likely to have postoperative PEs at higher
elevations compared to centers at sea level within 30 and 90 days of
their procedures, respectively.
It is thought that physiological effects on the body at higher
altitudes is one of the contributing factors that may predispose
patients to higher VTE rates [6e8,12e14]. As one would expect, the
body undergoes a host of physiologic changes as it enters a high-
altitude environment. First, it compensates by changing its venti-
lation rate. As the body adjusts, changes then occur to the oxygen-
 D. Damodar et al. / The Journal of Arthroplasty 33 (2018) 2627e2630 2629

Table 1
Demographics.

Patient Demographics Number of Patients (%)

Age group
64 and younger 3404 (7.9)
65-69 11,970 (27.9)
70-74 9747 (22.7)
75-79 8317 (19.4)
80-84 5720 (13.3)
85 and older 3218 (7.5)
Unknown 398 (0.9)
Gender
Female 25,663 (59.9)
Male 16,713 (39.0)
Unknown 398 (0.9)
Comorbidities
Hypertension 34,285 (80.2)
Diabetes 14,757 (34.5)
Hyperlipidemia 25,895 (60.5)
BMI 30 9484 (22.2) Fig. 2. Incidence of venous thromboembolism (VTE), deep vein thrombosis (DVT), and
Tobacco user 5798 (13.6) pulmonary embolism (PE) within 30 days of total hip arthroplasty (THA) in high- and
low-altitude patients. The incidence of PE was significantly higher in patients under-
Matched patient demographics of patients who have undergone THA in altitudes going THA at higher altitudes; there was no significant difference in incidence of VTE
>4000 feet and <100 feet. or DVT.
BMI, body mass index.

each. They then created a risk stratification scheme based on points,

hemoglobin dissociation curve to adapt to the lower oxygen levels. with 0-4 points as low risk, 5-8 as medium risk, and 6-10 as high
Results from high-altitude studies show that environmental con- risk. They validated this system by analyzing 8731 THA patients and
ditions such as hypoxia, dehydration, hemoconcentration, low 8653 TKA patients at 1 institution. They found that the low-risk,
temperature, use of constrictive clothing, and enforced stasis due to medium-risk, and high-risk groups had PE rates of 0.44%, 1.51%,
severe weather all support the possible occurrence of thrombotic and 2.60%, respectively. Their study demonstrated an accurate
disorders [7]. system to tier preoperative risk that correlated with rates of post-
Anand et al [14] reported a 30 times increased risk of sponta- operative PEs. At this time, further studies are needed to determine
neous vascular thrombosis among soldiers stationed at high alti- appropriate prophylaxis use based on the risk profile.
tude for an extended period of time. Some studies have suggested Although is it well established that routine chemoprophylaxis is
that changes in the coagulation profile at high altitude can cause a standard after TJA, several new studies are creating risk stratifi-
activation of the coagulation cascade and lead to increased throm- cation systems that help determine perioperative and postoperative
bosis. A recent investigation looked at patients at an altitude of 3500 DVT prophylaxis choice. Our study is the first to note that higher
feet and concluded a host of factors: erythrocytosis, increased altitude can act as an independent risk factor which can be used in
platelet count, platelet activation, and raised fibrinogen level com- future studies and contribute to the risk profile of THA patients.
bined with hypoxia and dehydration cause a thrombotic milieu to This study has several limitations. As with all database studies,
occur which predisposes patients to increased rates of VTE [15]. this review is potentially flawed by human error as it requires the
In the orthopedic literature, Tyson et al [9] reviewed 35,877 input of various data points into a complex coding system, creating
patients undergoing knee arthroscopy at 1000 feet vs 4000 feet and many opportunities for faulty coding or under-reporting. While this
determined those at the higher elevation were at a significantly may under-report actual VTE rates, theoretically these errors would
higher risk of DVT but not PE. Similarly, Cancienne et al [10] occur at equal rates in both cohorts. In addition, the use of a
reviewed 64,291 patients undergoing this same procedure but
compared 100-4000 feet. They determined that at both 30 and 90
days postoperatively, the rates of VTE, DVT, and PEs were increased
in the higher altitude cohort.
It is agreed by most joint surgeons that preoperative risk
stratification is an important part of deciding an effective and safe
VTE prophylaxis regimen. Several studies have developed risk tiers
and paired patient risk to choice of prophylaxis. Nam et al [16]
classified their THA patients as “high risk” or “low risk.” High-risk
patients met the following criteria: age >70, previous DVT, can-
cer, hypercoagulable disorder, multiple comorbidities, BMI >40, or
prolonged immobilization. These patients were treated with
warfarin, while the low-risk patients were treated with aspirin and
compression devices. Parvizi et al [17] retrospectively reviewed TJA
in 24,000 patients treated with warfarin and 1800 patients treated
with aspirin based on surgeon's preference. Based on a series of
comorbidities, these patients were classified as low, medium, or
high risk for VTEs. After controlling for risk factors, they found that
the type of prophylaxis used made no difference in rates of Fig. 3. Incidence of venous thromboembolism (VTE), deep vein thrombosis (DVT), and
pulmonary embolism (PE) within 90 days of total hip arthroplasty (THA) in high- and
symptomatic PE. Bohl et al [18] identified a several independent low-altitude patients. The incidence of PE was significantly higher in patients under-
risk factors for symptomatic PE in a large retrospective review, and going THA at higher altitudes; there was no significant difference in incidence of VTE
based on the magnitude of each factor, assigned a point value to or DVT.
2630 D. Damodar et al. / The Journal of Arthroplasty 33 (2018) 2627e2630

Table 2
Total Hip Arthroplasties.

n (%), >4000 ft n (%), <100 ft OR 95% CI P Value

30 d postoperatively
Total patients 39,607 39,493
VTE 118 (0.30) 100 (0.25) 1.1771 0.9015-1.5370 .2308
DVT 118 (0.30) 100 (0.25) 1.1771 0.9015-1.5370 .2308
PE 75 (0.19) 43 (0.11) 1.7406 1.1961-2.5329 .0038
90 d postoperatively
Total patients 39,607 39,493
VTE 258 (0.65) 218 (0.55) 1.1813 0.9858-1.4154 .0710
DVT 258 (0.65) 218 (0.55) 1.1813 0.9858-1.4154 .0710
PE 198 (0.50) 124 (0.31) 1.5952 1.2739-1.9974 <.0001

Bold values indicate statistically significant P values.

CI, confidence interval; DVT, deep vein thrombosis; OR, odds ratio; PE, pulmonary embolism; VTE, venous thromboembolism.

database such as Pearl Diver confers several intrinsic limitations.
There is an inability to screen patients preoperatively based on our
methods, and so pre-existing DVTs or PEs may not have been
excluded which keeps a high-risk population in the cohort; how-
ever, as discussed, this error would affect both groups equally.
Furthermore, the database does not specify how VTEs were diag-
nosed (Doppler ultrasound, clinically, or otherwise), whether sur-
geons at higher altitude are more likely to use one diagnostic
technique over another, or whether surgeons at different altitudes
were more or less rigorous with their postoperative VTE prophy-
laxis. As discussed previously, the type of VTE prophylaxis in the
postoperative period is controversial and variable for arthroplasty
surgeons, and we were unable to compare any discrepancies in our
cohorts that may bias one group. Furthermore, we were unable to
account for potentially increased screening or physician awareness
that occurred in higher elevation joints practices, as well as
whether recovery occurred at the same altitude as the primary
procedure, which was a major assumption of this study. Although
this is a matched controlled study with a multivariate analysis, and
while we controlled for several risk factors, there are also several
risk factors we could not account for including use of hormonal
replacement therapy, family history of VTE, and length of surgery,
which could all influence the final results.
Conclusion
Our study of Medicare patients demonstrates a significantly
increased risk of PEs in postoperative THA patients at altitudes
greater than 4000 feet. It is important to note, however, that there
was no significant difference in DVTs. Our results suggest that high
altitude may be problematic for VTE after THA; however, owing to
confounding variables that cannot be assessed retrospectively,
further prospective studies are warranted to evaluate this outcome
in more detail.
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[13] Hanna J. Climate, altitude and blood pressure. Hum Biol 1999;71:553e82.
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 The Journal of Arthroplasty 33 (2018) 2647e2651

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Anatomical Features of the Descending Genicular Artery

to Facilitate Surgical Exposure for the Subvastus
ApproachdA Cadaveric Study
Yuya Kawarai, MD a, *, Junichi Nakamura, MD, PhD a, Takane Suzuki, MD, PhD b,
Shigeo Hagiwara, MD, PhD a, Michiaki Miura, MD a, Seiji Ohtori, MD, PhD a
a
Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba City, Chiba, Japan
b
Department of Bioenvironmental Medicine, Graduate School of Medicine, Chiba University, Chiba City, Chiba, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Background: The purpose of this cadaveric study was to clarify the proximal limit for the subvastus
Received 15 January 2018 approach (SVA) in total knee arthroplasty to decrease potential vascular injury.
Received in revised form Methods: Seventy embalmed knees underwent a modified SVA using a 14-cm oblique medial incision.
9 March 2018
Anatomical features of the descending genicular artery (DGA) were investigated with regard to variation,
Accepted 17 March 2018
distance of the vessels from surgical landmarks, and sex differences.
Available online 27 March 2018
Results: The DGA was identified in 62 knees (89%), while it was absent in 8 knees (11%); in the latter, the
articular, saphenous, and muscular branches arose separately from the femoral artery. The mean dis-
Keywords:
total knee arthroplasty
tances from the tibial tuberosity and medial joint line to the origin of the DGA were 15.5 ± 1.6 cm and
subvastus approach 12.6 ± 1.6 cm, respectively. Both distances were significantly longer in males than in females (P < .01,
minimally invasive surgery respectively). A strong positive correlation was found between the distance from the tibial tuberosity to
anatomy the origin of the DGA and the distance from the medial joint line to the origin of the DGA (Spearman's
descending genicular artery correlation coefficient, R2 ¼ 0.72, P < .01). A weak positive correlation was found between the distance
from the tibial tuberosity to the origin of the DGA and lower leg length (R2 ¼ 0.13, P < .01). No vascular
injuries were observed in this surgical exposure.
Conclusion: The DGA showed several variations and was absent 11% of the time. An oblique medial
incision within 14 cm from the tibial tuberosity followed by arthrotomy is considered a safe zone for the
SVA.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is performed to relieve pain and
improve limited function in patients with knee osteoarthritis. The
need for TKA will increase in the next 15 years [1]. According to the
arthroplasty registries, about 95% of the prostheses last at least 10
years with improved procedures and instruments [2]. The medial
parapatellar approach (MPPA) has been popularized because of its
excellent exposures to the knee joint [3]. However, this approach
damages the extensor mechanism and blood supply to the patella,
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.046.
Funding: This research did not receive any specific grant from funding agencies in
the public, commercial, or not-for-profit sectors.
* Reprint requests: Yuya Kawarai, MD, Department of Orthopedic Surgery,
Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba City,
Chiba 260 8677, Japan.
and thus, it causes surgical complications such as patellar button
loosening, patellar dislocation, and anterior knee pain [4,5]. As the
number of TKAs increase, the desire of patients to integrate early
recovery has increased and surgeons have been encouraged to
explore a less invasive approach. Hofmann first reported the sub-
vastus approach (SVA) with a direct anterior midline incision of the
knee, which preserves the quadriceps muscle and the blood flow to
the patella; good results using this approach have been reported
[6e8]. But with the SVA, it is difficult to obtain sufficient exposure
of the surgical field, especially to evert the patella [4,9]. For better
exposure using the SVA, the incision and arthrotomy must be
extended proximally because the distal end is limited by the tibial
tuberosity. For proximal extension, attention must be paid to the
vascular anatomy. The descending genicular artery (DGA), the final
branch of the femoral artery, is at risk of damage, even though it is
protected by the intermuscular fascia and the adductor hiatus.
Faure et al [10] stated there were 2 patients with symptomatic

https://doi.org/10.1016/j.arth.2018.03.046
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2648 Y. Kawarai et al. / The Journal of Arthroplasty 33 (2018) 2647e2651
medial-thigh hematomas caused by damage of the DGA and its
branches in the SVA. The past study recommended that the prox-
imal limitation for mobilization of the vastus medialis in the SVA
was the adductor hiatus, with further mobilization increasing the
risk of damaging the DGA and its accompanying vein [11]. However,
in clinical practice, the adductor hiatus is seldom identified during
the usual SVA procedure. A cadaveric study is required to define the
safe zone between the DGA and the tibial tuberosity for the SVA.
The purpose of this cadaveric study was to clarify the proximal limit
for a safe incision and arthrotomy via the SVA in TKA to avoid po-
tential vascular injury.
Materials and Methods
The research protocol of this cadaveric study was in compliance
with the Helsinki Declaration, approved by the institutional review
boards, and informed consent was obtained for the donation before
death.
At the Clinical Anatomy Laboratory of our university, 80
embalmed human cadaver lower legs (40 male and 40 female) were
obtained. The inclusion criterion was a lower leg with 170 -190 of
femorotibial angle. The exclusion criteria were a history of previous
knee surgery and a knee with contracture greater than 20 of flexion,
or undesirable leg position. After the inspection, 70 embalmed
cadaver knees (35 male and 35 female) met the criteria. The average
age at the time of death was 86.0 years (range, 64-105 years).
The procedure for the SVA was modified with a 14-cm oblique
medial incision, starting from the tibial tuberosity along with the
midpoints of the muscle belly of the vastus medialis in the knee
extension position. Subcutaneous fat and the superficial fascial
layer were incised directly to the sheath of the vastus medialis
muscle. The sheath of the vastus medialis muscle was then incised
in the direction of the muscle fibers. The muscle fibers were
intentionally pulled laterally within the sheath by the surgeon's
index finger and 2 wound retractors to visualize the capsule of the
knee joint. The superficial layer of the medial capsule was incised
along with the incision, and then fat tissue was identified on the
deep layer of the capsule (synovial layer). The synovial tissue was
preserved in a flap as laterally as possible at arthrotomy, because it
was useful to reconstruct the medial capsule at closure in the TKA
procedure. After the knee arthrotomy, the sartorius and vastus
medialis muscles were mobilized from the intermuscular septum
with blunt dissection distally. After removal of the vastoadductor
Fig. 1. Classification of branching patterns of the DGA. Type 1: common trunk type (A) and the schema (B). Type 2B: isolated saphenous branch type (C) and the schema (D). The tip
of the forceps is pointing to the origin of the DGA. AB, articular branch; DGA, descending genicular artery; FA, femoral artery; MB, muscular branch; SB, saphenous branch.
membrane, the femoral artery and femoral vein were exposed to-
ward the knee joint, and the underlying vascular patterns were
isolated. The anatomical structures of the DGA and its 3 branches
(articular, saphenous, and muscular) were identified. This proced-
ure was performed by 2 board-certified orthopedic surgeons who
were well trained in this approach. Dissection was performed using
surgical loupes with 3.6 magnification. The first 4 specimens were
used as trial (data not shown) to provide an overview of the
anatomical structures located in the subvastus region and to
determine a reproducible technique in accordance with the method
described by Iorio et al [12]. We defined the most distal point of the
medial femoral condyle in a knee extension position as the point at
the medial joint line and the superomedial edge of the tibial tu-
berosity as the point of the tibial tuberosity. For each specimen, the
following data were collected thrice using a digital caliper in 0 of
knee extension; the 3 values were then averaged. In all cases,
several photographs of the anatomized vessels were obtained. All
measurements were taken by a single surgeon (M.M.).
(1) The branching pattern of the DGA, according to the classifi-
cation by Dubois et al [13] (Figs. 1 and 2). Type 1: the 3
branches (articular, saphenous, and muscular) arise from a
common trunk (DGA); type 2: one of these branches arises
from the femoral artery independently and the others
through a trunk (DGA); type 2A: isolated articular branch
type, type 2B: isolated saphenous branch type, and type 2C:
isolated muscular branch type; type 3: the 3 branches arise
separately from the femoral artery.
(2) Vascular injury of the DGA during exposure via the SVA.
(3) The distance from the superomedial edge of the tibial tu-
berosity to the origin of the DGA.
(4) The distance from the medial joint line of the knee to the
origin of the DGA.
(5) The distance from the lateral epicondyle of the femur to the
lateral malleolus of the ankle (lower leg length).
Statistical Analysis
Values were presented as mean ± standard deviation. Contin-
uous values were compared with Mann-Whitney U test using JMP
Pro 12 (SAS Institute Inc., Cary, NC). The Spearman's rank test was
calculated for correlations between lower leg length, the distance
 Y. Kawarai et al. / The Journal of Arthroplasty 33 (2018) 2647e2651
Fig. 2. Classification of branching patterns of the DGA. Type 2C: isolated muscle branch type (A) and the schema (B). Type 3: separate type (C) and the schema (D). The tip of the
forceps is pointing to the origin of MB and SB. DGA, descending genicular artery; MB, muscular branch; SB, saphenous branch.
from the tibial tuberosity to the origin of the DGA, and the distance
from the medial joint line to the origin of the DGA. A P value <.05
was considered significant.
Results
The DGA was identified in 62 of 70 knees (89%). In the remaining
8 knees (11%), the DGA was absent and the articular, saphenous,
and muscular branches arose separately from the femoral artery
(type 3 by the classification of Dubois et al [13]). The branching
patterns of the DGA showed type 1 in 47% (33 of 70 knees) and type
2 in 41% (29 of 70 knees). Type 2A was not observed (0%), but type
2B was found in 36% of cases (25 of 70 knees) and type 2C was
found in 6% (4 of 70 knees). No vascular injuries were observed in
this surgical exposure.
The mean distances from the superomedial edge of the tibial
tuberosity and medial joint line to the origin of the DGA were 15.5 ±
1.6 cm (range, 11.4-20.0 cm) and 12.6 ± 1.6 cm (range, 10.0-16.9 cm),
respectively. Both distances were significantly longer in males than
in females (16.3 vs 14.7 cm, P < .01, and 13.2 vs 11.9 cm, P < .01,
respectively) (Table 1). The mean lower leg length was 36.9 ± 2.9
cm (range, 31.0-42.0 cm).
A strong positive correlation was found between the distance from
the tibial tuberosity to the origin of the DGA and the distance from the
medial joint line to the origin of the DGA (Spearman's correlation
coefficient, R2 ¼ 0.72, P < .01, Fig. 3). A weak positive correlation was
found between the distance from the tibial tuberosity to the origin of
the DGA and lower leg length (R2 ¼ 0.13, P < .01, Fig. 4).
Discussion
The SVA was first described in the German literature by Erkes
[14] in 1929 and was popularized for TKA by Hofmann et al [8] in
Table 1
Distance of the Anatomical Structures.
Overall (n ¼ 70)
Origin of the DGA from the tibial tuberosity (cm) 15.5 ± 1.6 (11.4-20)
Origin of the DGA from the medial joint line (cm) 12.6 ± 1.6 (10-16.9)
Lower leg length (cm) 36.9 ± 2.92 (31-42)
Values are expressed as mean ± standard deviation (range).
DGA, descending genicular artery.
a
Mann-Whitney U test between male and female specimens.
2649
1991. The SVA was considered to be the more “anatomic” technique
because it preserved the extensor mechanism and minimized
vascular damage to the knee [15,16]. The SVA could provide better
pain relief with lower opioid consumption and quick recovery with
earlier straight leg raising and with greater knee flexion [4,17].
Compared with the MPPA, patellar tracking was more natural with
the SVA due to preservation of the extensor mechanism [6,17] and
reduction for a lateral release. Johnson and Eastwood stated that
the lateral release increased the incidence of wound complications
[18]. Unfortunately, the SVA has not been a standard approach for
primary TKA because of limited exposure of the surgical field [4,9].
To improve the exposure, the skin incision can be extended prox-
imally to the location of the DGA [11]. The original skin incision of
Hofmann et al [8] was a direct anterior midline incision of the knee,
and then the medial edge of the vastus medialis is lifted off the
periosteum and intermuscular septum for a distance of approxi-
mately 10 cm proximal. We modified the skin incision as an oblique
medial incision to directly approach the vastus medialis muscle
(direct medial approach). A proximal landmark of the midpoint of
the muscle belly of the vastus medialis was applied in this study
because the muscular branch of the DGA runs at the medial edge of
the muscle. The skin incision can be medialized more obliquely to
the medial edge of the muscle; the advantage is decreased skin
tension postoperatively in deep flexion, but the disadvantage is a
more technically demanding procedure for exposure.
The surgeon needs to be aware of anatomical features of the
SVA. In the present study, the anatomical variations in the
branching patterns of the DGA were type 1 (47%), type 2 (41%), and
type 3 (11%) by using the classification of Dubois et al [13]. This
result was almost the same as that of a study on the Thai people by
Sananpanich et al [19] (Table 2). However, in previous studies on
the Europeans, there were more type 1 cases than in the Asians, and
the DGA was present in >90% of the cases [11,13,20] (Table 2). This
Male (n ¼ 35) Female (n ¼ 35) P Value
16.3 ± 1.5 (13.9-20) 14.7 ± 1.4 (11.4-18) <.01a
13.2 ± 1.6 (10.8-16.9) 11.9 ± 1.2 (10-14.3) <.01a
38.6 ± 2.93 (31-42) 35.3 ± 1.75 (31-38) <.01a
2650 Y. Kawarai et al. / The Journal of Arthroplasty 33 (2018) 2647e2651

Fig. 3. Relationship of the distance from the medial joint line and the tibial tuberosity
to the origin of the DGA. Distance from the tibial tuberosity to the origin of the DGA
(cm) ¼ 4.29 þ 0.89  (distance from the medial joint line to the origin of the DGA
[cm]), R2 ¼ 0.72, P < .01, Spearman's rank correlation coefficient. DGA, descending
genicular artery.
Fig. 4. Relationship of the lower leg length and distance from the tibial tuberosity to
the origin of the DGA. Distance from the tibial tuberosity to the origin of the DGA
(cm) ¼ 7.58 þ 0.21 (lower leg length [cm]), R2 ¼ 0.13, P < .01, Spearman's rank
correlation coefficient. DGA, descending genicular artery.

suggests that the DGA exists in the Europeans than in the Asians;
thus, surgeons in the Europe should pay particular attention to the
DGA. To avoid potential vessel damage, it is very important for
surgeons to consider that the DGA is present in >87% of the cases
and that there are several variations in the branching of the DGA; in
0%-13% of the cases, it is absent. Furthermore, because the saphe-
nous branch is used for the medial femoral skin flap [22], this study
also helps to evaluate whether the flap surgery could be performed
for patients with postoperative skin disorders due to trauma,
infection, or impaired blood flow. The saphenous branch originated
from the DGA independently in a total of 47% of the specimens in
type 2B and type 3.
The mean distance from medial joint line to the origin of the
DGA was 12.6 ± 1.6 cm. Other studies reported the mean distance
from the medial joint line to the origin of the DGA was 12.6-14.5 cm
[11,12,19,20,21] (Table 2). These results support the validity of this
study, taking into account the fact that our study consisted of
elderly Asian people whose thighs were smaller than Europeans
and Americans. Scheibel et al [11] reported the proximal limitation
for a safe arthrotomy using the SVA was the adductor hiatus;
however, we do not expose the location of the adductor hiatus
during the usual SVA procedure in primary TKA. The mean distance
from the tibial tuberosity to the origin of the DGA was 15.6 ± 1.6 cm
(range, 11.4-20.0 cm). This value is useful in clinical practice
because the location of the tibial tuberosity is an important
anatomical landmark for the incision for TKA. To the best of our
knowledge, there has been no research about the distances from
tibial tuberosity to the DGA in the SVA. In our study, this distance
showed a strong correlation with the distance from the medial joint
line to the origin of the DGA (R2 ¼ 0.72, P < .01), suggesting that the
distance from the tibial tuberosity to the DGA is anatomically
reliable.
Sex and body size were related to the safe zone of the DGA. The
mean distances from the tibial tuberosity and medial joint line to
the origin of the DGA were significantly longer in males than in
females (16.3 vs 14.7 cm and 13.2 vs 11.9 cm, respectively). A weak
positive correlation was found between lower leg length and the
distance from the tibial tuberosity to the origin of the DGA (R2 ¼
0.13). We suggest that the distance to the DGA can be estimated
before surgery by sex and lower leg length. This knowledge can
help surgeons who face difficult cases in obese or muscular
patients.
No vascular injuries were observed in this surgical exposure. In
most cases, the DGAs run parallel to the femoral artery. We suggest
that DGA damage can be avoided when the skin incision is within
14 cm of the tibial tuberosity. If it is necessary to extend the incision
and arthrotomy more proximally than 14 cm, the MPPA or mid-
vastus approach is recommended.
Compared with the previous studies, the present study is unique
in several aspects. First, we investigated whether actual surgical
procedures cause vascular injuries. While previous studies have
examined the distance related to anatomical landmarks in detail,
no studies have specifically investigated vascular injuries caused by
the surgical approach and tools for TKA, such as retractors. Second,
our study takes sex and body size into account and clarifies the
associated differences in the relative distances from the anatomical
landmarks. Therefore, the present study can provide surgeons with

Table 2
Anatomical Patterns in Previous Studies.

Author Name Kawarai Dubois [13] Scheibel [11] Sananpanich [19] Garcia-Pumarino [20] Iorio [12] van der Woude [21]

Number of specimens 70 25 32 31 20 18 8
Condition of cadavers Formalin Fresh frozen Formalin Fresh frozen Thiel Fresh frozen Fresh frozen
Ethnic group Japanese French Germany Thai Spanish American Netherlander
Distance from MJL to DGA, 12.6 (10-16.9) NA 14.5 (12.5-16.5) 12.8 (10.3-15.3) 12.8 (6.5-15.5) 14.2 (NA) 13.3 (10.8-15.1)
mean (range), cm
Branching patterns of DGA (%)
Type 1 47 80 63 48 60 NA NA
Type 2 41 20 34 39 30 NA NA
Type 3 11 0 3 13 10 NA 13

DGA, descending genicular artery; MJL, medial joint line; NA, not applicable.
 Y. Kawarai et al. / The Journal of Arthroplasty 33 (2018) 2647e2651
useful and novel practical information. Third, the sample size was
more than twice as large as that of previous studies (Table 2).
Finally, specimens with severe deformity and previous surgeries
were excluded, and the ratio between males and females was
identical.
There were several limitations to this study. First, our specimens
were not fresh frozen but embalmed cadavers. Although the tissue
had become stiff, this study focused on the anatomic features in the
knee extension position, and therefore, embalmed cadavers should
provide an accurate analysis. Second, this study included only
elderly Asian individuals. To compensate for this limitation, we
evaluated data from other countries (Table 2). The distance from
the medial joint line to the DGA in the Asians was smaller than that
in the Westerners. This supports the results of our study in that
there is a correlation between the lower leg length and the distance
to the DGA. Therefore, this study may also be useful for other races.
Conclusions
The anatomical features of the DGA showed several variations,
and the DGA was absent in 11% of the cadaver specimens. An
oblique medial incision within 14 cm of the tibial tuberosity fol-
lowed by arthrotomy is considered a safe zone without vascular
injury of the DGA in the SVA for primary TKA.
Acknowledgments
The authors sincerely thank Dr. Koh Shimizu, Yasushi Wako,
Masahiko Sugano, Kento Nawata, Toshikazu Ando and all the
members of department of bioenvironmental medicine for their
help in carrying this research.
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 The Journal of Arthroplasty 33 (2018) 2640e2646

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Anthropometric Measurements of Knee Joints in the Hispanic

Population
Colin A. McNamara, MD, MBA, Amer A. Hanano, MD, Jesus M. Villa, MD,
Gustavo M. Huaman, MD, PA-C, Preetesh D. Patel, MD, Juan C. Suarez, MD *
Levitetz Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, FL

a r t i c l e i n f o a b s t r a c t

Article history: Background: Total knee arthroplasty (TKA) systems provide a set of incrementally sized tibial and
Received 21 November 2017 femoral components intended to accommodate most knee parameters. However, the most commonly
Received in revised form used systems in the United States were developed using data from Caucasian patients which might not
26 February 2018
lead to the best fit in non-Caucasians. Therefore, we wanted to evaluate whether these TKA systems
Accepted 20 March 2018
proportionally match femoral and tibial measurements in Hispanics.
Available online 27 March 2018
Methods: All lower extremity magnetic resonance imaging performed at our institution between January
2007 and October 2015 were screened. A total of 500 nonarthritic knees from the same number of
Keywords:
anthropometric
Hispanic patients were included in this retrospective descriptive radiographic study. Intraoperative
total knee arthroplasty osseous TKA resections were simulated on magnetic resonance imaging. Linear regression analyses were
Hispanic used to contrast the mediolateral (ML) width/anteroposterior (AP) length of simulated resected femoral
component sizing condyle and tibia with the ML/AP dimensions of components offered by 4 current TKA systems.
anthropometric knee measurements Results: Simulated resected male femurs tended to be wider than most TKA system components for a
mismatch given AP size, probably leading to component ML underhang. Altogether, systems studied accommo-
dated most AP and ML measurements of female condyles. However, we identified subsets of Hispanic
female patients with certain AP lengths and/or ML widths that particular knee systems could not
accommodate. Resected male and female tibias tended to be slightly narrower than all TKA systems for a
given AP size.
Conclusion: The results of our study provide valuable data concerning the unique morphology of the Hispanic
knee. These data can assist surgeons in the selection of the most suitable TKA systems for these patients.
© 2018 Elsevier Inc. All rights reserved.

Proper component sizing during total knee arthroplasty (TKA)
maximizes bone coverage and reduces overhang [1]. Many TKA
systems frequently used in the United States were developed using
data obtained from Caucasian patients [2e4]. Previous studies,
particularly in Asian patients, have demonstrated that non-
Caucasian subpopulations have unique femoral and tibial propor-
tional measurements that can preclude an appropriate match
between their resected bone cuts and the set of component sizes
offered by some TKA systems [2e15]. Consequently, TKA systems
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.052.
* Reprint requests: Juan C. Suarez, MD, Baptist Health South Florida, 8940 North
Kendall Dr, Suite 601E, Miami, FL 33176.
developed using data obtained from Caucasian patients might not
lead to the best fit in Hispanics who accounted for 17.4% of the
United States population in the 2014 Census [16] and represent an
even larger percentage of patients seen in our South Florida clinic.
When it comes to the fit of components offered by TKA systems, to
the best of our knowledge, no study has analyzed anthropometric
knee data obtained from the Hispanic population. As a result, we
designed this descriptive study to evaluate whether the set of
component sizes offered by TKA systems we commonly use pro-
portionally match the femoral and tibial measurements of patients
who self-identify as Hispanics.
Materials and Methods
The institutional review board approval was granted for this
retrospective descriptive study. We constructed and analyzed a
database of all lower extremity magnetic resonance imaging (MRI)

https://doi.org/10.1016/j.arth.2018.03.052
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646 2641

Fig. 1. (A) The resected femoral ML width, (B) the resected femoral AP length, and (C) the resected tibial AP length and the resected tibial ML width.

performed at our institution between January 1, 2007 and October
31, 2015. The medical record of each patient was reviewed to
include only those who self-identified as Hispanics and to exclude
those with any history of arthritis in the imaged knee. The database
was screened to ensure that only one MRI per patient was included,
repeat or contralateral extremity MRIs were excluded. Each MRI
was then arranged by age (in ascending order) and preliminarily
read to exclude those with radiographic signs of knee arthritis. The
first 250 males and 250 females with nonarthritic knees were
finally selected for analysis in this radiographic study.
The intraoperative osseous resections that characterize a
routine TKA were simulated on the MRI according to the methods
previously described by Chaichankul et al [13]. Knee MRI mea-
surements were performed by a fellowship-trained musculoskel-
etal radiologist and by an orthopedic surgery resident whom he
trained to perform such measurements.
Linear regression analysis was used to contrast the ML width and
AP length of the simulated resected femoral condyle and tibia (in
males and females) with the ML and AP dimensions of components
from 4 commonly used TKA systems: Persona (Zimmer), Attune
(DePuy), Triathlon (Stryker), and Vanguard (Biomet). The Persona
Narrow and Attune Narrow variants were also studied. The linear
regression lines (the lines that best fit the measurements) of the
bone cuts in males and females as well as the ones of the different
TKA systems studied are presented in scatterplot graphs to describe
the variations between them (fit/misfit or match). In all linear
regression scatterplots created, the ML width was plotted in the y
axis, whereas the AP length was plotted in the x axis. The scatter-
plots were created using SPSS statistics (IBM Corporation, Armonk,
New York, NY).
Results

Simulated Distal Femoral Condyle Resection The anthropometric data of the distal femoral condyles and
proximal tibias were gathered using MRIs obtained from 500
The TKA distal femoral bone cut was simulated as a line nonarthritic knees belonging to self-identified Hispanic patients.
perpendicular to the mechanical axis of the femur in the frontal The age, height, weight, and body mass index of these patients are
plane and 9 mm proximal to the level of the joint line. The anterior summarized in Table 1.
simulated femoral bone cut was made as a line drawn across the
anterior cortex of the distal femoral condyle, while the posterior cut Distal Femoral Condyle
was made as a line parallel through the transepicondylar axis and
10 mm from the lowest point of the medial posterior condyle [13]. The resected distal femoral condyle measurements for all pa-
tients in our studied cohort demonstrated a mean AP length of 47.8
Simulated Proximal Tibial Resection mm ± 4.1 mm, a ML width of 71.7 mm ± 6.6 mm, and an aspect ratio
of 150.6 ± 11.0%. In males, we found an AP length of 49.9 mm ± 3.8
The proximal tibial bone cut was simulated as a line perpen- mm, a ML width of 77.2 mm ± 4.1 mm, and an aspect ratio of 155.2
dicular to the shaft axis giving 7 of posterior slope and 10-mm ± 10.6%. The resected femoral condyle measurements for females
thickness of the high side of the tibial plateau [13]. revealed a mean AP length of 45.6 mm ± 3.2 mm, a ML width of
66.3 mm ± 3.0 mm, and an aspect ratio of 145.9 ± 9.3%.
MRI Femoral and Tibial Measurements Figures 2 and 3 compare the AP length  ML width linear
regression lines of femoral condyle measurements in males (Fig. 2)
Following these bone cut simulations, the resected femoral and females (Fig. 3) with the ones of the Persona/Persona Narrow
mediolateral (ML) width (Fig. 1A) and anteroposterior (AP) length Table 1
(Fig. 1B) as well as the resected tibial ML width and AP length Demographic Data.
(Fig. 1C) were measured. The femoral (ML/AP  100%) and tibial Parameters Total (Mean ± SD) Male (Mean ± SD) Female (Mean ± SD)
(AP/ML  100%) aspect ratios were also calculated and recorded.
Number of knees 500 250 250
Age (y) 35.18 ± 8.13 32.37 ± 6.97 37.98 ± 8.25
Statistical Analysis Height (cm) 169.65 ± 9.48 176.31 ± 7.28 163.03 ± 6.19
Weight (kg) 81.93 ± 19.28 90.81 ± 18.10 73.08 ± 16.13
Descriptive statistics (mean ± standard deviation) were used for BMI 28.32 ± 5.54 29.15 ± 5.09 27.48 ± 5.85

patient characteristics and anthropometric knee measurements. BMI, body mass index; SD, standard deviation.
2642 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646

Fig. 2. AP length vs ML width scatterplot of male femoral condyles and TKA systems.

(Zimmer), Attune/Attune Narrow (DePuy), Triathlon (Stryker), and
Vanguard (Biomet) femoral components. Figures 4 and 5 compare
the AP length  aspect ratio linear regression lines of femoral
condyle measurements in males (Fig. 4) and females (Fig. 5) with
the ones of the different TKA systems studied.
The simulated resected male femurs in the studied
cohort tended to be wider (larger ML width) than most system
components for a given AP size, probably leading to
component ML underhang (Fig. 2). The standard Zimmer
Persona TKA system (with the largest ML diameter for most AP

Fig. 3. AP length vs ML width scatterplot of female femoral condyles and TKA systems.
 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646 2643

Fig. 4. AP length vs aspect ratio scatterplot of male femoral condyles and TKA systems.

sizes) provided the best ML fit for the Hispanic male distal fe-
mur (Fig. 2).
Altogether, the 6 TKA systems evaluated accommodated most
AP length and ML width measurements of female condyles (Fig. 3).
However, we identified subsets of Hispanic female patients with
certain AP lengths and/or ML widths that particular TKA systems
could not accommodate or match. For given AP sizes, one knee
system (Zimmer Persona) had ML dimensions that exceeded most
ML width female condyle measurements probably leading to
overhang. On the other hand, a different TKA system (DePuy Attune
Narrow) had ML dimensions that were smaller than most ML width
female condyle measurements likely avoiding overhang even in
these smaller femurs (Fig. 3).
Proximal Tibia
The resected proximal tibia measurements for all patients in the
studied cohort demonstrated a mean AP length of 50.9 mm ± 4.8

Fig. 5. AP length vs aspect ratio scatterplot of female femoral condyles and TKA systems.
2644 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646

Fig. 6. AP length vs ML width scatterplot of male tibias and TKA systems.

Fig. 7. AP length vs ML width scatterplot of female tibias and TKA systems.

 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646 2645

Fig. 8. ML length vs aspect ratio scatterplot of male tibias and TKA systems.

mm, a ML width of 75.0 mm ± 6.4 mm, and an aspect ratio of 67.8 ±
3.1%. In males, we found an AP length of 54.7 mm ± 3.3 mm, a ML
width of 80.3 mm ± 4.0 mm, and an aspect ratio of 68.1 ± 3.1%. The
resected proximal tibia measurements for females revealed a mean
AP length of 47.1 mm ± 2.6 mm, a ML width of 69.8 mm ± 3.1 mm,
and an aspect ratio of 67.5 ± 3.0%.
Figures 6 and 7 compare the AP length  ML width linear
regression lines of proximal tibial measurements in males (Fig. 6)
and females (Fig. 7) with the ones of the Persona (Zimmer), Attune
(DePuy), Triathlon (Stryker), and Vanguard (Biomet) tibial com-
ponents. Figures 8 and 9 compare the ML length  aspect ratio
linear regression lines of proximal tibial measurements in males
(Fig. 8) and females (Fig. 9) with the ones of the different TKA
systems.
The resected male and female tibias (Figs. 6 and 7, respectively)
in the studied cohort both tended to be slightly narrower (smaller

Fig. 9. ML length vs aspect ratio scatterplot of female tibias and TKA systems.
2646 C.A. McNamara et al. / The Journal of Arthroplasty 33 (2018) 2640e2646
ML width) than all TKA systems for a given AP size likely leading to
overhang.
Discussion
The TKA systems most commonly used in the United States were
designed based on the anthropometric parameters obtained from
Caucasian individuals; consequently, these systems may not pro-
vide an optimal fit for some non-Caucasian persons [2e4,17].
Therefore, in this descriptive investigation, we sought to evaluate
whether the set of component sizes offered by current TKA systems
proportionally match the femoral and tibial measurements of pa-
tients who self-identify as Hispanics. We identified gender-specific
differences in the femoral and tibial measurements of Hispanics
that could be very relevant when it comes to the selection of a
particular TKA system for these patients.
Regarding the match between anthropometric measurements
and femoral component sizes offered by TKA systems, we identified
subsets of Hispanic patients (especially within females) with
certain AP lengths and/or ML widths that particular TKA systems
could not accommodate. In males, femurs tended to be wider than
most components for a given AP size. Thus, to obtain the best
femoral component fit in Hispanics, we recommend careful pre-
operative planning paying attention not only to the general features
of the different TKA systems but also particularly to the charac-
teristics (ML sizes for given AP sizes) of the components available
within each system to avoid overhang or underhang in the distal
femur of these patients. In general, a proper AP sizing of the femoral
component is necessary to maintain an appropriate flexion-
extension gap and patellofemoral tracking, whereas an appro-
priate ML sizing of the femoral component is necessary to ensure
adequate bone coverage and soft tissue tension [1].
Concerning the match between anthropometric measurements
and tibial component sizes available within the systems evaluated,
the tibias measured from Hispanic males and females tended to be
slightly narrower than all TKA system components for a given AP
size. However, surgeons can overcome this mismatch with the
rotational and sizing flexibility that is permissible when selecting
tibial components to provide acceptable fit to Hispanic tibias.
This investigation should be viewed in light of certain limitations.
One weakness is the lack of a direct comparison between the
anthropometric knee parameters of our Hispanic cohort of patients
with the ones of a Caucasian cohort or other subpopulations such as
African-Americans. Nonetheless, these direct comparisons are
beyond the scope of the current investigation and not central to
achieve the primary objective which is to evaluate whether the set of
component sizes offered by current TKA systems proportionally
match femoral and tibial knee measurements in Hispanics. Previous
studies have demonstrated that mismatches exist between the
common TKA systems and the resected bone cuts in various sub-
populations, with many authors postulating that these mismatches
occur because these components were designed based on parame-
ters obtained from Caucasian cohorts [2e15]. Of note, to the best of
our knowledge, no study has assessed the strength of the match
between current TKA system components and Caucasians knees.
Future studies directly addressing this question and comparing the
anthropometric parameters of Caucasian vs non-Caucasian knees or
other subpopulations could be beneficial. Another limitation relates
to the standardized bone resections performed for each patient in
our study. We simulated the distal femoral bone resection as a line
perpendicular to the mechanical axis of the femur in the frontal
plane and 9 mm proximal to the level of the joint line, whereas the
proximal tibial bone resection was simulated as a line perpendicular
to the shaft axis giving 7 of posterior slope and 10-mm thickness of
the high side of the tibial plateau. These bone resection parameters
are in accordance with our standard TKA technique and with stan-
dardizations previously reported in similar studies performed to
determine the anthropometric knee parameters of certain sub-
populations of patients. We recognize that in practice, this is not
always the case, as bone resections actually performed in patients
often deviate from such parameters based on patient-specific fac-
tors. However, to standardize procedures and limit bias, we deter-
mined it would be best to utilize the aforementioned bone resection
parameters in all 500 patients evaluated. It is important to note that
people who identify themselves as Hispanic or Latino (ethnicity)
may be of any race. Consequently, our findings can be extrapolated to
this ethnic group as a whole, without attempting to relate to a
particular race. This circumstance might represent another limita-
tion. Nevertheless, the knowledge of the anthropomorphic knee
parameters presented in the current investigation may help sur-
geons in their selection of TKA systems for Hispanic patients.
In conclusion, we found subsets of Hispanic female patients with
certain femoral AP lengths and/or ML widths that particular TKA
systems could not accommodate or match, while in males, femurs
tended to be wider than most components for a given AP size. The
results of our study provide valuable data concerning the unique
morphology of the Hispanic knee. Our scatterplot graphs can assist
surgeons in the selection of the most suitable TKA systems for these
patients. Future investigations should focus on the potential clinical
and functional implications of AP and ML mismatches between
commonly used TKA systems and the knees of Hispanic patients.
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 The Journal of Arthroplasty 33 (2018) 2677e2683

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Are Radiographic and Direct Measures of Acetabular Polyethylene

Wear Comparable?
Krista K. Parran, MS b, Christopher P. Bechtel, MD a, Rebecca D. Moore, MS b,
Jeremy J. Gebhart, MD a, Michael S. Reich, MD a, Matthew J. Kraay, MS, MD a, b,
Clare M. Rimnac, PhD b, c, *
a
Department of Orthopaedics, University Hospitals Cleveland Medical Center, Cleveland, OH
b
Department of Orthopaedics, Case Western Reserve University School of Medicine, Cleveland, OH
c
Department of Mechanical and Aerospace Engineering, Case Western Reserve University, Cleveland, OH

a r t i c l e i n f o a b s t r a c t

Article history: Background: All polyethylene acetabular liners wear over time, and numerous methods for calculating
Received 4 December 2017 linear wear rates exist. The objective of this study was to compare 2-dimensional wear rates between
Received in revised form direct, micrometer measurements and the computerized, edge-detection method using Hip Analysis
28 February 2018
Suite (HAS) 8.0.4.3.
Accepted 17 March 2018
Available online 27 March 2018
Methods: Two groups of retrieved acetabular liners from Harris-Galante Prosthesis I and Harris-Galante
Prosthesis II implants in situ for more than 10 years were evaluated. Group 1 (n ¼ 18) contained liners
with both early postoperative (<6 months) and prerevision radiographs taken within 1 month of explan-
Keywords:
wear
tation. Group 2 (n ¼ 55) included liners with only prerevision X-rays (ie, 1 radiograph for wear assessment).
polyethylene Average and maximum direct linear wear was calculated from thicknesses measured at 6 consistent, well-
total hip arthroplasty separated locations (3 in the worn and 3 in the unworn regions) using a calibrated, digital micrometer. HAS
acetabular liner 8.0.4.3 was used to calculate 2-dimensional wear from anteroposterior pelvic radiographs.
radiograph Results: Aggregate wear rates calculated by HAS were higher than those calculated by the average of direct
measurements for group 1 (P ¼ .020) and group 2 (P < .001). However, comparing the maximum direct
micrometer measurements to HAS showed no difference for either group 1 (P ¼ .351) or group 2 (P ¼ .451).
Linear regression analysis showed a strong correlation between HAS and both average and maximum direct
wear measures for both groups, though the coefficient for the direct maximum measurement comparisons
were closer to one, indicating a better one-to-one correspondence between HAS and direct maximum wear.
Conclusion: To our knowledge, this is the first study to compare and validate 2-dimensional wear rates in
polyethylene acetabular liners between direct measurements from retrieved components and a radio-
graphic computer-assisted technique (as opposed to comparison against a phantom component). Wear
rates determined by direct measurements from retrievals were consistent with computer-assisted
2-dimensional methods when comparing maximum wear measurements. In addition, a single pre-
revision radiograph appears to be sufficient to assess 2-dimensional in vivo wear.
© 2018 Elsevier Inc. All rights reserved.

One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.047.
Keisha French, MD, contributed to the direct wear measurements.
Funding: The study was partially supported by funding from the Wilbert J. Austin
Professor of Engineering Chair (C.M.R.) and by the Laura and Alvin Siegal Ortho-
paedic Research Internship (K.K.P.).
* Reprint requests: Clare M. Rimnac, PhD, Department of Mechanical and Aero-
space Engineering, Case Western Reserve University, 10900 Euclid Avenue, Cleve-
land, OH 44106.
Ultraehigh-molecular-weight polyethylene acetabular liners in
total hip arthroplasties wear over the service life of the implant.
Even in the era of wear-resistant, highly cross-linked polyethylene
materials, wear and osteolysis have been reported [1e4]. The wear
debris that is generated can stimulate macrophages to synthesize
proinflammatory cytokines which results in osteoclast differentia-
tion and can ultimately progress to osteolysis, aseptic loosening,
and implant failure necessitating revision [5e8]. A dose-response
relationship exists between polyethylene wear rate and the
development of osteolysis, thus underscoring the importance of
reliably assessing wear rates [9].

https://doi.org/10.1016/j.arth.2018.03.047
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2678 K.K. Parran et al. / The Journal of Arthroplasty 33 (2018) 2677e2683
There have been numerous methods developed to calculate
acetabular liner wear rates, which indirectly assess the amount of
polyethylene burden in the effective joint space, durability of the
polyethylene liners, and likelihood of a patient developing osteol-
ysis [10e22]. The earliest methods used manual measurements of
anteroposterior (AP) radiographs [10e14]. However, today, several
computer algorithmebased methods have been applied to the
measurement of liner wear; these methods include digital edge
detection, radiostereometric analysis, and other computer-assisted
techniques [15e22].
Hip Analysis Suite (HAS) utilizes an edge-detection method
developed by Martell and Berdia [18] for determining 2-
dimensional polyethylene wear based on femoral head penetra-
tion into the polyethylene liner. This technique has been shown to
be an accurate and reproducible method for detecting approxi-
mately 90% of 3-dimensional wear [23e25]. It has been reported
that its 2-dimensional wear measurements are 4 times more
repeatable than similar 3-dimensional methods, which require
cross-table lateral radiographs in addition to AP radiographs [25].
When implant components are retrieved at revision or removal
surgery, the component itself can be directly evaluated (eg, using a
micrometer) for wear [14,26e30]. However, it is unclear how well
direct micrometer measurements of retrieved polyethylene liners
ex vivo correspond to in vivo radiographic analyses that use these
computerized edge-detection techniques.
The primary aim of this study was to compare the linear wear
rate calculated from direct measurement of retrieved polyethylene
acetabular liners to the 2-dimensional linear wear rate calculated
by HAS. The secondary aim was to determine if the linear wear rate
could be assessed using a single prerevision radiograph.
Methods
This study evaluated wear in retrieved acetabular liners from
Harris-Galante Prosthesis I (HGPI) and HGPII implants (Zimmer,
Warsaw IN). Fifty-five HGPI and HGPII acetabular liners (in 55 pa-
tients, 28 women) with implantation times greater than 10 years
were retrieved between 1997 and 2010 at 4 institutions as part of a
multicenter retrieval program. There were 16 HGPI and 39 HGPII
liners. All polyethylene liners were made from GUR 4150 resin
(Ticona, Auburn Hills, MI) and were gamma irradiated in air with 25
kGy. These liners were selected for this study for their likelihood of
exhibiting substantial wear owing to their long implantation time
and their manufacture from a polyethylene formulation and ster-
ilization technique that exhibited high wear. After visual exami-
nation and confirmation of the implant design, the implants were
cleaned, catalogued, photo documented, and stored either at room
temperature or in a 80 C freezer. For both the HGPI and HGPII
liners, the inner diameter was either 28 mm or 32 mm with a mean
original, unworn liner thickness of 7.75 ± 2.6 mm (range: 4.3-15.3
mm), as provided by the manufacturer. Liners in both groups had
similar inner diameter and thickness of the polyethylene liner
(Table 1; P > .05). The femoral head material was known for 54 of
the 55 retrieved liners: cobalt-chromium alloy (n ¼ 44), zirconia
ceramic (n ¼ 7), alumina ceramic (n ¼ 2), and titanium alloy (n ¼ 1).
All liners had radiographs taken within 1 month before
explantation, while the availability of earlier radiographs varied.
Two groups were therefore classified based on the number of ra-
diographs available for assessment (Table 1). Group 1 (n ¼ 18)
consisted of liners that had at least 2 AP radiographs and included
an AP radiograph from within the first 2 years of implantation as
well as an AP radiograph taken before explantation. The liners in
group 1 were implanted for 15.3 ± 2.6 years. To evaluate wear using
only a single prerevision radiograph, we created a second group
(group 2, n ¼ 55) which was composed of the 18 liners from group
1, with an additional 37 liners for which we only had an AP
radiograph available from the last month before explantation. For
the 55 liners that composed group 2, the mean implantation time
was 18.5 ± 4.6 years. There was no difference in the implant lifetime
for acetabular liners, nor the type of acetabular component (HGPI
vs HGPII) in either group. Patients in both groups were of similar
gender distribution, age at primary surgery, and body mass index
(Table 1, P > .05).
Linear femoral head penetration of implants in both groups was
assessed directly from the retrieved components. Liner thickness
was measured using a calibrated digital micrometer (Mitutoyo,
Kawasaki, Japan, accuracy 0.001 mm) in 6 consistent and distinctly
separated locations within each polyethylene liner by 2 indepen-
dent observers. Measurements were taken at 3 locations in the
worn region and at 3 locations in the unworn region. A linear wear
rate was calculated by averaging each region and dividing the dif-
ference in thickness by the time implanted as previously described
[29,30]. No difference between measurements made by the 3 ob-
servers was found (P ¼ .51); thus, the measurements from the 2
observers were pooled for a total of 6 measured thicknesses in each
of the unworn and worn regions. In addition, a maximum linear
wear rate was calculated by finding the difference between the
maximum and minimum measured thicknesses of the unworn and
worn regions, respectively, and dividing that difference by the time
implanted.
A 2-dimensional linear wear rate was also calculated from
anteroposterior pelvic radiographs using HAS v8.0.4.3 (University
of Chicago, Chicago, IL). With this version of HAS, the accuracy of
the linear wear measurements is expected to be approximately 8
microns as per our analysis of the accuracy of HAS v8.0.3.0 [31].
Wear rates for group 1 were calculated by comparing 2 radio-
graphs: the first taken within the first 2 years of implantation and
the second taken within a month of revision surgery. Wear rates for
group 2 were calculated in HAS from a single radiograph taken
within a month of revision surgery. (This measure assumes that the
center of the hip is congruent with the center of the femoral head,
which is a reasonable assumption for the HGPI and HGPII designs).
Intraobserver reliability was assessed from 2 sets of measurements
taken by the primary observer and found not to be different
(P ¼ .61). Subsequently, measurements were taken by the primary
observer and an additional 3 independent observers, and there was
no difference in interobserver reliability between measurements
taken by any 2 observers (P ¼ .83, P ¼ .46). Thus, the measurements
from the 4 observers were pooled.
Comparisons between group 1 and group 2 in terms of patient's
age, body mass index, implant lifetime, and liner thickness were
determined using Student's t test and comparisons between groups
of patient gender, implant generation (HGPI:HGPII) ,and liner inner
Table 1
Clinical Demographics and Implant Characteristics for the 2 Groups.
Group 1a (N ¼ 18) Group 2a (N ¼ 55) P Value
Patient's age (y), 69.7 ± 14.8 68.4 ± 14.4 .777
mean ± SD
Gender (male:female) 6:12 27:28 .244
BMI (kg/m2), mean ± SD 26.5 ± 3.9 26.7 ± 3.9 .840
Implant lifetime (y), 15.5 ± 3.0 16.5 ± 3.6 .235
mean ± SD
Harris-Galante implant 3 HGPI: 15 HGPII 16 HGPI: 39 HGPII .297
generation
Inner diameter (mm) 14:4 41:14 .782
(28:32 mm)
Liner thickness (mm) 7.4 ± 1.9 7.8 ± 2.6 .551
BMI, body mass index; HGP, Harris-Galante Prosthesis; SD, standard deviation.
a
Note that group 1 is a subset of group 2.
 K.K. Parran et al. / The Journal of Arthroplasty 33 (2018) 2677e2683 2679

Fig. 1. Box-and-whisker plot showing annual linear wear measured directly using a digital micrometer (red boxes represent averages and orange boxes represent maximums) and
radiographically using Hip Analysis Suite software (blue boxes). The solid black bar indicates median, box indicates interquartile range, and whiskers show range. Statistical analyses
by Mann-Whitney U Test. Group 1 included 18 specimens with 2 radiographs spanning implantation available for analysis with Hip Analysis Suite. Group 2 contained 55 specimens
with a single radiograph taken within 1 month of revision available for analysis with Hip Analysis Suite.

diameter (28:32 mm) distributions were determined using chi-
squared analysis. Nonparametric Mann-Whitney U tests were
used to determine differences between wear rates calculated using
a digital micrometer and with HAS, the difference between mea-
surements taken by different observers, and between multiple
measurements taken by the same observer. The same test was also
used to evaluate the difference between wear rates calculated with
HAS using 2 radiographs vs 1 radiograph. The R Project for Statis-
tical Computing (version 3.0.1, R Foundation for Statistical
Computing, Vienna, Austria) was used for graphical and statistical
determinations. In addition, linear regressions with y-intercept
forced as 0 were conducted between HAS and both maximum and
average direct measures in group 1 and group 2. At time zero, we
assumed that the wear rate was zero. Coefficients and R-squared
values were tabulated, and scatter plots with a regression line and
95% confidence intervals were generated. This analysis was
completed in Minitab 18 (Minitab Inc., State College, PA).
Results
The median linear wear rate (interquartile range) for the average
direct measure of polyethylene liners was 0.139 mm/y (0.068-0.163
mm/y) and 0.135 mm/y (0.071-0.153 mm/y) for groups 1 and 2,
respectively. The median linear wear rate (interquartile range)
for the maximum direct measure of polyethylene liners was
0.171 mm/y (0.131-0.194 mm/y) and 0.166 mm/y (0.126-0.2 mm/y)
for groups 1 and 2, respectively. The median wear rate calculated
using HAS software was 0.184 mm/y (0.108-0.228 mm/y) and 0.182
mm/y (0.118-0.218 mm/y) for groups 1 and 2, respectively (Fig. 1).
When comparing direct measures of wear to those calculated
by HAS, HAS showed higher values than average direct measures
(P ¼ .020) but no difference between HAS measurements and
maximum direct measures for group 1 (P ¼ .351). The same was
true for group 2; wear rates calculated by HAS were higher than
average direct measures (P < .001) but were not different than
maximum direct measures (P ¼ .451). In both groups 1 (P ¼ .04) and
2 (P < .001), maximum direct measures gave larger wear rates than
average direct measures. There was no difference between the wear
rates calculated by HAS when using 1 radiograph vs 2 radiographs
(P ¼ .987).
The median linear wear rate (interquartile range) measured by
the average of direct measurements was 0.134 mm/y (0.102-0.155
mm/y) for HGPI liners and was 0.138 mm/y (0.060-0.153 mm/y) for
HGPII liners. Median wear rate (interquartile range) calculated from
the maximum of direct measurements was 0.166 mm/y (0.128-
0.195) for HGPI liners and was 0.168 mm/y (0.124-0.200 mm/y) for
HGPII liners. The wear rate calculated using HAS was 0.192 mm/y
(0.117-0.231 mm/y) for HGPI liners and 0.174 mm/y (0.122-0.214
mm/y) for the HGPII liners (Fig. 2). When controlling for liner
generation, there were no differences between measurement
methods for HGPI liners, neither between HAS and average digital
measurement (P ¼ .093) nor between HAS and maximum digital
measurements (P ¼ .624). In the HGPII cohort, there was no dif-
ference between wear rate measured by HAS and maximum digital
direct measures (P ¼ .569); however, wear rates measured by HAS
were larger than those measured by the average of digital measures
(P ¼ .0017). There was no difference between wear rates of the 2
generations of HGP liners measured by the average of digital
micrometer (P ¼ .499), maximum of digital micrometer (P ¼ .875),
or HAS (P ¼ .684).
Linear regression analysis of HAS vs direct average and direct
maximum measurements for group 1 demonstrated strong corre-
lations, with R2 ¼ 95.4% and 96.7%, and coefficients of 1.4 and 1.1,
respectively (Fig. 3A and B). Similarly, linear regression analysis of
HAS vs direct average and direct maximum measurements for
group 2 also demonstrated strong correlations, with R2 ¼ 91.4% and
91.4%, and coefficients of 1.4 and 1.1, respectively (Fig. 4A and B). In
both cases, the coefficients for the regressions were closer to one
for the comparison of HAS vs direct maximum measurement, and
the R-squared value was also closer to one, indicating better cor-
respondence between HAS and direct maximum wear caliper
measures.
Discussion
Radiographic assessment of acetabular liner wear using
computational methods is an important and valuable tool for
2680 K.K. Parran et al. / The Journal of Arthroplasty 33 (2018) 2677e2683
Fig. 2. Box-and-whisker plot comparing annual linear wear measured directly using a digital micrometer (red boxes represent averages and orange boxes represent maximums)
and radiographically using Hip Analysis Suite software (blue boxes) for the 2 generations of Harris-Galante Prosthetics (HGPI and HGPII). The solid black bar indicates median, box
indicates interquartile range, and whiskers show range. Statistical analyses by Mann-Whitney U Test.
tracking in vivo wear performance in total hip arthroplasty, even
when the liners are made of highly cross-linked polyethylene. Yet, it
is unclear how well these methods relate to direct measurements
taken from retrieved acetabular liners (or vice versa). This study
compared the 2-dimensional linear wear rates calculated by 3
methods: direct measurement using a digital micrometer (using
both the average of 3 measurements in the worn area and a single
measurement in the area of maximum wear) and indirect radio-
graphic measurement using HAS. The wear rates calculated by
these methods were consistent with previously reported wear rates
for HG liners [32,33]. The results demonstrated no difference be-
tween the maximum direct measurement and wear calculated by
HAS regardless of the number of radiographs used to ascertain
linear wear (ie, immediate prerevision radiograph alone vs early
postop radiograph and immediate prerevision radiograph). The
results, however, did show that wear rates calculated by HAS and a
single direct measurement in the area of suspected maximal wear
were larger than wear rates calculated by the average of 3 direct
measurements in the worn area.
This study has limitations. First, to determine wear rates using a
digital micrometer, we used only 3 measurements in both the worn
and unworn portion of the liner. It is possible that the region of
maximum wear was not always fully identified by our measure-
ments in some cases. However, the measurements were taken in a
well-spaced manner in the most common region of wear, and this
method has been used previously to report linear penetration wear
from retrievals [28]. In addition, the relatively small sample size of
acetabular liners in group 1 limits the power of our results
comparing the differences between the groups. Post hoc power
analysis revealed a power of 0.49 for group 1 and a power of 0.88
for group 2. We elected to confine the study to a single design
family (HGPI/HGPII) polyethylene and to retrievals with implanta-
tion times exceeding 10 years to minimize variability due to design
and to generate a study cohort with significant wear, which sub-
sequently limited our sample size. A potential limitation is that the
variations in manufacturing tolerances within a liner (ie, nonround
surfaces) and between liners could have influenced the results.
However, the magnitude of wear of the liners in this study is most
certainly greater than the small deviations in manufacturing
tolerances for these explants. Another potential limitation is that
there were 9 ceramic and 1 titanium femoral head, in addition to
the CoCr heads. While the femoral head material may be expected
to contribute to differences in bearing surface wear, it should not,
however, affect the actual measurement of wear that is the subject
of this study. In support of this, when the ceramic and titanium
heads were excluded from the analyses, the significance of the
comparisons were not changed. Another limitation is that the liner
material was historical (gamma radiation sterilized in air) poly-
ethylene and not a contemporary polyethylene formulation. How-
ever, the findings of this study with regard to comparing direct and
indirect wear measurements should be applicable regardless of
polyethylene formulation. In a previous study [31], we evaluated
the accuracy of HAS in a time zero (ie, zero wear) condition and
found that the accuracy was about 8 microns. In a more recent
study [34], the accuracy of HAS for 28-mm diameter femoral heads
was found to be much larger, approximately 58 microns. However,
HAS has been used successfully to monitor the linear head pene-
tration and evaluate the wear of total hip arthroplasty in several
different highly cross-linked polyethylene formulations [1,35,36].
Further, Kurtz et al [29] evaluated the wear of sequentially annealed
highly cross-linked polyethylene using direct measurements of
retrieved components implanted for an average 1.2 years (range:
0-5 years). Thus, we would expect that it is possible to compare
direct wear and HAS wear measurements of highly cross-linked
polyethylene components that should demonstrate less wear
than the conventional polyethylene liners evaluated in this study.
Another potential limitation is that the direct measurement
method has 2 inherent assumptions that produce opposing effects
on the “true” measure of femoral head penetration. On one hand,
this method assumes equal amounts of “bedding-in” between the
unworn and worn region; however, the vector of joint reactive
forces in the hip is directed towards the superior (worn) aspect of
the liner [37,38]. This theoretically would produce less plastic
deformation in the unworn region and lead to an underestimation
of femoral head penetration. On the other hand, this method also
assumes that the unworn region does not experience any wear;
however, Li et al [26] demonstrated wear and damage occurring in
every quadrant of acetabular liners, thereby overestimating femoral
 K.K. Parran et al. / The Journal of Arthroplasty 33 (2018) 2677e2683 2681

Fig. 3. (A) Scatterplot of wear rates measured by Hip Analysis Suite vs the associated average direct measure for each retrieved liner in group 1. The regression line is shown (solid)
as well as the 95% confidence interval (dashed lines). HAS ¼ 1.4*(average direct), R2 ¼ 95.4%. (B) Scatterplot of wear rates measured by Hip Analysis Suite vs the associated maximum
direct measure for each retrieved liner in group 1. The regression line is shown (solid) as well as the 95% confidence interval (dashed lines). HAS ¼ 1.1*(maximum direct), R2 ¼ 96.7%.

head penetration. These theoretical differences likely offset each
other to some extent, though the total effect on the calculated
acetabular wear rate is unknown.
To compare the results of the direct, digital micrometer mea-
surements, we decided to use 2-dimensional wear measurements
calculated by HAS edge-detection software. This method has
proven to reliably and accurately measure small amounts of
femoral head penetration on liners made of conventional and
highly cross-linked ultraehigh-molecular-weight polyethylene
[23,25,31,39]. The results of this study supports that HAS and
maximum direct measures calculate more similar amounts of linear
wear, with an overall better one-to-one correspondence, although
the direct average wear measurements were also highly correlated
with HAS wear measures, as would be expected. The maximum of
direct measurements may be a better method for determining
linear wear from implants than previously reported averages [28].
However, as demonstrated in Figure 4A and B, there can be indi-
vidual outliers that for which the relationship between HAS and
direct wear measures will be poor. The results from this study also
demonstrate HAS and maximum direct measures calculate signif-
icantly larger linear wear rates than those calculated from the
average of digital measurements, perhaps because not every caliper
measurement taken in the worn region of the cup accurately
identifies the thinnest section of the liners, leading to artificially
lower wear rates. This is similar to results directly comparing
radiostereometric analysis to a prior version of HAS, which yielded
wear rates 30% higher in the HAS group [24].
The same trends hold true when analyzing wear rates between
HGP generations. This result suggests that there is likely not a
confounding effect of analyzing both liner generations together.
An interesting finding was that there was no difference in
calculated wear rates when using only the prerevision radiograph
vs also using an early implantation radiograph. It may be that any
possible “bedding-in” [40,41] effect was relatively small in com-
parison to the amount of polyethylene wear in these liners that
had a relatively long implantation time, as this phenomenon may
2682 K.K. Parran et al. / The Journal of Arthroplasty 33 (2018) 2677e2683

Fig. 4. (A) Scatterplot of wear rates measured by Hip Analysis Suite vs the associated average direct measure for each retrieved liner in group 2. The regression line is shown (solid)
as well as the 95% confidence interval (dashed lines). HAS ¼ 1.4*(direct average), R2 ¼ 91.4%. (B) Scatterplot of wear rates measured by Hip Analysis Suite vs the associated average
direct measure for each retrieved liner in group 2. The regression line is shown (solid) as well as the 95% confidence interval (dashed lines). HAS ¼ 1.1*(direct maximum), R2 ¼ 91.4%.

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 The Journal of Arthroplasty 33 (2018) 2660e2665

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

A Retrieval Analysis of Impingement in Dual-Mobility Liners

Trevor P. Scott, MD a, Lydia Weitzler, MS b, *, Anthony Salvatore, MS a,
Timothy M. Wright, PhD b, Geoffrey H. Westrich, MD a
a
Adult Reconstruction and Joint Replacement Division, Hospital for Special Surgery, New York, NY
b
Department of Biomechanics, Hospital for Special Surgery, New York, NY

a r t i c l e i n f o a b s t r a c t

Article history: Background: Implant-related impingement is likely a major causative factor of total hip arthroplasty
Received 23 January 2018 (THA) instability. Dual-mobility (DM) cups can theoretically improve stability in THA, but impingement
Received in revised form rates with DM cups are not well studied. We examined retrieved DM THA liners to determine if less
1 March 2018
evidence existed for prosthetic impingement between the neck and the polyethylene liner than historical
Accepted 6 March 2018
studies from our institution on fixed-bearing THAs.
Available online 16 March 2018
Methods: DM components from 93 THAs were identified from 164 THAs whose DM components were
revised between 2008 and 2015 through our institutional review boardeapproved implant retrieval
Keywords:
total hip arthroplasty
program. The mean age was 63 ± 11 years, mean body mass index was 30 ± 7 kg/m2, and mean length of
revision total hip arthroplasty implantation was 2.08 ± 1.89 years. Two independent graders scored each liner for the presence and
instability severity of impingement. Radiographs were evaluated for inclination, anteversion, change in leg length,
impingement and combined offset.
dual mobility Results: Only 21.5% (20/93) of DM cups showed evidence of impingement compared to 77% (75/97) of
fixed-bearing cups found in a previous study performed at our institution (P < .001). Of the revision
components, 35.2% (5/14) demonstrated evidence of impingement compared to 19.7% (14/71) implanted
in primary surgery (P ¼ .189). In the cohort revised for instability, the rate of impingement was 35.3% (6/
17); for the implants revised for any other reason, the impingement rate was 18.4% (14/77) (P ¼ .126).
Conclusion: This study demonstrates that DM liners significantly reduce the rate of impingement (21.5%)
when compared to fixed-bearing liners (77%).
© 2018 Elsevier Inc. All rights reserved.

Implant dislocation is the leading cause of failure in total hip
arthroplasty (THA), and implant-related impingement is a major
causative factor in such instability [1,2]. Impingement can also
potentially cause implant loosening, wear, and pain [3]. Impinge-
ment is multifactorial and influenced by acetabular liner position,
femoral stem position, restoration of offset and leg length, combined
anteversion, head-neck ratio, soft-tissue integrity, and head size.
Among these factors, head size is modifiable by changes in
implant selection. Computer modeling had demonstrated a
decrease in component impingement as head size increases to 44
mm [4,5]. In an effort to decrease rates of instability, surgeons have
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.019.
* Reprint requests: Lydia Weitzler, MS, Department of Biomechanics, Hospital for
Special Surgery, 535 East 70th Street, New York, NY 10021.
increasingly begun using larger head sizes, including 36-mm heads,
over the past decade [6]. The routine use of heads larger than 36
mm in primary total hip arthroplasty with polyethylene (PE)
bearings is challenging due to concern over wear with thin PE4.
However, technology has emerged to allow the use of so-called
anatomic size heads including hard-on-hard bearings, resurfac-
ing, and dual-mobility (DM) cups and liners. These designs have
head sizes closer to that of the native hip. Metal-on-metal bearings
and resurfacings have fallen out of favor, but DM remains a popular
option for surgeons [7,8].
DM cups and 36 mm or larger femoral heads are both implant
options that can improve stability in THA by increasing the jump
distance and head-neck ratio [7,9e11]. Literature has emerged that
both are effective options for decreasing the risk of frank hip
instability events and that DM may indeed be superior to 36-mm
heads for this purpose [7,9e11]. DM designs functionally incorpo-
rate the outer PE liner into the head size, thus making the head size
at least 80% larger than it would be with a fixed-bearing head with
the same size cup [12].

https://doi.org/10.1016/j.arth.2018.03.019
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 T.P. Scott et al. / The Journal of Arthroplasty 33 (2018) 2660e2665
However, less is known about the effect of DM liners on
abnormal PE wear due to implant impingement. A prior study from
our institution in 2005 looking at impingement in fixed bearings
with head sizes including 22 mm, 26 mm, 28 mm, and 32 mm
demonstrated acetabular liner impingement in 56% of 162 THAs [3].
A similar article by Marchetti et al [13] demonstrated impingement
of 51.4% of retrieved liners. Tanino et al [14] showed an impinge-
ment rate of 27% in 48 retrieved liners with either 28- or 32-mm
heads. A recent second study from our institution of 28 mm, 32
mm, and 36 mm heads demonstrated an overall impingement rate
of 77.3% and specifically 70.3% for 36-mm heads [15].
DM cups have the unique failure mechanism of intraprosthetic
dislocation (IPD) of the femoral head from the inner PE bearing.
Philippot et al [16] identified 3 causes of IPD: type I was charac-
terized by homogenous PE rim wear, type II was external obstruc-
tion of the motion of the PE component such as by arthrofibrosis,
and type III was related to cup loosening. A recent study demon-
strated wear of both the inner and outer PE surface of anatomic
dual-mobility (ADM) cups (Stryker, Mahwah, NJ), suggesting that
fibrosis is not a significant issue at least in the short term [17].
Nonetheless, the rate of impingement in DM heads has not been
well studied with only one small study on modern highly cross-
linked PE bearings available in the literature [18]. The study
demonstrated 100% impingement of DM liners [18]. DM liners are
designed to accommodate standard physiologic impingement, but
excess or abnormal impingement, such as that driven by arthro-
fibrosis or ossification around the implant, can potentially lead to
PE wear and component failure. Further, no comparisons of
impingement rates have been performed between DM liners and
36-mm heads.
The goal of this study was to identify the rate of abnormal and
excessive PE wear due to implant impingement and the severity of
impingement in DM liners and to compare it to prior studies from
our institution on fixed-bearing liners. As a secondary goal, we
sought to identify radiographic or clinical factors associated with
impingement with DM liners. To achieve these goals, we examined
retrieved DM liners for evidence of impingement and compared the
resulting data to data from the earlier implant retrieval studies
from our laboratory [15].
Methods
Two hundred DM liners were identified from a series of 2684
retrieved THA liners collected during revision surgery between
August 2008 and September 2015 as part of our ongoing institu-
tional review boardeapproved implant retrieval program. Implants
were excluded if they had been severely damaged during removal,
permanently damaged from use in other studies; other implants
were unavailable, having been released to patients before the study.
This left 93 liners recovered from 92 patients.
Following retrieval, all liners were soaked in a 10% bleach so-
lution for 20 minutes, and then washed with a mild detergent and
tap water. Liners were rinsed in ethanol and allowed to air-dry
overnight. Patient demographic data including sex, height,
weight, body mass index (BMI), length of implantation (LOI), pa-
tient age at index procedure, reason for index surgery, and reason
for revision were collected. Implant type and sizes were also noted
(Table 1). Ages at index procedure, BMIs, and reasons for revision
were available for all patients. For 85 patients (92.6%), the reason
for index surgery with a DM liner was also known; the other 8
patients had had surgery performed at outside hospitals. The mean
age of our cohort was 63 ± 11 years, mean BMI was 30 ± 6 (17-49)
kg/m2, and mean LOI was 2.1 ± 1.9 years. Sixty-seven (72%) of the
93 retrieved components were ADM cups, and the remaining 26
(27.9%) were modular dual-mobility (MDM) cups. All but one of the
2661
Table 1
Demographics of Retrieved Dual-Mobility Liner Cohort.
Age (years) 63.01 ± 10.93
Sex (female:male) 56 (60.2%):27 (39.7%)
Height (m) 1.68 ± 0.1
Weight (kg) 85.45 ± 22.7
BMI 30.06 ± 7.3
Length of implantation (y) 2.08 ± 1.89
MDM:ADM 26 (27.9%):67 (72.0%)
Evidence of neurologic 8 (8.6%)
compromise
Reason for implantation Primary surgery, 71 (76.4%)
OA, 62; RA, 2; proximal femoral fracture, 5;
AVN, 1; SCFE, 1
Revision surgery, 14 (15.1%)
Instability, 10; replant, 3; HO, 1
Unknown, 8 (8.6%)
Reason for revision Recalled implants, 56 (60.2%)
Instability, 17 (18.3%)
Periprosthetic fracture femur, 7 (7.5%)
Infection, 6 (6.5%)
Acetabular osteolysis/failure of fixation, 5 (5.4%)
Acetabular malpositioning, 1 (1.1%)
Psoas impingement, 1 (1.1%)
ADM, anatomic dual mobility; BMI, body mass index; MDM, modular dual mobility;
OA, osteoarthritis; RA, rheumatoid arthritis; AVN, avascular necrosis; SCFE, slipped
capital femoral epiphysis; HO, heterotopic ossification.
patients had a 28-mm head; one of the MDM cups had a 22.2-mm
head. Seventy-one of the 93 implants (76.4%) were originally placed
as primary surgeries; the majority (87.3%) of which were for oste-
oarthritis. Fourteen DM cups (15.1%) were implanted in revision
surgery of which 10 were implanted to treat instability. Fifty-six
(60.2%) of the 93 cups were well functioning at the time of revi-
sion but were explanted for revision of a concomitantly implanted
recalled dual modular neck stem; another 17 (18.3%) were
explanted for instability (Table 1).
Liners were scored for evidence of impingement using a scoring
system adapted from our previous impingement study [3].
Impingement was defined as wear or surface deformation on the rim
of the liner based on visual and stereomicroscopic examinations.
Two independent graders (blinded) grouped the liners into 5 groups
based on the evidence of impingement: none (no evidence of
impingement, score of 0); minimal (small areas of evidence of
impingement, score of 1); mild (minimal evidence of impingement
extending 1 mm into the rim, score of 2); moderate (evidence of
impingement 1-2 mm onto rim, score of 3); and severe (damage due
to impingement extending to the edge of the rim, score of 4) (Fig. 1).
Prerevision patient radiographs, available for 86 of the 93 THAs,
were assessed for acetabular component inclination and version. In
each case, the anteroposterior radiograph was used to measure
acetabular inclination; the cross table radiograph was used to
measure acetabular anteversion using the method proposed by
Woo and Morrey [19]. Preindex surgery radiographs (ante-
roposterior pelvis and Lowenstein cross-table lateral) were avail-
able for 68 of 93 patients and were used to calculate changes in leg
length and total offset after surgery.
For statistical analyses, impingement was described in 2 ways
for each liner: incidence of impingement (yes or no) and severity of
impingement (none, minimal, mild, moderate, or severe). The DM
liners were compared to the historical fixed-bearing controls using
both criteria. Subgroups, including implantation for revision cases
vs primary, were examined for impingement rate and severity.
Finally, MDM (Stryker) and ADM cohorts were compared. An
analysis of variance test was used to determine significant differ-
ences (P < .05) in the following variables between the instability
group and other cause revision group and between the ADM and
MDM groups: rate of impingement, severity of impingement,
2662 T.P. Scott et al. / The Journal of Arthroplasty 33 (2018) 2660e2665

Fig. 1. Impingement was classified subjectively on a 1 to 4 scale based on the amount and extent of polyethylene wear and surface deformation of the rim of the component. (A)
grade I or minimal indicates minimal wear or deformation; (B) grade II or mild indicates damage extending less than 1 mm into the rim; the component; (C) grade III or moderate
indicates damage extending between 1 and 2 mm into the rim; (D) grade IV or severe indicates wear and deformation extending more than 2 mm into the rim.

inclination, anteversion, change in leg length, combined offset, and
evidence of neurologic compromise such as dementia or Parkin-
son's disease which could potentially increase the risk of
impingement and dislocation. Differences in continuous variables
(age, LOI, height, weight, BMI, inclination, anteversion, change in
leg length, combined offset, inner head diameter, outer head
diameter) for the impinged and nonimpinged subgroups were also
compared using an analysis of variance test. Differences in cate-
gorical variables (primary diagnosis, reason for revision, type of DM
liner, and orientation) for the impinged and nonimpinged sub-
groups were compared using chi-square tests. Multivariate linear
regression was performed for the impinged group compared to the
nonimpinged group while fixing the significantly different vari-
ables from the univariate analysis to determine if any other factors
contributed to significant differences.
Results
Of the 93 DM retrievals, 20 (21.5%) had evidence of impinge-
ment, while the remaining 73 (78.5%) had no evidence of
impingement. Of the 20 components that exhibited impingement,
4 (4.3%) liners had minimal impingement, 10 (10.8%) had mild
impingement, 5 (5.3%) had moderate impingement, and 1 (1.2%)
had severe impingement. Radiographic analysis revealed a
mean inclination angle of 45.1 ± 7.5 ; a mean anteversion angle of
26.4 ± 11.9 ; mean change in leg length of 1.4 ± 9.8 mm; and mean
change in offset of 2.8 ± 11.9 mm (Table 2).
DM liners were compared for impingement rate and severity of
DM cups placed in primary surgery (with an impingement rate of
14/71 [19.7%]) as compared with DM cups placed in revision cases
(with an impingement rate of 5/14 [35.7%]). This difference in
impingement rate was not significant (P ¼ .189).
In the primary implantation group (n ¼ 71), 1 (1.4%) had mini-
mal impingement; 9 (12.7%) had mild impingement; 3 (4.2%) had
moderate impingement, and 1 (1.4%) had severe impingement. In
the group implanted in revision cases (n ¼ 14), 3 (21.0%) had
minimal impingement; none (0%) had mild impingement; 1 (7.1%)
had moderate impingement, and 1 (7.1%) had severe impingement
(Fig. 2). Of those 14 DM liners implanted during revision cases, 9
were done with full cup exchanges, and in 4 cases, the liners were
implanted or cemented into existing cups. No relationship was
found between cup exchange and impingement.
Cases revised for instability were compared to those revised for
any other reason. In revision for all causes except instability, the
impingement rate was 18.4% (14/76), whereas in the group revised
for instability, the impingement rate was 35.3% (6/17); this differ-
ence was not significant (P ¼ .126). In the group revised for all other
causes (n ¼ 77), 2 (2.6%) had minimal impingement, 8 (10.5%) had
 T.P. Scott et al. / The Journal of Arthroplasty 33 (2018) 2660e2665 2663

Table 2 In comparing MDM and ADM cohorts, 13/67 (19.4%) ADM liners
Radiographic Analysis and Impingement Rates of DM Cohort. showed impingement vs 7/26 (26.9%) MDM liners (P ¼ .428). In the
Inclination Angle ( ) 45.13 ± 7.54 ADM group (n ¼ 67), zero had minimal impingement, 8 (11.9%) had
Change in leg length (mm) þ1.454 ± 9.831 mild impingement, 4 (6%) had moderate impingement, and 1 (1.5%)
Change in offset (mm) 2.79 ± 11.9 had severe impingement. In the MDM cohort (n ¼ 26), 3 (11.5%) had
Anteversion ( ) 26.419 ± 11.9
Wear type Mild 50
minimal impingement, 2 (7.7%) had mild impingement, 2 (7.7%) had
Moderate 39 moderate impingement, and zero had severe impingement (Fig. 2).
NA 4 The DM data were compared to the prior study from Waddell
Impingement rate 20/93 (21.5%) et al of 28- to 36-mm heads from our institution. Demographics are
Impingement severity Grade prevalence
compared in Tables 3 and 4. The impingement rate in the fixed-
0; 73/93 (78.5%)
1; 4/93 (4.3%) bearing study was 77.3%, which was significantly greater than in
2; 10/93 (10.8%) the 21.5% in DM cohort (P < .001) (Table 3). When 36-mm heads
3; 5/93 (5.3%) were isolated and compared to the DM cohort, both the dislocation
4; 1/93 (1.1%) rate (46.3% vs 18.3%; P ¼ .02) and impingement rate (70.5 vs 21.5%;
P < .001) were significantly greater for the fixed-bearing group
(Table 4).
mild impingement, 3 (3.9%) had moderate impingement, and 1 When the univariate analysis was performed, increased age was
(1.3%) had severe impingement. In the group revised for instability significantly associated with the risk for impingement (67.4 ± 11.5
(n ¼ 17), 3 (17.6%) had minimal impingement, 2 (11.8%) had mild vs 61.8 ± 10.5 years; P ¼ .041). No other factors examined, including
impingement, 1 (5.8%) had moderate impingement, and none LOI, BMI, primary diagnosis, revision reason, cup type, head
(0.0%) had severe impingement. diameter, PE diameter, or any radiographic criteria were associated
No significant difference was found in inclination or combined with an increased risk of impingement. Multivariate analysis per-
offset when those DM cups revised for instability were compared to formed on the impinged vs nonimpinged groups while fixing age
all other cause revisions. However, a significant decrease in ante- revealed no significant differences.
version was noted in those cups revised for instability (28.1 ± 11.5
vs 17.5 ± 10.1, P < .001). Similarly, a significantly larger change in Discussion
leg length was found in those cups subsequently revised for
instability (11.0 ± 22.9 mm vs 0.17 ± 3.8 mm, P ¼ .002). However, The goal of this study was to establish the incidence of liner
the difference in leg length was driven by a single case with a impingement in a cohort of retrieved DM inserts and compare
Girdlestone reimplant that subsequently dislocated; when this was these to the rate of impingement in a fixed-bearing cohort at our
removed from the data, the effect of leg length disappeared. Finally, institution. We found an overall impingement rate of 21.5% in DM
15 of the 17 cups revised for instability were MDM liners, a liners. This was significantly less than the overall impingement
significantly greater proportion than ADM liners (P < .001). rate of 77% in primary fixed-bearing THA liners from a previous

Fig. 2. Comparison of impingement rate and severity among the subgroups listed on the horizontal axis. Impingement grades I and II were combined into mild impingement and
impingement grades III and IV were combined into severe impingement for the purposes of this chart.
2664 T.P. Scott et al. / The Journal of Arthroplasty 33 (2018) 2660e2665

Table 3 The only prior study of impingement in DM liners was a small

Comparison of Demographics and Impingement Rates to Those Reported by Waddell 15-patient study of retrieved implants by Nebergall et al [18]. Their
et al [15].
study identified impingement in 100% of their retrievals, a large
Dual-Mobility Fixed-Bearing P Value difference from our findings. The authors attributed this to psoas
Liners Liners impingement as no evidence of arthrofibrosis was found in any of
N 93 97 their retrievals. They did not report whether other known causes of
Age (y) 63.01 ± 10.93 63.5 ± 10.6 .751 IPD such as homogenous rim wear, heterotopic ossification, or
Length of implantation (y) 2.08 ± 1.89 2.4 ± 3.44 .433
implant loosening were present. The reason for their exceptionally
% Female 60.2% 69% .226
% Revised for dislocation 18.3% 56.7% .001 high reported impingement rate is likely because of the use of
Impingement rate 21.5% 77.3% <.001 especially stringent impingement criteria, as no other study on
Impingement severity 0; 73/93 (78.5%) 0; 22/97 (22.7%) <.0001 fixed-bearing or DM liners has shown such a high impingement
1-2; 14/93 (15.05%) 1-2; 54/97 (56%) <.0001
rate. When restricting their results to only those with rounded
3-4; 6/93 (6.45%) 3-4; 21/97 (22%) .003
edges or loss of machine markings, only 20% of their liners showed
impingement. Similarly, they noted scratching or pitting as evi-
dence of impingement in 100% of their cases, even though these
study from our laboratory. It was also significantly less than the surface damage modes could be caused by other sources of wear.
70.3% impingement rate of 36-mm heads from the same study Their results could also be related to the reason for implantation of
[15]. Evaluating other studies, it also compares well to the 56% the DM cups, which was not reported [18].
impingement rate noted in the study of primary standard liners by No cases of IPD were present in our cohort, and only 1 case
Shon et al [3] and the 59% impingement rate in a study by Mar- involved psoas impingement. This case had evidence of mild
chetti et al [13]. Interestingly, a remarkable number of the liners impingement; however, given only 1 case, we were unable to either
were completely pristine in their appearance in the DM cohort. As support or refute the hypothesis that soft-tissue impingement may
DM liners are mobile bearings, it is expected that they will lead to impingement of the retentive rim. There were no reports of
experience contact with the femoral neck more often which arthrofibrosis and ossification and only 4 cases of cup loosening in
would likely increase the amount of damage seen; however, this our patients. These were the factors identified by Philippot et al [16]
was not the case. that lead to IPD .
DM cups theoretically increase the range of motion before We did note a trend towards increased impingement rates in
impingement. This is because the mobile outer PE liner increases DM cups placed for revisions cases and in DM cups explanted for
the effective range of motion until physiological impingement of instability, but neither reached significance. No clear relationship
the femoral neck against the acetabular shell and thus increases was found between cup exchange vs retention in revision cases and
functional size of the head, which in turn increases both the head- impingement. Also, no significant difference was noted in inclina-
neck ratio and the “jump distance” (the amount of translation tion or combined offset when those DM cups revised for instability
required for the femoral head center to clear the edge of the were compared to all other cause revisions. A significant relation-
acetabular liner and dislocate based on the McKee-Farrar principle) ship did exist between decreased cup anteversion and revision for
[20]. Evidence exists that DM liners may have lower dislocation instability vs all other cause revision. The correlation between
rates than normal heads [9]. Some authors have also shown a lower MDM use and revision for instability is likely a function of those
dislocation rate than 36-mm heads diameter heads [7]. cups having been used in complex primary cases or revision cases.
DM cups have a unique failure mechanism known as intra- Finally, stem anteversion, which we were unable to evaluate on
prosthetic dislocation that except in rare circumstances requires plain films, could have been partly responsible for some aspect of
open reduction. This was more prevalent with earlier generation PE instability.
liners that, before the development of cross-linking, were prone to The only radiographic or demographic characteristic that was
wearing of the retentive rim of the PE, which in turn allowed the related to impingement in our study was age, as older patients were
inner femoral head (historically 22 mm) to dislocate from the more likely to sustain rim impingement, possibly as a result of
construct. This type of wear leads to type I intraprosthetic dislo- either greater difficulty with postoperative restrictions or less
cations [16]. Adam et al [21] studied 40 retrieved implants from motion through their spines necessitating greater motion in their
early generation DM liners, 13 of which had sustained intra- hip joints [22].
prosthetic dislocation, and noted an 40% overall wear rate of the PE Our article does have several limitations. The first issue is that
collar, although they did not directly address impingement or dif- the majority of the patients were revised for implantation with a
ference in wear rates between intraprosthetic dislocations and stem with a dual modular neck that was subsequently recalled
other revisions. despite having well-functioning DM liners at the time of revision.
As such, the LOI was relatively short and thus may not be a
representative of the general patient population with DM acetab-
Table 4 ular components. LOI is a known risk factor for impingement from
Comparison of Demographic and Impingement Rates of DM Liners and the 36-mm prior studies [15]. Further, a study by Philippot et al. of 81 early
Fixed Bearing Heads From Those Reported by Waddell et al [15].
generation DM liners revised for IPD type II showed 46 of 81 cups
Dual-Mobility 36-mm Fixed P Value had evidence of arthrofibrosis or ossification reducing the mobility
Liners Bearing Liners of the PE liner, which occurred on average at 8 years; 26 of 81
N 93 39 dislocated secondary to homogenous retentive rim wear or IPD
Age (y) 63.01 ± 10.93 62.2 ± 12 .71 type I which occurred on average at 10.6 years; and 14 of 81 dis-
Length of implantation (y) 2.08 ± 1.89 1.4 ± 2 .06
located secondary to implant loosening or IPD type III which
% Female 60.2% 36% .0132
% Revised for dislocation 18.3% 46% .002 occurred at 9.2 years on average. Our study's follow-up time is too
Impingement rate 21.5% 72% <.001 short to reflect these outcomes [16]. However, we did include DM
Impingement severity 0; 73/93 (78.5%) 0; 11/39 (28%) <.0001 liners implanted for 10 years, yet univariate analysis revealed no
1-2; 14/93 (15.05%) 1-2; 20/39 (51%) <.0001 relationship with LOI for DM liners. In addition, half of our available
3-4; 6/93 (6.45%) 3-4; 8/39 (21%) .012
DM liners retrieved during the time of interest were lost to this
 T.P. Scott et al. / The Journal of Arthroplasty 33 (2018) 2660e2665
study because of the previous destructive testing or hardware being
returned to the patient. It is possible that the liners we used were
not completely representative. Another limitation of this study is
that we do not know the outer diameter (functional head size) of
the PE liners for any of these DM liners. Finally, we were unable to
evaluate the rotational alignment of the femoral stem and could not
assess the impact of femoral anteversion on the incidence of
impingement.
In summary, modern DM liners have a significantly lower rate of
impingement than that seen in prior studies of fixed-bearing liners
and remain a good surgical option. Further research is needed on
the long-term effects of implantation to show definitively that the
risk of impingement does not increase with time in DM liners.
Conclusion
This study demonstrates that DM liners significantly reduce the
rate of impingement (21.5%) when compared with fixed-bearing
liners (77%). A trend also exists toward increased rates of
impingement in implants revised for instability as compared with
DM liners revised for any other reason. Decreased cup anteversion
was related to increased risk of revision for instability.
Acknowledgments
The authors acknowledge the support of the Mary and Fred
Trump Institute for Implant Analysis.
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 The Journal of Arthroplasty 33 (2018) 2358e2361

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

AAHKS Symposium

Artificial Intelligence, Machine Learning, Deep Learning, and

Cognitive Computing: What Do These Terms Mean and How
Will They Impact Health Care?
Stefano A. Bini, MD *
Department of Orthopaedics, University of California, San Francisco, San Francisco, California

a r t i c l e i n f o a b s t r a c t

Article history: This article was presented at the 2017 annual meeting of the American Association of Hip and Knee
Received 12 February 2018 Surgeons to introduce the members gathered as the audience to the concepts behind artificial intelli-
Accepted 14 February 2018 gence (AI) and the applications that AI can have in the world of health care today. We discuss the origin
Available online 27 February 2018
of AI, progress to machine learning, and then discuss how the limits of machine learning lead data
scientists to develop artificial neural networks and deep learning algorithms through biomimicry. We
Keywords:
will place all these technologies in the context of practical clinical examples and show how AI can act as a
artificial intelligence
tool to support and amplify human cognitive functions for physicians delivering care to increasingly
machine learning
deep learning
complex patients. The aim of this article is to provide the reader with a basic understanding of the
cognitive computing fundamentals of AI. Its purpose is to demystify this technology for practicing surgeons so they can better
digital orthopedics understand how and where to apply it.
digital health © 2018 Elsevier Inc. All rights reserved.

Gartner is a research and advisory company that publishes the
yearly “technology hype cycle” [1,2]. Spend any time in the world of
digital health and you will see the term “hype cycle” used
frequently. Essentially, the concept describes what happens after
new technologies enter the public sphere and generate excitement
and hyperbolic claims of “disruption.” The expectations and fervor
that are generated are often unmatched by the initial capabilities of
the technology. As described by the Gartner researchers, the stage
of “innovation” yields to that of “inflated expectations.” Soon
thereafter, when the technology does not meet hyped-up expec-
tations, it falls into the “trough of disillusionment” (otherwise
known as the “valley of death”). With time, the technology matures,
achieves its promise, and yields to the “phase of enlightenment”
and eventually to the “plateau of productivity”. For most startups,
the challenge is to raise enough money during the peak of “inflated
expectations” to survive through the “valley of death” and make it
to the “plateau of productivity”.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.067.
* Reprint requests: Stefano A. Bini, MD, Department of Orthopaedics, University
of California, San Francisco, 500 Parnassus Avenue, MU 323-W, San Francisco, CA
94143-0728.
Currently, the technologies which are the top of the Gartner
Hype Cycle are all basically associated with artificial intelligence
(AI) [1]. The hype is so high that some are suggesting that AI will be
the harbinger of doom for humanity and call forth a dystopian
world view where machines run the planet [3,4]. Others offer a
more optimistic view with millions of new jobs and greater
economic growth spurred by smarter decision-making [5]. Laying
all that aside, there are many areas in health care where we are
already seeing a positive impact from this technology.
So, what is AI? There are multiple definitions for AI. One
definition from Wikipedia.com is that it is human intelligence
exhibited by machines. In computer science, the field of AI research
defines AI as the study of “intelligent agents,” which are devices
that “perceive their environment and take actions to maximize
their chance of success at some goal” [6]. The “and” part of the
definition is an important distinction.
There are many examples of AI in our lives. Apple's Siri is one
such example. Another is Amazon's Alexa. Natural language
processing technology, a form of AI, is used to translate languages in
Google Translate. Indeed, up to $30B has been invested in AI in the
past 5 years and 90% of it on research and development by
companies such as Google and Microsoft [7]. Because there is a
great deal of interest in this technology and its applications in
health care, many hospital systems and individual practitioners are
being approached by vendors who claim to be using AI in their

https://doi.org/10.1016/j.arth.2018.02.067
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 S.A. Bini / The Journal of Arthroplasty 33 (2018) 2358e2361
products. In some of these instances, this practice is called “AI
washing,” the idea of adding the label of AI to all and every software
platform. Buyers should therefore beware, often, as what is being
sold as AI is nothing more than a basic algorithm.
True AI has great applications in health care because it can
handle and optimize very complex data sets residing in very
complex systems. Caring for patients requires controlling many
steps, each of which is highly variable, and each of which is
dependent on or connected to multiple other steps. Furthermore,
these steps involve both machines and people in processes that are
more stochastic and less deterministic than a traditional assembly
line. To manage such variation, one needs a predictive and
centralized command and control system that can handle such
complex data and learn continually from its experience by
optimizing (read: rewrite) the very algorithms it uses to deliver
recommendations. While tracking so many variables is challenging
for people (see for example, many reports of wrong medication
administration or even wrong-side surgery), it is something that
computers are particularly adept at.
Some examples of where we are today with AI in health care
include work done at UC Health in Colorado where an AI-based
scheduling tool was used to optimize surgical schedules [8]. The
software evaluated historical data and future demand to create
recommendations around operating room (OR) block allocations.
The OR increased revenue by $15M (4%) by increasing the number
of blocks released by 47% and doing so 10% sooner. Furthermore,
they absorbed 6 new surgeons by optimizing but not increasing
their total staffed OR block allocation.
Another example involves NewYork-Presbyterian Hospital's 30
Bed Infusion Center [9]. By using one of several commercially
available AI solutions (www.leentaas.com, Santa Clara CA) to
optimize schedules and templates, their patient wait times
dropped by 50%. Sharp HealthCare in San Diego wanted to decrease
the time it took to transfer an emergency room patient to the ward.
They used the same platform to forecast the need for admissions,
provided visibility to workflows, and prioritize which patients to
discharge first from which unit and which room to clean first. In
doing so, they decreased the time from the admission order to
patient transfer by 3 hours.
Although these examples may be a far cry from the humanoid-
run cyberworlds of many science fiction movies, these examples
are real, pragmatic, and effective health care applications of AI in
place today.
AI has been around for a while. The term was coined by John
McCarthy at a lecture at Dartmouth College in 1956. Since then, the
idea of sentient computers has captured and terrorized our collective
imagination. When the HAL 9000 computer on board Discovery One,
the spaceship in Stanley Kubrick's movie 2001: A Space Odyssey, de-
cides to sacrifice human life to ensure the success of its mission, fear of
AI and computers was seared deep into our collective psyche.
And yet, it has taken quite some time for the technology to catch
up with the promise of AI and the hopes of computer science
specialists. Moore's Law, defined in 1965 by Intel cofounder Gordon
E. Moore, predicted that the number of transistors on integrated
circuits would double approximately every 2 years [10]. The law so
far has held true and created an exponential increase in computing
power that is hard to comprehend. In 1971, the Intel 4004 was proud
of its roughly 2300 transistors, by 1989 Intel's 80486 chip had
1,000,000 transistors, by 2010 an Intel Core processor with a 32 -nm
processing die and second-generation high-k metal gate silicon
technology held 560 million transistors. In 2016, the fastest chip in
the world had 10 billion transistors [10].
The price of computing has similarly plummeted. In today's
dollars, a computer that could perform comparably to a $100 iPad 2
in 2010 would have cost $10B in 1970. Similarly, if we normalize
2359
calculations per second to 10 for a computer built in 1970, today the
computing power is 10,000,000,000 calculations per second [11].
The problem we have as humans is that while we are relatively
comfortable understanding linear growth, we have a hard time
getting our head around exponential growth. We look back at the
pace of change in our lives and believe that we can understand and
adjust for it. Until one day, we realize that the amount of change we
experienced over one decade just occurred in 1 year and that,
looking to the future, a decade of change will occur over just a few
months. That is difficult to accept, never mind to understand [11].
Exponential growth is what is expected from AI in the coming
years [5]. Yes, it is at the top of the Gartner Hype curve, but many
people believe it is with good reason. While it is important to note
that we are still a long way away from the Sci-Fi version of cyborgs
that are human in all but physiology, many AI applications are
coming to health care, which will have profound impact in the care
that is delivered and how it is delivered.
To understand where AI is going, let's first go back to one of the
earliest forms of AI, a piece of software developed at IBM by Arthur
Samuel that could play checkers autonomously after gathering data
and looking at all available options before making a decision. For it to
work, every possible move in checkers had to be programmed into
the algorithm. Only then could the computer decide which among
the options available it should choose. Fortunately, checkers was a
relatively simple game with a limited number of options. The pro-
grammers were able to write the code for each possible option, and
the hardware could handle the computational load. It would take a
while before computers could handle the complexity of games such
as chess. But to handle games such as Go, which can have more
possible permutations than there are atoms in the known universe
(that is a lot of options), an entirely different form of AI had to be
invented, namely “deep learning.” But we will come to that later.
Let us consider machine learning (ML) first. We had to climb a
long way along the technology curve before ML was even possible.
ML is best considered as a subset of AI. ML learns from experience
and improves its performance as it learns. As we saw in the earlier
examples, it is a field which is showing promise in helping to opti-
mize processes and resource allocation. ML works as follows: let us
say we want to teach a computer how to recognize the species of an
Iris [12]. First, the programmers figure out which features are rele-
vant to the various types of Iris. Because over the past several cen-
turies, botanists have figured out exactly what differentiates one Iris
from another (petal length, width, and so forth), the programmer
can create a long table with multiple images of different species of
Iris (each flower would be considered an “instance”) and list their
characteristics (or “features” such as petal length and width, image
histogram, color distribution, unique color counts, and so forth) that
makes each Iris belong to a specific species. The specific set of fea-
tures would, of course, be the same for each instance of the same
species but differ between species. This data set is called the
“training data set” or “ground truth.” After “looking” or “learning
from” this training set of say 150 high-quality images, the software
will have learned what combination of attributes are associated
with any type of Iris. The magic occurs when software is shown a
picture of an Iris it has never seen before and accurately recognizes
which species it belongs to. The accuracy goes up with the number
and size of the training set (which is why everyone is so excited
about “big data”: the bigger the data set of known variables, the
more accurate the software can become when presented with un-
known variables). Furthermore, if trained through feedback loops
(right decision/wrong decision) it can adjust its own algorithm and
“learn.” The software literally recodes itself.
Probably the best-known example of ML software in health care
is IBM's Watson Health. Watson Health has been fed everything
ever written in any language at any time related to cancer
2360 S.A. Bini / The Journal of Arthroplasty 33 (2018) 2358e2361
diagnostics and treatment. Not only that, it continues to ingest all
new data as it is published. When presented with a specific patient
with cancer, Dr. Watson will recommend the treatment trial most
likely to cure that individual patient's cancer by considering their
genome, history, imaging, and pathology; coupled to all the
information known about the treatment of that cancer. The more
information Watson has about the patient, the more accurate it will
be. Basically, IBM's vision for AI is that it will support physician
decision-making rather than supplant it by doing those things that
it does best: manage and consider massive amounts of data and
present only the relevant information to the physician [13,14]. By
knowing all the data and sorting through it at incredible speed, AI
can make the physician smarter no matter where they are
geographically and what resources are available to them. This
application of AI, where AI is in a support role, is referred to as
cognitive computing [15]. It should be noted here that IBM Watson
Health has had some challenges such that its partnership with the
MD Anderson Clinic came to an end in 2017 due primarily to cost
overruns and challenges with migrating data across electronic
health records [16]. It is not all perfect yet.
Note that, in our ML example about flowers, the programmer
must know which features are relevant or important to define what
a flower “is.” Further, the “ground truth” in the data must be accurate
for the software to work. If Iris versicolor was consistently and
inaccurately labeled as Iris setosa, the algorithm will initially be
inaccurate. Furthermore, with ML, the programmer must get the
data to the computer in a form that it can understand. That usually
means converting data into a large spreadsheet consisting of many
rows and columns each holding unique numbers or values (this is
called “structured data,” something that is relatively scarce in health
care where so much of the information is in “unstructured” data sets
consisting mostly of clinical chart notes). Because designing and
selecting the features is very time consuming, software engineers
building ML algorithms need to be smart and only extract the
features (from the data) that can improve the model. But since in
most real-world scenarios engineers do not know which features
are useful until they train and test their model, developers can get
into long development cycles where the team has to identify and
develop new features, rebuild the model, measure results, and
repeat the cycle until the results are satisfactory. This is an extremely
time-consuming task and while, over time and with enough new
data and training, the algorithm can become increasingly accurate,
the process can take a long time. ML is thus challenged when dealing
with data sets with multiple dimensions where extracting the most
predictive features is not obvious or where there are large numbers
of both inputs and outputs that need to be addressed.
To handle large data sets and unstructured data without clear,
known, features computer scientists turned to biomimicry for
inspiration; that is, they copied nature. Thanks to the advent of
increasingly powerful computer chips and microprocessors,
scientists have created statistical models called Artificial Neural
Networks (ANNs) that can process data inputs much the same way
as the human brain does, by assigning a logical construct to the
information. This form of AI, “the state of the art of the state of the
art” as some call it, has been around conceptually for some time
(basically since the 70s) but in a very limited fashion (2 layers of
ANNs at most) due to the limits of computational power. When
plotted out, ANNs look very much like neurons with dendrites
going in many directions and connecting to more neurons, each of
which has more dendrites connecting to more neurons and so
forth. The idea is that each node can accept an input and then store
some information about it before passing the information up to the
next level. Thus, each layer has an increasingly complex “under-
standing” of the information it receives than the previous layer.
Although the concept has been there for some time [17], it was not
until the early 2000s with the introduction of the powerful NVIDIA
chips that neural networks could be stacked one on top of the other
to create more than one or two connections and achieve their full
potential. Today, some engineers are creating ANN networks that
are as many as 100 layers deep, hence the origin of the name “deep”
learning for these algorithms. With so many layers, the ANNs can
tackle and master increasingly complex data [18].
So, why is that interesting? Because these algorithms can be
shown raw data and extract their own features without human
input. Shown a large enough number of flowers, they can identify
the features that define each species without being told what those
features are. They can differentiate one face from the next. They do
not need structured data sets to learn from. It is pretty amazing:
they learn very much like children.
But what does that actually mean? It means that if we want a
deep learning algorithm to learn how to recognize and differentiate
faces in a photograph we do not have to create a massive spread-
sheet with features like “nose” and “eyes” and how these (and
hundreds of other features) differ from one person to another as we
would for a traditional ML algorithms. Indeed, Google's algorithms
can use deep learningebased facial recognition to identify the same
person (Uncle Bob) in 2 photographs taken a decade apart without
any human input. Although it was never told that Uncle Bob is the
one with the blond hair and crooked nose, if you identify that
person as “Uncle Bob,” the software can go and find him in all your
other pictures (or any on the web).
But AI can go many steps further. Google DeepMind's Deep
Q-learning software can learn how to play Atari's Breakout video game
without being told anything other than to maximize the score [19]. It is
not told what a ball or a bat is. It has no concept of tennis or ball games.
And yet, after a series of trial-and-error games from which it learns that
to maximize the score it must hit the “ball” with a “bat” to knock out
some targets, in a matter of minutes it can play at the level of a very
skilled person and achieve very high scores. And if that were not
enough, it can take those learned skills and apply them to other video
games. Shocking to everyone except the folks at Google, in May of
2016, Google's program called AlphaGo beat the Korean GO master at
the most complex game known to man [20]. However, as with humans,
the software is only as good as the data it is trained. A person trained as
a lawyer is not likely to be a great physician or a good plumber. Simi-
larly, the Atari playing software DeepMind would not be all that great
at face recognition, and I doubt AlphaGo is all that great at selecting the
right medications for patients.
There are applications for deep learning algorithms in health care
that are quite interesting. For example, the Food and Drug Adminis-
tration now allows pharmaceutical companies to model drug
interactions using AI algorithms that accurately identify drug toxicity
without the usual decade of animal testing [21] In fact, they encourage
it. Cancer detection in pathology slides is getting very close to
outperforming trained pathologists, and similar pattern recognition
software is getting quite accurate at reading radiographs [22e24]. The
reader is encouraged to search online for the latest advances in this
space because undoubtedly what may seem earth shattering at the
writing of this article may be old hat by the time it is being read.
With that caveat in mind, what does the immediate future
promise with respect to AI? As mentioned previously, on the
clinical front pattern recognition will improve the accuracy of
image-based diagnostics, and AI platforms will provide decision
support to clinicians (and patients and insurers). Analytics based on
historical data will be deployed by hospitals and clinics to optimize
workflows and resource allocations. While the impact on health
care of massive new amounts of data acquired by patients from
their interaction with the Internet of Things (otherwise known as
the IoT, this term refers to the web of digital data collected by the
world around us from our cars to our refrigerators, from our
 S.A. Bini / The Journal of Arthroplasty 33 (2018) 2358e2361
browsers to surveillance cameras at the mall, from our DNA
sequence to our Fitbit data) has yet to be fully appreciated, there is
no question that it will be an AI engine trained on that data that will
provide the insights. AI may be at the peak of the Gartner Hype
Cycle, but it is unlikely to fall deep into the Trough of Disillusion-
ment in the health care realm before coming out to the Phase of
Enlightenment and into the Plateau of Productivity. And, by then,
using AI for predictive analytics or cognitive computing will not be
“new”, it will be the new “normal”.
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 The Journal of Arthroplasty 33 (2018) 2465e2470

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Autologous Impaction Bone Grafting for Bone Defects of the

Medial Tibia Plateau During Primary Total Knee Arthroplasty:
Propensity Score Matched Analysis With a Minimum of 7-Year Follow-Up
Jong M. Sohn, MD, PhD a, Yong In, MD, PhD b, Sang H. Jeon, MD a, Jin Y. Nho, MD a,
Man S. Kim, MD a, *
a
Department of Orthopaedic Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Korea
b
Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

a r t i c l e i n f o a b s t r a c t

Article history: Background: The aims of this study were to (1) describe a novel technique for appropriate treatment of
Received 13 December 2017 bone defects in medial tibial plateau grafted with autologous resected bone and (2) compare clinical
Received in revised form outcomes, radiographic results, and survivorship of these knees with those of standard total knee
18 February 2018
arthroplasty (TKA) without bone defect.
Accepted 20 February 2018
Methods: We retrospectively reviewed 50 cases of primary TKA involving bone defects of medial tibial
Available online 6 March 2018
plateau managed with bone grafting for a minimum follow-up of 7 years. Autologous resected bones
were used for bone graft after removing solid cortical bones at the defect site. After bone graft group was
Keywords:
total knee arthroplasty
completed, one-to-one patient-matched control was accomplished based on propensity score matching
autologous bone graft of 50 knees. Survivorship was analyzed using the Kaplan-Meier method. The endpoint of survival was
bone defect revision of implant. Clinical outcomes were also assessed including Knee Society Score and Western
propensity score match Ontario and McMaster Universities Osteoarthritis Index score.
medial tibial plateau Results: The mean follow-up was 117 months in the group with bone graft and 108 months in the group
without bone graft. There were no significant differences in postoperative clinical scores and knee
alignment. Nonprogressive radiolucent lines measuring <2 mm were observed in 8 knees in the group
with bone graft and 9 knees in the group without bone graft. During the follow-up period, 1 patient with
late infection underwent 2-stage revision and another revision for tibial loosening occurred in both
groups. The 10-year cumulative survival rate for revision was 96.0% in both groups.
Conclusion: Our technique of management of medial tibial bone defect using autologous bone graft
yielded desirable results based on survival rate and clinical outcome.
© 2018 Elsevier Inc. All rights reserved.

Although total knee arthroplasty (TKA) provides excellent long-
term results in patients with end-stage osteoarthritis (OA) [1,2],
management of bone defects in primary TKA is still a challenge for
orthopedic surgeons [3]. Bone defects involving tibial side are
frequently encountered in primary TKA [4]. They are typically found
on medial or posteromedial aspects because of the predominance
of varus-deformed knee. They may also exist in the lateral
compartment of the valgus-angulated knee [5]. Restoration of such
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.082.
* Reprint requests: Man S. Kim, MD, Department of Orthopaedic Surgery, Incheon
St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 59
Dongsu-ro, Bupyeong-gu, Incheon 21431, Korea.
defects is mandatory for favorable alignment and secure compo-
nent fixation for longevity of the prosthesis [6].
Various methods have been used to treat bone defects based on
their size. In general, defects <5 mm are filled with bone cement or
effectively eliminated with a lower tibial resection. If the defect
depth is 5-10 mm, it can be filled with bone grafts. Metal
augmentation can be used for defects deeper than 10 mm [4].
Current prosthetic designs allow metal augmentation for larger
bone defects. Modular metal augments have been successfully used
with good midterm clinical results in small series [7,8]. However,
metal augments require additional resection of remaining half
bone, including cortical bone in affected compartment up to the
thickness of the block, which may lead to significant additional
bone loss during subsequent revision surgery [9]. Autologous bone
graft is commonly used in primary TKA because of its easy

https://doi.org/10.1016/j.arth.2018.02.082
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2466 J.M. Sohn et al. / The Journal of Arthroplasty 33 (2018) 2465e2470

Fig. 1. After tibial cuts, large bone defects of medial tibia plateau remained. (A) Multiple drill holes were made in the sclerotic base of defects. The sclerotic cortical bone was
removed using burr and small osteotome to expose the cancellous bony surface. (B) The uncontained peripheral defect was converted to contained defect with a 5-8 mm depth hole
to fix the bone block firmly in defects. The cancellous bone block was obtained from the resected femur or tibial bone. (C) After autografts were impacted into the hole, the
protruded grafted bone over the cutting level was resected with the oscillating saw to make a flat tibial surface for the tibia base plate (D).

accessibility and use [10]. However, advantages and disadvantages
of these methods are still disputed [11]. In particular, studies
investigating the outcomes of primary TKA with autologous bone
grafting are limited [6,12e15].
Therefore, the aims of the present study with a minimum of
7-year follow-up were to (1) describe a novel technique for
appropriate treatment of bone defects by grafting autologous
resected bone without any fixation device during primary TKAs
and (2) compare the clinical outcomes, radiographic results, and
survivorship of the knees with those of standard TKAs without
bone defect. Our hypothesis was that knees with bone defects
after primary TKAs using novel autologous bone graft technique
provide clinical outcomes, radiographic results, and survivorship
similar to those with standard TKAs without bone defect in long-
term follow-up.
Materials and Methods
Patient Selection
We reviewed the clinical and radiological data of patients' charts
and radiographs obtained between January 2001 and July 2010. A
total of 527 consecutive primary TKAs using the Medial Pivot fixed-
bearing prosthesis (ADVANCE, Wright Medical Technology,
Arlington, TN) were performed in 342 patients at one institution. A
total of 185 patients (54%) underwent bilateral TKA, whereas 157
patients (46%) underwent unilateral TKA. Autologous impaction
bone graft for medial tibial bone defects was the inclusion criterion
for outcome analysis of bone defect management. Exclusion criteria
were rheumatoid arthritis, other inflammatory arthritis, or trau-
matic arthritis, in patients treated with metal augmentation or
extended stem for management of medial tibial bone defects, with
a follow-up period <7 years. During this period, 59 knees (11.2%) of
total 527 knees were treated with autologous bone grafting for
tibial bone defects. 63 knees were excluded because of rheumatoid
arthritis (4 knees), metal augmentation and extended stem (1
knee), traumatic OA (1 knee), and follow-up period <7 years (57
knees including 9 autologous bone grafted knees). Therefore, the
initial candidates for analysis included 50 knees in the bone graft
group and 414 knees in the control group. Each patient in the bone
graft group was matched with control patients who underwent
TKAs without bone graft in the same database. After bone graft
group was completed, one-to-one patient-matched control of 50
knees was made by propensity score matching (PSM) [16]. The
matching was based on age, sex, body mass index (BMI), operation
side, flexion contracture, and further flexion. The 13 patients who
underwent TKA with bone grafting on one side and without bone
grafting on the other side were also included in this study. Six
patients were in the control group without bone graft after
matching (50 knees) and 7 patients were in the control group
without bone graft before matching (414 knees). This study was
approved by the institutional review board of our hospital. All pa-
tients provided written informed consent.
Surgical Procedure
All operations were performed by the senior author via standard
anterior midline skin incision and medial parapatellar arthrotomy
with tourniquet inflation to 300 mm Hg. Proximal tibial bone was
resected using an intramedullary tibial guide with a cutting block
with 3
of posterior slope perpendicular to the shaft of the tibia in
the coronal plane. The level of cutting was determined as 10 mm
 J.M. Sohn et al. / The Journal of Arthroplasty 33 (2018) 2465e2470
Table 1
Patient Demographics of 2 Groups (With or Without Bone Graft) After Propensity
Score Matching.
Bone Graft No Bone Graft
(n ¼ 50) (n ¼ 50)
Age, ya 71.1 ± 6.0 71.3 ± 5.7
Male/female (n) 1/49 1/49
BMI, kg/m2 25.7 ± 3.8 25.8 ± 4.2
Operation side
Right/left 21/29 21/29
Preoperative flexion contracture 11.1 ± 14.2 9.8 ± 11.1
Preoperative flexion angle 125.5 ± 28.6 124.5 ± 10.3
BMI, body mass index.
a
The values are presented as mean and standard deviation.
from the lateral tibial plateau on varus knees with medial defects.
After tibial cuts, the remaining large bone defects of medial tibia
plateau (10 mm depth) were measured and managed with
autologous bone graft. We measured the width and depth of defect
in millimeters using a ruler, intraoperatively. Anteroposterior (AP)
width, mediolateral width, and mean depth of bone defects were
22.8 mm (range 10-40 mm), 16.2 mm (range 10-30 mm), and 10.8
mm (range 10-20 mm), respectively. First, multiple drill holes were
made in the sclerotic base of defects with 2.5 mm drill bit for easy
removal of sclerotic bone. The sclerotic cortical bone was removed
using a burr and a small osteotome to expose the cancellous bony
surface to promote vascularity. Second, the uncontained peripheral
defect was converted to contained defect with a 5-8 mm depth hole
to fix the bone block firmly in defects. Third, the cancellous bone
block was obtained from the resected femur or tibial bone. Autol-
ogous bone was prepared carefully depending on the size of defect
using oscillating saw, and bony rongeurs. Finally, after
the graft bone was fitted into place and stabilized by impaction of
the graft bone to the floor with bone tamps and a mallet, the pro-
truded graft over the cutting level was resected with an oscillating
saw to create a flat tibial surface for the tibia base plate (Fig. 1).
Although subsequent fracture was predicted with bone impaction
using mallet, no fracture was observed in this study and no specific
complication during bone impaction. Internal fixation devices such
as screw or wire were not used. Posteriorly stabilized medial pivot
fixed-bearing prostheses were implanted in the hybrid system.
Porous-coated femoral component was inserted without cement
and the tibia implant was fixed using bone cement (PALACOS RþG,
Heraeus Medical, Wehrheim, Germany). Patella resurfacing was not
performed in all cases. Immediately after surgery, we instructed
patients to perform quadriceps-strengthening exercises and
straight leg-raising exercises. On the second postoperative day, the
drain was removed and patients tolerated weight bearing with the
aid of a walker. In addition, a continuous passive motion machine
was used for passive exercises once daily for 30 min. Patients were
discharged 7 days after surgery.
Clinical and Radiographic Evaluation
All knees were evaluated preoperatively and postoperatively at
6 weeks, 6 months, 1 year, and every 2-3 years thereafter. Clinical
evaluations were performed preoperatively and postoperatively to
determine the Knee Society Score (KSS) [17], Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) score [18],
and range of motion. Complications and revision for any reason
were also analyzed. Active range of motion of the knee was
measured using a standard 60-cm goniometer in supine position by
one of the authors. Radiological evaluations were performed on the
standing AP, lateral, tangential, and long standing from hip to ankle
2467
radiographs, preoperatively. One of the authors, a member of
Korean Orthopaedic Association, evaluated the radiographs. If there
was severe bone attrition (more than 10 mm) on AP radiograph, the
P Value need for autologous bone grafting was predicted partially.
However, the decision to select bone graft was finally confirmed
.851 intraoperatively. Alignment of the lower limb was assessed using
1.000 the femorotibial angle (FTA) and hip-knee-ankle (HKA) angle on
.798
long standing from hip to ankle radiographs. The FTA was the angle
1.000
between the anatomic femoral and tibial axis. The HKA angle was
.600 defined as the angle between the mechanical axis of the femur and
.816 the tibia [19]. Bony union was considered if there was bridging of
bony trabeculae in the standing AP radiograph by one of the
authors [12]. AP and lateral radiographs were assessed for the
presence of radiolucent lines (RLLs) between bone-cement
interfaces using the Knee Society Radiographic evaluation system
[20]. RLLs are defined as radiolucent intervals between bone and
cement [21]. Radiographic lines (>2 mm), osteolysis, and loosening
of implants represented radiological abnormalities [22].
Statistical Methods
All data are presented as mean and standard deviation.
Comparison of categorical variables between the 2 groups was per-
formed using Fisher exact test. Unpaired Student t test was used for
the analysis of continuous variables. Knee survival was determined
using the Kaplan-Meier method. End point event was revision for any
reason or a progressive RLL >2 mm, which was considered as aseptic
loosening [23]. IBM SPSS, version 21.0 (SPSS Inc, Chicago, IL), was used
for PSM and all statistical analyses. A P value < .05 was considered to
be statistically significant.
Results
The mean follow-up period was 117 months (range 84-172
months) in the group with bone graft and 108 months (range
84-185 months) in the group without bone graft with a minimum
7-year follow-up. Patient demographics after PSM are summarized
in Table 1. There were no significant differences in age, gender ratio,
BMI, operation side, preoperative flexion contracture, or flexion
angle because of PSM between the 2 groups. Preoperative knee
alignment, ie, FTA and HKA angle, were significantly different
between the 2 groups (both P < .001). However, there were no
significant differences in postoperative FTA and HKA between the 2
groups (P ¼ .332, P ¼ .285, respectively; Table 2). HKA was more
than 10
in all knees in the group with bone graft. The HKA of 37
knees ranged between 10
and 20
and exceeded 20
in 13 knees.
Surgical time was 142 minutes in the group with bone graft and
127 minutes in the group without bone graft. There was a
significant difference in surgical time (P ¼ .011).
Preoperatively, the mean KSS pain score was 19.4 for the group
with bone graft and 18.0 for the group without bone graft
(P ¼ .525). There were significant differences in function subscore of
KSS. The group with bone graft showed significantly (P ¼ .027)
Table 2
Radiological Assessment for Both Groups (With or Without Bone Graft).
Bone Graft No Bone Graft P Value
(n ¼ 50) (n ¼ 50)
Preoperative FTA,
a Varus 10.3 ± 5.0 Varus 3.6 ± 4.9 <.001
Preoperative HKA,
Varus 15.9 ± 5.0 Varus 9.6 ± 5.4 <.001
Postoperative FTA,
Valgus 3.4 ± 3.4 Valgus 4.2 ± 3.6 .332
Postoperative HKA,
Varus 2.1 ± 3.4 Varus 1.2 ± 4.5 .285
FTA, femorotibial angle; HKA, hip-knee-ankle angle.
a
The values are presented as mean and standard deviation.
2468 J.M. Sohn et al. / The Journal of Arthroplasty 33 (2018) 2465e2470

Table 3
Preoperative and Postoperative Clinical Scores.

Preoperative Last Follow-Up

Bone Graft No Bone Graft P Value Bone Graft No Bone Graft P Value
a
Total KSS
Pain 19.4 ± 9.5 18.0 ± 10.7 .525 46.8 ± 3.3 45.4 ± 5.9 .168
Function 92.9 ± 5.6 96.7 ± 10.0 .027 129.5 ± 7.9 126.7 ± 10.2 .159
Total WOMAC 70.4 ± 11.1 67.3 ± 9.8 .190 13.1 ± 11.0 16.8 ± 10.1 .122
Pain 14.0 ± 3.7 13.7 ± 3.8 .695 2.7 ± 4.4 2.5 ± 2.2 .841
Stiffness 4.4 ± 1.5 4.9 ± 1.7 .226 1.2 ± 1.3 1.2 ± 1.0 .758
Function 52.0 ± 8.0 48.6 ± 6.7 .046 9.7 ± 8.0 12.6 ± 8.0 .105

KSS, Knee Society Score; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
a
The values are presented as mean and standard deviation.

worse KSS function score than the group without bone graft
preoperatively. Function subscore of WOMAC was also significantly
(P ¼ .046) different between the 2 groups. However, there were no
significant differences in postoperative KSS or WOMAC score
between the 2 groups (Table 3).
The bone union rate was 98% in the group with bone graft. The
grafted autologous bones were completely incorporated into the
host bone (Fig. 2) within 1 year in all patients except one who
showed peripheral bone resorption 2 months postoperatively
without any clinical symptoms or further changes at a later
follow-up. Nonprogressive RLLs <2 mm were observed in 8 knees in
the group with bone graft and 9 knees in the group without bone
graft. There was no knee with an RLL >2 mm. Two knees underwent
revision surgery in both groups. In the group with bone graft, one
knee had 2-stage revision for late infection about 10 months after
operation, whereas the other knee was revised for aseptic
loosening postoperatively at 8 years. In the group without bone
graft, one knee was revised for aseptic loosening at 4 years after
first operation, whereas the other knee underwent 2-stage revision
for late infection at about 14 months after surgery. The presence of
RLL and the risk of revision were not significantly different between
the 2 groups. The cumulative survival rate for revision was 96.0% in
both groups at 10 years postoperatively (P ¼ .968; 95% confidence
interval: 82.1%~98.8% in group with bone graft vs 84.9%~99.0% in
group without bone graft; Fig. 3).
Discussion
The major finding of this study was that autologous bone graft
technique for managing large bone defects of medial tibia plateau
addressed all 50 knees with large bone defects during primary TKA
without additional fixation devices or implants. This technique
entailed 3 steps: (1) removal of defective sclerotic bone of tibia and
conversion of uncontained defect to contained defect, (2) obtaining
cancellous bone block from resected distal femur or proximal tibia,
and (3) impaction of bone block into the hole and cutting the
protruded grafted bone smoothly using an oscillating saw. At a
mean follow-up of 10 years, the knees showed comparable clinical
outcomes, radiological characteristics, and survival rates when
compared with the control group.
Peripheral bone defects of the medial tibia frequently occur in
primary TKAs for varus deformity [24]. Several options for treating
bone defects include filling with cement with or without screws
[25], resection of additional tibia [6], auto or allo bone grafting
[6,26], metal block augmentation, and custom-designed prosthesis
[27]. The cement failed to accurately distribute the load in large
bone defects because of inadequate pressurization. Excessive
cement with or without screws might be biomechanically inap-
propriate, resulting in fragmentation of cement and consequent
early failure of knee arthroplasty [8,25]. Cement fragmentation was
minimized in autologous bone graft [28]. Further tibial resection

Fig. 2. Preoperative radiograph showing large bone defect of medial tibia plateau (A). Grafted bone (arrow) was seen and sclerotic immediately after operation (B). The bone
trabeculae crossed from the grated bone (arrow) to host bone. The grafted bone was incorporated into the host bone (C).
 J.M. Sohn et al. / The Journal of Arthroplasty 33 (2018) 2465e2470
Fig. 3. Kaplan-Meier survival curve analysis of total knee arthroplasty (TKA) with
revision for any reason as the endpoint.
exposed the metaphyseal portion of the tibia and reduced the
strength of osseous support leading to the use of narrow tibial
implant, which reduced supporting area and increased loading
[29,30]. Intramedullary extended stems were needed for additional
support [29,30]. Recently, metal augmentation was widely used to
solve bone defects of tibia [27]. It was successfully used to deal with
peripheral bone defects of tibia plateau [8,27]. Although metal
augmentation can be carried out at various sizes, it may require
additional bone resection and cause stress shielding between bone
and metal, which can lead to bone loss [9]. In addition, it is
expensive. Moreover, intraoperative fitting is not always as satis-
factory as expected [24] and continuous pain due to irritation be-
tween metal and soft tissue may occur [31]. On the other hand,
autologous bone grafting for tibial defects has various advantages.
The custom-made prosthesis is not required. It has lower infection
risk than allograft [10]. It is more economical than metal
augmentation and allografts. It is easy to use for ligament
restoration with graft availability and biocompatibility [32]. It is
physiologically sound ensuring bone preservation [14]. Therefore,
we used autologous impaction bone grafting for bone defects of
medial tibia plateau during primary TKA.
Previous techniques were introduced using autologous bone
resected from distal femur and proximal tibia [12,14,15,28,33].
However, few studies have reported clinical outcomes using old
prostheses after autologous bone grafting for defects. Screw
fixation of the graft on single oblique cut at the base of the
deficiency resulted in successful union rates [12,14]. However, a
5-year follow-up of a midterm study [15] reported a success rate of
67% after this technique, suggested that bone grafting is only
suitable for smaller and circumscribed defects. Another method
includes inlay autologous bone grafting without additional fixation
originally described by Insall [33]. This method has shown 96%
good-to-excellent results in 26 primary TKAs at an average of
3-year follow-up [28,33]. However, these reports used a small
number of cases with old prostheses that are no longer in use. In
the present study, autologous bone grafting was used for large bone
defects of tibia without additional fixation. Satisfactory results
were obtained with instruments used currently after a long-term
follow-up of minimum 7 years.
Although autologous bone grafting is a good option for
managing bone defects with short-term union and bone incorpo-
ration, nonunion and fragmentation of the graft with absorption is
still a concern [14,15]. Dorr et al [14] first introduced bone grafting
in TKA and reported that 22 of 24 knees achieved bone union
despite 2 cases of nonunion, including 1 case of collapse. However,
they performed bone graft using allograft, not autograft [14]. Laskin
[15] demonstrated almost 33% failure rate after autograft for bone
defects at 5 years postoperatively. Subsequent studies showed
much higher bone union rates [6,12,13,34]. The union rate of grafted
bone has been reported to be 82%-100% [6,12,13,34]. In the present
2469
study, the bone union rate was 98% in 50 cases with autologous
bone grafting, comparable or superior with those of other studies.
A few studies have compared autologous bone graft group with a
control group in primary TKAs [15,35,36]. Preoperative patient
demographics such as age, gender, BMI, and preoperative flexion
contracture were associated with postoperative outcomes after
TKAs [37e39]. However, patient characteristics were not controlled
or adjusted in these studies [15,35,36]. The strength of the present
study was that a precise analysis of postoperative clinical outcomes
was possible after matching multiple baseline confounders by PSM.
Fair comparison with the studies mentioned previously was difficult
because of nonadjustment of preoperative confounding character-
istics in those studies. In the present study, preoperative clinical
scores such as KSS and WOMAC were significantly worse in the
group with autologous bone grafting. The difference in functional
score affected by deformity might be a significant factor indicating
statistical difference in preoperative scores. Results of the present
study are consistent with those of Ahmed et al [13] in terms of
functional improvements in autologous bone graft group. Ahmed
et al [13] also matched 2 groups by age, sex, diagnosis, and the type
of prosthesis, but not BMI or flexion contracture. No significant
differences were found in postoperative clinical scores including
KSS or WOMAC. Final clinical scores including KSS and WOMAC
were comparable with those of Lee and Choi [27] with a similar
follow-up period. Metal augmentation was used for tibial bone
defect during primary TKAs in their study.
Progressive RLLs are significantly related to early failure of TKAs
[23]. The rate of RLLs was similar between the 2 groups in the
present study. Altcheck et al [6] performed autologous bone graft in
tibial defect during TKAs. RLLs of 1-2 mm were observed in 4
(28.6%) of 14 knees at the bone-cement interface. There was no RLL
progression in a follow-up of 4.3 years [6]. Aglietti et al [12] have
also reported RLLs in 2 (11.8%) of 17 knees during the follow-up of 4
years. There was a single case of revision arthroplasty because of
loosening of femoral component [12]. Results of present study were
comparable with those of studies mentioned previously. Ahmed
et al [13] have compared 18 knees in bone-grafted group with 132
knees in the control group (no bone defect). There was no
radiological evidence of graft loss and no revision in either group
for 10-year follow-up [13]. This result was superior to that of the
present study. The survival free of revision for any reason was 96%
in both groups in the present study, similar to the survival rate of
95.1% reported by Aglietti et al [12], although their follow-up was
only 4 years. When aseptic loosening was used as the endpoint, the
survival was 98% in the present study.
The present study has several limitations. First, the gender ratio
was unbalanced, with a female predominance. It was difficult to
control the ratio of females-to-males because the prevalence and
incidence of OA in females was much higher than in males,
especially among Asians [40]. Second, this study was a retrospec-
tive cohort study based on the database of one institute. Thus, it is
difficult to control confounding factors. It is susceptible to selection
bias [41]. Third, although most patients who underwent TKA were
admitted for <3 days in the United States, all patients in this study
were Koreans, who stayed for 7 days in the hospital, which was a
common practice in our medical system. The length of hospital stay
after TKA varied widely from country to country, because it was
affected by the overall health care system in each country. Thus,
these findings might not be widely generalizable. Fourth, the
incorporation of bone graft was only evaluated radiographically.
There was no histological evidence of graft incorporation in the
present study. Fifth, metal augmentation was used when the graft
bone obtained was not a good fit with the dimension of the defect,
especially in one case. However, bone defects up to 20 mm depth
were managed successfully using autologous bone graft in this
2470 J.M. Sohn et al. / The Journal of Arthroplasty 33 (2018) 2465e2470
study. Finally, the follow-up period of minimum 7 years was not
long enough to determine the usefulness of autologous bone graft
in TKA. Therefore, the results of this study should be verified in a
study with a longer follow-up period.
Conclusion
Based on the results of at least 7 years of follow-up, we found
that management of medial tibial bone defects using autologous
impaction bone grafts resulted in favorable clinical outcomes and
survival rate. Therefore, autologous bone graft is a safe and effective
option for most medial tibial defects during primary TKA.
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 The Journal of Arthroplasty 33 (2018) 2362e2367

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Bundled Payments for Care Improvement in the Private Sector:

A Win for Everyone
Jared S. Preston, MD, MBA a, *, Darleen Caccavale, BS b, Amy Smith, MSN, RN b,
Lauren E. Stull, PA-C b, David A. Harwood, MD a, b, Stephen Kayiaros, MD a, b
a
Department of Orthopaedic Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
b
University Orthopaedic Associates, Somerset, New Jersey

a r t i c l e i n f o a b s t r a c t

Article history: Background: To help slow the rising costs associated with total joint arthroplasty (TJA), the Centers for
Received 13 November 2017 Medicare and Medicaid Services introduced the Bundled Payments for Care Improvement (BPCI)
Received in revised form initiative. The purpose of this study is to report our 1-year experience with BPCI in our 2 arthroplasty
1 March 2018
surgeon private practice.
Accepted 5 March 2018
Methods: In this series, a historical baseline group is compared with our first year under BPCI. We
Available online 14 March 2018
reviewed the cohorts with respect to hospital length of stay (LOS), readmission rates, discharge dispo-
sition, postacute care LOS, and overall savings on a per episode basis.
Keywords:
hip arthroplasty
Results: The baseline group included 582 episodes from July 2009 to June 2012. The BPCI study group
knee arthroplasty included 332 episodes from July 2015 to September 2016. We witnessed a substantial learning curve over
bundled payments the course of our involvement in the initiative. The total reduction in cost per episode for TJA was 20.0%
BPCI (P ¼ .10). Hospital LOS decreased from 4.9 to 3.5 days (P ¼ .02). All-cause 90-day readmission
CMS rates decreased from 14.5% to 8.2% (P ¼ .0078). Overall, discharges to home increased from 11.6% to 49.8%
discharge (P ¼ .005).
Conclusion: Our small, private, 2 arthroplasty surgeon orthopedic practice has shown improvement in
postoperative management for TJA patients in 1 year under the BPCI initiative, with increased discharges
to home, decreased skilled nursing admissions, days in skilled nursing, and overall readmissions. Because
BPCI includes fracture care arthroplasty, the model could be made more equitable if these patients were
reimbursed a rate commensurate with their increased costs and risks.
© 2018 Elsevier Inc. All rights reserved.

The US health care system accounts for 17% of gross domestic
product, with estimates from the National Healthcare Expenditure
Projections that this percentage will grow to nearly 20% by 2020
[1]. To help slow government spending, in 2013, the Centers for
Medicare and Medicaid Services (CMS) authorized the Bundled
Payments for Care Improvement (BPCI) initiative to test innovative
payment and service delivery models [2]. These new models have
the potential to reduce Medicare and Medicaid expenditures and
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.007.
* Reprint requests: Jared S. Preston, MD, MBA, Department of Orthopaedic Sur-
gery, Rutgers Robert Wood Johnson Medical School, 1 RWJ Place, MEB 422, New
Brunswick, NJ 08901.
encourage maximization of quality and value of health care in the
United States, while improving the quality of care to its benefi-
ciaries [2e4]. Total joint arthroplasty (TJA) has been a prime target
of the BPCI program, as TJA comprises a large share of CMS ex-
penditures and is expected to increase greatly in incidence over the
next decade [3,5e8].
Studies report that >80% of the cost of TJA is the result of the
index case (anchor stay) plus associated postacute care (PAC) ser-
vices [9]. PAC services include services such as subacute nursing
facilities (SNFs), home health care agencies, inpatient rehabilitation
facilities (IRFs), and long-term acute care hospitals. Reducing index
procedure length of stay (LOS) and discharging more patients to
home rather than PAC facilities has shown a significant reduction in
cost as well as a reduction in readmission rates, surgical site
infection rates, and reoperation rates [2,10e18]. Some health care
systems have been involved in the BPCI initiative before the
nationwide rollout and have shown successful implementation and

https://doi.org/10.1016/j.arth.2018.03.007
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J.S. Preston et al. / The Journal of Arthroplasty 33 (2018) 2362e2367
application, thanks to the ability to modify risk factors before
elective total hip arthroplasty and total knee arthroplasty (TKA)
[6,19,20].
The purpose of this study is to report the 1-year experience with
participation in the BPCI program in our private practice. We sought
to compare our hospital LOS, readmission rates, PAC utilization, and
PAC LOS for our historical cohort as compared with the first year
under the bundled payment program. In addition, we wanted to
quantify the cost savings for CMS under the program on a per
episode basis.
Materials and Methods
Institutional review board's approval was not required as all
patient data were deidentified. All Medicare patients with billing
codes DRG 469 and 470 were included in this study. Patients
treated with total hip arthroplasty for femoral neck fractures, TKA
for post-traumatic arthritis, and distal femoral arthroplasty for
distal femur fractures were also included in this study under the
aforementioned DRGs [21]. Although total ankle arthroplasty is
included under DRG 469/470, no total ankle replacements were
included in our study. Numerical data were compared using Stu-
dent t test, whereas categorical data were compared using chi-
squared or Fisher exact test. A P value of .05 was considered
significant.
Since July 2015, our practice, a private, multisubspecialty group
comprised 15 orthopedic surgeons, has participated in the BPCI
initiative for major joint replacement of the lower extremity. Sur-
geries were performed at 1 of 3 tertiary care university hospitals
with teaching affiliation with an orthopedic surgery residency
program. We chose to participate in the model 2 program, a
retrospective bundle payment where real claims are reconciled
against a predetermined target price per episode of care. The target
price was calculated according to the historical cohort, a 3-year
performance period of our practice from 2009-2012. Two
fellowship-trained joint replacement surgeons performed all elec-
tive arthroplasty cases for the bundle. Any particular physician in
our practice initiates the episode of care as it generates billing for
the DRG 469 or 470 for fracture admissions. Episode expenses
include all part A and part B expenses during the hospital stay, PAC,
as well as readmissions for 90 days postoperatively. We chose to
participate in BPCI with a third-party convener (Remedy Partners,
Darien, CT). The role of this convener was to serve as a mediator
between our practice and CMS. They assisted in educating hospital
and PAC facilities with discharge planning and protocols, and
maintained their own database of patients in the bundles that
tracked PAC usage. When needed, they also helped mitigate cases of
disputes, incorrect DRG coding, and/or inappropriate bundling of
patients between our practice and CMS. The convener also
compiled the historical cohort data of our practice and provided it
to CMS. After the CMS 2% discount, all subsequent funds thereafter
were distributed to our practice and the third-party convener in a
predetermined ratio (75% of the net reconciliation to the practice
and 25% to the third-party convener).
In this series, the BPCI initiative included 582 episodes from July
2009 to June 2012, defined as the baseline group, and 332 episodes
from July 2015 to September 2016 (2015Q3 e 2016Q3), defined as
the BPCI initiative group. All patients undergoing elective hip and
knee arthroplasties, regardless of participation in BPCI, were
treated with the same clinical protocol (CP) under the guidance of a
total joint coordinator [22,23]. The total joint coordinator is a paid
employee of the practice and assists in management of TJA patients
as well as patients undergoing surgeries with other physicians. The
CP was coordinated in conjunction with a quality measures/per-
formance improvement team (Remedy Partners). The CP included a
2363
preoperative optimization protocol, with hard stops including body
mass index >40 kg/m2, uncontrolled diabetes (fasting glucose >200
or HbA1c > 8), and anemia (hemoglobin <11 in females and <12 in
males). The joint coordinator is in charge of recording the Risk
Assessment and Prediction Tool preoperatively to predict post-
hospital discharge disposition [24,25]. Home discharge was
encouraged whenever possible. Based on our historical cohort, we
identified 56 SNFs where our patients were discharged. We eval-
uated utilization, readmission, and cost data of all SNFs provided to
us by the third-party convener. These data were compared with the
CMS Nursing Home Compare 5 Star Rating quality data and we
selected those with the lowest LOS, readmission rates, and highest
qualitative evaluation scores to create a preferred list of 19
geographically distributed SNFs for our patients. We then met with
the director of nursing, director of physical therapy, and discharge
planner of these facilities to communicate postoperative protocols
and discharge expectation. No financial arrangement existed
between our practice and the PAC facilities or the hospitals. All
patients had a nonbilled preoperative consultation with one of our
physical therapists to review home safety and expectations for
postoperative recovery and home exercise education. An
methicillin-sensitive Staphylococcus aureus/methicillin-resistant
Staphylococcus aureus nasal screening and decolonization protocol
was implemented for all patients.
The joint coordinator organized the entire process for managing
our arthroplasty patients in the BPCI program, from preoperative to
postoperative at all 3 hospitals. Preoperatively, the total joint
coordinator was responsible for patient and family education on
expectations for inpatient hospital stay and PAC, coordinating re-
ferrals to preferred home care agencies and creating and commu-
nicating the posthospital discharge plan of care. During the
postoperative period, the joint coordinator kept a database of pa-
tients in the bundle and followed their PAC, managed discharge
protocols with the hospital's case manager and social worker, and
called patients at home and communicated with our preferred SNFs
to gauge patient progress. The joint coordinator regularly met with
SNF staff to ensure that our expeditious protocols were being
followed.
Claims data were provided by CMS on a monthly basis, with
reconciliations occurring quarterly. CMS reconciliation began 9
months after the quarter's end. The CMS reconciliation process
completes all denials and appeals approximately 15 months after
the last quarter of episodes.
Results
The baseline group was calculated from 582 episodes that
occurred from July 2009 to June 2012. The BPCI study group
included 332 episodes from July 2015 to September 2016. The total
BPCI savings per episode during the study, as defined by reduction
in total cost for CMS per episode, represented a 20.0% reduction in
overall costs, from $34,299 to $27,453, saving CMS an average of
$6846 per episode (P ¼ .10; Table 1). Because of a large standard
deviation in BPCI episode costs (±$19,735), this only trended to-
ward statistical significance.
The average hospital LOS demonstrated decreased from 4.9 to
3.49 ± 2.71 days (P ¼ .02; Table 1). All-cause readmissions within 90
days of surgery also decreased from 14.5% to 8.2% (P ¼ .0078).
Discharge disposition drastically improved under BPCI. Before BPCI,
only 11.6% of patients were discharged home, which improved to
49.8% after the initiative (P ¼ .005). Discharges to SNF and IRF
reduced from 78.5% to 48.3% (P ¼ .001) and 9.6% to 1.8% (P ¼ .015),
respectively. Overall, SNF days used per episode also decreased
from 23 to 15.8 days (P ¼ .02), with only 13.3 days used on average
in the last quarter.
2364 J.S. Preston et al. / The Journal of Arthroplasty 33 (2018) 2362e2367
Table 1
Adjusted Historic Average vs First Year Under BPCI.
Jul 2015 to Sep 2016 Adjusted Historica (n) BPCIb (n)
(2015Q3-2016Q3)
Episode count 582 332
Hospital LOS, d 4.9 3.49 ± 2.71
% Patients discharge home 11.6% (67) 49.8% (165)
% Patients discharge SNF 78.5% (457) 48.3% (162)
% Patients discharge IRF 9.6% (56) 1.8% (6)
90-d readmission rate 14.5% (84) 8.2% (28)
Average cost per episode $34,299 $27,453 ± $19,735
SNF days 23.0 15.8 ± 10.9
BPCI, Bundled Payments for Care Improvement; IRF, inpatient rehabilitation facility; LOS, length of stay; SNF, subacute nursing facilities.
Bold font represents significant values (P < .05).
a
Baseline group: July 2009 to June 2012.
b
BPCI group: July 2015 to September 2016, with standard deviations where appropriate.
c
Elective and fracture cases within the BPCI group, with standard deviations where appropriate.
Comparison of first quarter (2015Q3) with last quarter (2016Q3)
with BPCI demonstrated a trend toward improvement in dis-
charges, with an 8.3% increase in home discharges (P ¼ .367), and a
combined 8.5% drop in usage of SNF and IRF (P ¼ .647, P ¼ .564)
(Table 2). Subacute nursing facility days significantly decreased
from 17.0 to 13.3 days per episode (P ¼ .03). The overall trend to-
ward increased discharges to home and decrease in utilization of
rehabilitation facilities vs the historic cohort is illustrated in
Figure 1.
Comparison of fracture and elective cases under BPCI
demonstrated multiple important results (Table 1). When
compared with patients treated electively, patients treated for
fractures had a trend toward longer LOS (5.1 ± 2.16 vs 4.1 ± 1.52
days, P ¼ .31). Fracture patients had lower rates of home dis-
charges (6.1% vs 56.2%, P < .001), greater reliance on SNF (83.7% vs
43.1%, P < .001) and IRF (8.2% vs 0.01%, P < .001), required more
days in rehabilitation (23.4 ± 11.9 vs 14.6 ± 18.9 days, P ¼ .0017),
had a higher 90-day readmission rate (16.3% vs 8.1%, P ¼ .06),
and each episode costs nearly 70% more ($46,390 ± $17,366 vs
$27,418 ± $18,812, P < .001).
Discussion
The BPCI initiative models have shown great potential with
improved outcomes and lowered cost of care [2,9,15,17,22]. A recent
publication of TJA quality metrics comparing first with third year
BPCI participation reported improvements in LOS, readmission
rates, and discharge to home rates [26]. In a study similar to ours,
Edwards et al [22] also reported average hospital LOS decreasing
from 3.81 to 2.57 days for the BPCI group. Our LOS improved from
4.9 to 3.5 days, which represents a modest, but statistically signif-
icant improvement. We hypothesize that this reflects our group's
challenges to educate hospital staff on accelerated clinical path-
ways as well as successfully implementing and adopting these
pathways. In addition, when appropriate, we allowed patients to
stay an extra day in the hospital to promote home discharge when
patients would have otherwise been discharged to SNF. When LOS
was broken down between elective cases and fracture cases, there
was a marked difference, with LOS being 4.1 days among elective
arthroplasty cases and 5.1 days among fracture cases. Mandatory
participation in the Comprehensive Care for Joint Replacement
Model did not occur until April 2016, which signifies a lag time of
almost 1 year from when we enrolled in the BPCI initiative. We
coordinated with hospital staff including administrators, social
workers, case managers, physical therapists, and nurse practi-
tioners to develop streamlined discharge planning protocols for hip
and knee arthroplasty patients. One of the hospitals that we were
affiliated with eventually retained the third-party convener to
Change From Baseline Electivec (n) Fracturec Differences: Elective vs
Fracture
283 49
¡1.4; P ¼ .02 4.1 ± 1.52 5.1 ± 2.16 1.0; P ¼ .31
þ38.0%; P ¼ .005 56.2% (159) 6.1% (3) 50.1%; P < .001
¡30.2%; P ¼ .001 43.1% (122) 83.7% (41) 40.6%; P < .001
¡7.8%; P ¼ .015 0.01% (2) 8.2% (4) 8.2%; P < .001
¡6.3%; P ¼ .0078 8.1% (23) 16.3% (8) 8.2%; P ¼ .06
$6846; P ¼ .10 $27,418 ± $18,812 $46,390 ± $17,366 $18,972; P < .001
¡7.2; P ¼ .02 14.6 ± 18.9 23.4 ± 11.9 8.8; P ¼ .0017
manage a system-wide BPCI initiative, which further aided in
developing discharge planning protocols. Improvements in 90-day
all-cause readmission rates under BPCI have also been promising,
which we also demonstrated [15,22].
Improvement in LOS and readmission rates is believed to be
multifactorial. Utilization of enhanced support systems better
define the patient's social support network, providing early inter-
vention for any identified barriers and maintaining communi-
cations throughout the 90-day episode [22,23,27]. Our patients
were instructed to call the joint coordinator for any issues or con-
cerns; many were triaged over the phone or managed with a same
day or next day office appointment avoiding an emergency room
visit and potential readmission.
Pelt et al [15] noted a bias toward discharges to PAC services, as
many patients continue to have a belief and entitlement that they
will be discharged to PAC services after release from the hospital,
citing the need for higher level care to receive a better outcome, the
lack of support at home to help when they left the hospital, and
even the need to have a break from home duties after their surgery.
The challenge of debunking the myth in the public eye that “I have
to go to rehab to get better care and therapy” is significant and we
have encountered this in our experience. We have been able to
make steady progress in this regard through counseling and edu-
cation to patients and family/support system, and ensuring that
patients receive the same message from multiple providers across
the different care settings. During our education sessions, patients
were asked to identify their support person during their recovery
period and were encouraged to bring them to their physical therapy
education session and preoperative visit with the surgeon. A
multidisciplinary approach to improve patient education and
establish appropriate expectations is a key to improving disposi-
tions postoperatively [15]. “Fast track arthroplasty” can also
improve hospital LOS and has also been shown to be safe in
Medicare TKA patients [28]. Klingenstein et al [28] demonstrated
that when Medicare TKA patients met discharge criteria and were
discharged home within a day of surgery, they did not have an
increased risk of 30-day and 90-day readmissions compared with
traditional stay patients.
In our study, the BPCI group had a 20.0% ($6846) reduction in
overall cost to CMS, from $34,299 to $27,435 per episode in the
most recent quarter. This reduction is inline with previous studies,
demonstrating reductions of 11%-20% with BPCI [2,22,26,29].
Studies report that the anchor stay, also known as the index pro-
cedure, represents the largest cost associated with the TJA episode
[23], up to 55%-66% of the episode cost [22]. We were not able to
include any anchor stay costs savings in our study.
Discharges to anywhere but home lead to increased LOS, read-
missions, and substantially increased costs [2,9,14,15,26]. In a
 J.S. Preston et al. / The Journal of Arthroplasty 33 (2018) 2362e2367 2365

review of over 400 patients before and after BPCI implementation,

Change From Baselinec Change From 2015Q3 to 2016Q3

Pelt et al [15] found that discharge to PAC services was associated with
2.4 and 3.1 times greater risk for 30-day readmissions and 30-day
reoperations, respectively. In addition, patients discharged to PAC
services were also at greater risk for both 90-day readmissions and
90-day reoperations. PAC services are not only a risk factor for read-

4.3%; P ¼ .647
4.2%; P ¼ .564
missions and reoperations, but Edwards et al [22] showed that they
8.3%; P ¼ .367

0.2%; P ¼ .982
¡3.7; P ¼ .03
$7609; P ¼ .1
represent a large opportunity for cost savings. In their study, PAC
services accounted for 22% of their overall episode cost, but 87% of
episode savings were achieved in the PAC phase. They had an
impressive discharge home rate of 98.3% for their BPCI, whereas
discharge to IRFs, SNFs, or long-term acute care hospitals was 0%, 1.7%,
and 0%, respectively. We improved our discharge to home rate by 38%,
þ38.0%; P ¼ .005
¡30.2%; P ¼ .001

¡6.3%; P ¼ .0078
¡7.8%; P ¼ .015

$6846; P ¼ .10

from 11.6% to 49.8%, which is similar to those previously published by

¡7.2; P ¼ .02

Dundon et al [23] and Iorio et al [19], who report relative reductions in

discharges to PAC services of 34% and 38%, respectively.
There remains some controversy over the safety of increasing
home discharges, as it has been shown that patients discharged
$27,435 ± $11,889

to PAC services are usually older and have more medical

comorbidities [30e32]. However, multiple studies have shown
that despite age, sex, or ASA classification, discharge to PAC
services remains an independent risk factor for readmissions
2016Q3

0.01%
56.3%
43.7%

8.5%

and reoperations [2,15,19,33,34]. Indications for discharge to PAC

13.3
71

facilities may still exist, so it is not prudent to completely

$27,503 ± $13,977

remove them from the clinical pathway. Further studies are

needed to identify these indications. In our practice, we
continue to use the Risk Assessment and Prediction Tool to help
identify patients who may need PAC services. When these do
2016Q2

53.0%
45.5%
0.0%
4.5%

arise, we prefer that patients use our preselected facilities that

17.1
67

meet strict criteria for our postoperative protocols and discharge

$29,637 ± $13,293

expectations. We do not have absolute control over this, how-

ever, as we are still challenged with patients who choose to go to
BPCI, Bundled Payments for Care Improvement; IRF, inpatient rehabilitation facility; SNF, subacute nursing facility.

nonpreferred facilities for a variety of reasons. As shown in

2016Q1

Tables 1 and 2, this has led to a marked drop in subacute nursing

41.6%
54.5%
3.9%
6.5%
19.0

facility LOS from our historic average of 23 to 13.3 days in the

77

most recent quarter.

$33,012 ± $20,399

Additional cost savings may also include discontinuation of

routine use of outpatient physical therapy for all total hip arthro-
plasties, which has been shown to not be necessary for some pa-
2015Q4

tients [35]. Up to 3% savings has been documented with this tactic

44.9%
53.6%
1.4%
11.6%
25.4

[22]. In addition Edwards et al [22] demonstrated that when TKA

69

patients were directed to use outpatient physical therapy, it

Comparison of Our Adjusted Historic Average vs Quarter by Quarter Under BPCI.

$35,044 ± $36,355

resulted in a 60% reduction in cost for home health care services per
episode.
Change from baseline: comparison of historical cohort vs BPCI group.

Although we report large improvements with implementa-

2015Q3

tion of BPCI, it is difficult to report individual readmissions or

48.0%
4.2%
8.3%

BPCI group: July 2015 to September 2016 (2015Q3-2016Q3).

48.0

17.0

costs for an individual patient. In addition, our overall

48

improvement in costs was significantly impacted by the inclu-

$27,453 ± $19,735

sion of arthroplasties for fracture care. Patients who were

captured by the bundle because they were treated with arthro-
49.8% (165)
48.3% (162)

15.8 ± 10.9

plasty for fractures required longer LOS and had a higher inci-
8.2% (28)
1.8% (6)
BPCIb (n)

Bold font represents significant values (P < .05).

dence of discharges to rehabilitation facilities, and also had a

332

Baseline group: July 2009 to June 2012.

double 90-day readmission rate vs their elective counterparts

(Table 1). This patient population is the most challenging to
Historica (n)

78.5% (457)

manage under the current model. These results substantiate

11.6% (67)

9.6% (56)
14.5% (84)
Adjusted

$34,299

prior findings that fracture patients undergoing hip arthroplasty

23.0
582

for fracture care are significantly older and have more medical
comorbidities than patients treated on an elective basis, leading
90-d readmission rate

to more in-hospital complications, greater LOS, increased

Discharge to home

admission to the intensive care unit, increased hospital costs, and

Discharge to SNF
Discharge to IRF

significantly more hospital readmissions [13,21,36,37]. It is

important that future bundled payment models include an
SNF days
Episodes

adjustment for management of fracture patients and that it be

Table 2

Cost

adequately large enough to prevent incentives against providing

a
b
c

arthroplasty for hip fracture patients.

 2366 J.S. Preston et al. / The Journal of Arthroplasty 33 (2018) 2362e2367
web 4C=FPO
Fig. 1. Line graph demonstrating increased rate of discharges to home along with decreases in usage of SNF, IRF, and episodes with a readmission over the course of our first 5
quarters under BPCI. The adjusted historic cohort data are also included for comparison. BPCI, Bundled Payments for Care Improvement; IRF, inpatient rehabilitation facility; SNF,
subacute nursing facility.
Limitations to this study include the small study size of a private
practice with only 2 joint replacement surgeons. It is expected that
larger institutions would have more influence with hospital
compliance to new clinical pathways and onboarding PAC facilities
to further improve LOSs and decrease readmissions. In addition, our
historical cohort comprised data from 5 years before imple-
mentation of BPCI, and thus there may be numerous confounders
lowering the Medicare claims over that period. There is also a
learning curve with implementation of care with the BPCI initiative
as we continue to counsel and educate patients on postoperative
expectations, with the limitations of being able to do this efficiently
in the private setting. Optimizing patient's health and changing
postdischarge expectations is a time-consuming process and being
able to do so efficiently in a private practice setting is challenging.
Also, our practice does not participate in capitated pricing for im-
plants, which can further improve cost savings [22]. We also did not
break down costs associated with improved LOS and other anchor
stay cost savings. Unfortunately, because of the deidentified nature
of our data, we were not able to compare comorbidities or ages
between the historical cohort and BPCI cohort. There is the possi-
bility that participation in BPCI leads to cherry picking of patients,
and thus, better results with BPCI. Lastly, the inclusion of arthro-
plasty for fracture patients certainly impacted mean hospital and
PAC LOSs.
Conclusion
Overall, our small, private multisubspecialty orthopedic practice
has shown great improvement in postoperative management for
TJA patients in just 1 year under the BPCI initiative, with increased
discharges to home, decreased readmissions, decreased episode
costs for CMS. We expect discharge dispositions to continue to
improve with the use of our CP, which will lead to an overall
decrease in CMS costs per episode. With the help of a third-party
convener and a dedicated total joint coordinator, participation in
BPCI not only results in improved patient outcomes, which can be
translated to all patients undergoing elective arthroplasty, but it
also leads to significant cost savings for CMS. Because of the in-
clusion criteria of the model, postacute management of patients
undergoing arthroplasty for fracture continues to pose a consider-
able challenge. This bundled payment model could be improved by
reimbursing at proportionately higher rates for patients undergo-
ing arthroplasty for femoral neck fracture because they tend to be
more expensive than their elective counterparts with longer LOS
and more readmissions [21]. With the current administration
having scaled back the Comprehensive Care for Joint Replacement
Model and shifting focus to voluntary bundles, our results suggest
that BPCI is a favorable way for CMS to achieve its goal of reducing
spending while preserving or improving quality.
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 The Journal of Arthroplasty 33 (2018) 2623e2626

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Other

Chronic Obstructive Pulmonary Disease Is Associated With

Short-Term Complications Following Total Knee Arthroplasty
George A. Yakubek, DO a, Gannon L. Curtis, MD a, Anton Khlopas, MD a,
Mhamad Faour, MD a, Alison K. Klika, MS a, Michael A. Mont, MD a,
Wael K. Barsoum, MD b, Carlos A. Higuera, MD a, *
a
Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio
b
Department of Orthopaedic Surgery, Cleveland Clinic Florida, Weston, Florida

a r t i c l e i n f o a b s t r a c t

Article history: Background: Chronic obstructive pulmonary disease (COPD) is a major global health issue and a leading
Received 12 February 2018 cause of morbidity and mortality. Patients with COPD are at increased risk of complications following
Received in revised form surgery. The purpose of this study is to evaluate the postoperative total knee arthroplasty (TKA) out-
2 March 2018
comes in these patients in comparison to a non-COPD matching cohort. Specifically, we asked the
Accepted 6 March 2018
Available online 15 March 2018
following questions: (1) “Is COPD associated with adverse perioperative outcomes?” and (2) “Does COPD
increase the risk of short-term complications following TKA?”
Methods: The American College of Surgeons National Surgical Quality Improvement Program database
Level of Evidence:
Level III, Therapeutic study
was used to identify 111,168 patients who underwent TKA between 2008 and 2014. A total of 3975
patients with COPD were identified. Both COPD and non-COPD cohorts were compared in terms of the
Keywords: following outcomes: hospital length of stay, discharge disposition, and 30-day postoperative
total knee arthroplasty complications.
chronic obstructive pulmonary disease Results: COPD was a predictor for a prolonged length of stay and a discharge to an extended care facility
lengths of stay
(P < .001). They were at significantly increased risk of any complication including increased mortality,
readmission
discharge disposition
pneumonia, reintubation, use of a mechanical ventilator for >48 hours, cardiac arrest, progressive renal
complications insufficiency, deep infection, return to operating room, and a readmission within 30 days postoperatively.
Conclusion: Patients with COPD are more likely to experience postoperative complications following TKA
when compared to non-COPD patients. Pulmonary evaluation and optimization are crucial to minimize
adverse events from occurring in this difficult-to-treat population.
© 2018 Elsevier Inc. All rights reserved.

Chronic obstructive pulmonary disease (COPD) is characterized as
a nonreversible progressive limitation of airflow caused by chronic
inflammation induced by either particles or noxious gases [1,2]. It
poses an important worldwide health burden and is a leading cause
of morbidity and mortality with an estimated prevalence of 11% in
Disclaimer: ACS NSQIP and the hospitals participating in the ACS NSQIP are the
source of the data used herein; they have not verified and are not responsible for
the statistical validity of the data analysis or the conclusions derived by the authors.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.011.
* Reprint requests: Carlos A. Higuera, MD, Department of Orthopaedic Surgery,
Cleveland Clinic, Cleveland, OH 44195.
adults over 40 years of age [1,3]. Despite the large number of afflicted
individuals, reports suggest that COPD is actually underdiagnosed [4]
and is projected to be ranked third of disorders contributing to in-
creases in mortality worldwide by the year 2020 [1,2]. In addition, it
has been demonstrated that patients with COPD are at an increased
risk of postoperative complications [5e9].
As the population is aging with longer life expectancies, the
prevalence of both COPD and osteoarthritis (OA) is on the rise.
These patients may be part of the growing number of those who
experience marked disability and diminished quality of life and
require a total knee arthroplasty (TKA) [10]. Furthermore, more
physicians will provide care for patients with COPD who require
TKA or surgical intervention as these trends continue. Multiple
studies have reported that it is a risk factor for certain complica-
tions following TKA [11,12], leading to potentially more difficult
surgical and postoperative patient management.

https://doi.org/10.1016/j.arth.2018.03.011
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2624 G.A. Yakubek et al. / The Journal of Arthroplasty 33 (2018) 2623e2626

Although some studies have identified COPD as a surgical risk Table 1

factor, to the best of the author’s knowledge, no studies have Comparison of Preoperative Variables Including Demographics, Blood Lab Values,
and Comorbidities.
comprehensively identified postoperative complications and or
adverse outcomes associated with TKA. Therefore, the purpose of Demographics Control Group COPD Group P Value
this study was to evaluate the perioperative variables and post- (N ¼ 107,193) (N ¼ 3975)

operative outcomes of COPD patients who underwent TKA in Age (y) (mean ± SD) 66.8 ± 9.7 68.7 ± 9.7 <.001
comparison to a matching non-COPD cohort. We asked the Sex, female (%) 67,437 (63) 2436 (61) .041
BMI (kg/m2) (mean ± SD) 32.9 ± 7.1 34.1 ± 7.7 <.001
following questions: (1) “Is COPD associated with adverse periop-
Active smoker (%) 8350 (8) 1034 (26) <.001
erative outcomes including increased hospital length of stay (LOS) Functional status (%) <.001
and discharge to a nonhome facility?” and (2) “Does COPD increase Independent 105,185 (98) 3814 (96)
the rate of early postoperative complications (ie, within 30 days) Somewhat independent 1746 (2) 137 (4)
Completely dependent 63 (<1) 4 (<1)
including return to the operating room and a readmission within 30
ASA class,  3 (%) 49,418 (46) 3260 (82) <.001
days following TKA?” We hypothesize that these patients will be at Anesthesia, general (%) 56,979 (53) 2211 (56) .001
increased risk of developing adverse perioperative outcomes and
Lab Values Control Group COPD Group P Value
postoperative complications when compared to patients who do
not have COPD. Sodium (mEq/L) 139.5 ± 2.7 1.39.3 ± 3.1 <.001
(mean ± SD)
Creatinine (mg/dL) 0.92 ± 0.42 0.98 ± 0.47 <.001
Methods (mean ± SD)
BUN (mg/dL) (mean ± SD) 18.1 ± 7.0 18.4 ± 8.0 .112
Database Hematocrit (%) 40.6 ± 4.0 40.4 ± 4.4 .006
WBC (cells/mcL) 7.0 ± 2.1 7.7 ± 2.4 <.001
(mean ± SD)
The American College of Surgeons National Surgical Quality Platelets (platelets/mcL) 244 ± 66 244 ± 72 .949
Improvement Program (ACS NSQIP) database was queried for this (mean ± SD)
study from January 1, 2008, to December 31, 2014. It is a risk-
Comorbidities Control Group COPD Group P Value
adjusted, case-weighted clinical database containing more than
300 variables and it tracks patients for 30 days after surgery [13]. Hypertension (%) 71,162 (66) 3075 (77) <.001
CHF (%) 204 (<1) 47 (1) <.001
Skilled reviewers from over 700 contributing mostly high-volume Diabetes (%) 18,890 (18) 997 (25) <.001
academic and community hospitals prospectively collect these Acute renal failure (%) 30 (<1) 1 (<1) >.999
data [13]. The data collection methodology has been described in Dialysis (%) 146 (<1) 13 (<1) .002
greater detail elsewhere [14,15]. This study was deemed exempt by Cancer (%) 99 (<1) 8 (<1) .059
Ascites (%) 19 (<1) 0 (0) >.999
our institutional review board as the data used are de-identified
Steroid use (%) 3159 (3) 307 (8) <.001
and publicly available. Bleeding disorder (%) 2678 (3) 188 (5) <.001
Transfusion (%) 51 (<1) 2 (<1) .715
Patient Selection Wound infection (%) 362 (<1) 41 (1) <.001

COPD, chronic obstructive pulmonary disease; SD, standard deviation; BMI, body
Patients who had knee OA and who received a primary TKA mass index; ASA, American Society of Anesthesiologists; BUN, blood urea nitrogen;
between January 1, 2008, and December 31, 2014, were identified WBC, white blood cell; CHF, congestive heart failure.

using International Classification of Disease, 9th edition codes

715.98 and Current Procedural Terminology code 27447. This search
yielded a total of 112,034 patients. Patients were excluded if they
underwent a nonelective surgery (n ¼ 201; 0.2%) or had a con-
current surgery during their admission (n ¼ 209; 0.2%). A total of
111,168 eligible cases (99.6%) were identified. In the ACS NSQIP
database, a patient is listed as having COPD if the medical record
documents this diagnosis and one of the following within 30 days
of surgery: a functional disability due to COPD (ie, dyspnea),
chronic bronchodilator therapy, an exacerbation requiring hospi-
talization, or a forced expiratory volume in 1 second less than 75%
of expected. Of the 111,168 eligible patients, 3975 (mean age, 68.7 ±
9.7 years) had a diagnosis of COPD before surgery and 107,193 pa-
tients (mean age, 66.8 ± 9.7 years) did not. Preoperative variables
were collected and included demographics, blood lab values, and
comorbidities (Table 1).
Perioperative and Postoperative Outcomes
Hospital LOS and discharge destination status comprised admis-
sion outcomes. Complication rates were tracked for 30 days post-
operatively. These included any complication, mortality, stroke, deep
vein thrombosis, pulmonary embolism, cardiac arrest, myocardial
infarction (MI), superficial surgical site infection (SSI), deep SSI, or-
gan/space SSI, wound dehiscence, pneumonia, reintubation, venti-
lator needed for >48 hours, urinary tract infection , progressive renal
insufficiency, acute renal failure, systemic sepsis, septic shock, blood
transfusion, return to operating room, and 30-day readmission as
defined by the ACS NSQIP [13]. Surgical and medical complications
were both included in the variable “any complication.” However, this
study focused more on medical complications and we did not
identify surgical complications.
Data Analysis
The data for each cohort were extracted into a Microsoft Excel
spreadsheet (2013 Microsoft Office Professional Plus; Redmond,
WA). Independent t-tests were applied to numerical values, while
chi-square or Fisher exact tests were used for categorical variables.
Multivariate regression models were developed using variables
which were significantly different after bivariate analysis. These
models were used to adjust for confounding variables and identify
COPD as a risk factor for each complication. All tests were 2-sided
and a significance of P  .05 was used. Statistical tests were run
on IBM SPSS Statistics 23 for Mac (IBM Corporation, Armonk, NY).
Results
Perioperative Outcomes
Bivariate analysis revealed statistical differences (P  .05) in
LOS and nonhome discharge (Table 2). Multivariate regression
revealed COPD to be an independent risk factor for LOS, nonhome
discharge disposition, return to operating room, and a 30-day
 G.A. Yakubek et al. / The Journal of Arthroplasty 33 (2018) 2623e2626 2625

Table 2 Table 4
Comparison of Perioperative Hospital Outcomes. Adjusted Multivariate Regression Analysis of Perioperative Outcomes and Post-
surgical Complications Following Primary Total Knee Arthroplasty in Patients With
Perioperative Outcomes Control Group COPD Group P Value Chronic Obstructive Pulmonary Disease (N ¼ 3975).
(N ¼ 107,193) (N ¼ 3975)
Variable b-Coefficient (b) 95% Confidence Interval P Value
Length of stay (d) (mean ± SD) 3.2 ± 3.6 3.7 ± 6.2 <.001
Discharge disposition other than 28,326 (30) 1520 (44) <.001 Length of stay 0.28 0.15-0.40 <.001
“home” (%) Nonhome discharge 1.41 1.30-1.52 <.001
Return to operating room (%) 1233 (1.1) 81 (2.0) <.001
Odds Ratio 95% Confidence Interval P Value
30-d Readmission (%) 3053 (3.4) 246 (7.3) <.001
Any complication 1.17 1.08-1.28 <.001
COPD, chronic obstructive pulmonary disease; SD, standard deviation.
Mortality 2.08 1.14-3.78 .016
Pneumonia 2.84 2.07-3.90 <.001
readmission (P < .05 for all). Patients with COPD had a longer Reintubation 2.53 1.59-4.01 <.001
mean LOS at 3.7 days (standard deviation, ± 6.2 days) vs 3.2 days Ventilator >48 h 2.42 1.24-4.75 .010
(standard deviation, ± 3.6 days) (b, 0.28; 95% confidence interval Cardiac arrest 2.53 1.35-4.76 .004
Myocardial 1.10 0.62-1.95 .757
[CI], 0.15-0.40; P < .001). Approximately 44% of patients who had
infarction
COPD were discharged to a nonhome facility following TKA, Progressive renal 2.13 1.21-3.74 .008
compared to 30% of patients who did not have COPD (odds ratio insufficiency
[OR], 1.41; 95% CI, 1.30-1.52; P < .001). Acute renal 1.92 0.81-4.57 .139
failure/dialysis
Systemic sepsis 1.17 0.67-2.03 .591
Septic shock 1.93 0.90-4.16 .093
Postoperative Complications
Superficial SSI 0.97 0.65-1.43 .874
Deep SSI 1.96 1.10-3.48 .023
Following bivariate analysis, the following 30-day complications Organ/space SSI 1.31 0.63-2.74 .472
were found to be significantly different (P  .05) between the co- Blood transfusion 0.99 0.89-1.10 .828
horts: any complication, mortality, pneumonia, reintubation, use of Return to operating 1.35 1.06-1.72 .016
room
a ventilator for more than 48 hours, cardiac arrest, MI, progressive 30-d Readmission 1.67 1.45-1.94 <.001
renal insufficiency, acute renal failure necessitating dialysis, sys-
SSI, surgical site infection.
temic sepsis, septic shock, superficial SSI, deep SSI, organ/space SSI,
Adjusted for age, gender, body mass index, American Society of Anesthesiologists
blood transfusion, return to the operating room, and readmission class, anesthesia type, functional status, comorbidities (hypertension, diabetes,
(Table 3). Multivariate regression analysis (Table 4) identified COPD chronic obstructive pulmonary disease, acute renal failure, dialysis, steroid use,
as a predictor of any complication (OR, 1.17; 95% CI, 1.08-1.28; P < bleeding disorders, active smoker), and preoperative laboratory values (sodium,
.001), mortality (OR, 2.08; 95% CI, 1.14-3.78; P < .001), pneumonia blood urea nitrogen, creatinine, white blood cell count, hematocrit, platelets).

(OR, 2.84; 95% CI, 2.07-3.90; P ¼ .016), reintubation (OR, 2.53; 95%
CI, 1.59-4.01; P < .001), use of a ventilator for >48 hours (OR, 2.42;
95% CI, 1.24-4.75; P ¼ .010), cardiac arrest (OR, 2.53; 95% CI, 1.35- Discussion
4.76; P ¼ .004), progressive renal insufficiency (OR, 2.13; 95% CI,
1.21-3.74; P ¼ .008), deep SSI (OR, 1.96; 95% CI, 1.10-3.48; P ¼ .023), The prevalence of both COPD and knee OA in the aging popu-
return to the operating room (OR, 1.35; 95% CI, 1.06-1.72; P ¼ .016), lation is rapidly increasing worldwide, with more of these patients
and a 30-day readmission (OR, 1.67; 95% CI, 1.45-1.94; P < .001). undergoing TKA. Physicians and surgeons who are managing care
Regression analysis did not find COPD to be an independent risk for these patients must be aware of the potential increased com-
factor for MI, acute renal failure, sepsis, septic shock, superficial SSI, plications and risks associated with COPD and TKA. Therefore, the
organ/space SSI, or blood transfusion. purpose of this study is to report on the perioperative outcomes
and postsurgical complications within 30 days following TKA in
patients with COPD. Bivariate analysis demonstrated multiple sig-
Table 3 nificant differences between the 2 groups, highlighting the
Comparison of Short-Term Postoperative Complications Within 30 Days. importance of using multivariate analysis to properly identify in-
Complications (%) Control Group COPD Group P Value dependent risk factors. This study revealed that these patients had
(N ¼ 107,193) (N ¼ 3975) longer mean LOS, were more likely to be discharged to a nonhome
Any complication 16,866 (15.7) 829 (20.8) <.001 facility, and had an increased risk of developing a postoperative
Mortality 120 (0.1) 15 (0.4) <.001 complication, including pneumonia, reintubation, use of mechan-
Pneumonia 336 (0.3) 56 (1.4) <.001 ical ventilation greater than 48 hours, urinary tract infection, sys-
Reintubation 164 (0.2) 24 (0.6) <.001
temic sepsis, and a superficial SSI, return to the operating room, and
Ventilator >48 h 70 (0.1) 12 (0.3) <.001
Cardiac arrest 91 (0.1) 12 (0.3) <.001 a readmission within 30 days. The data from this study reinforce
Myocardial infarction 230 (0.2) (0.4) .031 the crucial importance of thorough perioperative pulmonary
Urinary tract infection 1106 (1.0) 51 (1.3) .124 evaluation and optimization and may aid physicians and surgeons
Progressive renal insufficiency 120 (0.1) 16 (0.4) <.001 when counseling patients regarding risks associated with COPD
Acute renal failure/dialysis 67 (0.1) 6 (0.2) .046
patients who undergo TKA. Therefore, a thorough pulmonary
Deep venous thrombosis 1047 (1.0) 39 (1.0) .975
Pulmonary embolism 729 (0.7) 33 (0.8) .259 evaluation and medical optimization are a critical step in preop-
Stroke 91 (0.1) 5 (0.1) .398 erative management for these patients considering TKA as many of
Systemic sepsis 232 (0.2) 15 (0.4) .034 the complications identified from this study are medical in nature.
Septic shock 73 (0.1) 9 (0.2) .003
This study had several limitations. The study focused more on
Superficial SSI 595 (0.6) 32 (0.8) .038
Deep SSI 155 (0.1) 14 (0.4) .001 medical complications; therefore, we did not correlate certain
Organ/space SSI 130 (0.1) 10 (0.3) .023 variables, such as periprosthetic fractures and dislocations, to the
Wound dehiscence 209 (0.2) 12 (0.3) .137 presence of COPD, which can be the basis for future work.
Blood transfusion 11,118 (10.3) 459 (11.5) .017 Furthermore, we used one of the large national database which is
COPD, chronic obstructive pulmonary disease; SSI, surgical site infection. often criticized for their lack of precision and accuracy. However,
2626 G.A. Yakubek et al. / The Journal of Arthroplasty 33 (2018) 2623e2626
the ACS NSQIP uses trained personnel to manually abstract data
from patient medical records, rather than solely relying on
administrative data through coding [16e19]. Its main limitation is
being a large database with a disproportionately large contribution
by academic institutions. However, most COPD patients would
more likely be done in these institutions. In addition, this study
cohort had a short-term postoperative follow-up of 30 days with a
longer follow-up that may have provided information on additional
later complications which otherwise might not be seen. Further-
more, there may have been some complications which were not
statistically significant likely due to having an extremely low inci-
dence and would require a much larger cohort of COPD patients for
proper identification. In addition, this study did not determine
reasons for returns to the operating room, which could be studied
using a different database. Despite these limitations, this is the
largest study to evaluate the increased risks of overall complica-
tions in COPD patients following TKA, to the best of our knowledge.
Multiple other studies have reported similar findings in COPD
patients. Higuera et al [20] evaluated 502 patients who underwent
either TKA (n ¼ 204) or THA (n ¼ 198) and found that COPD was
associated with a prolonged LOS after TKA (relative risk, 1.25; 95%
CI, 1.01-1.57), as well as THA (relative risk, 1.30; 95% CI, 1.03-1.64),
but not for discharge destination. Keswani et al [21] reported COPD
to be an independent risk factor for nonhome discharge destination
(OR, 1.39; 95% CI, 1.30-1.50) and unplanned 30-day readmission
(OR, 1.51; 95% CI, 1.32-1.72). Similarly, Pugely et al [22] identified
COPD to be a risk factor for an unplanned readmission following
TKA and reported 30-day readmission incidence of 5.34% vs 3.34%
in patients without COPD (P ¼ .013). Furthermore, Courtney et al
[23] evaluated 1012 TKAs and THAs and found COPD to be an in-
dependent risk factor for having a complication within 24 hours of
postsurgical time (OR, 4.16; 95% CI, 1.86-9.32).
Conclusion
In conclusion, this study determined that patients with COPD
who undergo primary TKA are at an increased risk of complica-
tions requiring a hospital readmission. It provides valuable in-
formation from a large cohort of COPD patients who underwent
TKA, in highlighting the increased risks of adverse outcomes in
this difficult-to-treat population. These data reinforce the critical
importance of thorough perioperative pulmonary evaluation and
optimization and will aid physicians and surgeons when coun-
seling patients about medical optimization, and the risks for
patients with COPD who are undergoing a primary TKA.
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 The Journal of Arthroplasty 33 (2018) 2684e2693

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Review

Clinical Outcomes of Gap Balancing vs Measured Resection in Total

Knee Arthroplasty: A Systematic Review and Meta-Analysis
Involving 2259 Subjects
Shuxiang Li, MD, Xiaomin Luo, MD, Peng Wang, MD, Han Sun, MD,
Kun Wang, PhD, MD, Xiaoliang Sun, PhD, MD *
Articular Orthopaedics, The Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, China

a r t i c l e i n f o a b s t r a c t

Article history: Background: The argument on the clinical effects between gap balancing (GB) and measured resection
Received 2 February 2018 (MR) in total knee arthroplasty remains to be resolved. A systematic review and meta-analysis was
Received in revised form performed to investigate which technique in total knee arthroplasty has better clinical effect.
26 February 2018
Methods: A total of 20 studies involving 2259 cases were included in the meta-analysis. The primary
Accepted 2 March 2018
outcome measure was Knee Society Score (KSS), whereas the secondary outcomes included other
Available online 17 March 2018
function assessment systems (eg, range of motion, Western Ontario and McMaster University Osteoar-
thritis Index), radiological outcomes (eg, femoral component rotation, total outliers), revision rate,
Keywords:
measured resection
complications (eg, infection, loosening, instability), and surgical time.
gap balancing Results: The GB technique was associated with statistically significant increases in the primary outcomes
total knee arthroplasty of KSS-function in 1 year. However, a mean difference of 2.12 points was below the minimal clinically
systematic review important difference of 6 points. No differences were found in the analyses of KSS-knee and KSS-function
meta-analysis in any other follow-up periods. Secondary outcome assessments showed significant decreased surgical
time (mean difference, 16.18; P < .00001) for MR. Although statistically significant difference in favor of
GB was identified in total outliers (risk ratio, 1.72, P ¼ .0004), the 2 techniques were comparable in range
of motion, Western Ontario and McMaster University Osteoarthritis Index, femoral component rotation,
complications, and revision rate.
Conclusion: We conclude that both techniques can result in equivalent results when done properly, and
each surgeon must understand the strengths and weaknesses of each technique.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) may be the best treatment for the
elderly patients with end-stage osteoarthritis [1]. To achieve a
balanced knee, 2 techniques have been widely used: measured
resection (MR) and gap balancing (GB). In the MR, anatomic land-
marks such as posterior femoral condylar axis and anterior-
posterior are used to direct the resection of bone and determine
femoral component rotation. And soft tissue releases are subse-
quently undertaken to ensure balance of the extension and flexion
Shuxiang Li and Xiaomin Luo contributed equally to this work.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.015.
* Reprint requests: Xiaoliang Sun, PhD, MD, Articular Orthopaedics, The Third
Affiliated Hospital of Soochow University, 185 Juqian Road, Changzhou 213003,
Jiangsu, China.
gaps [2,3]. In contrast, the GB uses soft tissue releases to create a
rectangular gap in extension. The flexion gap in the GB technique is
determined by placing the knee under tension in flexion and
rotating the femoral component to create a symmetric flexion gap,
which is performed parallel to the resected surface of the tibia [2,4].
On the basis of decreased incidence of condylar lift-off, the GB
technique has been thought to potentially improve implant insta-
bility when compared with the MR technique [4]. Moreover, the
difference in femoral component rotation in favor of GB has been
noted in 2 meta-analyses [5,6]. Overall, clinical results after TKA
might be affected by kinematic differences between the 2
techniques.
Recently, controversy still exists regarding the clinical effects of
MR or GB technique in TKA. As far as we know, few meta-analyses
have directly compared clinical outcomes between the 2 tech-
niques. Only 1 meta-analysis has been recently published in 2017 to

https://doi.org/10.1016/j.arth.2018.03.015
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693 2685

compare Knee Society Score (KSS) between the techniques based on
3 randomized, controlled trials (RCTs) [6]. Between 2016 and 2018,
many new controlled trials were published to investigate clinical
outcomes between the 2 techniques [7e13]. Thus, we included 20
articles (15 RCTs) to conduct a systematic review and meta-analysis
to make a relatively more credible and overall assessment about
which technique in TKA has better clinical effects.
phrases “gap balancing,” “gap balanced,” “measured resection,”
“total knee arthroplasty,” and “total knee replacement” for all
relevant English language trials. In addition, references cited by the
relevant sources were also hand-searched to identify any additional
articles that were not found in our database query.
Inclusion and Exclusion Criteria

Methods Study included in our meta-analysis had to meet the following

Search Strategy
The Preferred Reporting Items for Systematic Reviews and
Meta-Analyses reporting guidelines [14] and the recommendations
of the Cochrane Collaboration [15] were followed to conduct the
present meta-analysis. From the inception to January 2018, 2 in-
dependent investigators searched the PubMed, EMBASE, Web of
Science, and Cochrane Library electronic databases using the key
criteria: (1) patients with noninflammatory osteoarthritis of the
knee requiring primary TKA; (2) RCTs or nonrandomized,
controlled trials (nRCTs) focusing on comparing MR and GB tech-
niques during TKA intervention; (3) articles written in the English
language; (4) at least one of the following outcome measures was
reported: functional assessment (eg, KSS, range of motion [ROM],
Western Ontario and McMaster University [WOMAC] Osteoarthritis
Index), radiological outcomes (eg, femoral component rotation,
total outliers), revision rate, complications, and surgical time.

Records identified through database

searching
(n = 1040)
PubMed = 309
Web of Science = 336
EMBASE = 359

Removed after duplicating

(n = 527)

Records after duplicates removed

(n = 472)
Exclusion after title/abstract
review
(n = 431)
Full-text articles assessed
for eligibility
(n = 41)
Meta-analysis (n = 2)
Conference abstract (n = 5)
No comparison of GB
and MR techniques (n = 8)
Introduction of technique (n = 3)
Lack of useful outcomes (n = 2)
A comparison of patient individualized
jigs with GB (n = 1)

Studies included in
quantitative synthesis
(meta-analysis)
(n = 20)

Fig. 1. Flow diagram showing details of literature search; MR, measured resection; GB, gap balancing.
2686 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693

Table 1
Study Characteristics and Patient Demographic Details.

Study Design Year Country Journal No of Patients No of Knees MR GB Gender (M/F) Average Mean Follow-Up
Age (y)

MR GB MR GB

Hommel et al RCT 2017 Germany Eur J Orthop Surg Traumatol 50 50 25 25 14/11 15/10 68.4 67.6 1y
Hommel et al RCT 2018 Germany The Open Orthop J 200 200 100 100 37/63 38/62 66.9 67.1 10 y
Teeter et al RCT 2017 Canada J Arthroplasty 23 24 12 12 7/5 3/8 70.0 67.2 1y
Babazadeh et al RCT 2014 Australia J Arthroplasty 103 103 52 51 22/30 14/37 70.2 69.9 2y
Babazadeh et al RCT 2018 Australia J Arthroplasty 88 88 43 45 NC NC NC NC 5y
Becker et al RCT 2012 Germany Knee Surg Sport Tr A 116 116 63 53 NC NC 68.9 68.9 1y
Lee et al RCT 2010 South Korea Knee Surg Sport Tr A 116 116 56 60 2/54 3/57 67 66 NC
Lee et al RCT 2011 South Korea Knee Surg Sport Tr A 60 60 30 30 2/28 2/28 68.9 68.9 2y
Lee et al RCT 2017 South Korea Bmc Musculoskel Dis 101 101 51 50 2/49 1/49 68.6 70.8 2y
Luyckx et al RCT 2012 Belgium J Bone Joint Surg Br 96 96 48 48 14/34 18/30 64 65 NC
Pang et al RCT 2011 Singapore Knee Surg Sport Tr A 140 140 70 70 12/58 10/60 70 68 2y
Singh et al RCT 2012 UK J Orthop Surg-hong K 52 52 26 26 21/31 73 2y
Stephens et al RCT 2014 USA Knee 200 200 100 100 NC NC NC NC NC
Tigani et al RCT 2010 Italy Knee Surg Sport Tr A 123 123 66 57 20/46 15/42 69 67 NC
Baier et al RCT 2014 Germany Int Orthop 40 40 21 19 15/25 70 6 mo
Nikolaides et al Prosp 2014 Greece J Orthop Surg-hong K 63 63 34 29 2/32 4/25 71 70 7d
Churchill et al Retrosp 2018 USA J Knee Surg 214 221 116 105 NC NC 66 3y
Clement et al Retrosp 2017 UK Knee 144 144 92 52 50/42 15/37 69.2 68.7 5.4 y
Matsumoto et al Retrosp 2014 Japan Int Orthop 224 255 120 135 9/95 14/106 74.0 74.6 2 y
Sabbioni et al Retrosp 2011 Italy Musculoskelet Surg 67 67 36 31 8/28 6/25 69 67 NC

MR, measured resection; GB, gap balancing; M, male; F, female; RCT, randomized, controlled trial; NC, not clear; Prosp, prospective trial; Retrosp, retrospective trial.

Articles with no assessment of outcomes mentioned above or no
comparison of GB and MR techniques were not included into
analysis. Biochemical trials, reviews, case reports, letters, and
conference abstract were excluded. Duplicate and cadaver reports
were also eliminated.
Data Extraction
Two independent reviewers extracted and collected the following
descriptive information from the included trials: (1) study charac-
teristics such as author, study design, year of publication, country,
and journal; (2) patient demographic details such as number of
cases, average age, and gender; (3) mean follow-up period. The pri-
mary outcome measure was KSS, whereas the secondary outcomes
included other function assessment systems (eg, WOMAC, ROM),
femoral component rotation, total outliers (an outlier of mechanical
axis [coronal tibiofemoral angle] was defined as a deviation over 3
of the varus or valgus), revision rate, complications, and surgical
time. The data would be collected into different subgroups of similar
periods when a study reported outcomes at multiple follow-up time.
If the data could not be extracted directly, we contacted the authors
to ensure that the information integrated. Otherwise, we extracted

Table 2
Methodological Assessment According to 7 Domains of Potential Biases (ROBINS-I).

nRCT Study ¼ 5 Bias due to Bias in Bias in Bias due to Departures Bias due to Bias in Bias in Selection of Overall Bias
Confounding Selection of Measurement From Intended Missing Data Measurement the Reported Result
Participants of Interventions Interventions of Outcomes

Nikolaides et al, 2014 Low Low Low Low Low Moderate Low Low
Churchill et al, 2018 Moderate Low Low Low Moderate Moderate Moderate Moderate
Clement et al, 2017 Moderate Moderate Low Low Low Moderate Low Moderate
Matsumoto et al, 2014 No information Serious Moderate No information Serious Moderate Low Serious
Sabbioni et al, 2011 Moderate Critical Moderate Low Low Low Serious Moderate

Methodological Assessment According to 6 Domains of Potential Biases (Cochrane Risk of Bias Tool).

RCT Study ¼ 15 Sequence Allocation Blinding of Blinding of Outcome Incomplete Selective Other Potential Overall Bias
Generation Concealment Participants Assessors Outcome Data Outcome Threats to Validity
and Personnel Reporting

Hommel et al, 2017 Low Unclear Low Low Low Low Low Low
Hommel et al, 2018 Low Low Low Low Low Low Low Low
Teeter et al, 2017 Low Low Unclear Unclear Low Low Low Low
Babazadeh et al, 2014 Low Unclear Unclear Low Low Low Low Low
Babazadeh et al, 2018 Low Unclear Unclear Low Low Low Low Low
Becker et al, 2012 Low Low Unclear Low Low Low Low Low
Lee et al, 2010 Low Unclear Low Low Low Low Low Low
Lee et al, 2011 Low High High Low Low Low Low High
Lee et al, 2017 Low Low Low Low Low Low Low Low
Luyckx et al, 2012 Low High Low High Low Low Low High
Pang et al, 2011 Low Low Unclear Low Low Low Low Low
Singh et al, 2012 Low Low Low Low Low Low Low Low
Stephens et al, 2014 Low Low Low Low Low Low Low Low
Tigani et al, 2010 Low Low Unclear Low Low Low Low Low
Baier et al, 2014 Low High Low Low Low Low Low Low

nRCT, nonrandomized, controlled trial; ROBINS-1, Risk of Bias in Non-Randomized Studies of Interventions.
 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693 2687

them from figures or calculated them with the guideline of Cochrane
Handbook for Systematic Reviews of Interventions 5.1.0.
Statistical Analysis
The present study was performed by Review Manager Software
(RevMan version 5.3, the Cochrane Collaboration, Copenhagen,
Denmark). Risk ratios (RR) with a 95% confidence interval (CI) or
mean difference (MD) with 95% CI were assessed for dichotomous
outcomes or continuous outcomes, respectively. P < .05 was set as
the level of significance. It was also considered as statistically sig-
nificant if “1” was not included in the 95% CI of RR or “0” was not
included in the 95% CI of MD. The Q test and I2 statistic were used to
assess the heterogeneity. When I2 < 40%, it was considered to
represent no significant heterogeneity, and then the fixed effect
model was used. On contrary, a random effects model was used for
the heterogeneity if I2  40%. We also conducted the sensitivity
analysis to evaluate whether any single study had the weight to
skew on the overall estimate and data. The Z test was used to assess
the overall effect.
Assessments of Study Quality
The risk of bias of included RCTs was independently evaluated
by 2 reviewers using the Cochrane risk of bias tool. This tool was
employed to assess the quality of RCTs by using the following 7
items: random sequence generation, allocation concealment,
blinding of participants and personnel, blinding of outcome
assessment, incomplete outcome data, selective reporting, and
other bias. The Risk of Bias in Non-Randomized Studies of In-
terventions assessment tool was used to assess the quality of nRCTs
[16]. This tool also includes the following 7 domains: bias due to
confounding, bias in the selection of participants, bias in mea-
surement of interventions, bias due to departures from intended
interventions, bias due to missing data, bias in measurement of
outcomes, and bias in selection of the reported result. Any con-
troversy was resolved by discussing with a third reviewer to ach-
ieve a final consensus.
As many outcome measures were investigated, we only assessed
publication bias of primary outcomes using funnel plot diagram.
The funnel plots of KSS-knee or KSS-function in 5 years were not

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Fig. 2. Forest plots of Knee Society Knee Score in the GB group and the MR group. (A) Follow-up in 6 months. (B) Follow-up in 1 year. (C) Follow-up in 2 years. (D) Follow-up in 5
years. SD, standard deviation; IV, inverse variance; CI, confidence interval.
2688 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693

provided in our study because only 2 studies were involved. The
funnel plot asymmetry was evaluated by an Egger's linear regres-
sion test to reveal any possible publication bias [17].
Results
Study Selection
On the basis of the key words mentioned above, a total of 1040
potentially relevant citations were initially identified from the 4
electronic databases: 359 from EMBASE, 336 from Web of Science, 309
from PubMed, and 36 from Cochrane library. After excluding 527
duplicate studies, 472 irrelevant articles were ruled out based on a title
and abstract review. We reviewed full text of the remaining 41 studies,
and 21 citations were deleted for reasons such as systematic reviews,
conference abstract, no comparison of GB and MR techniques, intro-
duction of technique, and lack of useful outcomes. In addition, 1 trial
comparing GB with patient-individualized jigs was also excluded [18].
Ultimately, 20 trials from 2010 to 2018 fulfilled the selection criteria
and were included in the present meta-analysis (Fig. 1).
Study Characteristics and Quality Assessment
The study baseline characteristics and patient demographic de-
tails can be seen in Table 1. A total of 2259 cases were enrolled in this
meta-analysis, with 1161 undergoing the MR technique and 1098
undergoing the GB technique. The rates of male between groups
were similar, as the male was 28.2% (6.6%-58.3%) in the MR group
and 27.9% (2.0%-60.0%) in the GB group (P ¼ .43). The average age in
the MR group was 67.5 years (64.0-74.0), while in the GB group was
67.8 years (65.0-74.6; P ¼ .67). The minimum follow-up period was 6
months and the maximum follow-up time was 10 years.
Fifteen RCTs [9e13,19e28], 1 prospective trial [29], and 4
retrospective comparative studies were assessed [7,8,30,31]. The
study qualities are shown in Table 2.
The Primary Outcome Measurements
KSS-Knee
Thirteen trials that included 1436 knees reported on KSS-knee
in different follow-up periods. On the basis of follow-up time, we

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Fig. 3. Forest plots of Knee Society Function Score in the GB group and the MR group. (A) Follow-up in 6 months. (B) Follow-up in 1 year. (C) Follow-up in 2 years. (D) Follow-up in 5
years.
 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693 2689

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Fig. 4. Forest plots of other functional outcomes in the GB group and the MR group. (A) WOMAC at 1 year. (B) ROM at 2 years. WOMAC, Western Ontario and McMaster University
Osteoarthritis Index; ROM, range of motion.

divided the results of KSS-knee into 4 subgroups. The differences
between the MR and GB groups were not statistically significant in
4 subgroups: (1) follow-up in 6 months: (MD, 0.39; 95% CI, 1.62
to 0.84; P ¼ .53; I2 ¼ 17%); (2) follow-up in 1 year: (MD, 0.38; 95%
CI, 1.93 to 1.17; P ¼ .63; I2 ¼ 48%, random effect model was used);
(3) follow-up in 2 years: (MD, 0.71; 95% CI, 2.18 to 0.77; P ¼ .35;
I2 ¼ 0%); (4) follow-up in 5 years: (MD, 1.58; 95% CI, 5.87 to 2.71;
P ¼ .47; I2 ¼ 52%, random effect model was used; Figs. 2A-2D).
neither of any group was insignificant (MD, 1.08; 95% CI, 0.26 to
2.43; P ¼ .11; I2 ¼ 0%; Fig. 4A).
Eight studies involving 1248 knees reported on the ROM 2
years postoperatively. There was no statistically significant dif-
ference in the ROM between the 2 groups (MD, 0.36; 95%
CI, 2.16 to 1.45; P ¼ .70; I2 ¼ 76%, random effect model was used;
Fig. 4B).

KSS-Function
KSS-function was available in 12 studies involving 1412 knees.
We also divided the KSS-function results into 4 subgroups based on
the follow-up period. The differences were comparable in 3 sub-
groups: (1) follow-up in 6 months: (MD, 0.46; 95% CI, 8.20 to 9.12;
P ¼ .92; I2 ¼ 82%, random effect model was used); (2) follow-up in 2
years: (MD, 1.73; 95% CI, 3.95 to 0.49; P ¼ .13; I2 ¼ 56%, random
effect model was used); (3) follow-up in 5 years: (MD, 1.91; 95%
CI, 4.30 to 0.47; P ¼ .12; I2 ¼ 0%). However, the difference between
the 2 groups was in favor of the GB group in 1 subgroup: (4) follow-
up in 1 year: (MD, 3.37; 95% CI, 6.33 to 0.40; P ¼ .03; I2 ¼ 50%,
random effect model was used; Figs. 3A-3D).
The Secondary Outcome Measurements
Other Functional Outcomes
Four studies with 367 knees showed the WOMAC at 1-year
follow-up. The difference between the 2 groups in favor of
Surgical Time
Surgical time was only found in 3 studies consisting of 400
knees. According to analysis, there were statistically significant
differences in favor of the MR group in surgical time (MD, 12.75;
95% CI, 20.76 to 4.74; P ¼ .002; I2 ¼ 92%, random effect model
was used; Fig. 5).
Radiological Outcomes
Five studies including 476 knees calculated femoral compo-
nent rotation. Data pooled from these studies showed no sig-
nificant difference between both groups (MD, 0.09; 95%
CI, 0.71 to 0.89; P ¼ .82; I 2 ¼ 75%, random effect model was
used; Fig. 6A).
Total outliers were found in 219 of the 685 knees (32.0%) in the
MR group and in 121 of the 679 knees (17.8%) in the GB group. There
was a significant difference between the 2 groups in favor of the GB
group (RR, 1.72; 95% CI, 1.72 to 2.32; P ¼ .0004; I2 ¼ 48%, random
effect model was used; Fig. 6B).

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Fig. 5. Forest plot of surgical time in the GB group and the MR group.
2690 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693

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Fig. 6. Forest plots of radiological outcomes in the GB group and the MR group. (A) Femoral component rotation. (B) Total outliers. M-H, Mantel-Haenszel.

Complications and Revision Rate
One of the 255 knees (0.4%) in the MR group and 3 of the 219
knees (1.4%) in the GB group had infection. The difference was not
significant (RR, 0.42; 95% CI, 0.08 to 2.21; P ¼ .31; I2 ¼ 0%; Fig. 7A).
Loosening was found in 13 of the 320 knees (4.1%) in the MR
group and in 7 of the 283 knees (2.5%) in the GB group. The meta-
analysis showed no significant difference between both groups (RR,
1.64; 95% CI, 0.71 to 3.79; P ¼ .25; I2 ¼ 0%; Fig. 7B).
Only 1 study reported instability. It was present in 1 of the 116
knees (0.86%) in the MR group and in 1 of the 105 knees (0.95%) in
the GB group. The difference was also not significant (RR, 0.91; 95%
CI, 0.06 to 14.29; P ¼ .94; I2 ¼ 0%; Fig. 7C).
Total complications were presented in 5 articles. Twenty-three
of the 390 knees (5.9%) in the MR group and 16 of the 353 knees
(4.5%) in the GB group showed total complications. Similarly, the
pooled result revealed that the 2 groups were comparable in terms
of the total complications (RR, 1.34; 95% CI, 0.74 to 2.45; P ¼ .34; I2 ¼
0%; Fig. 7D).
Four studies reported the revision rate in different follow-up
periods. Total revisions occurred in 14 of the 328 knees (4.3%) in
the MR group and in 10 of the 294 knees (3.4%) in the GB group.
However, we could not conduct a meta-analysis of the revision rate
on account of different follow-up periods in each included study.
Moreover, no statistically significant difference in revision rate was
revealed in all 4 studies (Table 3).
Sensitivity Analysis and Publication Bias
The sensitivity analysis showed that excluding any one single
study did not change the statistical results of KSS-knee in 1 year,
KSS-function in 6 months, 1 year, and 2 years, surgical time, and
total outliers. Therefore, we believe that our findings in this review
are reliable. However, in terms of ROM and femoral component
rotation, the I2 value still exceeded 40% no matter which article was
excluded, indicating an unstable result. Only 2 studies reported
KSS-knee in 5 years; thus, the sensitivity analysis could not be
conducted.
The funnel plots of KSS-knee and KSS-function were symmet-
rical, indicating a low risk of publication bias. However, publication
bias in our meta-analysis could not be totally excluded as the
reliability of assessment was weak and only English articles were
included into analysis (Figs. 8A-8F).
Discussion
TKA is a popular treatment for the elderly patients with osteo-
arthritis. However, there remains a controversy regarding the
clinical effect of the MR or GB technique in TKA [32]. Compared to
the MR technique, surgeons hold positive attitudes toward the GB
technique because of its advantage in theory. As far as we know,
few meta-analyses have directly compared clinical outcomes be-
tween the 2 techniques in TKA. Therefore, this meta-analysis was
conducted to make a relatively more credible and overall assess-
ment about which technique in TKA has better clinical effects.
In our analysis of primary outcome, we performed a subgroup
analysis based on the follow-up period and firstly found that the GB
technique did not provide a significantly improved KSS-knee
compared with the MR technique in TKA. As for KSS-function, our
meta-analysis found that in the follow-up period of 1 year, KSS-
function was relatively better in the GB group, compared with the
MR group (P ¼ .03, I2 ¼ 50%). When we excluded the source of
heterogeneity to perform a sensitivity analysis, an MD of 2.12 points
between the MR and GB groups in terms of KSS-function at 1 year
was found (P ¼ .03, I2 ¼ 0%). However, this MD was below the
minimal clinically important difference for the KSS-function and
the clinical significance of this statistical advantage is therefore
limited. Furthermore, no significant differences were found be-
tween the 2 techniques in follow-up time of 6 months, 2 years, and
5 years. Hommel et al [11] carried out a randomized, prospective
trial with a follow-up time of 10 years and found that the GB and
 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693 2691

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Fig. 7. Forest plots of complications in the GB group and the MR group. (A) Infection. (B) Loosening. (C) Instability. (D) Total complications.

MR groups both achieved favorable results in KSS-knee or KSS- 1364 cases, our analysis also indicated a statistically significant
function. In addition, several previous trials [7,8,12,28] also re- difference in favor of GB in total outliers (P ¼ .0004, I2 ¼ 48%). An
ported that there were no statistical differences comparing GB to outlier of mechanical axis was defined as a deviation over 3 of the
MR in KSS over 2 years, which was consistent with our analysis. varus or valgus. Stephens et al [20] proposed that the outliers might
Our findings are in disagreement with a meta-analysis con- be lead to functional deficit and increased risk of aseptic loosening.
ducted by Huang et al [6] that reported an MD of 2.52 points for However, no significant differences were observed in our study in
KSS-Knee and an MD of 5.03 points for KSS-function in favor of the terms of infection, loosening, instability, and total complications
GB technique. However, compared to 1436 knees and different between the 2 techniques. Furthermore, as for revision rate, we
follow-up periods in our study, relatively small sample size (295 could not conduct a meta-analysis due to different follow-up
knees) was included in his meta-analysis and follow-up was only
limited to 2 years postoperatively. Furthermore, we also did not
identify differences in the ROM 2 years postoperatively and Table 3
Revision Rate.
WOMAC at 1-year follow-up, which further confirmed the similar
functional outcomes in the GB and MR techniques. Study Minimum Follow-Up (y) Events of Total P Value
In our analysis of secondary outcomes, we found that MR Revision Knees
technique presented a statistically significant advantage in surgical MR GB MR GB
time (P ¼ .002, I2 ¼ 92%). When we excluded the source of het- Churchill et al 2 2 3 116 105 >.05
erogeneity to perform a sensitivity analysis, an MD of 16.18 minutes Clement et al 4 1 1 69 44 >.05
between the MR and GB groups in terms of surgical time was found Babazadeh et al 5 1 0 43 45 >.05
(P < .00001, I2 ¼ 0%). Although the data showed that MR did take Hommel et al 10 10 6 92 89 >.05

less time, it did not lead to any improved outcomes. On the basis of MR, measured resection; GB, gap balancing.
2692 S. Li et al. / The Journal of Arthroplasty 33 (2018) 2684e2693
Fig. 8. Publication bias of Knee Society Score in the GB group and the MR group. (A) Knee Society Knee Score in 6 months. (B) Knee Society Knee Score in 1 year. (C) Knee Society
Knee Score in 2 years. (D) Knee Society Function Score in 6 months. (E) Knee Society Function Score in 1 year. (F) Knee Society Function Score in 2 years. SE, standard error; MD,
mean difference.
periods in each included study, but no statistically significant dif-
ferences in revision rate were revealed in all 4 studies.
All of 5 studies calculated the femoral component rotation using
computed tomography. It was defined as the difference between
the femoral component and the transepicondylar axis of the knee.
Many complications such as anterior knee pain, femoral compo-
nent wear, patellar fracture, or dislocation may be caused by
excessive femoral component rotation. A cadaveric study con-
ducted by Katz et al [33] showed that no significant difference in
rotation when using Whiteside’s line compared to the GB tech-
nique. Fehring [34] reported that the rotation of femoral compo-
nent in 45% of patients would be >3 if bony landmarks were used.
Our meta-analysis identified that the 2 techniques were compa-
rable in femoral component rotation. However, our study results
are in disagreement with the findings of recent meta-analyses by
Moon et al and Huang et al [5,6]. A statistically significant difference
with MD of 0.77 in favor of GB was showed in the study by Moon
et al [5], which included 3 studies [23,28,29]. Huang et al [6] only
included 2 studies [23,28] and also identified a statistically signif-
icant difference with MD of 0.86 in favor of GB. After careful ex-
amination, we found that Moon et al wrongly incorporated the data
of the original article into analysis. On the basis of 476 knees, no
statistically significant difference in femoral component rotation
was found between the 2 groups.
Limitations and Strengths
The main strength of our study includes the following: (1) we
searched all available clinical trials which directly compared MR to
GB; (2) most of the studies included in our meta-analysis are high-
quality RCTs; (3) on the basis of large sample size, we extracted and
analyzed largest number of clinical outcome variables. The present
meta-analysis also includes many limitations. (1) One prospective
study and 4 retrospective studies were incorporated into the meta-
analysis, so the qualities of the studies were not uniform. (2) Only 1
trial had 10 years of follow-up and 2 trials had 5 years of follow-up,
most follow-ups were 1-2 years. It is difficult to reach a convincing
conclusion due to the lack of long-term follow-up time. (3) The
analysis of some outcome measures such as complications,
WOMAC, and surgical time was based on a relatively small sample
size, and firm conclusions cannot be derived. (4) Publication bias is
unavoidable because the identified language was restricted to En-
glish. (5) Although our meta-analysis consists of a relatively large
sample size (2259 TKAs), it might still lead to overestimating and
could not explain all outcomes.
Conclusion
To our knowledge, this is the first systematic review and meta-
analysis comparing the MR with GB techniques during TKA in light
of a full analysis of functional outcomes. Although our meta-
analysis shows that the GB technique may be associated with less
mechanical axis outliers, the 2 surgical techniques have compara-
ble outcomes in terms of KSS, WOMAC, ROM, complications, revi-
sion rate, and femoral component rotation. On the basis of these
findings, we conclude that both techniques can result in equivalent
results when done properly, and each surgeon must understand the
strengths and weaknesses of each technique.
Acknowledgments
We would like to show sincere appreciation to the anonymous
reviewers for their many useful comments on the early version of
the manuscript.
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 CONFLICT OF INTEREST STATEMENT
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 The Journal of Arthroplasty 33 (2018) 2405e2411

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Conversion vs Primary Total Hip Arthroplasty: Increased Cost

of Care and Perioperative Complications
Sean P. Ryan, MD *, Marcus DiLallo, David E. Attarian, MD,
William A. Jiranek, MD, FACS, Thorsten M. Seyler, MD, PhD
Department of Orthopaedic Surgery, Duke University Hospital, Durham, North Carolina

a r t i c l e i n f o a b s t r a c t

Article history: Background: With the increasing incidence of hip fractures and hip preservation surgeries, there has been
Received 19 December 2017 a concomitant rise in the number of conversion total hip arthroplasties (THAs) performed. Prior studies
Received in revised form have shown higher complication rates in conversion THA. However, there is a paucity of data showing
3 February 2018
differences in cost between these 2 procedures. Currently, the Center for Medicare and Medicaid Services
Accepted 1 March 2018
bundles primary and conversion THA in the same Medicare SeverityeDiagnosis Related Group for hospital
Available online 15 March 2018
reimbursement. More evidence is needed to support the reclassification of conversion THA.
Methods: The cohort provided by the institutional database included 163 conversion THAs between
Keywords:
total hip arthroplasty
January 1, 2012 and December 31, 2015. Intraoperative complications, estimated blood loss, operative
conversion time, postoperative complications, and perioperative cost data were analyzed for 163 primary THA pa-
primary tients matched to the conversion THA cohort.
complications Results: Compared with primary THA, conversion THA had significantly (P < .05) greater cost for direct
cost labor, other direct costs, intermediate nursing services, other diagnostic/therapy, surgery services,
resources physical/occupational/speech therapy, radiology, laboratories, blood, medical/surgical supply, and total
direct costs. In addition, the conversion THA group had significantly greater operative times, estimated
blood loss, length of stay, intraoperative complications, and postoperative complications.
Conclusion: Conversion THA, as compared with primary THA, is associated with greater costs (approx-
imately 19% greater), increased surgical times, and perioperative complications. To prevent these addi-
tional expenses from creating patient selection bias and a barrier to care, the conversion THA Medicare
Severity-Diagnosis Related Group should be reclassified, or modifiers created.
© 2018 Elsevier Inc. All rights reserved.

The incidence of total hip arthroplasty (THA) in the United States
is continuing to increase, with an estimated 572,000 yearly cases to
be performed by 2030 [1]. Although partially driven by the expan-
sion of the aging “baby boomers,” the number of procedures is also
increasing because of the successful outcomes and expanding in-
dications for THA. Consequently, for current arthroplasty surgeons,
conversion to THA from prior interventions stemming from femoral
or acetabular pathology may constitute a significant portion of their
practice. Common interventions undergoing conversion to THA may
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.006.
* Reprint requests: Sean P. Ryan, MD, Department of Orthopaedic Surgery, Duke
University Hospital, 2301 Erwin Rd, Durham, NC 27710.
include, but are not limited to, operative fixation of femoral neck,
intertrochanteric, and acetabular fractures, hip arthroscopy for
femoroacetabular impingement (FAI) or labral tears, proximal
femoral osteotomies or periacetabular osteotomies for dysplasia, and
free vascularized fibular grafts (FVFGs) or core decompression for
avascular necrosis (AVN) [2e9].
These different index procedures undergoing conversion THA
are classified as equivalent to primary THA by the Center for
Medicare and Medicaid Services (CMS). CMS determines hospital
reimbursement by categorizing procedures into Diagnosis Related
Groups (DRGs) [10,11]. Over time, DRGs have evolved for THA to
account for revision surgery and medical comorbidities (Medicare
SeverityeDRGs [MS-DRGs]), as evidence throughout the literature
showed that these patients had higher complication rates and
require greater hospital resource, ultimately resulting in a financial
burden to high-volume tertiary care centers [11e15]. Currently,
primary and conversion THA share MS-DRG 469 (primary THA with

https://doi.org/10.1016/j.arth.2018.03.006
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2406 S.P. Ryan et al. / The Journal of Arthroplasty 33 (2018) 2405e2411
major complication/comorbidity) and 470 (primary THA without
major complication/comorbidity). Although multiple studies have
shown that conversion THA has a higher complication rate compared
with primary THA, there are limited data regarding the different cost
of care for these 2 procedures [3,5,11,16e25]. The available early
studies suggest that conversion THA may consume a disproportionate
number of hospital resources [11,26]. Furthermore, because Medicare
is the primary payer for most THAs [27], discrepancies in reim-
bursement could result in financial losses for conversion THA pro-
cedures performed, and ultimately limit patient access to care.
The purpose of this study is to (1) compare postoperative
complications between primary and conversion THA whether or
not hardware was in place at the time of conversion and (2)
compare resource utilization through cost of care analysis for
conversion and primary THA. We hypothesize that conversion THA
will have significantly higher cost as well as intraoperative and
postoperative complications compared with primary THA. Given
the limited research in this arena, this could have significant impact
on future CMS classifications.
Materials and Methods
After institutional review board's approval, the study population
was retrospectively obtained from a prospectively collected data-
base at a single tertiary referral center. The cohort was established
by searching for Current Procedural Terminology code 27132
(conversion THA) from January 1, 2012 to December 31, 2015. This
search yielded 288 possible conversion THAs. The electronic med-
ical record was then manually reviewed for inclusion criteria of a
positive history of previous surgery on the same joint, and non-
revision THAs. A total of 103 patients were excluded for revision
THA and 22 patients excluded with prior hip resurfacing or hemi-
arthroplasty, which were felt to be most similar to revision
arthroplasty, leaving 163 patients who underwent conversion THA.
This group was then further subdivided based on the presence or
absence of implants/hardware (including suture anchors during hip
arthroscopy) from the surgery preceding conversion THA.
The primary THA control group was then established using Cur-
rent Procedural Terminology code 27130 (primary THA), resulting in
2457 procedures within the study dates identified. These encounters
were randomized and the electronic medical records were reviewed
for inclusion criteria of absence of prior surgery on the same joint,
lack of prior periarticular infection, and lack of primary THA for an
acute fracture. Demographic information including age, gender,
body mass index (BMI), and American Society of Anesthesiologists
(ASA) score were then collected for primary and conversion THA
groups. One hundred sixty-three primary THA patients were then
selected as a group for comparison with the conversion THA cohort
based on mean age (matched within 2 years), BMI (matched within 1
kg/m2), and ASA score (matched within 1).
Progress notes, operative reports, and discharge summaries
were reviewed for primary and conversion THA patients. Outcome
variables evaluated included operative time, estimated blood loss
(EBL), presence of intraoperative or postoperative complications,
length of stay (LOS), discharge disposition, and need for revision
Table 1
Patient Demographics.
Group Age, y [Mean (SD)]
Primary THA (n ¼ 163) 53.6 (15.7)
Conversion THA (n ¼ 163) 51.7 (17.7)
P value .313
Patient age, BMI, and ASA score are reported as mean (SD). Gender is reported as male (female).
ASA, American Society of Anesthesiologists; BMI, body mass index; SD, standard deviation; THA, total hip arthroplasty.
surgery. Intraoperative complications included the need for trans-
fusion or fracture. Postoperative complications included the need
for transfusion during admission, hematoma that required addi-
tional clinic visits/care, wound dehiscence, deep venous throm-
bosis, pulmonary embolism (PE), periprosthetic fracture,
dislocation, aseptic loosening of the components, surgical site
infection (SSI), and the need for any revision surgery.
Hospital expenses were collected for each patient encounter
through the use of EPSi, a comprehensive financial platform
housing all cost, pricing, and budget data used at the investigating
institution. Cost variables for comparison included direct labor
costs, other direct costs (which include all supplies, drugs, and
equipment expenses), intermediate nursing services, pharmacy,
other diagnostic/therapy services, surgery services, respiratory
care, physical/occupational/speech therapy (PT/OT/Speech), radi-
ology, laboratories, blood, medical/surgical supply, and total direct
costs.
Three comparisons were made for patient outcomes: (1) con-
version THA vs primary THA, (2) hardware conversion THA vs pri-
mary THA, and (3) nonhardware conversion THA vs primary THA.
For cost variables, primary and conversion THAs were compared
directly, and hardware/nonhardware conversion subgroup analysis
was then performed. Lastly, cost analysis of the 3 most common
conversion procedures (open reduction internal fixation [ORIF], hip
arthroscopy, and FVFG conversion) was performed to directly
compare each with primary THA resource utilization. Chi-squared
or Fisher exact test was used to compare categorical data,
whereas continuous variables were compared using Student t test.
Statistical analysis was performed using JMP Pro 13 software (SAS
Institute, Inc., Cary, NC) and Mac Wizard Pro software (E Miller,
Chicago, IL). Data are reported as mean (standard deviation). A P
value <.05 was considered to be statistically significant.
Results
A total of 326 patients were included after primary and con-
version THA groups were matched for mean age, BMI, and ASA
score. There was no significant difference in gender (P ¼ .428;
Table 1). The indications for conversion THA included osteoarthritis
(n ¼ 87), AVN (n ¼ 45), malunion/non-union (n ¼ 28), and failure of
hardware (n ¼ 3). The index procedures included ORIF (n ¼ 57), hip
arthroscopy (n ¼ 43), FVFG (n ¼ 25), percutaneous pinning (n ¼ 11),
intramedullary nailing (n ¼ 10), core decompression and bone
grafting for AVN (n ¼ 7), periacetabular osteotomy (n ¼ 4), femoral
osteotomy (n ¼ 3), and surgical hip dislocation (n ¼ 3). There were
132 patients (81.0%) with hardware and 31 patients (19.0%) without
hardware placed at the index procedure before conversion THA.
The hardware group had mean age, BMI, and ASA score of 51.5
(19.0) years, 28.4 (6.4) kg/m2, and 2.41 (0.67), respectively. The
nonhardware group had mean age, BMI, and ASA score of 52.5
(11.2) years, 29.6 (8.1) kg/m2, and 2.32 (0.60), respectively. The
mean time to conversion THA was 62.7 months (range 0.73-634.2
months). The indications for primary THA in the control group
included osteoarthritis (n ¼ 92), AVN (n ¼ 65), rheumatoid arthritis
(n ¼ 5), and pigmented villonodular synovitis (n ¼ 1).
Gender [M (F)] BMI, kg/m2 [Mean (SD)] ASA Score [Mean (SD)]
61 (102) 29.4 (6.5) 2.32 (0.47)
68 (95) 28.7 (6.8) 2.40 (0.65)
.428 .295 .206
 S.P. Ryan et al. / The Journal of Arthroplasty 33 (2018) 2405e2411 2407

Table 2
Conversion, Hardware, and Nonhardware vs Primary THA.

Variables Primary (n ¼ 163) Conversion (n ¼ 163) Hardware (n ¼ 132) Nonhardware (n ¼ 31)

Primary vs Primary vs Primary vs

Conversion Hardware Nonhardware
P Value P Value P Value

Intraoperative
Operative time, min 110.0 (28.5) 16.1 (68.3) <.001 161.2 (69.9) <.001 134.2 (57.4) <.001
EBL, mL 258.6 (121.2) 530.2 (468.0) <.001 538.2 (471.2) <.001 496.5 (460) <.001
Intraoperative 4 (2.5%) 17 (10.4%) .003 15 (11.4%) .002 2 (6.5%) .239
complication
Postoperative
LOS, d 2.4 (1.1) 3.4 (1.7) <.001 3.3 (1.7) <.001 3.55 (1.8) <.001
Discharge to SNF 11 (6.8%) 26 (16.0%) .009 24 (18.3%) .002 2 (6.5%) .945
Transfusion 10 (6.1%) 30 (18.4%) <.001 25 (18.9%) <.001 5 (16.1%) .056
Hematoma 5 (3.1%) 3 (1.8%) .474 2 (1.5%) .384 1 (3.2%) .963
Dehiscence 2 (1.2%) 1 (0.6%) .562 0 (0%) .202 1 (3.2%) .408
DVT/PE 0 (0%) 3 (1.8%) .082 3 (2.3%) .053 0 (0%) 1.000
Periprosthetic fracture 6 (3.7%) 5 (3.1%) .759 4 (3.0%) .759 1 (3.2%) .901
Dislocation 4 (2.5%) 13 (8.0%) .025 12 (9.1%) .012 1 (3.2%) .804
Aseptic loosening 1 (0.6%) 0 (0%) .317 0 (0%) .367 0 (0%) .662
Surgical site infection 1 (0.6%) 10 (6.1%) .006 7 (5.3%) .014 3 (9.7%) .001
Revision surgery 8 (4.9%) 19 (11.7%) .027 15 (11.4%) .040 4 (12.9%) .090
Postoperative complication 22 (13.5%) 50 (30.7%) <.001 42 (31.8%) <.001 8 (25.8%) .082

Data are presented as mean (standard deviation) for continuous variables, and number (%) for categorical variables.
DVT, deep venous thrombosis; EBL, estimated blood loss; LOS, length of stay; PE, pulmonary embolism; SNF, skilled nursing facility; THA, total hip arthroplasty.

Comparison of intraoperative and postoperative outcomes of
primary and conversion THAs (including subgroup analysis for
conversion with and without hardware) was performed for 15
metrics (Table 2).
Outcomes of Conversion THA vs Primary THA
Intraoperative outcomes for conversion THA identified signifi-
cantly prolonged operative times (P < .001) compared with primary
THA. EBL was double for the conversion group (P < .001), and the
rate of intraoperative complications was approximately 4 times
that of the matched primary THA cohort (P ¼ .003). Intraoperative
complications for the primary THA group included 3 fractures
treated with cables and 1 transfusion. Complications for the con-
version THA group included 12 fractures treated with cables, 1
greater trochanter fracture, 3 transfusions, and 1 postoperative
nerve palsy. Postoperative outcomes revealed significant differ-
ences (P < .05) for 7 of the measured metrics: LOS, discharge to
skilled nursing facility (SNF), transfusion rate, dislocation rate, SSI,
revision surgery, and total postoperative complications. There was
no significant difference found in hematoma formation, wound
dehiscence, venous thromboembolism, periprosthetic fracture, or
aseptic loosening between groups. Given that many of the com-
plications analyzed have described low incidence in the literature,
and were rare in our cohort, a statistical power analysis was per-
formed to determine if our sample size was large enough to
determine a significant difference. For deep venous thrombosis/
pulmonary embolism (which had a 0% and a 1.8% rate in our
cohort), based on an alpha ¼ 0.05 and power ¼ 0.80, the projected
sample size required is approximately 536 patients in each group,
indicating that our study was underpowered to detect clinical
significance for these very rare complications.
Outcomes of Conversion THA With Hardware vs Primary THA
Intraoperative outcomes for conversion THA with hardware (n ¼
132) showed significantly higher operative times (P < .001), EBL (P
< .001), and intraoperative complications (P ¼ .002) compared with
primary THA. Postoperatively, conversion patients with hardware
were found to have significantly (P < .05) greater LOS, discharge to
SNF, transfusion rates, dislocations, SSIs, rates of revision, and
postoperative complications compared with primary THA patients
(Table 2). Other metrics including hematoma formation, wound
dehiscence, venous thromboembolism, periprosthetic fracture, and
aseptic loosening showed no significant difference between groups
with the numbers available.
Outcomes of Conversion THA Without Hardware vs Primary THA
Of the 31 patients without hardware in place undergoing con-
version THA, there was a significant increase in operative time (P <
.001) and EBL (P < .001) compared with the primary THA cohort.
There was no significant difference in the rate of intraoperative
complications. Postoperatively, there was significantly greater LOS
(P < .001) and SSI (P ¼ .001) for conversion patients, but no sta-
tistical difference with the numbers available in the rate of trans-
fusion, hematoma formation, wound dehiscence, periprosthetic
fracture, dislocation, aseptic loosening, revision surgery, or
discharge to SNF (Table 2).
Cost of Conversion THA vs Primary THA
The cost of care analysis for conversion vs primary THA revealed
significantly increased cost for direct labor, other direct costs, in-
termediate nursing services, other diagnostic/therapy services,
surgery services, PT/OT/Speech, radiology, laboratories, blood,
medical/surgical supply, and total direct costs. Pharmacy and res-
piratory care were not significantly different between groups
(Table 3). Subanalysis for hardware conversion THA revealed
identical significant cost differences, whereas nonhardware con-
version THA patients had no significant difference in cost of other
diagnostic/therapy services, surgery services, and PT/OT/Speech.
Total direct cost for conversion THA, hardware, and nonhardware
groups were significantly higher (P < .001), representing an average
increase of 19.1%, 20.5%, and 13.2%, respectively, compared with
primary THA.
Cost of Common Conversions vs Primary THA
The 3 most common index procedures performed in the con-
version cohort were ORIF (n ¼ 57), hip arthroscopy (n ¼ 43), and
FVFG (n ¼ 25). As shown in Table 4, ORIF conversion patients had
2408 S.P. Ryan et al. / The Journal of Arthroplasty 33 (2018) 2405e2411

Table 3
Conversion, Hardware, and Nonhardware vs Primary THA Cost Comparison.

Primary (n ¼ 163) Conversion (n ¼ 163) Hardware (n ¼ 132) Non-hardware (n ¼ 31)

Mean (SD) Mean (SD) P Value Mean (SD) P Value Mean (SD) P Value

Direct labor costs 2576 (625) 3400 (1320) <.001 3451 (1265) <.001 3182 (1537) <.001
Other direct costs 7710 (1247) 8849 (2800) <.001 8941 (2998) <.001 8459 (1694) .004
Intermediate nursing services 882 (470) 1382 (918) <.001 1386 (850) <.001 1367 (1118) <.001
Pharmacy 557 (572) 607 (539) .419 611 (498) .396 590 (700) .777
Other diagnostic/therapy 5 (59) 75 (309) .004 87 (335) .002 28 (156) .148
Surgery services 8214 (1220) 8876 (3034) .010 9161 (2972) <.001 7661 (3042) .088
Respiratory care 32 (48) 45 (107) .161 47 (114) .115 33 (68) .884
PT/OT/Speech 350 (118) 383 (132) .016 382 (126) .025 389 (156) .107
Radiology 79 (67) 130 (115) <.001 130 (109) <.001 129 (138) .002
Laboratories 42 (59) 113 (169) <.001 122 (179) <.001 77 (106) .009
Blood 79 (225) 224 (375) <.001 222 (339) <.001 235 (509) .007
Medical/Surgical supply 28 (55) 371 (1487) .003 195 (998) .034 1121 (2621) <.001
Total direct costs 10,286 (1606) 12,249 (3761) <.001 12,392 (3928) <.001 11,641 (2922) <.001

Numbers are reported as mean (SD). The P values represent comparison of each group (conversion, conversion with hardware, and conversion without hardware) with
primary THA.
Prices are in US dollars ($).
SD, standard deviation; THA, total hip arthroplasty.

significantly increased costs in 12 of the 13 metrics evaluated.
Pharmacy costs trended toward increased cost with ORIF conver-
sions; however, this difference was not significant. Hip arthroscopy
conversion patients similarly showed increased cost for direct la-
bor, intermediate nursing services, radiology, laboratories, medical/
surgical supply, and total direct costs compared with primary THA.
Lastly, FVFG conversion patients had significant increases in other
diagnostic/therapy services and medical/surgical supply. This
group, however, represented only 25 patients (the smallest of the
3), and given the broad standard deviation seen in resource utili-
zation, other cost discrepancies in direct labor costs and radiology
were not significantly different.
Discussion
Modern orthopedics require close attention to patient out-
comes, complications, and cost of care to justify reimbursement.
Currently, Medicare is the primary payer for THAs in the United
States [12,27], and prior research on outcomes and cost analysis has
resulted in changes to their bundled classification system, specif-
ically with regards to revision THA [10e14,28,29]. We are now
beginning to see similar evidence in the literature for conversion
THA, as patients undergoing conversion THA have more
complications than primary THA patients [2,5,16,20e26,30,31];
however, there is limited information regarding the cost discrep-
ancies between these 2 groups [11]. Therefore, we aimed to report
both the differences in complications and resource utilization for
patients undergoing conversion THA at our institution to add to the
growing body of evidence for CMS and other payers to consider
when determining future revisions to MS-DRGs.
Our results support the reclassification of conversion THA.
Compared with primary THA, conversion has greater operative
times, EBL, and intraoperative complications, as well as greater LOS,
transfusions, dislocations, SSIs, revision surgeries, total complica-
tions, and are more likely to be discharged to an SNF. Patients
without hardware in place from their index procedure continued to
show higher operative times, EBL, LOS, and SSI compared with
primary THA patients. Furthermore, our cost analysis shows a sig-
nificant increase in direct labor costs, other direct costs, interme-
diate nursing services, other diagnostic/therapy services, surgical
services, PT/OT/Speech, radiology, laboratories, blood, medical/
surgical supply, and total direct costs for conversion THA compared
with primary THA. This discrepancy in direct cost remains whether
or not hardware is in place at the time of conversion.
In our study, the 3 main groups undergoing conversion THA
included patients with AVN and prior FVFG or core decompression,

Table 4
Cost Comparison of ORIF, Hip Arthroscopy, and FVFG Conversion to Primary THA.

Primary (n ¼ 163) ORIF Conversion (n ¼ 57) Hip Arthroscopy Conversion FVFG Conversion (n ¼ 25)
(n ¼ 43)

Mean (SD) Mean (SD) P Value Mean (SD) P Value Mean (SD) P Value

Direct labor costs 2576 (625) 3976 (1415) <.001 2957 (1293) .007 2822 (491) .062
Other direct costs 7710 (1247) 10,200 (3765) <.001 8142 (1520) .056 7388 (1145) .226
Intermediate nursing services 882 (470) 1687 (917) <.001 1267 (1089) <.001 904 (379) .826
Pharmacy 557 (572) 693 (406) .100 556 (603) .986 478 (196) .492
Other diagnostic/therapy 5 (59) 163 (416) <.001 0 (0) .598 84 (421) .023
Surgery services 8214 (1220) 10,083 (3780) <.001 7685 (2550) .053 8134 (1119) .759
Respiratory care 32 (48) 74 (160) .003 29 (60) .768 15 (44) .106
PT/OT/Speech 350 (118) 391 (128) .027 381 (143) .141 337 (98) .600
Radiology 79 (67) 168 (131) <.001 122 (124) .002 104 (36) .069
Laboratories 42 (59) 201 (223) <.001 65 (92) .045 38 (72) .772
Blood 79 (225) 353 (426) <.001 168 (432) .068 23 (16) .217
Medical/Surgical supply 28 (55) 264 (1284) .020 819 (2269) <.001 92 (140) <.001
Total direct costs 10,286 (1606) 14,176 (4798) <.001 11,099 (2385) .009 10,210 (1421) .823

Numbers are reported as mean (SD). The P values represent comparison of each procedure with the primary THA subgroup.
Prices are in US dollars ($).
FVFG, free vascularized fibular graft; ORIF, open reduction internal fixation; SD, standard deviation; THA, total hip arthroplasty.
 S.P. Ryan et al. / The Journal of Arthroplasty 33 (2018) 2405e2411 2409

patients with FAI or hip dysplasia and prior arthroscopy, and pa-
tients with hip fractures and prior operative fixation. A literature
review of postoperative complications and outcomes comparing
these conversion procedures with primary THA was performed and
is shown in Table 5. For patients with prior operative intervention
for AVN (namely FVFG or core decompression), long-term results in
the literature are variable with conversion THA reported in
10.5%-50% of patients [3,32,33]. Conversion THA for these patients
requires unique technical considerations, namely the use of a
high-speed burr to remove residual fibular graft to prevent varus
component malpositioning, which results in increased operative
time and blood loss [5].
For FAI, the incidence of hip arthroscopy has dramatically
increased [34,35], with the rate of conversion THA at approximately
34% within 10 years [8,36]. Studies on the impact of prior hip
arthroscopy on the outcomes of conversion THA have been incon-
sistent. Although some authors have reported no differences
compared with primary THA in terms of complications and
functional scores, several have noted increased operating room
time [19,37e39]. Furthermore, Perets et al [24] described increased
complications and lower functional outcomes, warning that this
should be considered before performing arthroscopy. Similarly,
conversion THA of prior surgical hip dislocation for FAI has been
shown to have longer operative times and complications, namely
heterotopic ossification [17].
Conversion THA for patients with prior operative fixation of hip
fracture has also been shown to be associated with worse outcomes
than primary THA. Conversion of prior hip screw is associated with
a 47% complication rate with higher intraoperative fractures of the
greater trochanter and postoperative hip dislocations [40]. Cepha-
lomedullary nail conversion has also been shown to have greater
EBL and operative times, and is associated with special technical
considerations intraoperatively, frequently requiring THA stems
with diaphyseal fit or revision components [6,9,26,41]. Further-
more, conversion THA for femur fractures is associated with
increased rates of dislocation, periprosthetic fractures, infection,

Table 5
Literature Review of Conversion THA Compared With Primary THA Complications.

Author Year Conversion/Total Findings

Hips (n)

Spencer-Gardner et al [17] 2016 24/48 Increased OR time, but no difference in EBL for conversion of prior surgical hip dislocation. No difference in
clinical outcomes between primary THA and arthroscopy
Zingg et al [19] 2012 18/1271 Increased OR time, but no difference in EBL or outcome scores for conversion of prior arthroscopy
Perets et al [24] 2017 35/70 Increased complications and lower functional outcomes for conversion of prior arthroscopy
Haughom et al [38] 2016 42/126 No difference in Harris Hip Scores or complications, but primary THA had significant improvement in hip scores
relative to conversion of prior arthroscopy
Parker et al [39] 2017 35/105 No significant differences between primary THA and conversion of prior arthroscopy
Charles et al [37] 2017 39/78 No significant differences between primary and conversion of prior arthroscopy
Mahmoud et al [23] 2016 Meta-analysis Increased deep infection, early dislocation, overall complications, and periprosthetic fracture for conversion THA
for failed femoral neck fracture fixation
Exaltacion et al [6] 2012 20/- High risk of greater trochanter fracture, greater EBL and OR time for conversion THA of failed intramedullary hip screw
Archibeck et al [43] 2013 102/- Increased risk of periprosthetic fracture and postoperative dislocation for conversion of failed internal fixation
D’Arrigo et al [44] 2009 21/- Salvage THA resulted in acceptable outcomes with few serious complications for failed treatment of proximal
femoral fractures
Mortazavi et al [45] 2012 154/- Conversion THA with prior intertrochanteric fracture fixation is technically challenging with longer OR time and
EBL compared with femoral neck fracture fixation, but has good outcomes
Shi et al [46] 2015 31/- Salvage THA with long-stem prosthesis after failed intertrochanteric fracture fixation is effective
DeHaan et al [47] 2013 46/- Similar complications and revision rates observed during conversion THA regardless of prior fracture pattern.
Implant type plays a larger role than fracture pattern
Pui et al [48] 2013 91/- Conversion from CMN has higher complication rates compared with conversion from sliding hip screw and side plate
Lee et al [22] 2017 33/66 Increased OR time, EBL, and intraoperative fractures for conversion THA of failed intertrochanteric fracture
fixation
Haidukewych and 2003 60/- Revision type implants are often required, but overall outcomes are good after conversion THA of failed
Berry [49] intertrochanteric fracture fixation
Winemaker et al [25] 2006 36/72 Increased complications and fractures for conversion THA of failed ORIF, but outcomes similar to primary THA at 1 y
McKinley and 2002 107/214 Increased superficial infections and dislocations for conversion THA for failed fixation of intracapsular hip
Robinson [16] fractures. Worse survival rate of conversion THA
Thakur et al [50] 2011 15/- Tapered, modular cementless stems allow good fixation and functional outcomes after failed fixation of
intertrochanteric fractures
Abouelela [51] 2012 16/- Revitan curved cementless modular stems are effective for salvage in peritrochanteric fractures without normal
bony anatomy after failed fixation
Davis et al [5] 2006 20/56 For FVFG, use of high-speed burr improved femoral component alignment, but increased blood loss and
operative time
Berend et al [3] 2003 89/- Conversion from FVFG results in improved functional outcomes comparable with primary THA in young patients
Schwarzkopf et al [26] 2017 119/370 Conversion THA has increased operative time, length of stay, and requires revision implants. Outcomes are also
worse than primary THA
Tabsh et al [18] 1997 53/106 Increased operative difficulty and transfusions for conversion THA of prior fixation of proximal femur fractures.
Final outcome scores not significantly different
Zhang et al [52] 2010 83/203 No difference in OR time, EBL, transfusion, dislocation, or infection were seen, but significantly higher
intraoperative fractures were noted for conversion THA of failed fixation of femoral neck fractures
Franzen et al [21] 1990 84/883 Higher rate of prosthetic failure for conversion of prior femoral neck fixation
Baghoolizadeh and 2016 2009/69,868 Increased 30-d complications, surgical site infection, unplanned intubation, CVA, blood transfusions, sepsis, and
Schwarzkopf [20] length of stay for conversion THA
Qin et al [31] 2017 2145/12,766 Increased 30-d complications, length of stay, and nonhome discharges for conversion THA
McLawhorn et al [30] 2017 2018/4036 Higher 30-d complication rates, longer length of stay and OR times, increased transfusion rates, and discharges
to nursing facilities with conversion THA

Table includes findings of the included articles. Letter n denotes the number of hips included and (-) indicates that no comparison primary THA group was included in the
article.
CMN, cephalomedullary nail; EBL, estimated blood loss; FVFG, free vascularized fibular graft; OR, operating room; THA, total hip arthroplasty; CVA, cerebrovascular accident.
2410 S.P. Ryan et al. / The Journal of Arthroplasty 33 (2018) 2405e2411
longer operative times, and longer hospital stays compared with
primary THA [23,26]. Given the increasing incidence of hip frac-
tures in the United States and reported 10.8%-30% fixation failure
rates, the costs and complications associated with conversion THA
become important [7,23,42].
Despite these prior studies showing increased complications and
special technical considerations associated with conversion THA
compared with primary THA, only Chin et al [11] have performed a
cost analysis. In their study, they analyzed 51 conversion THAs
compared with 105 primary THAs. For conversion THA patients, they
found a significantly greater total hospital cost, direct hospital cost,
hospital operating direct cost, and hospital operating total cost [11].
To our knowledge, the present study is the first study to evaluate
both the outcomes and costs associated with conversion THA
compared with primary THA in the same cohort. Similar to prior
research, our results show increased rates of intraoperative and
postoperative complications, longer operative times, and higher EBL
for conversion THA whether or not hardware was used at the index
procedure. Furthermore, our cost analysis shows an approximately
19% greater total direct cost for conversion THA compared with pri-
mary THA. With hardware present, total direct cost was 20.4% greater
on average. This is similar to the findings of Chin et al [11], who re-
ported a 24.7% greater direct hospital cost for conversion THAs.
Similar to the previously described findings on cost and
outcome differences associated with primary and revision THAs,
we are beginning to see similar discrepancies throughout the
literature for primary and conversion THAs. To avoid economic
disincentives to hospitals for treating these patients, which has
been shown to disproportionately burden tertiary referral centers
[11,28], we agree with Chin et al’s findings and support CMS
updating their classification system to reimburse conversion THA at
a level reflective of the resources required.
As with any retrospective review, there are several limitations to
this study. There is a relatively small sample size after the inclusion
and exclusion criteria which limits our findings. For FVFG patients,
for example, which included 25 patients, several trends in our cost
analysis did not meet the criteria for a significantly different change
(P < .05). Further work will be needed to specifically examine this
cohort. In addition, because of a relatively small sample size, we
were unable to further match patients based on surgeon and sur-
gical approach, which would have eliminated more patients from
the study (particularly young patients where primary THA matches
are rare). Future research should focus on expanding the cohort to
match patients based on surgeon and approach, which may be
confounding factors in our study. Despite our relatively small
sample size, in its current form, this represents the largest available
cost analysis in the literature. The study is also restricted to a single
institution, and may not be applicable to other institutions that use
different perioperative procedures. Lastly, the cost analysis per-
formed, while including multiple subgroups for analysis of where
hospital costs are distributed, continues to be incomplete with “other
direct costs” and “other diagnostic and therapy services,” which may
contain other unrecognized expense inconsistencies. In addition,
postacute care costs were unavailable for analysis given multiple in-
surance providers paying for services outside of the investigating
institution, although a higher percentage of conversion patients went
to skilled nursing homes on discharge. Despite these limitations,
however, this study adds to the growing body of evidence that con-
version THAs constitute a greater surgical and financial burden and
should be reclassified by CMS as a separate MS-DRG.
Conclusion
Patients may undergo conversion THA for multiple reasons,
most commonly after prior hip arthroscopy, surgical intervention
for AVN (including FVFG and core decompression), and operative
fixation of hip fractures. These patients have longer operative
times, greater perioperative complications, and greater cost of care
compared with primary THA patients. They should be counseled
about the increased risks of the procedure. Our findings, in addition
to the current literature, support the reclassification of conversion
THA as a separate MS-DRG from primary THA to reflect the greater
resources these patients require perioperatively.
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 The Journal of Arthroplasty 33 (2018) 2652e2659

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Correct Assessment of Acetabular Component Orientation in Total

Hip Arthroplasty From Plane Radiographs
Diana Widmer, MD a, b, *, Kilian Reising, MD a, Elmar Kotter, MD c, Peter Helwig, MD a
a
Department of Orthopedic Surgery and Traumatology, University Hospital Freiburg, Freiburg, Germany
b
Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany
c
Department of Radiology, University Hospital Freiburg, Freiburg, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Background: Correct positioning of the cup is an important factor in total hip arthroplasty. Assessing its
Received 27 November 2016 position from a plain anteroposterior pelvic radiograph is known to be hampered by systemic errors. This
Received in revised form study focuses on developing a correction method to adjust for these potential sources of error and to
25 January 2018
eliminate them based on a 3D geometric analysis.
Accepted 3 February 2018
Available online 2 March 2018
Methods: Computed tomography scans of 113 (66 male, 47 female) pelvices were reconstructed and virtually
projected onto a plain radiograph with varying rotational and translational positions. Thus cup inclination
and anteversion as measured on a 2D-radiograph and in the 3D environment were correlated. Projected
Keywords:
total hip arthroplasty
offset of the symphysis from the mid-sacrum served as a mean to measure pelvic right/left-rotation. Pelvic tilt
radiographic evaluation was determined from the projected height of the contour of the small pelvis. Correction formulas were
plain radiograph verified by projecting a gimbal-mounted artificial pelvis with a cup implanted in a known position.
cup anteversion Results: We found gender-specific formulas that correct for malrotated and off-centered radiographs.
correction Applying these formulas cup inclination was assessed as close as 1.3
(±1.90
) to the true 3D value and
cup anteversion as close as 1
(±1.91
) although deviations between directly measured plain values and
corrected values rose up to 18
.
Conclusion: Inherent effects of central projection and malrotations due to pelvic tilt, pelvic rotation, and
noncentered radiographs are corrected. Evaluation of radiographic inclination and anteversion of
acetabular cups from plain 2D-radiographs show improved precision. Real values are approached better
than 1.3
when applying our correction formulas.
© 2018 Elsevier Inc. All rights reserved.

It is common practice to take anteroposterior (AP) radiographs
of the pelvis during follow-up after total hip arthroplasty (THA).
These serve as a standard mean to control the initial positioning of
the prosthetic hip components and any changes in their position,
orientation, stability, and further clinical conditions thereafter. The
outcome, the prognosis, and the long-term success of a THA highly
depend on component positions [1]. So, not only correct implan-
tation during surgery is important but also correct measurement of
cup orientation, that is, cup inclination and anteversion, is of
utmost importance [2] in order to provide a reasonable rating of the
results. It is known that direct measurements on plain radiographs
are affected by incidental and system-related errors [3].
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.023.
* Reprint requests: Diana Widmer, MD, Eye Center, Faculty of Medicine, Univer-
sity of Freiburg, Kilianstr. 5, 79106 Freiburg, Germany.
As a matter of principle, it is challenging to derive correct 3D
parameters from a plain 2D radiograph mainly because it is
produced by an enlarging central projection and direct access to the
third dimension is not obvious. One of the immanent problems is
that reversing central projection is mathematically under-deter-
mined. Numerous methods have already been proposed to address
this issue but there is nothing else than accepting an approxima-
tion. Most of these approximating methods apply trigonometric
functions while some prescribe specific techniques to be followed.
Methods that have become accepted include various planar
measuring techniques [4e6], the “Einbildro €ntgenanalyse” [7,8],
radiostereometric analysis (RSA) as described by Selvik [9],
template methods [10], and 2D/3D image transformation [11]. The
latter methods require additional measurements to be taken, which
can be time-consuming, complex, and some methods can only be
applied prospectively [12].
All methods that are based on plain radiographs require addi-
tional adjustments to address the effects of the central projection

https://doi.org/10.1016/j.arth.2018.02.023
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659 2653

and/or other distorting projection details. For example, Tannast

et al [5] proposed to use the horizontal distance between the
midsymphysis and the sacrococcygeal joint as a correcting value to
correct any rotation around the body axis to the left or the right,
and he also suggested to use the vertical distance between the
upper border of the symphysis and the center of the sacrococcygeal
joint to evaluate the amount of the pelvic tilt.
Although there are precise guidelines as to how AP radiographs
of the pelvis are to be exposed, it is rarely possible to adhere closely
to these precise guidelines in the clinical routine.
Therefore, distorted exposures occur. Unfortunately, any
inaccuracy further limits the usefulness of such radiographs for
quantitative measurements [13].
Hence, the aim of this study was to use standard 2D radiographs
of the pelvis for cup orientation measurements in THA and to
identify potential inaccuracies, to develop simple correction
procedures and to test them for precision and efficiency. Ergo this
study intends to contribute to an improved validity of acetabular
cup orientation measurements from plain radiographs in THA
without introducing additional devices or additional guidelines for
radiographic exposure. This should enable radiographic routines to
be continued as usual.

Materials and Methods

Principles of Radiographic Exposure and Measurements

Translational Positioning of the Patient

The central beam of each X-ray machine always hits the center
of the exposed image plane. The positioning of the patient with
respect to the mediolateral and craniocaudal placement on a
standard AP radiograph is targeted in such a way that this central
X-ray beam hits the midpoint between the centers of both hip
joints. For practical purposes, this beam is directed tangential to the
superior contour of the symphysis.
If this adjustment is not reached, the middle between the hip
joint centers and the central X-ray beam do not coincide and the
result is a translatory noncentered projection of the pelvis. Hence,
the distance between the center of the image plane and the
midpoint between both hip centers indicates the offset of the pelvis
from the standard and therefore can be used to evaluate the
translational offset mediolaterally and/or craniocaudally from the
standard position. Both of these distances will then be used to
correct the raw results for the cup orientations as derived from the
well-known trigonometric equations. One of these equations being
the basic trigonometric equation saying that the (radiographic)
anteversion ¼ arcsin(short axis/long axis) of the projected ellipse. It
has to be noted again that this anteversion angle is nothing more
than a first approximation for the real anteversion except the hip
center is centered in the central X-ray (Fig. 1).
Rotational Positioning of the Patient
According to the rules for standard exposure, the pelvis is placed in
its neutral right/left rotation, that is, the central X-ray beam is in the
midsagittal plane projecting the symphysis in line with the mid-
sacrum. If this is not the case, the pelvis is not in its neutral rotation
and the projected offset d between the symphyses and the mid-sacrum
indicates the deviating rotational angle F from the neutral pelvic
rotation. For practical reasons, the midpoint between both pubic tu-
bercles is used and the midpoint between the 2 inferior contours of the
iliosacral joint surfaces is defined as the mid-sacrum (Fig. 2).
In order to determine the pelvic tilt around the mediolateral
axis, a rectangle is placed around the inlet of the small pelvis. This
rectangle is formed cranially by the tangent to the 2 inferior ilio-
sacral joint contours, caudally by the tangent to the pubic tubercles,
Fig. 1. Effects of central projection: the cup on the right implanted in (epsilon)
anatomic anteversion appears to have 0
anteversion on the AP radiograph; the cup on
the left implanted in real 0
anteversion appears to have an apparent retroversion on
the AP radiograph. AP, anteroposterior.
and on both sides by the right and left vertical tangents to the
contour of the inlet, that is, the tangents to the linea terminalis. Any
change of the projected height H of this rectangle indicates a
change in pelvic tilt, whereas simultaneously its width B remains
unchanged (Fig. 3). Therefore, the height/width (H/B) ratio of the
pelvic inlet can be used as a very sensitive measure for pelvic tilt.
Inherent Effect of Central Projection
One of the challenges of quantitative measurements on 2D
images produced by central projection is that all objects outside the
central beam are projected obliquely [14], that is, they are projected
perspectively. This is true for the whole image and therefore
particularly relevant for both hip joints even on a correctly posi-
tioned pelvic radiograph [13,15]. The object beams directed to both
hip joints deviate by an angle ε away from the central beam (Fig. 1).
Therefore, the X-rays strike the acetabular cups obliquely at an
angle of ε. As a consequence of this obliquity, a cup appears to have
an apparent retroversion of ε as derived routinely from the
projected elliptical image of the cup opening while in reality it is
implanted in a true 0
anteversion. On the other hand when the
object beam is tangent to the opening plane of the cup so that the
ellipse does not have a short axis, that is, when it degrades to a line,
it is suggested that the cup is implanted in an apparently neutral
position while in the 3D reality the cup is implanted at a true
anteversion of ε degrees (Fig. 1). This is an inherent effect of central
projections which requires correction for all objects that lay outside
of the central X-ray. This need for correction can only be overcome
if the object is moved into the central beam, that is, when an exact
ipsilateral view of the hip joint is performed rather than centering
the image on the symphysis [16]. Essentially, all known methods to
2654 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659
Fig. 2. Pelvic rotation: Distance d, that is, the projected offset between mid-symphysis and mid-sacrum, serves as a measure for pelvic rotation angle (F) (A, anterioposterior view;
and B, axial view).
Fig. 3. Pelvic tilt: projected pelvic inlet height HN denotes neutral pelvic tilt, increased
height HI denotes anterior pelvic tilt (A), reduced height HR denotes posterior pelvic
tilt (B). APP anterior pelvic plane, FPP functional pelvic plane.
determine cup anteversion from plain radiographs must take this
specific effect of the central projection into account.
Datasets and Correction Formulae
In this study, 3D computed tomography (CT) reconstructions
were used to obtain the correlation of 3D rotation and translations
with the measurements based on plain radiographs. For this pur-
pose, 113 randomly selected, anonymized CT scans of the pelvis
from the Archives of the Radiological Department of our clinic were
morphologically analyzed. For this type of study, formal consent is
not required.
Three-dimensional coordinates of 14 anatomic landmarks were
assessed from 3D CT reconstructions using “3D Doctor” software
(Able Software Corp., Lexington, MA) for each pelvis. The 3D
coordinates of each landmark were used to track their 3D motion
when rotating the pelvis around the longitudinal and the medio-
lateral body axis alone and in combinations.
In a mathematical simulation, each pelvis of all 113 patients was
rotated in 1
increments, that is, for R/L rotation from 20
to þ20

around the longitudinal body axis, and for pelvic tilt from 25

to þ25
around the mediolateral axis through both hip centers.
Each of the 14 landmarks was projected on to a virtual radiographic
plane that is placed at a distance of 15 cm dorsal to the coronal
plane through both hip joints in order to account for the enlarging
effect. Thus, a (virtual) radiograph for each patient and each tilted
and/or translational positioned pelvis is generated resulting in a
total of more than 3Mio data points. These calculations were per-
formed using the MAPLE software (Maplesoft, Waterloo, Canada).
The coordinates of the ASIS and pubic tubercles were used to
determine the anterior pelvic plane (both anterior superior iliac
spines). The sacrum midpoint and the tubercles’ midpoint were
used to determine the offset d for each position and to compute the
 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659
Fig. 4. Gimbal-mounted model male pelvis (Synbone AG, Malans, Switzerland) in a
plexiglas frame with locking mechanisms to control R/L rotation and to adjust pelvic
tilt in increments of 7.5
and/or 10
(to validate the correction formulae).
correlation between the R/L rotation and the offset d for each pa-
tient. The corresponding computation was done to correlate the H/
B ratio of the rectangle around the pelvic inlet with the amount of
the pelvic tilt.
The equations of the correlations are providing the statistical
basis for the correction formulae for both, the rotational and
translational corrections.
Validation
To validate the correction formulae, an artificial pelvis was pre-
pared (male pelvis, Synbone AG, Malans, Switzerland, serial number
4083/9400404300). A hemispherical acetabular cup had been
implanted at 45
radiographic inclination and 20
radiographic
Fig. 5. Digital analysis of X-ray data for the model pelvis with the OrthoPlanner Software (Localite Ltd, Sankt Augustin, Germany). Equatorial wires on the centered sphere are
projected as crossed lines indicating neutral tilt and rotation.
2655
anteversion referred to the coronal, that is, the APP and sagittal plane,
respectively (ANA.NOVA Pressfit cup Hybrid outer diameter 54 mm,
ImplanTec Company, Austria). The centers of both hip joints were
marked by metal balls with a diameter of 2 mm. This model pelvis was
mounted on a cardan joint so that R/L rotation and anterior or pos-
terior pelvic tilt could be adjusted independently (Fig. 4). A total of 50
radiographs were obtained with the model in the neutral position and
at defined angles of R/L rotation and pelvic tilt. The radiographs were
taken with a standard X-ray machine (Philips Medical Systems, PCR
Eleva). The values d and H/B, the raw (¼uncorrected) radiographic
anteversion, and inclination of the cup were measured on the radio-
graphs using the orthopedic planning software OrthoPlanner
(Localite Ltd, Sankt Augustin, Germany; Fig. 5).
The raw values were entered into the correction formulae. This
was done to verify how well the formulae could be used to correct
the raw anteversion and inclination angles and yield the known
real values of 20
radiographic anteversion and 45
radiographic
inclination. Corrections were applied to the surgical anteversion
applying the rotation matrix for the mediolateral axis and to the
anatomic anteversion for the longitudinal body axis accordingly.
Intermediate results were converted back to the corrected radio-
graphic anteversion and inclination [17] (see online Excel
worksheet for details).
Results
A total of 113 pelvic CT scans were analyzed: 75 male, 29 to 79 years,
mean value 57.9 ± 10.3 years and 58 female, 27 to 83 years, mean value
63.9 ± 10.3 years. All CT scans were obtained at a gantry tilt of 0
.
2656 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659

Fig. 6. Correlations for pelvic tilt (A) and R/L rotation (B).

Correlations for Pelvic Tilt and Rotation
A linear correlation between pelvic tilt and the quotient H/B of
the projected pelvic inlet was found for the range from 25
anterior
to 25
posterior pelvic tilt (Fig. 6A). It turned out that at a 0
pelvic
tilt, that is, at neutral tilt with the APP parallel to the coronal plane,
the H/B ratio is typically 1:2, that is, the rectangle is twice as wide as
it is high. This makes it rather easy to pre-estimate by eye whether
the pelvis is anteriorly or posteriorly tilted or whether it is close to
the neutral position.
A linear correlation was also found between the pelvic rotation
and the offset d for pelvic rotations from 20
to the left and to the
right (Fig. 6B). The results for male and female individuals differ
slightly. For male, an offset distance of 2 mm corresponds to a 1

rotation to the left or to the right, while for female this offset dis-
tance is 1.9 mm only.
 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659 2657

Fig. 7. Raw data (yellow) and corrected data (green) for cup inclination (A) and cup anteversion (B).

Correction Formulae for Pelvic Tilt and Rotation
Correction formulae are derived from the correlations. For
details please see Appendix. Only 3 raw measures have to be
evaluated for rational corrections from the plain radiographs: these
are the height H and the width B of the rectangle around the pelvic
inlet and the offset d between the symphysis and the mid of the
sacrum. These measures serve as input into the Equations (1), (2),
(3), and (4) (see Appendix). Evaluating each equation will provide
the angles that have to be used to correct the raw measured angles
for pelvic tilt and rotation according to the surgical definition and
anatomic definitions for males and females accordingly [17]
(see Appendix for examples). The computation is facilitated using
a tabulation worksheet in Excel where only 5 numbers have to be
filled in.
Correction Formulae for Translation
Offsetting the midpoint between both hip joints away from the
central beam either craniocaudally and/or mediolaterally affects
both the surgical and the anatomic anteversion, respectively. There
is a simple trigonometric equation that explicitly corrects the effect
of the central projection (see Appendix for details and Fig. 1). Only 2
2658 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659
distances have to be measured additionally to serve as input into
Equation (5) (see Appendix).
Validation of Correction Formulae on the Model Pelvis
A total of 50 radiographs of the model pelvis were taken at
different translational and rotational pelvic positions in order to
test and justify the correction equations. The raw values for cup
inclination and anteversion of the model pelvis were directly
measured on each of the radiographs and were converted to the
corrected values using the aforementioned correction formulae.
Thus, corrected their deviation from the true value was reduced
considerably and the corrected values reached the true values very
closely.
The corrected raw data of cup inclination angles ranged from
45.4
to 44.2
after correction and the corrected raw data for cup
anteversion reached a corrected mean angle of 20.1
.
Correcting the data for translational misalignment improved the
cup anteversion raw data range of 13
-21
to the corrected range of
19
-21
(mean 19.35
, ±0.42).
Correspondingly, the raw cup inclination range from 44
-47

was corrected to 44
-45
(mean 44.3 ± 0.36).
Correcting the raw data for rotational misalignment of the
pelvis, that is, for both the pelvic tilt and R/L rotation, reduced the
broad range of 40
-58
for cup inclination to the mean corrected
value 43.7
(SD ± 1.90
) and the raw data range for cup anteversion
of 0
-38
was corrected to the mean value of 19.85
(SD ± 1.91
;
Fig. 7).
In essence, after correction a maximum discrepancy of 1.3
be-
tween the true and the corrected value occurs for cup inclination,
whereas the corrected cup anteversion approached the true value
within a 1
deviation range.
Discussion
This study provides a method to improve quantitative mea-
surements of cup orientation from plain 2D radiographs in THA by
correcting raw measurements from standard and nonstandard
radiographs. In the first part, the correcting formulae to improve
these measurements for acetabular cup orientation were derived
from a random sample of patient CT scans. In the second part, the
correcting formulae thus established were validated using a model
pelvis with a cup implanted at a known orientation.
The correction method presented here markedly improves the
evaluation of the correct cup inclination and anteversion from plain
2D standard radiographs. This is achieved by systematically cor-
recting discernible deviations from the standard X-ray settings and
applying the correction formulae to the raw values directly
measured from the radiograph.
It is not necessary to introduce additional guidelines for X-ray
exposure and no additional markers are required so that the
method is equally suitable for retrospective and prospective
investigations [9].
Likewise, it is a big advantage that it is suitable for radiographs
that were acquired using standard techniques that have been
practiced for years. The additional effort for the correction is min-
imal because only 3 points have to be evaluated additionally.
Accuracy is not compromised despite its simplicity. The method
meets the same accuracy requirements as Einbildro €ntgenanalyse
and the more recent 2D/3D methods, which means that the mean
error is less than 2
[7,11]. The performance was proven by the
results obtained from multiple measurements from the model
pelvis in different projections during validation of the correction
formulae. In addition, these formulae are straightforward and can
be applied immediately to a single postoperative standard AP
radiograph. There is no need to get multiple radiographs before
evaluation can be started.
Translatory misalignment should be corrected first. Trans-
lational decentralization of the central X-ray beam by 2 cm
produces an apparent rotation of 1.15
, either R/L rotation or pelvic
tilt. The acetabular cups are decentralized by about 8 to 10 cm from
the midsagittal plane even when all guidelines for a standard AP
pelvic radiograph are met. Hence, a correction for this effect is
always required [13,14] (see Appendix for an example). Without
such a correction, radiographic cup anteversion will be under-
estimated or overestimated by about 4
to 5
[18] depending on the
direction in which the deviating shift occurs.
Pelvic tilt greatly influences functional cup anteversion. Studies
in recent years have concluded that in each individual patient [19],
pelvic tilt does have its proper value but is relatively constant and
hence it is an individual characteristic. It remains more or less
unchanged throughout a person’s life and it changes only slightly
between the standing and supine posture [20e22], although there
is a trend for an increased anterior pelvic tilt from the standing to
the supine positioning while there is a trend to posterior pelvic
tilting during aging. Typically, patients with coxarthritis tend to
have an increased anterior pelvic tilt as a result of a flexion
contracture and/or a hyperlordosis. After successful joint arthro-
plasty, their individual pelvic tilt is restored closer to its former
more erected position, that is, in general the pelvis tilts posteriorly
about 5
after THA [23]. In cases where the orientation of the APP
must be known explicitly, it can be acquired via a lateral pelvic
radiograph or EOS imaging with the patient in the standing posture
[24,25].
Nowadays, the preferred reference plane for cup positioning is
the coronal plane, also called the functional anterior pelvic plane
[19,21,26]. Thus, the measured cup orientation parameters are not
dependent on the pelvic tilt but the individual angle between the
functional pelvic plane and the APP continues to be relevant.
Especially when surgery is performed in the lateral decubitus, the
APP serves as the most important reference plane during surgery.
When the patient is positioned supine on the operating table, the
functional pelvic plane mostly runs parallel to the coronal plane
which is also parallel to the plane of the operating table and to the
radiographic plane. Ergo, it is best to reference the orientation of
the cup to the functional pelvic plane and the correction for the
pelvic tilt can be disregarded and the focus for the corrections as
proposed in this study can be restricted to the R/L rotation and the
translational decentralization mediolaterally and/or craniocaudally,
the latter including the inherent effect of the central projection (see
Appendix for examples).
The proposed method yields more than adequate corrections for
the shortcomings of a routine 2D standard radiograph with respect
to 3D measurements. The correction formulae presented here have
proven to correct errors that have been set intentionally when
imaging the model pelvis at 50 different positions. The average
deviation from the true value could be reduced to less than 1.3

from the real orientation.
It is important to note that the good results obtained here may
have been influenced by 2 factors: first, the model pelvis was an
average male pelvis, and second, the X-ray settings to take the
radiographs were precisely controlled during the exposure and also
at the time of evaluating the X-rays which may not be the case in
the daily routine.
Three general rules emerged from this study. The first rule
applies to the correction of R/L rotations and it namely tells that a
displacement of the midsymphysis vs the mid-sacrum of 2 mm on
the radiograph corresponds to a rotation of the pelvis of 1.15
about
the body’s longitudinal axis. Tannast et al [25] obtained similar
results with the Hip2 Norm software. The second rule says that
 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659
statistically spoken a height/width ratio of 1:2 of the circumscribed
rectangle about the pelvic inlet indicates that the APP is vertically
oriented, that is, it is parallel to the coronal plane or in other words
the pelvis has a 0
pelvic tilt.
The third rule applies to translatory decentralization where a 2
cm off-center displacement corresponds to an apparent 1
rotation,
either around the longitudinal or the mediolateral body axis.
The intention behind this study was to make the measurement
of the angular orientation of acetabular cups as extracted from
standard AP radiographs more accurate while keeping the method
as simple as possible. The formulae are derived from 113 CT scans.
Therefore, they are based on the statistical distribution within this
random sample. A larger study sample may confirm these formulae
or provide even more precise corrections.
It is also true that the formulae are linear equations. Linearity
can be assumed within the range of the deviating angles that were
investigated in this study. A more mathematically accurate
computation applying all the details of perspective projections and
applying the known formulae for 3D matrix-rotation throughout
the entire computation could theoretically provide even more
precise corrections and also extend the range for the correction
[27,28]. But with respect to practicability and also to serve
simplicity, we sticked to linearity. Our formulae could demonstrate
to deliver more than adequate corrections as long as they are used
within the scope of the translational and/or rotational deviations
tested in this study.
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Appendix

The correlation of “pelvic tilt” to the quotients H/B (height/width) of the projected pelvic inlet results in a linear correlation

H=Bm ¼ 0:0159*pelvic tilt+ þ 0:502; R2 ¼ 0:9960

for male patients and

H=Bf ¼ 0:0143*pelvic tilt+ þ 0:509; R2 ¼ 0:9947

for female patients.
The factors “0.502” and “0.509,” respectively, indicate that for a pelvis in 0
, that is, in neutral pelvic tilt, the rectangle around the pelvic
inlet has an H/B ratio of 1:2, that means, it is twice as wide as it is high.
The correlation of the “R/L rotation” of the pelvis with the offset d also results in linear regression equations

dm ¼ 2:0322*R=L rotation+ þ 0:3189; R2 ¼ 1:0

for male patients and

df ¼ 1:9307*R=L rotation+ þ 0:6072; R2 ¼ 0:9999

for female patients (Fig. 6).
It follows from these correlations that a measured offset d of about 2 mm corresponds to an R/L rotational angle of 1
.
Solving the correlation equations for pelvic tilt provides the correction formula. These 2 gender-specific formulae are:
 
Correction of pelvic tilt+m ¼ H Bm 0:0159 þ 31:44 ðmaleÞ (1)

 
Correction of pelvic tilt+f ¼ H Bf 0:0143 þ 35:59 ðfemaleÞ (2)

This means that the values “H” and “B” as measured from the radiograph are used as input into Equations (1) and (2). Evaluating each
equation will provide the angle that has to be used to correct the raw measured angles according to the surgical definition for males and
females, respectively.
The correlation equations for the R/L rotation provide the appropriate correction formulae. These are as follows:

Correction of R ¼ L rotationþf ¼ dm 2:032 þ 0:157 ðmaleÞ (3)


Correction of R=L rotation+f ¼ df 1:931 þ 0:315 ðfemaleÞ (4)

This means that the values “dm” and “df” as measured from the radiograph is used as input into Equations (3) and (4). Evaluating each
equation will provide the angle that has to be used to correct the raw measured angles according to the anatomic definition for males and
females, respectively.
Offsetting the midpoint between both hip joints away from the central beam either craniocaudally and/or mediolaterally affects both the
surgical and the anatomic anteversion.
From trigonometry, it explicitly follows that both angles are corrected according to the following trigonometric equation:

Correction angle+ ¼ arctanðt=1000Þ (5)

with t ¼ mediolateral and/or craniocaudal distance in mm (calibrated) of the midpoint of both hip joints from the central beam (center of X-
ray image).
Computation is done by an Excel worksheet or a Smartphone app.
 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659 2659.e2

Fig. A3. Xc denotes the central X-ray, that is, the center of the radiographic plane, the
horizontal plane is given by the tear drop line. There is no rotatory malalignment. The
Fig. A1. Xc denotes the central X-ray, that is, the center of the radiographic plane, the
central X-ray hits the midpoint between both hip centers. Wo is the horizontal offset of
horizontal plane is given by the tear drop line. Wo is the horizontal and Vo is the
the left hip center from the central X-ray. The cup’s inclination is directly measured on
vertical offset of the right hip center from the central X-ray. There is no rotatory
the radiograph as 36
, the cup’s anteversion is evaluated solving the equation cAV ¼
malalignment (d ¼ 0). The cup’s inclination is directly measured on the radiograph as
arcsin(short/long). cAV has to be corrected due to the offset Wo from the central beam,
45
, the cup’s anteversion is evaluated solving the equation cAV ¼ arcsin(short/long).
see Table A1 row 4 (yellow cells are input).
cAV has to be corrected due to the offset from the central beam, see Table A1 row 1
(yellow cells are input). There is a compensating effect between the Wo and the Vo
offset.

Fig. A2. Xc denotes the central X-ray, that is, the center of the radiographic plane, the
horizontal plane is given by the tear drop line. Wo is the horizontal and Vo is the
vertical offset of the hip centers from the central X-ray. There is a rotatory malalign-
ment indicated by the projected offset d of the symphysis and the midpoint between
both inferior edges of the iliosacral joints. The cup’s inclination is directly measured on
the radiograph as 45
and 40
, respectively, the cup’s anteversions are evaluated
solving the equation cAV ¼ arcsin(short/long). cAV has to be corrected due to the offset
Vo and Wo from the central beam and to rotatory malalignment, see Table A1 rows 2
and 3 (yellow cells are input).
2659.e3 D. Widmer et al. / The Journal of Arthroplasty 33 (2018) 2652e2659

Table A1
Steps to Get Corrected Acetabular Cup Orientation.

Long (Long Short (Short Radiographic Radiographic Measured Measured Distance Measured Vertical Corrected Corrected
Ellipse Diameter) Ellipse Diameter) Anteversion
Inclination
Horizontal d (mm, Calibrated) Offset Vo Radiographic Radiographic
as Measured as Measured (Without (Without Offset Wo (mm, Calibrated) Anteversion
(RA) Inclination
(RI)
Correction) Correction) (mm, Calibrated)

Fig. A1
Right 70.5 26.5 20.6 45 82.1 0.0 64.2 21.3
42.6

Fig. A2
Right 76.0 31.5 22.5 45 81.5 12.1 64.2 19.2
44.8

Left 76.0 30.5 21.9 40 80.9 12.1 63.8 25.7
35.3

Fig. A3
Left 72.0 21.0 16.3 36 93.7 0.0 0.0 19.4
34.6

First measure short and long axis of the projected ellipse, determine radiographic anteversion and inclination, correct for horizontal and vertical offset and offset d, calculate
corrected radiographic anteversion and inclination, convert to anatomic anteversion and inclination, correct anatomic orientation due to horizontal offset,convert to
radiographic anteversion and inclination (formulas for correction and conversion are filled in the corresponding cells of the Excel table, the user must fill in yellow cells only,
calculation is then performed automatically).

Long (Long Short (Short Radiographic Radiographic Convert to Convert to Measured Horizontal (Anatomic) Correction
Ellipse Diameter) Ellipse Anteversion
Inclination
Anatomic Anatomic Offset Wo Angle for AA due
Diameter) (Without Correction) (Without Correction) Anteversion
(AA) Inclination
(AI) (mm Calibrated) to Wo

Fig. A1
Right 70.5 26.5 20.6 45 28.0 48.6
82.1 4.7

Fig. A2
Right 76.0 31.5 22.5 45 30.4 49.2
81.5 4.7

Left 76.0 30.5 21.9 40 32.0 44.7
80.9 4.6

Fig. A3
Left 72.0 21.0 16.3 36 26.4 39.0
93.7 5.4

Conversion Factors

Radians_to_Degree Degree_to Radians

57.29577951 0.017453293
 The Journal of Arthroplasty 33 (2018) 2480e2484

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Correlation Between Intraoperative Anterior Stability and Flexion

Gap in Total Knee Arthroplasty
Shinichiro Nakamura, MD, PhD *, Shinichi Kuriyama, MD, PhD,
Kohei Nishitani, MD, PhD, Hiromu Ito, MD, PhD, Koichi Murata, MD, PhD,
Shuichi Matsuda, MD, PhD
Department of Orthopedic Surgery, Kyoto University, Graduate School of Medicine, Kyoto, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Background: Instability is a common failure mode after total knee arthroplasty. There have been only a
Received 25 January 2018 few methods to quantify anterior translation with fixed forces applied during surgery. The purpose of the
Received in revised form study was to measure the anterior translation with a new device and to analyze the relationships be-
12 March 2018
tween the amount of anterior translation and the joint gaps.
Accepted 13 March 2018
Available online 21 March 2018
Methods: Fifty knees with medial osteoarthritis underwent surgery using a posterior-stabilized implant.
During surgery, measurement of anterior translation was performed at 90
of knee flexion with a trial
implant, applying a traction force of 70 N. The joint gap was measured using a tensor device, applying a
Keywords:
total knee arthroplasty
distraction force of 178 N in flexion. The Pearson correlation coefficient was calculated between anterior
instability translation and joint gaps and laxity.
anterior translation Results: On average, anterior translation during surgery was 8.5 mm (standard deviation [SD] ¼ 3.6 mm).
joint gap Medial gap (correlation coefficient [r] ¼ 0.30), medial laxity (r ¼ 0.33), and center laxity (r ¼ 0.29) had a
flexion positive correlation with anterior translation, and anterior translation increased with larger joint gap or
greater laxity.
Conclusion: Anterior translation was measured with a new device by applying the anterior force to the
tibia, and the correlations between anterior translation and joint gap and laxity were analyzed. A larger
medial gap and greater medial laxity were correlated with greater anterior translation, which could
cause symptomatic feelings of instability. Surgeons should pay attention to the tension of medial
structures in flexion and avoid excessive medial release during surgery.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is one of the most successful
procedures to improve pain and functional disabilities in ortho-
pedic surgery [1e5]. However, it has been reported that patient
satisfaction after TKA is not as high as after total hip arthroplasty
[6,7]. Instability is reported as a major complication, which results
in knee pain, patient dissatisfaction, and revision surgery. In several
recent registry data and studies, instability has been reported as a
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.030.
* Reprint requests: Shinichiro Nakamura, MD, PhD, Department of Orthopedic
Surgery, Kyoto University, Graduate School of Medicine, 54 Shogoin-Kawaharacho,
Sakyo-ku, Kyoto 606-8507, Japan.
common failure mode in early term to midterm follow-up after TKA
[8e12].
During TKA, the anterior cruciate ligament (ACL) is sacrificed,
except in the case of bicruciate-retaining TKA. Release of the medial
collateral ligament (MCL) has been performed frequently when the
medial joint gap is tighter than the lateral joint gap [13]. In
posterior-stabilized (PS) TKA, posterior stability is achieved using a
post-cam mechanism. However, the posterior cruciate ligament
(PCL) is sacrificed, which leads to an opening of the flexion gap and
the subsequent possibility of flexion instability [14e17]. Due to the
sacrifice and/or release of knee multi-ligaments during surgery,
patients with inadequate medial-lateral ligament balance and
imbalance in the extension and flexion gaps sometimes complain of
feelings of instability after TKA. In ACL-deficient knees, MCL is
known as the second restraint to prevent anterior translation of the
tibia [18e21]. In TKA, it is unknown whether the joint gap has some

https://doi.org/10.1016/j.arth.2018.03.030
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 S. Nakamura et al. / The Journal of Arthroplasty 33 (2018) 2480e2484
effect on anterior translation of the tibia, although medial struc-
tures seem to be important for postoperative stability.
A limited number of clinical studies have reported the rela-
tionship between anterior translation and clinical symptoms. The
association between the objective anterior laxity in midrange
flexion and the subjective healing of instability was analyzed, in
which an anterior displacement 7 mm was an independent risk
factor for feelings of instability [22]. In a kinematic study of the
flexion gap and kinematics, laxity of the MCL induced abnormal
kinematics, including anterior translation, whereas the lateral
flexion gap had a smaller effect on knee kinematics [23]. This study
would be beneficial to improve clinical outcomes and evaluate
what factors are directly correlated with the amount of anterior
translation during surgery to prevent excessive translation.
Previously, there have been only a few methods to quantify
anterior translation applying fixed forces during TKA. In the present
study, a new device applying the anterior force to the tibia was
developed to measure the amount of anterior translation. The
purpose of the study was to measure the anterior translation with a
new device and to analyze the relationships between the amount of
anterior translation and the joint gaps measured using a tensor. The
hypothesis was that the loose flexion gap, especially at the medial
side, causes excessive anterior translation of the tibia.
Materials and Methods
The joint gap and anterior translation of 50 knees were
measured during TKA from July 2016 to October 2017. The inclusion
criterion for this study was primary TKA for medial osteoarthritis of
the knee using a ceramic tricondylar PS implant. Patients pre-
senting any valgus deformity or varus deformity of more than 30

were excluded from this analysis. A total of 5 men and 45 women
with an average age of 77.6 years (standard deviation [SD] ¼ 5.4)
were included at the time of the surgery. The average height and
weight were 151.6 cm (SD ¼ 7.2) and 60.1 kg (SD ¼ 11.0), respec-
tively, and the mean body mass index (BMI) was 26.2 (SD ¼ 3.8).
The average hip-knee-ankle angle was 12.0
varus (SD ¼ 5.2) pre-
operatively. Informed consent was obtained from all patients. The
appropriate ethics review boards approved the study design.
A single surgical team performed all TKAs in a uniform manner,
and anesthesia was induced in the same manner in all patients. The
procedures were performed using the medial parapatellar
approach with PCL sacrificing. The bone was cut using the following
measured resection technique to obtain the neutral alignment. The
distal femur was cut perpendicular to its mechanical axis. Rota-
tional alignment of the femoral component was adjusted to the
surgical epicondylar axis. The size of the femoral component was
determined based on the anteroposterior (AP) length of the femur
with anterior referenced jig, which was independent of the flexion
gap. The tibia was cut perpendicular to the mechanical axis in the
coronal plane. Approximately 10 mm of bone was resected from the
most proximal part of the lateral tibial plateau. In the sagittal plane,
the posterior slope was set to 5
relative to the tibial shaft. Rota-
tional alignment of the tibial component was adjusted to the AP
axis of the tibia (the Akagi line) [24]. Osteophytes on the medial
side of the femur and tibia were removed. The patella was resur-
faced for all knees. Regarding ligament balancing, the philosophy
was to aim near-normal medial stability, because the lateral side
was laxer than the medial side in normal knees [25]. In a clinical
study, implanted knees with medial joint laxity during flexion
resulted in an inferior postoperative outcome, and lateral joint
laxity did not influence patient satisfaction or function [26].
Therefore, the deep layer of the MCL was released within 1 cm from
the joint line for bone resection and osteophyte removal. No
2481
Fig. 1. Anteroposterior (left) and lateral (right) views of Bi-Surface knee (Kyocera,
Kyoto, Japan). This implant has a ball-and-socket joint in the mid-posterior portion of
the femoral condyle and the polyethylene insert.
additional medial release was performed to acquire equal medio-
lateral joint gap balance, even if lateral laxity was observed.
The implant used in the present study was a ceramic tricondylar
PS implant (Bi-Surface knee: Kyocera, Kyoto, Japan; Fig. 1). This
implant was developed to fit a life style requiring frequent deep
flexion activities, and it has a ball-and-socket joint as a third condyle
in the mid-posterior portion to induce femoral rollback. This ball-
and-socket joint has been proven to work as a post-cam mecha-
nism in vivo in previous biomechanical studies [27e29]. The third
condyle induced intensive posterior translation of both condyles and
did not prevent axial rotation [30]. The femoral component has a
multi-radius sagittal geometry with identical medial and lateral
condyles [31,32]. Regarding the polyethylene, the medial condyle has
a more concave design to provide better conformity, whereas the
lateral condyle has a flatter surface around the posterior portion to
tolerate greater posterior translation and rotation.
Measurement of anterior translation was performed at 90
of
knee flexion with a trial implant, including the trial tibial insert,
before cementation. The device was fixed to the anterior part of the
tibial tray, and the puddle was set on the medial side of the femoral
component (Fig. 2A). A pin was inserted through the femoral
component to secure the puddle on the distal surface of the femoral
component. A traction force of 70 N was applied to the tibial
component to pull the tibia anteriorly after the patella was reduced
(Fig. 2B). Concerning the reliability and reproducibility of this de-
vice, we measured the actual traction force 5 times, and the stan-
dard error was 1.7 N. The distance between the anterior tibia and
the distal femur was measured with this device. The zero position
was defined at the anterior edge of the tibial tray. The distance was
measured 3 times before and after applying the force, and the
amount of anterior translation was calculated.
The joint gap was measured using a tensor device while
applying a distraction force of 178 N [14,33]. The measurement was
taken with the knee in 90
of flexion, using a trial femoral
component, after removing the trial tibial tray and tibial insert. The
center gap and varus-valgus angle were measured with this tensor
device. The medial and lateral gaps were calculated based on the
center gap and the varus-valgus angle. To evaluate the effects of
medial, center, and lateral laxity on anterior translation, medial and
lateral laxity were defined by subtracting the trial tibial insert
thickness from the medial, center, and lateral gaps in flexion.
2482 S. Nakamura et al. / The Journal of Arthroplasty 33 (2018) 2480e2484
Fig. 2. (A) Lateral view of the device applying anterior force to the tibial component. The zero position was defined at the anterior edge of the tibial tray. (B) Photographs taken
during surgery. The measurement of the position was taken before and after applying the force.
All statistical analyses were performed using JMP Pro software
version 11.0.0 (SAS Institute Inc, Cary, NC). Pearson correlation co-
efficients were calculated to determine the correlations between
anterior translation and medial, center, and lateral gaps, and laxity
and varus-valgus angle. Also, the correlation between anterior
translation and patient demographics including height, weight,
BMI, and preoperative alignment was determined. If the correlation
coefficients were significant, a regression line was determined. The
level of significance was defined as P < .05.
Results
On average, anterior translation during surgery was 8.5 mm
(SD ¼ 3.6 mm). Medial, center, and lateral gaps at 90
of knee
flexion were 11.4 mm (SD ¼ 3.1 mm), 11.9 mm (SD ¼ 2.9 mm), and
12.3 mm (SD ¼ 3.1 mm), respectively. The average thickness of the
trial tibial insert was 9.1 mm (SD ¼ 0.5 mm). The average medial
and lateral laxity was 2.3 mm (SD ¼ 3.0 mm) and 3.2 mm (SD ¼ 3.0
mm), respectively. The varus, neutral, and valgus balance was
observed for 28, 13, and 9 knees, respectively. The average varus-
valgus angle was 1.4
varus (SD ¼ 3.0
).
Medial gap, medial laxity, and center laxity had a positive cor-
relation with anterior translation, where anterior translation
increased with a larger joint gap or greater laxity. The varus-valgus
angle, center gap, lateral gap, and lateral laxity were not correlated.
No correlations were found with height, weight, BMI, and preop-
erative alignment (Table 1). In the regression analysis, the regres-
sion line was calculated as follows (y ¼ anterior translation).
y (mm) ¼ 0.34x (mm) (x ¼ medial gap) þ 4.66 (Fig. 3A)
y (mm) ¼ 0.39x (mm) (x ¼ medial laxity) þ 7.65 (Fig. 3B)
y (mm) ¼ 0.37x (mm) (x ¼ center laxity) þ 7.52 (Fig. 3C)
Discussion
Instability is a major complication after TKA, resulting in revi-
sion surgery. In the present study, anterior translation was
measured with a new device that applies anterior force to the tibia,
and the correlation between anterior translation and medial and
lateral joint gaps was calculated. The medial gap and medial laxity
in flexion had positive correlations with anterior translation,
whereas the lateral gap and laxity did not. Excessive medial laxity
could cause anterior instability; therefore, medial tightness
without extensive medial release seems to promote knee stability
after TKA.
Instability has been one of the most common failure modes in
early term to midterm follow-up after primary TKA, although the
overall revision rate and prevalence of polyethylene-related prob-
lems are decreasing [8,11]. In several studies and registry data, the
percentage of failure due to instability reached 10%-30% [11,34e39].
In a systematic review, the average time between the primary and
revision TKA was 44.7 months, and the need for revision due to
instability was frequently reported in a younger patient cohort,
most commonly in female TKA patients [12]. In PS TKA, it is possible
to have an excessive flexion gap by sacrificing the PCL, which allows
substantial anterior tibial translation and subjective instability
[14e17]. The management of flexion instability has been chal-
lenging although several surgical procedures, such as stepwise
surgical correction, have been developed [40]. Little information is
 S. Nakamura et al. / The Journal of Arthroplasty 33 (2018) 2480e2484 2483

Table 1
Correlation Coefficient for Anterior Translation.

Correlation Coefficient P Value

Varus-valgus angle 0.17 .230

Medial gap 0.30 .036
Center gap 0.26 .071
Lateral gap 0.19 .192
Medial laxity 0.33 .020
Center laxity 0.29 .043
Lateral laxity 0.21 .140
Height 0.07 .628
Weight 0.08 .563
Body mass index 0.05 .721
Preoperative alignment 0.23 .106

available on the intraoperative factors contributing to instability in

flexion, which would be important for surgeons to prevent flexion
instability after TKA.
Anterior instability has not been analyzed fully, although the
ACL was sacrificed during most TKAs. In several studies, AP insta-
bility was measured manually with a navigation system to evaluate
the effects of the polyethylene design [41,42]. There is no study that
measured the anterior translation during surgery with a repro-
ducible device by applying the same force. In several biomechanical
studies, the effects of the MCL on anterior translation in ACL-
deficient unimplanted knees were evaluated. ACL deficiency
caused a significant increase in the MCL insertion site and contact
forces in response to anterior tibial loading [18]. In addition, the
MCL carried 60% more force than the ACL at 90
flexion [20]. In the
present study, the laxity of the medial structure was related to
larger anterior translation in the implanted knees. This phenome-
non can be explained in terms of the anatomic features of the ACL
and MCL, even for implanted knees.
Patients with flexion instability complained of various symp-
toms, such as a sense of instability without giving way, substantial
difficulty ascending or descending stairs, recurrent knee joint
swelling, and diffuse anterior knee pain or tenderness [43]. AP
laxity, including PCL function, was evaluated after TKA in several
studies. Laxity of around 5 mm was considered suitable for a
satisfactory clinical outcome, and less stability 10 mm in flexion
was associated with worse clinical scores [44,45]. In another study,
the association between subjective healing of instability and AP
laxity in flexion was analyzed, and AP displacement 7 mm was
identified as an independent risk factor for feelings of instability
[22]. A direct comparison between the present study and previous
studies might be difficult because AP displacement was analyzed
during surgery in the present study. However, excessive flexion
gap, especially at the medial side, could lead to symptomatic AP
instability. Surgeons should pay special attention to the tension of
medial structures and avoid excessive medial release during sur-
gery. If the medial laxity is detected during surgery, up-size and/or
flexed position of the femoral component can be options.
The present study has several limitations. First, AP displacement
Fig. 3. (A) Correlation coefficients between anterior translation and medial gap. (B)
was measured only at 90
of knee flexion under general anesthesia Correlation coefficients between anterior translation and medial laxity. (C) Correlation
for all patients, and the testing was performed before component coefficients between anterior translation and center laxity.
cementation. Trial components may have allowed for slightly more
laxity than cemented components. The results could be different
for the measurement in midflexion range, in the awake state or cruciate-retaining, and cruciate-substituting implants. Third, the
after cementation. Second, the polyethylene geometry and the force applied was identical and independent of each patient’s
congruency between the femoral component and the polyethylene weight and height. Moreover, the number of patients included in
insert might have significant effects. The degree of posterior lip the present study was relatively small. The physical constitution of
especially may influence anterior translation. The design in the the patients might have affected the results. Fourth, surgery was
present study was very unique with a possibly different kinematic performed with measured resection technique to aim near-normal
philosophy, which may be valid only for a certain set of circum- medial stability and accepted lateral laxity, so the knees were not
stances. The results may not necessarily apply to the standard PS, truly balanced. The question of gap balancing vs measured
2484 S. Nakamura et al. / The Journal of Arthroplasty 33 (2018) 2480e2484
resection still remains a controversial point for ligament balancing
during surgery. The results might be different for the balanced
knees with a gap balancing technique. Finally, relationships be-
tween AP laxity and clinical outcomes were not evaluated in the
present study. While some correlation seems to exist between
increased anterior laxity and subjective instability, their exact
relationship remains elusive. It is still unclear how much AP laxity is
detrimental to certain clinical outcomes, patients’ feelings, and
overall satisfaction.
Conclusion
Anterior translation was measured with a new device used to
apply anterior force to the tibia in consecutive patients, and the
correlation between anterior translation and medial and lateral
joint gaps was analyzed. A larger medial gap and greater medial
laxity were correlated with greater anterior translation, which
could cause symptomatic feelings of instability, although the
design concept and surgical procedures may have an effect on AP
stability. Surgeons should pay attention to the tension of the
MCL in flexion and avoid the excessive medial release during
surgery.
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 The Journal of Arthroplasty 33 (2018) 2491e2495

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Cruciate-Retaining vs Posterior-Stabilized Primary Total

Arthroplasty. Clinical Outcome Comparison With a Minimum
Follow-Up of 10 Years
Ricardo Serna-Berna, MD a, Alejandro Lizaur-Utrilla, PhD, MD a, c, *,
Maria F. Vizcaya-Moreno, PhD, MD b, Francisco A. Miralles Mun~ oz, MD a,
Blanca Gonzalez-Navarro, MD , Fernando A. Lopez-Prats, PhD, MD c
a

a
Department of Orthopaedic Surgery, Elda University Hospital, Alicante, Spain
b
Clinical Research Group, Faculty of Health Sciences, University of Alicante, Alicante, Spain
c
Traumatology and Orthopaedia, Miguel Hernandez University, Alicante, Spain

a r t i c l e i n f o a b s t r a c t

Article history: Background: Controversy continues regarding whether the posterior cruciate ligament should be
Received 8 January 2018 retained or removed during total knee arthroplasty (TKA) procedure. The objective was to compare the
Received in revised form clinical outcomes with a minimum follow-up of 10 years between patients who received contemporary
12 February 2018
cruciate-retaining or posterior-stabilized primary TKA.
Accepted 26 February 2018
Available online 17 March 2018
Methods: Case-control study of 268 patients who underwent cruciate-retaining TKA vs 211 to posterior-
stabilized design, with the same arthroplasty system, and a minimum follow-up of 10 years. Clinical
assessment was performed by Knee Society scores, Western Ontario and MacMasters Universities and
Keywords:
total knee arthroplasty
Short-Form 12 questionnaires, range of motion, and patient satisfaction.
cruciate-retaining Results: Successful outcomes were found for both designs. No significant differences in functional scores,
posterior-stabilized range of motion, patient-related scores, or patient satisfaction. Between the 5-year and last postoperative
functional outcome follow-up, there were a significant decrease of all clinical scores in both groups. In addition, complication
patient satisfaction rate and implant survival were similar between groups.
Conclusion: The superiority of one design over the other was not found. Both designs can be used
expecting long-term successful outcomes and high survival. The choice of the design depended on the
status of the posterior cruciate ligament and surgeon preference.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) has provided high rate of suc-
cessful outcomes in patients with end-stage knee osteoarthritis [1].
Several designs have been developed to improve the durability and
function of this procedure. However, the most widely used designs
for primary arthroplasty have been, and continue to be today,
cruciate-retaining (CR) and posterior-stabilized (PS) [2]. Currently,
controversy still continues regarding whether the posterior cruci-
ate ligament (PCL) should be retained or removed during the pro-
cedure [3]. Advantages and disadvantages for both CR and PS
designs have been reported in numerous biomechanical and
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.094.
* Reprint requests: Alejandro Lizaur-Utrilla, PhD, MD, Department of Orthopaedic
Surgery, Elda University Hospital, Ctra Elda-Sax s/n, 03600 Elda, Alicante, Spain.
kinematic studies [4e7]. However, the impact of the kinematic
differences on the clinical outcomes has been controversial, and the
superiority of one design over the other has not been unequivocally
demonstrated in vivo [8].
There were a large number of publications examining the clin-
ical differences between CR and CS designs, but most of them had
small size and a follow-up as short as 5 years and the findings on
clinical outcomes were controversial [9e12]. As far as we know,
only 3 studies have reported comparative clinical outcomes with a
minimum follow-up of 10 years [13e15]. One of these [13] was a
randomized study of 62 patients at 2 years and then reviewed at 10
years where the authors reported similar range of motion (ROM)
and functional outcomes. The 2 others were retrospective
comparative studies with follow-up of 10 years, one of which re-
ported better ROM and function in the PS group [14], and the other
reported better ROM in the PS group but similar functional scores
[15]. Thus, evidences on long-term functional outcomes are limited

https://doi.org/10.1016/j.arth.2018.02.094
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2492 R. Serna-Berna et al. / The Journal of Arthroplasty 33 (2018) 2491e2495

and controversial. Several systematic reviews comparing both de- (cementless femoral component) and PS design had cemented
signs have reported no significant clinical differences with the fixation of both components. Tibial preparation was performed
available evidences [3,8], and the authors suggested that longer first, and intramedullary alignments were used for femur and tibia
follow-up investigations were needed. in all patients. Care was taken during bone resections to balance
The main purpose of this study was to compare the clinical flexion and extension gaps. All patellae were routinely resurfaced
outcomes with a minimum follow-up of 10 years between patients with an all-polyethylene cemented design. After intraoperative
who received contemporary CR or PS primary TKA. We hypothe- assessment, all patients with sufficient PCL received CR TKA.
sized that long-term outcomes are similar. Among patients receiving PS TKA, 26 had sufficient PCL and the
remaining 185 had insufficient PCL.
Patients and Methods According to the standard protocol, all patients received anti-
biotic prophylaxis with first generation cephalosporin for 24 hours
This long-term retrospective case-control study was approved (started 1 hour before skin incision) and thromboembolic prophy-
by our institutional review board and informed consent was laxis with low-molecular-weight heparin for 30 days. Standardized
required to perform a new patient evaluation. at our center, continuous passive knee motion started on the first
A search to identify patients who underwent CR and PS primary postoperative day and from the third day active motion under the
TKA between 2001 and 2006 was performed on the departmental supervision of the therapist and full weight-bearing were allowed.
arthroplasty database using diagnostic and surgical codes. The in-
clusion criterion was primary TKA. The exclusion criteria were Evaluations
diagnosis of posttraumatic or inflammatory arthritis, if bone
grafting was required, varus/valgus deformity >15
, or prior knee At our institution, the arthroplasty register prospectively col-
osteotomy. lects clinical and radiographic data on all patients treated with
Six hundred ten patients meeting the criteria were identified. Of arthroplasty with a minimum follow-up of 5 years. Standardized
them, 82 patients (13.4%) were excluded for death within 10 assessment was performed preoperatively and postoperatively at 1,
postoperative years unrelated to the TKA (38 CR and 44 PS), 31 3, 6 months, and then yearly until at least 5 years. For this study,
could not be contacted or they were unable to return for re- those patients with a follow-up of <10 years were invited to return
evaluation (17 CR and 14 PS), and 18 refused to participate in a for a new clinical and radiological evaluation. For clinical evalua-
new evaluation (12 CR and 6 PS). Among the remaining 479 pa- tions, the Knee Society scores (KSSs) [16], reduced Western Ontario
tients, 268 received CR and 211 PS arthroplasty. In that time, the and MacMasters Universities (WOMAC) [17] and Short-Form 12
indication of one or the other TKA design depended on intra- [18] questionnaires were used. The ROM of the knee joint was
operative PCL status, and the first years also on preference of the assessed with a standard goniometer. Flexion and extension lag
surgeon. Baseline characteristics at the time of the TKA in both items were also analyzed separately from KSS. The WOMAC was
groups are shown in Table 1. There were no significant differences transformed to a 0-100 scale, so a higher value implies a better
in preoperative data between groups. outcome. In addition, patient satisfaction was evaluated at final
follow-up by a 0-10 visual analogue scale.
Radiological evaluation was performed using standard standing
Operative Protocol
anteroposterior, lateral, and skyline views. The latest radiographs
were analyzed by 2 independent surgeons who did not know the
The operations were performed by several experienced sur-
clinical evaluations of the patients. The Knee Society radiographic
geons, according to the standardized practice in our center. All
evaluation system [19] was used for position of components and
procedures were performed in operating room with laminar flow,
zones of radiolucency or osteolysis. Loosening of the arthroplasty
under spinal anesthesia. A standard anterior midline skin incision
was defined by continuous or progressive radiolucent lines or by
and medial parapatellar arthrotomy was used in all patients.
migration of any component.
Standard operative techniques were used for all patients with the
respective instrument systems.
Statistical Analysis
The same modular TKA systems were used in all patients
(Trekking, Samo, Italy). The 2 designs (CR and PS) were identical
Statistical analyses were performed with SPSS software, v. 15.0
except for the cam-post mechanism. CR design had hybrid fixation
(SPSS Inc, Chicago, IL). Normal distribution was determined by the
Table 1 Kolmogorov-Smirnov test. Comparisons between categorical vari-
Baseline Characteristics at the Time of the TKA. ables were made with chi-squared test or nonparametric Fisher
CR Group, n ¼ 268 PS Group, n ¼ 211 P Value exact test or Mantel-Haenszel test, and for continuous variables
with Student t test or Mann-Whitney U test. Comparisons between
Age at TKA, y 68.8 (7.1) 70.1 (8.3) .108
Gender (F/M) 196/72 144/67 .142 preoperative and last follow-up data were made by paired t test or
BMI, kg/m2 31.6 (5.2) 32.5 (5.8) .118 Wilcoxon signed rank test. Multivariate analyses by logistic
Alignment pre 4.2
(4.8
) VR 4.6
(5.1
) VR .438 regression models were used to analyze independent factors
KSS knee 35.9 (14.6) 36.4 (15.2) .746 affecting final ROM and KSSs. These data were presented as odds
KSS function 45.3 (15.9) 47.2 (14.7) .229
ROM 91.6 (12.4) 90.8 (13.5) .553
ratio (OR) with 95% confidence interval (CI). Kaplan-Meier test was
Flexion 94.4 (10.7) 92.6 (11.3) .116 used for TKA survival analysis with revision for any reason as end
Extension lag 3.2 (3.4) 3.3 (3.7) .787 point, and comparison between groups was made by the Mantel-
Global WOMAC 40.6 (9.2) 39.8 (8.7) .387 Haenszel log-rank test. Significance was considered for P values
SF-12 physical 21.5 (5.7) 20.8 (6.1) .255
<.05 in all tests.
SF-12 mental 42.4 (9.8) 41.6 (9.6) .426

Continuous data as mean (SD). Alignment, preoperative. Results

BMI, body mass index; CR, cruciate-retaining; KSS, Knee Society score; PS, posterior-
stabilized; ROM, range of motion; SD, standard deviation; SF-12, Short-Form 12;
TKA, total knee arthroplasty; VR, varus femorotibial; WOMAC, Western Ontario and Mean final follow-up from index TKA to the last assessment was
MacMasters Universities. 13.4 years (range 10-15 years) in the CR group and 12.7 years (range
 R. Serna-Berna et al. / The Journal of Arthroplasty 33 (2018) 2491e2495 2493

10-15 years) in the PS group. All clinical scores significantly improved was in 5 unrevised knees (zones 1 and 4). No radiolucent lines
from preoperative to last follow-up in both groups (P ¼ .001). around the femoral or patellar component were found in either
Over the time, there were no significant differences (all, P < .05) group.
in any functional outcome between 3 and 5 postoperative years in Overall, there were 21 revisions (5.5%), 9 (4.2%) in the CR group
both groups. Between 5 and 8 postoperative years, there were and 12 (7.2%) in the PS group (P ¼ .259). There were no revisions of
significant decreases in KSS knee (P ¼ .044) in both groups and CR because of PCL deficiency. Complications with subsequent re-
extension lag (P ¼ .032) in only CR group, and no significant dif- visions included 3 early wound deep infections (1 CR and 2 PS) that
ferences in KSS function (P ¼ .395) or knee flexion (P ¼ .128) in both were treated with 2-stage revisions; 9 aseptic tibial loosening (4 CR
groups. Between 5 postoperative years and final follow-up and 5 PS) with a time revision ranged from 4 to 9 years; 5 poly-
(Table 2), there were significant decreases in both groups for all ethylene insert wear (2 CR and 3 PS) with a time revision ranged
functional scores except extension lag in the PS group. However, all from 4 to 8 years, of which 2 were treated with only insert ex-
these differences in numbers were small. changes and the 3 other with tibial revision; and 4 periprosthetic
At the final follow-up, there were no significant differences in femoral fracture (2 CR and 2 PS) at 4-9 years, of which 3 were
any KSS or ROM between groups at either 5 postoperative years or treated with retrograde intramedullar nail and the another with
final follow-up (Table 2). Multivariate analysis showed that only arthroplasty revision. The cumulative survival of the TKA at 14
preoperative ROM had significant influence on last ROM (OR 1.7; years for any reason (Fig. 1) was 95.7% (95% CI, 93.0%-98.5%) in the
95% CI 1.1-2.3; P ¼ .026), and TKA design had not (OR 0.9; 95% CI CR group and 92.7% (95% CI, 88.8%-96.7%) in the PS group, and this
0.3-3.7; P ¼ .394). Likewise, TKA design had not significant influ- difference was not significant (log-rank, P ¼ .209).
ence on last KSS knee score (OR 0.3; 95% CI 0.02-2.8; P ¼ .514) or
KSS function score (OR 1.1; 95% CI 0.07-2.7; P ¼ .613).
Regarding the patient-reported outcomes, there were no sig- Discussion
nificant differences over the time between 3, 5, and 8 postoperative
years in both groups (all, P < .05). However, significant differences Currently, controversy regarding the advantages and disadvan-
in both groups were found between 5 postoperative years and the tages of CR and PS designs continue, and the clinical superiority of
final follow-up (Table 3) in SF-12 scores (all, P ¼ .001). There was no one design over the other has still not been demonstrated [3]. The
significant change in WOMAC score between 5-year follow-up and main objective of the present study was to compare long-term
final in either group. At the final follow-up, there were no signifi- clinical outcomes between both designs. The main findings were
cant differences between groups in any patient-reported scores. successful outcomes for both CR and PS arthroplasties, with no
The 86% of patients in the CR group and 84% in the PS group significant differences at a minimum postoperative follow-up of 10
were satisfied with the functional outcome of their knees after 10 years in functional scores, ROM, patient-related scores, or patient
postoperative years (P ¼ .565). At the final follow-up, there was no satisfaction. Between the 5-year and final postoperative follow-up,
significant difference between groups in the level of visual there were a significant decrease of all clinical scores in both
analogue scale satisfaction (P ¼ .151). There were no significant groups, although the differences in numbers were small. In addi-
differences in patient rate with residual pain knee between groups tion, complication rate and implant survival were similar between
(8% in the CR group vs 6% in the PS group, P ¼ .547). A higher patient groups.
rate in the PS group reported a greater frequency of swelling or Potential advantages of CR designs include more normal knee
tightness of their replaced knee than patients in the CR group (12% kinematics, especially increased femoral rollback on the tibia dur-
vs 7%), but this difference was not significant (P ¼ .109). ing flexion, intact PCL preventing anterior translation of the femur
In the CR group, 7 unrevised knees had nonprogressive, on the tibia, greater inherent stability of the prosthesis, increased
incomplete radiolucent line <1 mm in at least 1 zone around the proprioception, greater passive knee ROM, enhanced quadriceps
tibial component (zones 1, 3, and 4), whereas in the PS group, this muscle power, preservation of bone, and less blood loss [20,21]. On
the other hand, with PS designs have been reported advantages
such as greater ease of balancing of soft tissues, more congruent
Table 2
Functional Outcomes Over the Time. articulations, increased rollback with reduced posterior tibial sub-
luxation and greater range of flexion, and superior patellofemoral
CR Group PS Group P Value
kinematics [6,22,23].
KSS knee
At 5 y 88.3 (6.4) 87.7 (6.9) .382 Table 3
At final follow-up 86.4 (7.1) 85.2 (7.6) .117 Patient-Reported Outcomes Over the Time.
P value .015 .001
CR Group PS Group P Value
KSS function
At 5 y 88.1 (8.4) 87.9 (9.3) .826 Global WOMAC
At final follow-up 84.4 (9.1) 85.6 (9.8) .223 At 5 y 84.4 (19.2) 86.7 (20.2) .262
P value .001 .029 At final follow-up 82.2 (20.1) 83.3 (19.6) .592
ROM P value .249 .120
At 5 y 104.3 (9.7) 102.9 (10.1) .174 SF-12 physical
At final follow-up 101.2 (10.4) 100.7 (10.7) .648 At 5 y 40.6 (7.2) 41.8 (8.1) .134
P value .001 .054 At final follow-up 38.2 (8.1) 36.9 (8.9) .143
Flexion P value .001 .001
At 5 y 105.2 (10.9) 103.1 (11.4) .069 SF-12 mental
At final follow-up 101.3 (11.1) 100.4 (9.6) .399 At 5 y 49.4 (7.4) 48.8 (7.9) .446
P value .001 .020 At final follow-up 44.1 (8.2) 43.4 (9.3) .445
Extension lag P value .001 .001
At 5 y 1.0 (1.6) 1.3 (1.4) .056 VAS satisfaction
At final follow-up 1.4 (1.8) 1.2 (1.9) .299 At final follow-up 7.9 (1.9) 7.6 (2.1) .151
P value .016 .585
Data as mean (SD). Global WOMAC: amount of pain and physical function.
Data as mean (SD). CR, cruciate-retaining; PS, posterior-stabilized; SD, standard deviation; SF-12,
CR, cruciate-retaining; KSS, Knee Society score; PS, posterior-stabilized; ROM, range Short-Form 12; VAS, visual analogue scale for patient satisfaction; WOMAC, West-
of motion; SD, standard deviation. ern Ontario and MacMasters Universities.
2494 R. Serna-Berna et al. / The Journal of Arthroplasty 33 (2018) 2491e2495
Fig. 1. Kaplan-Meier cumulative survival curves (P ¼ .209). CR, cruciate-retaining; PS,
posterior-stabilized.
There were a large number of studies comparing clinical dif-
ferences between CR and CS designs, but few of them had a follow-
up of 10 years. Scott and Smith [12], in a randomized study,
compared 55 patients who received a CR design and 56 PS design
with a mean follow-up of 4 years, reported similar clinical and
radiographic outcomes between both, although the PS patients
received significantly more transfusions than CS patients. However,
other studies have reported no difference in blood loss between CR
and PS designs [24] or higher blood loss with the design [25]. In
other randomized study of 98 patients, Chaudhary et al [9] reported
similar pain, ROM, function, quality-of-life scores, and complication
rates between CR and PS groups after a follow-up of 2 years. Clark
et al [26], in other randomized study of 143 patients with a mini-
mum 2-year follow-up reported no significant differences between
groups regarding functional scores or ROM. On the contrary, other
randomized studies found significant clinical differences.
Maruyama et al [27], in a randomized comparison of 20 patients
who were bilaterally operated with both CR and PS designs re-
ported similar knee scores, but higher ROM in the PS knees after a
mean follow-up of 2 years. Harato et al [10], in a multicenter ran-
domized study of 99 CR patients and 99 PS patients with a mini-
mum follow-up of 5 years, found no significant differences between
both groups in functional outcomes, satisfaction or complication
€ [6] Becher C, Heyse TJ, Kron N, Ostermeier S, Hurschler C, Schofer MD, et al.
rate, but improvement in ROM was better in the PS group. Ozturk
et al [11], comparing randomly 33 CR patients and 28 PS patients
with a deformity >10
and follow-up of 7 years, reported that both
types of prosthesis produced similarly successful functional out-
comes, but flexion arc was larger in PS knees. Overall, a recent
meta-analysis of randomized controlled trials [2] found similar
clinical outcomes regarding knee function, pain, ROM, and com-
plications between CR and PS designs.
To our knowledge, only 3 studies have reported on the
comparative clinical outcomes with follow-up over 10 years
[13e15] and with controversial findings. In agreement with us,
Mayne et al [15] found similar functional scores, ROM, and revision
rate between both designs. Likewise, Beaupre et al [13] found no
differences in functional outcomes or revisions, although ROM data
were not reported. On the contrary, other long-term study of 414
patients [14] reported significantly better functional outcomes and
ROM with the PS design, although excellent 10-year survival was
also reported for both designs. However, although clinical score
differences were significant, to our understanding those differences
in numbers were small. On the other hand, other large retrospec-
tive study [28], showed a significant difference in TKA survival at 15
years between CR and PS designs (90% vs 77%), although unfortu-
nately they did not report functional results.
Strengths of the present study were the relatively large number
of patients from a single center, follow-up over 10 years, and
relatively low rate of loss of follow-up. To our knowledge, this was
one of the largest studies on comparative long-term outcomes
published to date. However, the study was not according to usual
practice because patients with severe knee deformity were
excluded. Moreover, inherent to any long-term study involving
elderly patients, there were 13% of patients lost to follow-up.
In addition, this study had other limitations. First, this study was
limited by its retrospective design. Our patient cohorts were not
randomized, and patient selection bias may have occurred. On the
other hand, our findings could be specific to the implant used and
not be generalized to other arthroplasty systems. In addition, CR
model was hybrid, whereas the PS was cemented, which could be a
confounding factor on outcomes or longevity of the prosthesis.
Conclusions
The present study demonstrated successful survival for both
designs with similar clinical outcomes between CR and PS designs
at long-term follow-up. Thus, the superiority of one design over the
other was not found. Both designs can be used expecting long-term
successful outcomes and high survival. The choice of the design
depended on the status of the PCL and surgeon preference.
Currently, we prefer the CR design whether the ligament is suffi-
cient because it requires less bone resection.
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 The Journal of Arthroplasty 33 (2018) 2344
Contents lists available at ScienceDirect
The Journal of Arthroplasty
journal homepage: www.arthroplastyjournal.org
AAHKS Symposium
Digital Health and Advanced Technology in Arthroplasty
We are in rapidly changing times and see the impact of tech-
nology all around us. The smart phone was introduced less than a
decade ago, and its touch screen has revolutionized the way we
communicate. Newspapers and other media are being forced to
respond or go out of business. Financial transactions are now
seamless and instantaneous, with novel means of money transfer
emerging, thanks to the adoption of worldwide standards in the
banking industry. And with speed and convenience, quality and
reliability of the transactions remain high. Similarly, technology
has turned retail, manufacturing, travel, entertainment, and
every other industry upside down. And it happened quickly.
How we in medicine will be impacted by this new wave of inno-
vation remains the subject of considerable investigation and
debate. There is both considerable optimism and expressed
concern. Some argue that the primacy of the physician-patient rela-
tionship is at risk as the field explores virtual encounters, while
others believe that new technology helps level the playing field,
empowering and enabling patients to become more active in their
own care. One thing is clear. The world has changed immensely in
recent years led in large part by the advent of mobile tools, most
notably the smart phone, advanced computing that enabled
augmented and artificial intelligence, and engineering advances
that allow smart instruments and 3D printing of tools and implants.
Health care has been an enigma. Although we continuously
search for new solutions and are enamored with new technology,
we are also reminded of the need to ask for evidence before aban-
doning an established method of care. As such, despite the explo-
sion of potential digital solutions, and the fact that the world
around medicine is changing rapidly, the path forward has been un-
clear. Patients want the same ease of access, precision, automation,
and value as they get in every other part of their modern lives. And
they want it on their phone. But they also realize the stakes are
high, their health is on the line, and decisions in medicine have a
more serious air about them, driving a healthy degree of caution
as this transition is embraced.
It is also noteworthy and puzzling that health care has, in the
recent past, had a very different, and some would say difficult, rela-
tionship to digital technology. The most challenging enigma has
been the electronic health record which has improved care, but
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.092.
https://doi.org/10.1016/j.arth.2018.02.092
0883-5403/© 2018 Elsevier Inc. All rights reserved.
has also created some degree of dissatisfaction for its lack of utility.
This may be due to the fact that the electronic health record was
adopted, not because of its utility or competitive advantage, as
would be the case in most industries, but rather because of massive
government subsidies. And we ended up with a system that is
highly fragmented, lacks standards or interoperability, and is at
least as frustrating as it is helpful for large segments of the clinical
world.
The articles presented here will provide a glimpse into a few
areas of digital health that will impact physicians in the near future
and explore what that could mean for the way our patients, our
employers, and payers will expect us to deliver care. As we dive
headlong into the future, at least 4 distinct areas have required
our attention: digital health, robotics and assistive technologies,
3D printing, and artificial intelligence.
As we ponder the impact of these topics, it is helpful to hold up a
lens derived from 3 key questions that may prove useful in our eval-
uation of these new methods and discoveries.
1) What problem or problems is it attempting to solve that matters
to our patients and to us?
2) How does it compare with existing solutions: how it is better
from a quality or cost or experience standpoint?
3) What are the risks of adoption and how do we look at it in terms
of potential unintended consequences?
There is no doubt that the future is here and we would be wise
to embrace it with a measure of both enthusiasm and circumspec-
tion. These 4 articles can provide some foundational concepts as we
move forward on this journey.
Mark I. Froimson, MD, MBA*
Riverside Health Advisors
Hunting Valley
Ohio
*
Reprint requests: Mark I. Froimson, MD, MBA, Riverside Health
Advisors, 15000 County Line Road, Hunting Valley, OH 44022.
 The Journal of Arthroplasty 33 (2018) 2588e2594

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

Does Prior Failed Debridement Compromise the Outcome of

Subsequent Two-Stage Revision Done for Periprosthetic Joint
Infection Following Total Knee Arthroplasty?
Ashok Rajgopal, MS, MCh, FRCS (Ortho) a, *, Inayat Panda, MS, DNB (Ortho) a,
Arun Rao, BPT b, Vivek Dahiya, DNB (Ortho) a, Himanshu Gupta, MS (Ortho) a
a
Department of Orthopaedics, Fortis Bone and Joint Institute, New Delhi, India
b
Department of Physiotherapy, Fortis Bone and Joint Institute, New Delhi, India

a r t i c l e i n f o a b s t r a c t

Article history: Background: There has been a debate regarding the outcomes of 2-stage revision total knee arthroplasty
Received 19 December 2017 (TKA) when debridement, antibiotics, irrigation, and implant retention (DAIR) had been carried out
Received in revised form previously. The purpose of this study is to evaluate the influence of prior failed DAIR (F-DAIR) on the
6 February 2018
outcomes of 2-stage revision TKA done for periprosthetic joint infection (PJI).
Accepted 22 February 2018
Methods: This is a retrospective study of a consecutive series of 184 knees that completed 2-stage
Available online 9 March 2018
revision TKA for PJI, operated by a single surgeon between January 2000 and July 2011. The cohort
was divided into 2 groups: (1) with previous F-DAIR (88 knees) and (2) direct 2-stage revision (96 knees).
Keywords:
prosthetic joint infection
Results: At an average follow-up of 5.3 years, the failure rate was 23.86% (21/88 knees) in the F-DAIR
revision total knee arthroplasty group and 15.62% (15/96) in the direct 2-stage revision group. Prior F-DAIR procedure was associated
failed irrigation and debridement (DAIR) with approximately twice the risk of failure compared to direct 2-stage surgery (hazards ratio 1.94, 95%
MRSA confidence interval 1.01-3.714, P ¼ .047). Excluding PJIs caused by methicillin-resistant Staphylococcus
2-stage TKA aureus, methicillin-resistant Staphylococcus epidermidis, and Pseudomonas from analysis revealed similar
reinfection rates failure rates between the 2 groups. The Knee Society Clinical Score, Knee Society Functional Score, and
final range of motion at final follow-up were lower in the F-DAIR group. Incidence of culture negativity
and infection with resistant organisms was higher in the F-DAIR group. The rates of eradication of
methicillin-resistant Staphylococcus aureus and Pseudomonas infection were much lower in the F-DAIR
group.
Conclusion: A failed prior DAIR results in higher failure rates, lower functional outcome, and increased
risk of wound-related complications.
© 2018 Elsevier Inc. All rights reserved.

The incidence of periprosthetic joint infection (PJI) following
primary total knee arthroplasty (TKA) ranges from 0.4% to 2% [1].
Two-stage revision and reimplantation is considered the “gold
standard” with success rates of 80%-100% reported in literature [2].
Risk factors associated with high risk of treatment failure and lower
functional outcome as reported in literature include patient
comorbidities, anemia, heart disease, diabetes mellitus, infection
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.087.
* Reprint requests: Ashok Rajgopal, MS, MCh, FRCS (Orth), Fortis Bone and Joint
Institute, Fortis Escorts Research Institute, Okhla Road, New Delhi 10025, India.
with resistant organisms (eg, methicillin-resistant Staphylococcus
aureus [MRSA]), culture negativity, increased reimplantation
operative time, chronic lymphedema, etc. [3e5].
The role of a previous failed debridement, antibiotics, irrigation,
and implant retention (DAIR) procedure on the outcomes of 2-stage
revision has been analyzed in a few previous studies with variable
results.
In an earlier study, Sherrell et al [6] had reported that a previous
failed debridement procedure resulted in reduced rates of infection
clearance after a subsequent 2-stage revision. Two recent studies
have reported contradictory results, with one reporting similar
rates of success [7] and other reporting higher rates of infection
clearance [8] in patients undergoing a failed debridement before a
2-stage revision. The effect of prior failed DAIR (F-DAIR) on the
eventual long-term functional outcome, range of motion (ROM),

https://doi.org/10.1016/j.arth.2018.02.087
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 A. Rajgopal et al. / The Journal of Arthroplasty 33 (2018) 2588e2594
Fig. 1. Algorithm for the diagnosis of periprosthetic joint infection. ESR, erythrocyte sedimentation rate; CRP, C-reactive protein.
and survivorship after the 2-stage reimplantation has not been
reported in any of these studies.
The aim of our study is to compare the long-term failure rates,
functional outcome scores, and final ROM among patients who
completed a 2-stage revision TKA with history of previous F-DAIR
and those undergoing a direct two-stage revision (DTSR) surgery.
Materials and Methods
We retrospectively reviewed the hospital records of 215
consecutive patients who had undergone a 2-stage revision for a
diagnosed deep periprosthetic infection, operated by a single
surgeon (A.R.) between January 2000 and July 2011. An Institutional
Review Board approval was obtained prior to commencement of
the study.
Only those patients who had completed the second stage of
reimplantation were included in our final study cohort. Exclusions
included 3 patients who had undergone a previous arthroscopic
debridement, and 9 others who required repeated debridement
after stage 1 of revision to control infection. All patients in our
cohort had undergone a single previous DAIR and in the event of
failure proceeded to a 2-stage revision. Seven patients did not
undergo further reimplantation: 3 due to noneradication of infec-
tion, 2 refused second surgery, and 2 underwent more radical
procedures such as arthrodesis (1) or above-knee amputation (1).
Four patients were deceased within the first 18 months due to
some unrelated medical complications. Seven patients were lost to
follow-up.
Patient characteristics including age, gender, body mass index
(BMI), underlying diagnosis needing primary TKA, comorbid
medical conditions, dates of previous surgeries, microbiology
results, and antibiotic regimen given were recorded from the clin-
ical sheets and investigation reports as denoted in our
2589
prospectively maintained database. Surgical and anesthesia record
sheets were also analyzed to record the ASA (American Society of
Anesthesiologists) grade, relevant intraoperative findings, and
surgical technique.
A diagnosis of PJI was established based mostly on the clinical
judgment of discharge, nonhealing surgical wound site, local
erythema, or a chronic sinus tract communicating with the knee.
This was supplemented by hematological parameters such as an
elevated erythrocyte sedimentation rate (>20 mm/h), raised
C-reactive protein levels (>6 mg/dL), and high total leucocyte count
(>11,000/mm3) with high synovial fluid neutrophil counts (>65%).
Other indicators of infection include purulent discharge during
revision surgery, positive fluid aspiration cultures and deep tissue
cultures, and intraoperative histopathological analysis showing >5
neutrophils per high power field (Fig. 1). These criteria were used
prior to the introduction of the international consensus group
guidelines for infection (Musculoskeletal Infection Society criteria
2011) [9]. Only those cases with a confirmed diagnosis of infection
in the records and a minimum of 2 years of follow-up were
included in our study.
The medical records of patients undergoing the initial DAIR pro-
cedure outside our institute (46 patients) were critically analyzed
with regards to onset of symptoms, clinical features, and laboratory
parameters leading to diagnosis of infection, timing of intervention,
and adequacy of surgical debridement. The criteria laid out in the
algorithm (Fig. 1) were strictly followed while selecting patients who
had undergone DAIR at an outside institute and only those cases who
had the procedure within 4 weeks of symptoms were included in our
analysis. Patients with incomplete records, with unconfirmed
diagnosis of infection, and those undergoing DAIR for infection
duration greater than 4 weeks due to any reason (inappropriate
treatment, associated medical comorbidities, patient discretion, etc.)
were excluded from the analysis.
2590 A. Rajgopal et al. / The Journal of Arthroplasty 33 (2018) 2588e2594

Table 1
Patient Demographics.

F-DAIR Failure DTSR Group Failure P Value Overall

Group (n ¼ 21) (n ¼ 96 Knees) (n ¼ 15) (Difference Between (N ¼ 184 Knees)
(n ¼ 88 Knees) 2 Groups)

Age (mean, range) (y) 69.5 (55-81) 68.2 (58-82) .097 69.1 (±5.62)
>70 37 8 20 6
Gender .102
Male 43 (48.9%) 10 35 (36.5%) 6 78 (42.4%)
Female 45 (51.1%) 11 61 (63.5%) 9 106 (57.6%)
BMI (mean, range) (kg/m2) 28.78 (23-36) 27.35 (22-35) .164 27.95
>30 22 6 28 9 50 (27.2%)
ASA grade (mean) 2.23 2.32 .251
1 4 1 7 3 11 (6%)
2 61 12 53 7 114 (62%)
3 22 7 34 4 56 (30.4%)
4 1 1 2 1 3 (1.6%)
Comorbidities
Diabetes 30 7 20 5 .246 50 (27.2%)
Rheumatoid arthritis 10 4 8 4 .089 18 (9.8%)
Hypothyroidism 16 4 15 2 .487 31 (16.8%)
Long-term anticoagulants 11 4 9 2 .844 20 (10.9%)

The final cohort consisted of 184 knees that had completed a
2-stage revision TKA. This consisted of a subgroup of 88 knees that
had undergone a previous F-DAIR procedure. The cohort was
divided into 2 groups: (1) those that had undergone a prior F-DAIR
before the 2-stage revision (F-DAIR group; 88 knees) and (2) those
that had proceeded to 2-stage revision TKA directly after the
diagnosis of infection (DTSR group; 96 knees). Only those cases
with a minimum of 2 years of follow-up were included.
The technique of 2-stage revisions performed was similar in all
the cases and was operated by a single surgeon (A.R.). During the
first stage of the procedure, all components of previous prosthesis
were removed followed by thorough debridement of local tissue
and synovium, including the deep intramedullary regions of the
femur and tibia and pulse lavage with at least 10 L of normal saline.
A temporary static spacer made from antibiotic-impregnated
polymethylmethacrylate containing gentamicin or tobramycin
(2.4-4.8 g) and vancomycin (2-4 g) was kept in place for 4-10 weeks.
The patients were kept on antibiotics based on their sensitivity
reports or on empirical broad spectrum antibiotics (in culture
negative cases). The choice of antibiotic therapy was done in due
consultation with the infectious diseases specialist at our center.
Antibiotics were continued for a minimum period of 6 weeks. In
cases of infection with resistant organisms or those with indeter-
minate cultures, antibiotics were continued for 10 weeks. The
antibiotic regimen included 3-4 weeks of parenteral therapy
followed by another 2-7 weeks of oral regimen. This was followed
by an antibiotic-free period of 1-2 weeks and the patients were
monitored clinically and hematologically for recurrence of
infection. Patients in the F-DAIR group were exposed to a longer
duration of antibiotic therapy (average 14.4 weeks, range 8-31)
compared to the DTSR group (average 8.5 weeks, range 6-12).
Patients with a healed surgical wound with no clinical signs of
local infection and a sequential fall in erythrocyte sedimentation
rate and C-reactive protein levels over the next 2-3 weeks were
considered to be free of infection, and reimplantation was done in
those cases. Aspiration of joint was done in selected cases with
borderline clinical and hematological parameters and was not
routinely performed prior to the second-stage surgery. Following
reimplantation, antibiotics were continued for another 3 weeks. A
quadriceps snip [10] had to be performed in 27 knees in the F-DAIR
and 12 knees in the DTSR group.
Full weight-bearing mobilization using walker was allowed
from day 2 of surgery. Gradual knee bending was allowed using a
dial-lock brace over the next 2-3 weeks.
Patients were followed up at 3 weeks, 6 weeks, 6 months, 1 year,
and yearly from there on. Clinical examination, assessment of
functional scores, ROM achieved, and occurrence of any complica-
tions were recorded at each visit by the senior surgeon. ROM was

Table 2
Effect of Demographic Parameters and Comorbidities on Risk of Failure.

Parameters Failure Rate Failure Rate Odds Ratio (95% CI) P Value
in Patients Without the
With the Condition Condition

Age >70 24.6% (14/57) 17.3% (22/127) 1.55 (0.73-3.32) .25

Female gender 18.9% (20/106) 20.5% (16/78) 0.90 (0.43-1.88) .78
BMI >30 30% (15/50) 15.6% (21/134) 2.31 (1.07-4.95) .032a
ASA 3 and 4 22.0% (13/59) 18.4% (23/125) 1.29 (0.60-2.78) .51
Diabetes mellitus 24% (12/50) 17.9% (24/134) 1.45 (0.66-3.17) .36
Rheumatoid arthritis 40% (8/18) 17.1% (28/166) 3.94 (1.42-11.88) .008a
On anticoagulation therapy 35.5% (6/20) 16.3% (30/164) 1.91 (0.68-5.39) .22
Hypothyroidism 30% (6/31) 18.4% (30/153) 0.98 (0.37-2.61) .97
Organism isolated
Staphylococcus aureus 11.9% (7/59) 23.2% (29/125) 0.44 (0.18-1.09) .075
MRSA 47.8% (11/23) 15.5% (25/161) 4.99 (1.98-12.55) .0006a
Pseudomonas 55.6% (5/9) 17.7% (31/175) 5.80 (1.47-22.9) .012a
All gram-negative organisms 19.5% (8/41) 19.6% (28/143) 0.9 (0.41-2.39) .99
Polymicrobial 44.4% (4/9) 18.3% (32/175) 3.57 (0.90-14.06) .07
Culture negative 10.7% (3/27) 21.2% (33/157) 0.47 (0.13-1.66) .24
a
Statistically significant data.
 A. Rajgopal et al. / The Journal of Arthroplasty 33 (2018) 2588e2594 2591

Table 3
Micro-Organisms Isolated.

F-DAIR Group Failure DTSR Group Failure Overall Failure

(n ¼ 88 Knees) (n ¼ 21) (n ¼ 96 Knees) (n ¼ 15) (N ¼ 184 Knees) (n ¼ 36)

Staphylococcus aureus 24 3 35 4 59 7
Staphylococcus epidermidis 3 0 1 0 4 0
MRSA 14 8 9 3 23 11
MRSE 2 1 1 0 3 1
Streptococcus 3 0 6 1 9 1
Escherichia coli 9 0 13 2 22 2
Pseudomonas 5 4 4 1 9 5
Klebsiella 3 0 5 1 8 1
Enterococcus 2 1 3 0 5 1
Enterobacter 2 0 0 0 2 0
Polymicrobial 4 2 5 2 9 4
Culture negative 16 2 11 1 27 3
Others 1 0 3 0 4 0

measured using a standard goniometer. The functional outcome
scores were recorded using the Knee Society Clinical Score (KSCS)
and the Knee Society Functional Score (KSFS) [11] by an indepen-
dent senior physiotherapist. The difference in the final ROM
achieved between the 2 groups was also evaluated.
Failure was defined as follows: (1) inability to eradicate the
infection after the 2-stage procedure; (2) recurrence of infection
either proven clinically or following positive culture reports; (3)
requiring chronic antibiotic suppression over 6 months; and (4)
requiring a further surgical procedure due to inability to eradicate
the infection, which may or may not involve removal of the implant
components. This was derived from the criteria defined by the
Delphi-based international multidisciplinary consensus [12].
Descriptive statistics were expressed in terms of mean or average
with standard deviation, percentages, or range. Fisher's exact test
was used for nominal data and independent t-test was used to
compare the differences between functional outcome between the 2
groups including differences in scores (KSCS and KSFS) and final
ROM. Cox regression predictive model was used to calculate the
hazards ratio (HR) for recurrence of infection after a F-DAIR. The
odds ratio (OR) was calculated for other individual prognostic vari-
ables to determine the risk for failure. Kaplan-Meier curves were
used to express the failure rates over the time period. All data were
analyzed using Statistical Package for Social Sciences version 23.0.
Statistical significance was defined as P-value less than .05.
Results
The results of 184 knees that completed a 2-stage revision for
infection of primary TKA prosthesis at our center showed eradica-
tion of infection in 152(80.8%). The average duration of follow-up
was 5.3 (2.5-9.8) years for the entire cohort and 4.6 (2.5-9) years
for the F-DAIR group and 5.6 (2.6-9.8) years for the DTSR group. The
rate of reinfection was 23.86% (21/88) in knees that had undergone
prior F-DAIR (F-DAIR group) and 15.62% (15/96) in knees
undergoing DTSR (DTSR group).
Mean time to failure was 269 (18-1106) days in the F-DAIR and
408 (51-1675) days in the DTSR group (P ¼ .25) indicating that
knees undergoing a prior debridement procedure failed early.
Using the Cox regression analysis to calculate the HR for
recurrence of infection, the risk was found to be higher in patients
undergoing prior failed debridement (F-DAIR group) with a HR of
1.94 (95% confidence interval [CI] 1.01-3.71, P ¼ .047) indicating
almost 2 times higher risk compared to those proceeding to a DTSR
surgery (DTSR group).
Patient Demographics
The cohorts in the F-DAIR and DTSR groups were comparable in
terms age, gender, BMI, ASA grade, and incidence of various
comorbidities (Table 1).
The influence of various demographic parameters and patient-
related comorbidities on the recurrence of infection within the entire
cohort was calculated by describing the OR for each of the variables
(Table 2). Factors associated with statistically significantly higher odds
of failure included those patients with BMI >30 (OR 2.31, 95% CI 1.07-
4.95, P ¼ .032) and rheumatoid arthritis (OR 3.94, 95% CI 1.42-10.88,
P ¼ .008). Age, gender, BMI, ASA grade, diabetes mellitus, hypothy-
roidism, and long-term anticoagulation therapy were not associated
with statistically increased risk of failure in our study population.
Microbiology
Sensitive Staphylococcus aureus (n ¼ 59, F-DAIR 24/88 and DTSR
35/96) was the most common organism isolated constituting 32.1%
of the cases with an overall failure of 7/59 (11.9%) among these
cases (Table 3). MRSA constituted 23 of 184 (12.5%) cases, was more
common in the F-DAIR group (14 vs 9 in DTSR), and this was
associated with a significantly higher risk of failure at 11 of 23 cases
(47.8%) (OR 4.99, 95% CI 1.98-12.55, P ¼ .0006). A high failure rate
was also seen in patients infected with Pseudomonas (failure rate of
5/9, 55.6%, OR 5.8, 95% CI 1.47-22.87, P ¼ .012) and polymicrobial
infection (failure rate of 4/9, 44.4%, OR 3.57, 95% CI 0.90-14.06,
P ¼ .068). On excluding the patients infected with MRSA,
methicillin-resistant Staphylococcus epidermidis (MRSE), and Pseu-
domonas, the failure rate was almost similar between the 2 groups:
12% (8/67) in the F-DAIR group and 14% (11/78) in the DTSR group.

Table 4
Functional Outcome Measures.

F-DAIR Group DTSR Group P Value (Difference Between

Postoperative Values of Both Groups)
Preoperative Postoperative Preoperative Postoperative

ROM (mean, range) 48.4 (20 -70 ) 88.4 (40 -110 ) 55.9 (20 -80 ) 96.5 (45 -120 ) .018a
KSCS (mean, range) 32.4 (18-38) 70.3 (62-80) 36.3 (14-43) 76.6 (64-83) .082
KSFS (mean, range) 34.2 (15-41) 66.7 (60-75) 31.6 (16-44) 70.4 (59-78) .124
a
Statistically significant value.
2592 A. Rajgopal et al. / The Journal of Arthroplasty 33 (2018) 2588e2594

Table 5
Cumulative Survival Rates.

F-DAIR Group (%) DTSR Group (%) Overall (%)

(n ¼ 88) (n ¼ 96) (N ¼ 184)

6 mo 90.90 94.79 91.84

1y 82.95 88.54 85.87
2y 79.54 85.41 82.60
5y 77.27 84.37 80.98
10 y 76.13 84.37 80.43

rates were lower for patients in the F-DAIR group (79.5% at 2 years
and 76.13% at 10 years) compared to the DTSR group (85.4% at 2
years and 84.4% at 10 years). On excluding infections with MRSA,
MRSE, and Pseudomonas from analysis, the rates of survival were
similar between the 2 groups (Fig. 3).

Discussion
Fig. 2. Kaplan-Meier curve showing cumulative incidence of failure in patients un-
dergoing prior failed DAIR and direct 2-stage revision.
In our retrospective study involving 184 knees at an average
follow-up of 5.3 years, we found that patients who had undergone a
Recurrence of infection among those infected with MRSA was prior failed surgical intervention (F-DAIR) had a higher chance of
seen in 57.1% (8/14 knees) in the F-DAIR group and 33.3% (3/9 recurrence of infection (21/88 knees, 23.86%) following a 2-stage
knees) in the DTSR group. Among those with PJI due to Pseudo- revision compared to the other group undergoing a DTSR (15/96
monas, recurrence was seen in 80% (4/5 knees) in the F-DAIR while knees, 15.62%). A prior F-DAIR procedure was associated with
25% (1/4 knees) in the DTSR group. This shows a lower rate of approximately twice the risk of failure or reinfection compared to
clearance of MRSA and Pseudomonas in the F-DAIR group. direct 2-stage surgery (HR 1.94, 95% CI 1.01-3.714, P ¼ .047).
Incidence of culture negative infection was higher in the F-DAIR Recent published literature has reported a divided opinion on
group (16/88, 18.18%) compared to the DTSR group (11/96, 11.5%), the difference in success rates and outcome of 2-stage revision TKA
which may be because of the use of antibiotics prior to 2-stage for PJI in patients who have undergone a prior therapeutic DAIR
revision surgery in the F-DAIR group. procedure.
Although the overall reinfection rate was lower in our study, our
findings are consistent with a similar study by Sherrell et al [6] who
Functional Outcome Measures
reported a high failure rate of 34% in 83 knees undergoing 2-stage
revision after a failed irrigation and debridement.
In the long term, the mean functional outcome scores at final
However, in a recent study by Brimmo et al [8], which included
follow-up were higher in the patients undergoing DTSR (DTSR
750 patients who had undergone a 2-stage revision TKA [among
group: mean KSCS 76.6, range 64-83 and KSFS 70.4, range 59-78)
which 57 (7.6%) had a prior incision and drainage (I&D)], they
compared to those undergoing 2-stage revision after an F-DAIR
reported a lower failure rate among the prior I&D group (8.7% vs
(F-DAIR group: mean KSCS 70.3, range 62-80 and mean KSFS 66.7,
17.5%) at 4 years. The adjusted HR was 0.49 which indicated that the
range 60-75) though the difference between the scores was not
risk of failure was almost half than those without previous I&D. The
significant (P ¼ .082 and .124 for KSCS and KSFS, respectively)
study cohort was derived from multiple institutions and this is
(Table 4). At final follow-up, the average KSCS was 73.6 (62-83) and
KSFS was 68.8 (59-78) in the entire study cohort.
The average ROM achieved was 88.4 (40 -110 ) in the F-DAIR
group and 96.5 (45 -120 in the DTSR group and the difference
between the 2 groups was significant (P ¼ .018). Forty-eight knees
(54.5%) in the F-DAIR group and 65 knees (67.7%) in the DTSR group
achieved ROM greater than 90 . Eight (9%) knees in the F-DAIR
group and 2 (2%) in the DTSR group developed post-revision TKA
stiffness (with ROM <50 ).
The mean residual flexion deformity at final follow-up was 1.3
(range 0 -10 ) in the F-DAIR group and 0.45 (range 0 -10 ) in the
DTSR group (P ¼ .081). Flexion deformity less than 10 was more
common in the F-DAIR group (12/88 knees) compared to the DTSR
group (7/96 knees). Additional soft tissue procedure for wound
coverage was required in 6 patients in the F-DAIR group (none in
the DTSR group).

Survival Analysis

Most of the failures (72.2%) were seen within 1 year following

revision TKA (71.4% in the F-DAIR group and 73.3% in the DTSR Fig. 3. Kaplan-Meier curve showing cumulative incidence of failure in patients un-
group) (Fig. 2). The overall infection-free survival was 82.6% at 2 dergoing prior failed DAIR and direct 2-stage revision (excluding MRSA, MRSE, and
years, 81% at 5 years, and 80.4% at 10 years (Table 5). The survival Pseudomonas).
 A. Rajgopal et al. / The Journal of Arthroplasty 33 (2018) 2588e2594
prone to a selection bias and presumably differences in the
treatment protocol within the cohort.
Nodzo et al [7] reported similar success rates among patients
undergoing a previous debridement (82.2%) and those who
underwent DTSR (82.5%).
A major limitation of the above 2 studies is the smaller size of
the subgroup population who had undergone a failed debridement
prior to the definitive 2-stage revision.
The variable results notwithstanding, the adverse consequences
of a prior failed debridement on the functional outcome, ROM, and
surgical wound-related complications have not been addressed in
these studies. The microbiology profile and more importantly the
incidence of resistant organisms have not been clarified in the latter
2 studies.
Many previous studies in literature have identified the fact that
repeated surgeries over the same knee were associated with higher
chances of failure following 2-stage revision. In the study by
Gardner et al [13], a high failure rate of 42% was seen among the 19
patients, who underwent a repeat 2-stage debridement after an
F-DAIR. The high failure rate of 36% and numerous complications
following 2-stage revision TKA in 58 knees in the study by Pelt et al
[14] can be explained by emphasizing the fact that 39 of 58 knees
have had a prior surgery between primary TKA and first stage of
revision. Among this 20 had undergone a prior F-DAIR procedure.
In our study, the KSS clinical and functional scores were lower in
those undergoing previous debridement even though the long-
term differences were not statistically significant. The final ROM
achieved was significantly lower in those with previous failed
debridement (mean 88.4 vs 96.5 , P ¼ .018). Patients in the F-DAIR
group reported a higher incidence of post-TKA stiffness (ROM <50 )
(8 vs 2) for which manipulation under anesthesia was carried out in
5 patients in the F-DAIR group. The rate of surgical site wound
necrosis requiring muscular flap cover was higher (6 vs 0) in the
F-DAIR group indicating higher rates of wound complications due
to multiple surgeries.
Another important finding was a higher incidence of MRSA
positive (F-DAIR: 14/88, 15.9% vs DTSR: 9/96, 9.4%) and culture
negative (F-DAIR: 16/88, 18.2% vs DTSR: 11/96, 11.4%) samples in the
F-DAIR group. MRSA PJI has classically been associated with a high
rate of failure following 2-stage revision TKA [15]. In our study, we
observed that while we could achieve eradication of infection in
91.2% knees infected with sensitive S aureus, the 47.8% failure rate
among the patients with MRSA infection is a cause of concern.
On comparing both the subgroups, patients undergoing a prior
DAIR (F-DAIR group) had higher rates of MRSA infection recurrence
(57.1%; 8/14 knees) compared to the DTSR group (33.3%; 3/9 knees).
Similarly, 4 of 5 (80%) knees infected with Pseudomonas in the
F-DAIR group developed a recurrent infection, in contrast to a failure
rate of 1 in 4 (25%) knees in the DTSR group. Even though the
absolute number of patients with MRSA and Pseudomonas infection
were less to draw a statistically significant correlation, our
observation shows that patients undergoing a failed debridement
procedure have an increased incidence of infection with resistant
and more virulent organisms (MRSA) with lower chances of
subsequent infection eradication after a 2-stage revision TKA. The
failure rates between the 2 groups were found to be similar (12%
F-DAIR vs 14% DTSR) when knees with MRSA, MRSE, and Pseudo-
monas infection were excluded from the analysis. This indicates that
the higher failure can be attributed to the higher incidence of
infection with resistant and virulent organisms in the F-DAIR group.
The retrospective nature of our study is subject to a few limi-
tations relating to exact documentation of the surgical technique
and patient reported history. The smaller sample size precludes
carrying out statistical analysis to identify other weaker risk factors.
The details of duration of symptoms, previous debridement
2593
procedure, organism isolated, and uniformity of treatment protocol
may not be accurate, particularly in patients who underwent the
DAIR procedure outside our institute and this may act as a con-
founding factor. There may be a bias in selection of treatment and
changing antibiotic protocol based on experience of the team
during the study period. Although an attempt was made to aspirate
the knees prior to reimplantation during second stage of revision,
this was done only in doubtful cases and not routinely performed
which is a limitation of the study. The study was conducted before
the Musculoskeletal Infection Society criteria were published,
though the parameters for diagnosis of infection were similar.
However, the strengths of our study are that all the 2-staged
revisions were performed by a single surgeon with the surgical
team following a fairly uniform surgical technique and treatment
protocol during the study period. A static cemented spacer was
used in all our cases and hence the final functional outcome scores
and ROM were comparable. Even though a formal matching could
not be done, both the subgroups were similar in terms of various
demographic parameters, further reducing the number of con-
founding variables.
Conclusion
It can be reasonably concluded by the following:
1. A F-DAIR procedure before a 2-stage revision TKA is associated
with a higher probability of failure (almost twice the risk)
compared to those undergoing a DTSR. This is also associated
with lower functional outcome scores, lower ROM, and higher
wound-related complications, a fact that should be emphasized
to the patient to make an informed decision.
2. A higher incidence of patients with MRSA and Pseudomonas
infection were noted in the F-DAIR group. Also, the chances of
eradication of these organisms are diminished in the prior failed
debridement group compared to those undergoing a direct
2-stage surgery. We recommend that patients with PJIs caused by
these organisms should undergo an early 2-stage revision.
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[11] Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical
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 The Journal of Arthroplasty
Official Journal of the American Association of Hip and Knee Surgeons

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AMERICAN ASSOCIATION OF HIP AND KNEE SURGEONS

Craig J. Della Valle, MD, President
Michael P. Bolognesi, MD, First Vice President
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Immediate Past President
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 The Journal of Arthroplasty 33 (2018) 2530e2534

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Evaluation of the Learning Curve When Transitioning From

Posterolateral to Direct Anterior Hip Arthroplasty: A Consecutive
Series of 1000 Cases
Andrea H. Stone, MSN, CRNP a, Udai S. Sibia, MD, MBA b, Ryan Atkinson, BS c,
Timothy R. Turner, PhD c, Paul J. King, MD d, *
a
Research Fellow, Department of Surgical Research, Anne Arundel Medical Center, Annapolis, Maryland
b
General Surgery Resident, Anne Arundel Medical Center, Annapolis, Maryland
c
Department of Surgical Research, Anne Arundel Medical Center, Annapolis, Maryland
d
Director, Center for Joint Replacement, Anne Arundel Medical Center, Annapolis, Maryland

a r t i c l e i n f o a b s t r a c t

Article history: Background: The direct anterior approach (DAA) for primary hip replacement has been gaining more
Received 2 January 2018 attention and widespread use in recent years. There are a number of published studies evaluating the
Received in revised form learning curve when a surgeon changes technique; these studies typically look at complications during
19 February 2018
the initial cases. This study examines procedure and total operating room (OR) time along with all
Accepted 28 February 2018
Available online 8 March 2018
complications for a surgeon transitioning from the posterolateral approach (PA) to DAA.
Methods: A retrospective review of a single surgeon series of 1000 initial DAA procedures. Total OR time,
procedure time, and complications were collected and analyzed. One-way analysis of variance and post
Keywords:
total hip arthroplasty
hoc least significant difference tests were used for statistical analysis.
direct anterior approach Results: There was an initial increase in both procedure and OR times compared with the mature PA, by
learning curve 34% and 30%, respectively. The procedure time became statistically equivalent to the mature PA time after
wound complication the 400th DAA case, and significantly shorter after the 850th case. The total OR time became statistically
femoral loosening equivalent after the 900th DAA case. There were 18 early (<90 days) and 18 late reoperations performed
in this series with a nonsignificant trend toward femoral complications occurring early in the series.
Minimum follow-up time was 2 years.
Conclusion: There was an initial increase in both total OR time and procedure time when an experi-
enced surgeon introduced the DAA. By the end of the series, procedure time was significantly shorter
and total OR time was equivalent. Complications overall were low and femoral complications
decreased with time.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) is one of the most common elective
surgical procedures performed in the United States. Approximately,
572,000 hip arthroplasties will be performed annually in the United
States by the year 2030, an increase of 174% from 2005 [1]. There are
3 main approaches for performing hip arthroplasty: posterolateral,
direct lateral, and direct anterior approaches [2]. According to
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.086.
* Reprint requests: Paul J. King, MD, Center for Joint Replacement, Anne Arundel
Medical Center, 2000 Medical Parkway, Suite 101, Annapolis, MD 21401.
Chechik et al [3], the direct anterior approach (DAA) currently
accounts for about 10% of all THAs, but this approach has been
gaining more attention recently.
DAA hip arthroplasty is a true internervous and intermuscular
technique, leaving all muscular attachments intact. It has been
associated with increased early recovery, better functional out-
comes, decreased risk of dislocation, and decreased postoperative
pain [4e6]. Proponents of the DAA also contend that acetabular
component positioning is more consistent because of the use of
fluoroscopy intraoperatively [7,8]. Opponents of the approach point
to the learning curve associated with changing techniques and an
increased complication rate, especially in the early cases [9], and
several published meta-analyses have failed to favor the DAA over
either the posterolateral (PA) or direct lateral approaches [10e12].

https://doi.org/10.1016/j.arth.2018.02.086
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2530e2534
The learning curve is defined as the number of cases a surgeon
requires of a new procedure before outcomes approach a steady
state compared with their standard procedure. The learning curve
associated with DAA hip arthroplasty has been previously
described as 50-100 cases [13]. There are no published studies
looking at a consecutive series of greater than 500 DAA THA to
establish a potentially longer learning curve. In the present study,
we will attempt to establish a learning curve by looking at 1000
consecutive DAA hip arthroplasties with an emphasis on total
operating room (OR) time, procedure time, and complication rate.
Materials and Methods
Study Design
Institutional review board's approval was obtained. All data
were collected retrospectively and deidentified. This study was a
longitudinal analysis in which the primary outcome of interest was
to determine the impact of cumulative volume of consecutive cases
on OR time, procedure time, and complication rate.
Population and Data
We retrospectively reviewed a single surgeon series of the
initial consecutive 1000 DAA primary unilateral THA procedures
from March 2010 through June 2015. Operating room times and
procedure times were collected using an administrative database.
All data were deidentified for this analysis. Operating room time
was defined as the interval between a patient entering the OR and
leaving the OR. Procedure time was defined as the interval
between first incision to wound closure completed. Procedures
were ordered from the earliest (first procedure date in March
2010) to the latest (last procedure date in June 2015). Mean OR
times and mean procedure times were calculated in consecutive
intervals of 50 procedures. DAA times were compared with his-
toric mean PA times. For the first 100 DAA cases, there were strict
patient selection criteria in place based on body habitus and case
complexity. After 100 cases, the DAA was used for all routine
primary THA. Complications requiring reoperation were also
collected from the facility electronic health record and categorized
by reason for revision, what interval they occurred in and the time
to revision.
Performing Surgeon
All procedures were performed by a fellowship-trained joint
reconstruction surgeon whose practice focused on total hip and
knee replacements. At the start of this review (January 2010), the
performing surgeon had performed approximately 1500 THAs via
the PA approach and also performed >200 THAs per year. Direct
anterior hip replacements were first introduced in this institution
at the start of this review (March 2010). Before its introduction, the
performing surgeon had no experience with the DAA. He received
didactic training, surgeon mentorship, assisted another surgeon at
another institution, and cadaver training in the DAA technique and
began performing the DAA in select patients in 2010.
Surgical Technique
Posterolateral approach hip replacements were performed in
the lateral decubitus position with division and subsequent repair
of the hip external rotators and posterior capsule. Direct anterior
hip replacements were performed in the supine position on a
modern fracture table with fluoroscopy and subsequent repair of
the anterior capsule.
2531
Outcome and Statistical Analysis
The primary outcomes of interest were the number of cases
required to achieve operational efficiency of the DAA compared
with the PA (defined by total OR time) and the time to procedural
efficiency (defined by procedure time) for the DAA compared with
the PA. To ascertain these effects, we analyzed mean OR time and
mean procedure time for a longitudinal series of DAA cases in in-
tervals of 50 cases. The mature mean PA times were calculated
using the last 50 PA cases before initiating the DAA. Analysis of
variance with post hoc analyses (where appropriate) was used to
examine significant differences in OR times and procedure times
between the cumulative DAA case intervals. Complications
requiring reoperation were also cataloged and evaluated using the
independent samples medians test. All analyses were performed
using IBM SPSS Statistics, version 23 (Armonk, NY). A P value
.05
was treated as statistically significant.
Results
The mature mean procedure time for the PA was 81.56 minutes
(95% confidence interval [CI], 74.88-88.24 minutes). Figure 1 pre-
sents the mean procedure time and CI by case interval along with
the mean PA procedure time. Transitioning from the PA to the DAA
increased procedure times by 34%, from 81.56 minutes to
108.98 minutes over the first 50 DAA cases (P < .001). Procedure
times decreased over the next 50 DAA cases to an average OR time
of 88.98 minutes (P < .001).
Table 1 presents the post hoc analysis identifying the DAA case
interval after which procedure times for the DAA became equiva-
lent and then improved compared with the traditional PA. The
mean procedure time for the PA (81.56 minutes) was significantly
shorter through the 151-200 case interval, then again at the
301-350 and 351-400 case intervals. After 400 DAA cases, the
procedure time was equivalent to the PA time, and then signifi-
cantly shorter in the 601-650 case interval and again after 850
cases. By the last interval studied, the DAA time (71.57 minutes) was
14% shorter than the historic PA time.
The mature mean OR time for the PA was 117.78 minutes (95% CI,
110.47-125.09 minutes). Figure 2 presents the mean OR time and CI
by case interval along with the mean PA procedure time. Tran-
sitioning from the PA to the DAA increased OR times by 30%, from
117.78 minutes to 152.94 minutes over the first 50 DAA cases
Fig. 1. Operating room time by cumulative case volume. Circles represent the means
with 95% confidence intervals. Red line is the reference for the posterolateral approach
operating room time (mean, 117.78 minutes).
2532 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2530e2534

Table 1 Table 2
Post Hoc LSD Analysis Comparing Procedure Times for the PA With the DAA Tech- Post Hoc LSD Analysis Comparing OR Times for the PA With the DAA Technique at
nique at Different Cumulative Case Volumes. Different Cumulative Case Volumes.

Direct Anterior Mean Standard P Value 95% Confidence Interval Direct Anterior Mean Standard P Value 95% Confidence Interval
Case Interval Difference Error Case Volume Difference Error
Lower Bound Upper Bound Lower Bound Upper Bound

0-50 27.420 3.165 .000 33.63 21.21 0-50 35.160 3.621 .000 42.26 28.06
51-100 7.420 3.165 .019 13.63 1.21 51-100 14.640 3.621 .000 21.74 7.54
101-150 6.093 3.181 .056 12.34 0.15 101-150 13.322 3.639 .000 20.46 6.18
151-200 8.380 3.165 .008 14.59 2.17 151-200 20.440 3.621 .000 27.54 13.34
201-250 3.660 3.165 .248 9.87 2.55 201-250 18.460 3.621 .000 25.56 11.36
251-300 5.960 3.165 .060 12.17 0.25 251-300 21.860 3.621 .000 28.96 14.76
301-350 10.685 3.181 .001 16.93 4.44 301-350 27.200 3.639 .000 34.34 20.06
351-400 6.401 3.149 .042 12.58 0.22 351-400 22.436 3.603 .000 29.51 15.37
401-450 1.020 3.165 .747 7.28 5.19 401-450 19.640 3.621 .000 26.74 12.54
451-500 1.260 3.165 .691 7.47 4.95 451-500 13.380 3.621 .000 20.48 6.28
501-550 5.460 3.165 .085 0.75 11.67 501-550 7.560 3.621 .037 14.66 0.46
551-600 3.600 3.165 .256 2.61 9.81 551-600 10.540 3.621 .004 17.64 3.44
601-650 6.560 3.165 .038 0.35 12.77 601-650 3.600 3.621 .320 10.70 3.50
651-700 2.540 3.181 .425 1.87 10.55 651-700 8.608 3.639 .018 15.75 1.47
701-750 4.340 3.165 .171 3.61 8.81 701-750 8.580 3.621 .018 15.68 1.48
751-800 2.600 3.165 .412 2.90 9.65 751-800 10.920 3.621 .003 18.02 3.82
801-850 3.372 3.198 .292 2.90 9.65 801-850 12.261 3.639 .001 19.40 5.12
851-900 6.360 3.165 .045 0.15 12.57 851-900 10.420 3.621 .004 17.52 3.32
901-950 10.340 3.165 .001 4.13 16.55 901-950 1.500 3.621 0.679 8.60 5.60
951-1000 9.989 3.181 .002 3.75 16.23 951-1000 5.300 3.621 0.144 12.40 1.80

DAA, direct anterior approach; LSD, least significant difference; PA, posterior DAA, direct anterior approach; LSD, least significant difference; OR, operating room;
approach. PA, posterior approach.
P
.05 in bold. P
.05 in bold.

(P < .001). Operating room times then decreased over the next 51-
100 DAA cases to an average OR time of 132.42 minutes (P < .001).
There was a second period in which OR times increased by 11%,
from 131.10 minutes during the 101-150 DAA case interval to
144.98 minutes during the 301-350 DAA case interval (P < .001).
Table 2 presents the post hoc analysis identifying the DAA case
interval after which OR times for the DAA become equivalent to
those of the traditional PA. The mature mean OR time for the PA
(117.78 minutes) was significantly shorter than the DAA case
intervals until after 900 cumulative cases had been performed, with
the exception of the 601-650 interval. After performing 900 DAA
cases, the mean OR time for DAA procedures (119.28 minutes) was
statistically equivalent to that of the traditional PA approach
(117.78 minutes, P ¼ .679).
Complications requiring reoperation were identified with a
minimum 2-year follow-up, the case interval in which the initial
surgery was performed was noted, and the time to revision was
noted (Table 3). Thirty-six total complications in 33 separate pa-
tients requiring reoperation occurred in this series of 1000 cases for
a 3.6% complication rate. Eighteen complications (1.8%) occurred
within 90 days of the index procedure, 4 femoral fractures, 2
acetabular complications, 1 dislocation, and 11 wound complica-
tions, of which 4 were for hematoma formation and 7 for infection.
The remaining 18 complications (1.8%) occurred more than 90 days
after the initial surgical procedure; mean time to revision for the
late complications was 22.9 months (range 7.4-60.7 months).
Further examining the complications, there were 7 cases of
femoral loosening (0.7%). Four additional revisions were performed
for thigh pain with a well ingrown component (0.4%). There were 4
periprosthetic femur fractures (0.4%), all of which occurred
between 1 and 2 weeks postoperatively. There was 1 periprosthetic
dislocation (0.1%) that occurred while the patient was still under
the influence of spinal anesthesia and required only closed reduc-
tion with no recurrence. There were 3 acetabular complications
(0.3%), one was an early failure in the presence of significant patient
factors, one after a fall in the early postoperative period, and one
occurred >2 years after the initial surgery after a traumatic event.
One patient required revision for symptomatic heterotopic

Table 3
Complications Requiring Reoperation and Average Time to Revision.

Complication Type Number Mean Time to

Revision (Range)

Femoral looseningdfibrous ingrowth 7 20.6 mo (12.3-25.9)

Thigh pain
Periprosthetic femur fracture
Heterotopic ossification
Acetabular failure early
Acetabular failure late
Wound complicationdhematoma
Wound complicationdinfection
Fig. 2. Procedure time by cumulative case volume. Circles represent the means with
Late infection
95% confidence intervals. Red line is the reference for the posterolateral approach
Dislocation
procedure time (mean 81.56 minutes).
4 18.2 mo (7.4-41.1)
4 1.8 wk (1-2.1)
1 14.2 mo
2 6 d (4-8)
1 28.2 mo
4 2.9 wk (1.9-4.3)
7 4.1 wk (1.6-9.0)
5 30.7 mo (19.6-60.7)
1 1 d (closed reduction)
 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2530e2534
ossification (0.1%). There were 11 wound complications requiring
reoperation (1.1%), 4 of these were for hematoma formation and 7
were for infection. Of these 7 patients with infection (0.6%), 5 of
these needed only irrigation and debridement along with appro-
priate antibiotic treatment and 2 required 2-staged revision. There
were a total of 5 late infections (0.5%), all of whom required 2-
staged revision.
Complication rates for each of the case intervals of the DAA were
evaluated using the independent samples medians test. There was
no significant difference in the distribution of the total complica-
tions across case intervals. Looking at all femoral complications
(femoral loosening, thigh pain, and femoral fractures), there
appeared to be a learning curveelike pattern (Fig. 3), with the
greatest number of complications occurring in the 0-50 case
interval, although the remainder of these complications were
evenly distributed and this was not statistically significant. Of the 7
cases of femoral loosening, 3 occurred in the first 10 DAA cases,
with the remaining 4 interspersed until the 601-650 case interval
and none after 650 cases.
Discussion
Acquiring new surgical techniques is part of continuing medical
education, although not without risk. Practicing medicine involves
a commitment to ongoing education, learning new techniques, and
refining current skills to provide quality and cost-effective care that
improves patient outcomes [14]; the DAA is one such technique.
There have been a number of attempts to define the learning curve
for DAA hip arthroplasty using various data points including pro-
cedure time, complication rate, fluoroscopy time, and estimated
blood loss [13,15e18]. Most of these studies place the time to
technical proficiency at around 50 cases, although none of these
studies extend the number out to more than 500 cases from a single
surgeon. In this retrospective study, we have attempted to add to
the literature defining the learning curve by studying one high-
volume surgeon as he transitioned to the DAA and looking at the
first 1000 cases compared with his historic PA times, with a mini-
mum 2-year follow-up. We also elected to look at both technical
efficiency by studying procedure time, and operational efficiency
by looking at total OR time.
When looking at procedure times, a distinct learning curveelike
pattern occurred. Procedure time dropped 22% from the first
interval to the second interval, and the first time interval remained
significantly longer than every other interval evaluated. This likely
isolates the surgeon learning curve, and is consistent with previ-
ously published literature [13,17]. The DAA procedure time was
longer than the PA time until 400 cases had been performed, and
after 850 cases, the DAA procedure was significantly shorter. For
Fig. 3. Femoral complications by case interval.
2533
this particular surgeon, after adequate experience, the DAA is more
efficient.
The DAA is a more equipment and personnel intensive
procedure than PA hip replacement. This series of cases represents
the first DAA hip arthroplasties performed at this institution and
extensive education was required for the entire team including
nursing staff, surgical technologists, anesthesia staff, radiology
technicians, central sterile processing, and environmental service
staff. There was a significant learning curve for the team at this
high-volume institution with the vast majority of THA before
instituting the DAA being performed from the PA. The specialized
table also necessitates additional training because of the need for a
nonsterile assistant to dislocate and relocate the hip intra-
operatively and also to safely position the patient. There have also
been reports of patient injury because of improper positioning,
particularly increased risk of ankle fractures [7]. Our data do show a
significant learning curve for the entire OR team, taking approxi-
mately 900 cases before the total OR time for the DAA are equiva-
lent to the PA, although no iatrogenic patient injuries were
reported.
After case 100, OR times did increase somewhat for the next 200
cases before they trended down again. This is presumed to be due
to the removal of patient selection criteria based on body habitus
during the first 100 cases. For the first 100 DAA cases, 56% of the
overall THA case volume was performed with the DAA approach,
whereas 44% were performed using the PA approach. After the first
100 DAA cases, 96% of the overall THA case volume was performed
using the DAA.
A confounding factor potentially contributing to the increased
OR time is the anesthesia type. PA procedures were typically
performed under general anesthesia. After the conversion to the
DAA, more patients had spinal anesthesia, with spinal anesthesia
being used exclusively by the end of this series. In our institution,
this is performed after the patient has been brought into the OR,
potentially contributing to increased induction time before the
start of the procedure. Although spinal anesthesia is not an
essential component of the DAA, we have found that spinal anes-
thetic has a number of benefits including improved muscle relax-
ation and decreased blood loss.
There have been mixed results in the literature when comparing
the complication rates of the DAA with the PA. Some studies show
an increased rate of complications with the DAA [13,19,20] and
other studies show no difference in the complication rate
[4,21e23]. The complication rate in this series is overall comparable
with other studies in most aspects and more favorable in some
areas. The dislocation rate reported in the literature for the PA is
1.7%-3.9% and for the DAA is 0.6%-1.2% [21,22,24e26]. In this series,
the dislocation rate was 0.1%. Examining early complications
specifically, this series reported 1.8% of patients experienced com-
plications in the first 90 days postoperatively. This is comparable
with another published study that looked at just early complica-
tions in a larger, multi-institutional study with surgeons who were
experienced in the DAA [23]. Our experience also mirrors one of the
early studies on the learning curve for the DAA, Masonis et al [27],
who found that transitioning to the DAA was overall safe.
Although there were no statistically significant patterns of
complications in the sample, largely because of the small numbers,
there were a couple of interesting trends noted. Of the patients who
had femoral loosening 3 occurred in the first 10 cases, and of the
remaining 4 none occurred after case 650. There were no femoral
complications after case 700. The femoral complications were also
fairly evenly interspersed through the series, with the exception of
the first 3 cases of femoral loosening. The first 2 periprosthetic
femur fractures occurred in the case interval 101-150, after elimi-
nation of the patient selection criteria, one occurred at the 351-400
2534 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2530e2534
case interval and one at the 601-650. All 4 periprosthetic fractures
were calcar fractures identified postoperatively within the first
2 weeks and associated with stem subsidence. Unlike other pub-
lished studies, we experienced no greater trochanter fractures or
femoral perforations in this series of cases [5,12,20,27]. Contrary to
Hartford et al [20], the fractures were evenly distributed between
male and female, and average body mass index of the 4 patients
was 29.5 kg/m2. We attribute the decline in femoral complications
through this series of case to be due to surgeon experience and
improved exposure that comes with technical proficiency.
There are limitations to this study. It is a retrospective chart
review rather than a prospective randomized trial. There was also
careful patient selection in the early cases involving the DAA. This is
high-volume surgeon operating in a high-volume hospital, and
other studies have shown that these 2 factors contribute to
improved clinical outcomes [13,28,29]. It is likely that surgeon and
hospital volume would affect both the technical and operational
efficiency also. We also acknowledge that there are confounding
variables when examining total OR time that may not accurately
reflect the learning curve. In a lower-volume institution, it is
possible that the learning curve would be extended. Although there
is only 2 years of follow-up for the most recent cases, most of the
reported complications had occurred by the 2-year mark. We are
also unable to account for any complications that may have
occurred outside of our institution.
Strengths of this study include the large volume of cases studied
and the minimum 2-year follow-up (range 2-7 years). We also
examined both procedure time and total OR time, allowing us to
define learning curves both for the surgeon and the OR team as a
whole. Team factors appear to play a significant role in achieving
operational efficiency. We also examine the complications that
occurred in detail, identifying some interesting trends.
Conclusion
When transitioning from the PA to the DAA, surgeons will likely
experience a decrease in efficiency, with longer procedure times
and total OR time. After 500 DAA cases, the procedure time is the
same or shorter than the mature PA time, and after 850 cases, the
DAA time was 14% shorter than the PA. Total OR time was equiva-
lent after 900 cases, underscoring the importance of the entire OR
team in efficiently performing the DAA. This series experienced a
low complication rate overall, particularly a low dislocation rate.
Femoral complications decreased over time.
Acknowledgments
The authors would like to acknowledge James H. MacDonald,
MD, for his support with manuscript review.
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 The Journal of Arthroplasty 33 (2018) 2398e2404

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Evidence-Based Thresholds for the Volume and Cost Relationship

in Total Hip Arthroplasty: Outcomes and Economies of Scale
Heather S. Haeberle, BS b, Sergio M. Navarro, BS b, William C. Frankel, BS b,
Michael A. Mont, MD a, Prem N. Ramkumar, MD, MBA a, *
a
Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, OH
b
Department of Orthopaedic Surgery, Baylor College of Medicine, Houston, TX

a r t i c l e i n f o a b s t r a c t

Article history: Background: High-volume surgeons and hospital systems have been shown to deliver higher-value care
Received 7 February 2018 in several studies. However, no evidence-based volume thresholds for cost currently exist in total hip
Received in revised form arthroplasty (THA). The objective of this study was to establish meaningful thresholds in cost for sur-
23 February 2018
geons and hospitals performing THA. A secondary objective was to analyze the market share of THAs for
Accepted 26 February 2018
each surgeon and hospital stratifications.
Available online 15 March 2018
Methods: Using a database of 136,501 patients undergoing THA, we used stratum-specific likelihood
ratio analysis of a receiver operating characteristic curve to generate volume thresholds based on costs
Keywords:
total hip arthroplasty (THA)
for surgeons and hospitals. In addition, we examined the relative proportion of annual THA cases per-
volume formed by each surgeon and hospital stratifications.
cost Results: Stratum-specific likelihood ratio analysis of cost by annual surgeon THA volume produced
receiver operating characteristic (ROC) stratifications at: 0-73 (low), 74-123 (medium), and 124 or more (high). Analysis by annual hospital THA
stratum-specific likelihood ratio (SSLR) volume produced stratifications at: 0-121 (low), 122-309 (medium), and 310 or more (high). Hospital
threshold costs decreased significantly (P < .05) in progressively higher volume stratifications. High-volume cen-
ters perform the largest proportion of THA cases (48.6%); however, low volume surgeons perform the
greatest share of these cases (44.6%).
Conclusion: Our study establishes economies of scale in THA by demonstrating a direct relationship
between volume and cost reduction. High-volume hospitals are performing the greatest proportion of
THAs; however, low-volume surgeons perform the largest share of these cases, which highlights a po-
tential area for enhanced value in the care of patients undergoing THA.
© 2018 Elsevier Inc. All rights reserved.

The United States healthcare system has progressively transi-
tioned to a model of value-based care [1]. However, the definition
of value remains elusive. Although most experts agree that it is the
ratio between the outcome of the rendered service over the cost of
care, few agree on how these metrics are captured. The “numerator
problem” represents the challenge of measuring outcomes, which
led to the advent of patient-reported outcome measures. However,
Ramkumar et al [2] demonstrated that no consensus patient-
reported outcome measure exists. Furthermore, Press Ganey Sur-
veys report outcomes and are most closely tied to reimbursement,
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.093.
* Reprint requests: Prem N. Ramkumar, MD, MBA, 2049 E 100th St, Cleveland,
OH 44195.
but often times fail to capture meaningful metrics [3e7]. Further-
more, functional measurements can be lacking although they used
to be the gold standard for the physician-led characterization of
surgical outcomes. Similarly, cost issues remain as difficult to
measure because of lack of transparency and consensus as to
whether they should refer to price from the insurance, patient,
hospital, industry, or federal perspective.
Despite the aforementioned measurement issues, value-based
care is gaining importance in orthopedic surgery because of the
elective nature of many procedures, the increasing cost of care, the
rising procedural volumes, and geographic variations [8]. Several
studies have demonstrated that greater value is achieved in or-
thopedic surgery with higher surgeon and hospital volumes, as
these models are able to provide superior outcomes at a lower cost
[9e11]. Lower costs may be attributed to the industrial concept of
“economies of scale,” which demonstrate diminishing costs as the
service volume increases [12e14].

https://doi.org/10.1016/j.arth.2018.02.093
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 H.S. Haeberle et al. / The Journal of Arthroplasty 33 (2018) 2398e2404 2399

The relationship between increased value with increased sur- Table 1

geon and hospital volume has been demonstrated in total hip Demographic Data of Patients Studied.

arthroplasty (THA), although previous stratification criteria are No. (%)

varied because of the arbitrary nature by which numerical thresh- Gender
olds were established [15e21]. Most commonly, data are divided Female 73,276 (53.7)
linearly such that volume stratifications are a function of the total Male 63,225 (46.3)
patients studied. Although simple for analysis, this methodology Age groups, y
18-29 400 (0.3)
does not reflect reality as output in surgery is more likely to be a step-
30-49 12,636 (9.2)
wise progression, rather than a linear one. For example, from a 50-69 77,058 (56.5)
clinical perspective, do surgeons who perform 1000 arthroplasties 70 or older 46,375 (34)
annually deliver greater value than those who perform 900? Race
Caucasian 114,282 (83.7)
Moreover, the lack of consensus regarding appropriate thresholds
African American 10,213 (7.5)
for volume categories has contributed to interstudy variability, Other race 11,433 (8.4)
which has prevented suitable comparisons between reports, Multiracial 573 (0.4)
limiting the applicability of the volume levels on the achievement of Insurance type
value-based care [15e21]. At present, a data driven approach is Medicare 63,219 (46.3)
Blue Cross/BC&BS 29,225 (21.4)
needed to define volume-value relationships in orthopedic surgery.
Private insurance 22,314 (16.3)
Stratum-specific likelihood ratio (SSLR) analysis allows for the Other types 21,743 (16)
determination of meaningful volume-based thresholds, as outlined Total 136,501
by Peirce and Connell [22]. SSLR analysis applies receiver operating BC&BS, Blue Cross and Blue Shield.
characteristic (ROC) curves to identify volume thresholds with
significant differences for the outcome of interest. This approach was derived from 193 hospitals and 1224 surgeons within the state
was initially used for risk stratification of heart transplants and has of New York. The mean age for patients undergoing THA was 65
been applied to orthopedic surgery in total knee arthroplasty, years (±14 years). We calculated the mean age by weighting bucket
shoulder arthroplasty, THA in terms of one outcome variable (ie, (eg, 50-69 years) means assuming a standard distribution within
length of stay), and pediatric spinal fusion for scoliosis [23e27]. No each bucket. The patient pool (Table 1) was more likely to be female
study to date has applied SSLR analysis to determine meaningful (53.7%), over the age of 50 years (90.5%), and Caucasian (83.7%).
value-based thresholds for costs in THA. Therefore, we analyzed the Medicare (46.3%), Blue Cross/Blue Cross and Blue Shield (21.4%), and
volume-value relationship using hospital cost as the dependent Private insurance (16.3%) were the most common payer types.
outcome to generate meaningful volume thresholds in THA. The Annual surgeon volume was defined as the total number of THAs
purpose of this study was to establish evidence-based thresholds performed in that calendar year, using the unique Attending and
with SSLR analysis using an ROC curve to analyze the volume-value Operating Surgeon identifiers. Annual surgeon volume combines
relationship in THA, including (1) the volume thresholds for sur- the comprehensive case volume for each surgeon who operates at 1
geons and hospitals most predictive for hospital costs and (2) the or more hospitals in New York. Similarly, we defined annual hospital
associations between SSLR-generated surgeon and hospital volume volume as the total number of THA procedures that were performed
thresholds and the risk of increased hospital costs. A secondary in that calendar year, using the unique Hospital identifier.
objective was to subsequently assess the market share of THA for Cost was available in the database and was derived from the
the newly stratified hospitals and surgeons performing THA. Institutional Cost Report (ICR) and SPARCS data. The ICR is a uni-
form report completed by New York State facilities reporting in-
Materials and Methods come, expenses, assets, liabilities, and statistics to the Department
of Health. Estimates of inpatient costs were calculated using the
Two SSLR analysis models were performed for the following hospital discharge data from the SPARCS and ICR data. ICR data
scenarios: (1) surgeon volume vs cost and (2) hospital volume vs included cost for each facility in addition to ratios of cost to charges
cost. Clinical Classification Software (CCS) and All Patient Refined (RCCs). RCCs are certified, calculated, and reported by facilities and
Diagnosis Related Groups (APR DRGs) codes were used to define subject to external audit. Specifically, the reported cost was the
primary THA procedures performed. Surgeon and hospital volume total amount charged for the patient’s operative admission by the
were analyzed annually from January 1, 2009 to December 31, 2015. individual hospital less the attributed RCC value. Therefore, cost
was specific to both the orthopedic procedure and the hospital
Data Sources and Study Population because the RCC, provided by ICR data, was multiplied by the
charge data from the procedure, as provided by the SPARCS data.
We used the New York State Department of Health’s Statewide The mean overall cost was $19,311.92.
Planning and Research Cooperative System database, a reporting
system which publishes patient-level data on all discharges from Predictors
nonfederal acute-care hospitals of New York state. The data set
used included patient-specific data from 2009 through 2015, as We performed a univariate analysis controlling for patient-level
more detailed expense data were not available until 2009. comorbidity burden based on the APR risk of mortality (minor,
The cohort for the 2 models included patients undergoing pri- moderate, major, or extreme), and found comorbidity to be asso-
mary THA who met the following CCS and APR DRGs code criteria: ciated with increased cost, as shown in Table 2. Measures of annual
(1) CCS Diagnosis Code 203d“Osteoarthritis”; (2) CCS Procedure hospital volume and surgeon volume were included in each model.
Code 153d“Hip replacement, total and partial”; and (2) APR DRG
coded301 “Hip Joint Replacement”. These specifications were used Statistical Analysis
to filter the initial cohort of patients to include only those patients
who underwent THA, whereas excluding those patients who un- SSLR analysis has been used to conduct ROC curve analysis
derwent revision THA or partial hip arthroplasty (ie, hemi- because of its ability to identify volume thresholds at which sta-
arthroplasty). The refined cohort included 136,501 patients. Analysis tistically significant changes of risk probability occur [24e28]. SSLR
2400 H.S. Haeberle et al. / The Journal of Arthroplasty 33 (2018) 2398e2404
Table 2
The Effect of APR Risk of Mortality on Cost.
APR Risk of Mortality
Extreme
Major
Moderate
Minor
APR, all patient refined.
analysis includes dividing the cohort into many different groupings
and calculating a risk ratio for each group. These groups are then
merged into increasingly larger groups until a significant difference
in risk ratios is demonstrated between adjacent groups. This
analysis generates discrete groups with statistical significance,
providing an objective method of partitioning data sets into
volume-based groupings.
We applied SSLR analysis to ROC curves for expenses to generate
sets of volume stratifications for both surgeons and hospitals. SSLR
analysis was calculated as the ratio of sensitivity (ie, true-positive) to
1-specificity (ie, false-positive). The sensitivity and 1-specificity were
based on the associated threshold cost level established, allowing for
determination where cost was meaningful. The average THA cost for
our cohort was $19,312 (rounded up to $20,000). Threshold analyses
were performed in a stepwise fashion from $20,000-$40,000,
increasing by $2500 in each subsequent analysis. A cost threshold of
$27,500 was chosen, as it produced an ROC curve with the greatest
area under the curve. A P value of <.05 was used as the definition of
statistical significance to allow for curve comparison and the estab-
lishment of statistically significant thresholds. Odds ratios and con-
fidence intervals were calculated to allow for the comparison of group
thresholds using a point estimate and the confidence coefficient and
standard error. The highest volume grouping was used as the refer-
ence group for each respective analysis. SSLR analyses were per-
formed in Microsoft Excel (Microsoft, Redmond, WA), and all other
statistical analyses were performed using SPSS (International Busi-
ness Machines, Armonk, NY).
Results
Full data from SSLR analysis of the ROC curves for both the
surgeon and hospital analyses can be visualized in Figure 1. Surgeon
volume ranged from 0-555 annual THAs, whereas hospital volume
ranged from 0-4428 annual cases.
Surgeon Volume Stratifications vs Cost
SSLR analysis of the ROC curve for expenses by surgeon volume
identified 2 thresholds at 74 and 125 surgeries per year, respec-
tively, yielding 3 volume stratifications: 0-73 (low), 74-124
Fig. 1. SSLR analysis of the receiver operating characteristic curves for both the surgeon and hospital analyses. SSLR, stratum-specific likelihood ratio; THA, total hip arthroplasty.
(medium), and 154 or greater (high) (Table 3). Unadjusted costs
were $19,524, $19,434, and $19,000 per case for low-volume, me-
Total Cost dium-volume, and high-volume surgeons, respectively.
$46,080.00
$29,070.61 Hospital Volume Stratifications vs Cost
$21,544.67
$19,394.26
SSLR analysis of the ROC curve for expenses by hospital volume
identified 2 thresholds at 122 and 310 surgeries per year, respec-
tively, yielding 3 volume stratifications: 0-121 (low), 122-309
(medium), and 310 or greater (high) (Table 4). Unadjusted costs
were $21,045, $20,285, and $17,924 per case for low-volume, me-
dium-volume, and high-volume hospitals, respectively.
Market Share of Total Hip Arthroplasties by Hospital and Surgeon
Stratifications
Low-volume surgeons performed the greatest share of THA
cases (44.6% compared with 18.0% and 37.5% for medium-volume
and high-volume hospitals, respectively). The highest proportion
of these cases, however, were performed at high-volume hospitals
(48.6% compared with 23.0% and 28.4% for low-volume and
medium-volume hospitals, respectively). Figure 2 displays a full
breakdown of the relative market share among surgeon and hos-
pital volume stratifications.
Discussion
Efficiency is often achieved via generating favorable “economies
of scale” by delivering more goods or services on a larger scale with
reduced input costs. As health care and medicine transforms into a
more cost-conscious system, economic best practices and princi-
ples are increasingly applied. Delivering high value care has
become increasingly important in orthopedic surgery particularly
for THA, one of the most commonly performed and reimbursed
procedures in the United States [29]. Although several studies have
explored the relationship between volume and value through
various analyses evaluating outcomes and cost, meaningful
thresholds establishing the levels for “low” and “high” volume
surgeons or hospitals have remained lacking. This study used the
statistical technique of SSLR with ROC analysis to establish
evidence-based stratifications in THA for both hospitals and sur-
geons in terms of cost to assess value of care delivered. Only a few
studies in orthopedics to our knowledge, by Ramkumar et al in
shoulder arthroplasty, Navarro et al in spinal fusion, and Wilson
et al in THA, have used SSLR to establish meaningful volume
thresholds for cost [24e27]. Although various thresholds were
established in our study, cost decreased with each volume stratifi-
cation and demonstrated that an evidence-based, direct relation-
ship between surgeon and hospital volume of THA and value of care
 H.S. Haeberle et al. / The Journal of Arthroplasty 33 (2018) 2398e2404 2401

Table 3
Surgeon Volume vs Cost.

Volume 1-Specificity Sensitivity SSLR Category P Values No. Odds Ratio

0 1 1 1 Low .010 3813 4.828 (2.374-9.820)

1 0.812 0.891 1.10
2 0.669 0.800 1.21
3 0.586 0.756 1.30
5 0.491 0.688 1.42
10 0.355 0.661 1.60
25 0.154 0.632 2.31
50 0.077 0.605 2.48
74 0.044 0.583 2.95 Medium .013 256 1.968 (0.820-4.727)
80 0.040 0.5 2.96
95 0.032 0.146 2.99
102 0.028 0.108 3.17
112 0.025 0.078 3.13
125 0.015 0.060 4.38 High 261 Reference
139 0.013 0.048 4.70
140 0.013 0.036 4.26*
150 0.013 0.026 3.78

Low: $19,524.37, Medium: $19,434.30, and High: $19,000.33.

SSLR, stratum-specific likelihood ratio.
*
When sampling is low, sensitivity and 1-specificity are low, and thus may cause SSLR to decrease within a grouping as observed with the above volumes at 140 and 150.

delivered indeed exists. The additional key finding in this study was
that high-volume surgeons are not necessarily performing most of
the procedures, which is corroborated by the study results from
Ramkumar et al analyzing the same THA population in terms of
length of stay. This finding demonstrates that although volume and
value are directly related, surgeon and hospital volumes may not be
a key determinant of decision-making when accessing THA from
either the administrative or patient perspectives.
This study had several limitations. The results were derived from
a statewide administrative database, which was not specifically
designed for outcomes research. Although the database uses coding
practices which have been shown by Saucedo et al [30] to be error
prone, its accuracy was validated in a study by Quan. The thresholds
from this SSLR analysis, as with area under the curve analysis, are
specific to the database and outcome metrics. Given the relatively
small differences in risk between volume stratifications, a productive
SSLR requires a very large sample size. That means that although
more than 100,000 surgeries across more than 150 hospitals in the
state of New York are sufficient for preliminary conclusions, more
data are needed for generalizable thresholds and to make
nationwide conclusions. Thus, it is tempting to focus on the exact
thresholds reported, but these values are not yet generalizable at this
stage [28,31]. More surgeon and hospital data are required, as well as
the specifics of each procedure, to perform risk-adjusted analyses. To
establish even more meaningful thresholds, a single value-based
index or summative metric for a procedural episode of care should
be created and applied to an even greater database of patients than
the 136,501 patients analyzed. In addition, the inability to combine
the surgical volumes from 1 surgeon operating at >1 center, each
with its own billing number, is a further limitation of the study. In
addition, annual surgeon volume does not correspond to a surgeon’s
cumulative career surgical volume, perhaps failing to account for an
important contributing factor in the relationship between surgeon
volume and cost. Despite these limitations, this study provides
evidence-based thresholds for the volume-value relationship in THA,
analyzing data from over 100,000 procedures.
The threshold findings for cost by surgeon THA volume pro-
duced stratifications at: 0-73 (low), 74-123 (medium), and 124 or
more (high). These thresholds are highly consistent with those
based on length of stay from a previous study by Ramkumar et al

Table 4
Hospital Volume vs Cost.

Volume 1-Specificity Sensitivity SSLR Category P Values No. Odds Ratio

0 1 1 1 Low .010 837 13.387 (1.843-97.215)

1 0.986 0.982 1.00
2 0.942 0.966 1.03
3 0.878 0.950 1.08
5 0.76 0.910 1.16
10 0.656 0.823 1.25
25 0.432 0.671 1.55
50 0.269 0.527 1.96
75 0.163 0.417 2.55
100 0.116 0.331 2.87
122 0.068 0.285 4.19 Medium <.001 228 3.165 (0.398-25.169)
150 0.048 0.228 4.78
200 0.04 0.144 3.52
250 0.034 0.112 3.30
298 0.017 0.086 5.06
310 0.007 0.084 12.35 High 70 Reference
320 0.007 0.078 11.46*
348 0.007 0.073 10.71
362 0.007 0.069 10.12

SSLR, stratum-specific likelihood ratio.

Low: $21,044.92, Medium: $20,285.48, and High: $17,924.48.
*
When sampling is low, sensitivity and 1-specificity are low, and thus may cause SSLR to decrease within a grouping as observed with the above volumes at 320, 348,
and 362.
2402 H.S. Haeberle et al. / The Journal of Arthroplasty 33 (2018) 2398e2404

Fig. 2. Distribution of surgeon and hospital market share using evidence-based thresholds.

[26], which were 0-69 (low), 70-121 (medium), and 122 or more
(high). Based on these findings, it appears that there are 2 impor-
tant cutoffs at approximately 70 and 120 annual cases, which may
signify thresholds where cost savings are rendered, allowing sur-
geons to deliver higher-value care. Shi et al [17] reviewed admin-
istrative claims data from the Taiwan Bureau of National Health
Insurance of 78,354 patients undergoing THA over an 11-year
period and found that THA cases performed by high-volume sur-
geons cost 7% less than those performed by low-volume surgeons.
In the aforementioned study, high-volume surgeons were arbi-
trarily defined as those performing 25 or more THA cases per year.
Despite this arbitrary delineation, these results corroborate the
findings of our study, specifically that higher-volume surgeons
deliver care to their patients at a lower cost in the context of THA.
The threshold findings for cost by hospital THA volume produced
stratifications at: 0-121 (low), 122-309 (medium), and 310 or more
(high). The volume thresholds for the previous study by Ramkumar
et al [26] in the context of length of stay were 0-120 (low), 121-357
(medium), and 358 or more (high). The thresholds for high-volume
centers varied slightly between the 2 studies with critical threshold
at approximately 120 and 330 annual cases wherein hospitals are
able to deliver higher-value care to patients undergoing primary
THA. Thus, these are the potentially critical levels at which hospital
begin achieving efficiency improvements, or “economies of scale,” in
which institutions are able to achieve reduced costs as surgical
volume increases [27]. This phenomenon may be explained by the
ability of high-volume institutions to reduce fixed costs (ie, im-
plants) as well as variable expenses (ie, staff, dedicated orthopedic
operating room) [32e34]. High-volume institutions are more likely
to use specialized care teams and postoperative care plans, allowing
for increased efficiency as multidisciplinary team members gain
familiarity with the procedure [35,36]. It is important to note this
study does not elucidate what operational factors specifically
contribute to this, which necessitates further study. The study by Shi
et al [17] found that THA cases performed at high-volume hospitals
cost 6% less than those performed at low-volume hospitals. Again,
however, the threshold for high-volume hospitals was arbitrarily
designated at 100 annual THA cases. Historically, “very high” volume
centers were defined as those performing more than 200 THAs a
year [37,38]. Our analysis suggests that the cutoff for “high” or “very
high” volume centers may in fact be higher than previously thought,
and that a threshold exists above 300 annual cases wherein hospi-
tals can further optimize the value of THA.
Of note, APR risk of mortality, a patient-level modifiable risk
factor, was positively associated with cost in the univariate analysis.
This result reinforces the well-described finding that patient
comorbidities directly impair surgeons’ ability to provide value in
the setting of THA. There was no significant difference in the

Fig. 3. Distribution of APR risk of mortality among hospital and surgeon volume thresholds. APR, all patient refined.
 H.S. Haeberle et al. / The Journal of Arthroplasty 33 (2018) 2398e2404
Table 5
Combined Cost Breakdown Using Hospital and Surgeon Stratification Analysis.
Low-Volume Medium-Volume High-Volume
Surgeons Surgeons Surgeons
Low-volume $20,636.66 $21,422.58 $31,169.33
hospitals
Medium-volume $19,660.24 $20,157.88 $21,860.81
hospitals
High-volume $17,197.47 $18,125.55 $18,119.80
hospitals
distribution of APR risk of mortality or severity of illness between
volume thresholds for hospitals and surgeons, as shown in Figure 3.
Kaneko et al [18] reported that age and gender also factored into the
complication rate, although with a much smaller cohort. An addi-
tional notable finding from our study was that the lowest volume
stratification surgeons performed the greatest proportion THA
cases, whereas the largest share of these cases were performed at
the highest volume stratification hospitals. More granular data are
needed to derive meaningful conclusions, but this may suggest
consolidated, high-volume hospital systems delivering high value,
employ many staff performing these procedures with lower indi-
vidual surgeon volume. A study by Laucis et al [39] supports our
finding that arthroplasty patients are having their procedures at
higher-volume hospitals because 82% of patients live within a 50-
mile radius of a hospital that performed more than 400 cases
annually. However, our study adds that the surgeon performing
the procedure at a high-volume institution may not necessarily
be considered high-volume themselves. Low-volume surgeons at
high-volume hospitals provided THA at the lowest cost ($17,197),
whereas high-volume surgeons at low-volume institutions had
the highest cost ($31,169), suggesting that hospital volume may
be the driving factor in this relationship, as seen in Table 5.
Moreover, the cost difference between low-volume and high-
volume was much higher for hospitals ($21,045 vs $17,924, or
~17.4%) than for surgeons ($19,524 vs $19,000, or ~2.8%). Addi-
tional study is needed capturing the cumulative experience of
surgeons to better understand this relationship. High-volume
surgeons and institutions had the highest percentage of pa-
tients with private insurance (26.6% and 27.6%, respectively, vs
21.2% and 20.0% for low-volume surgeons and institutions), a
population with the highest average costs ($19,882). Thus, the
distribution of insurance type may be a confounding factor in this
relationship.
In a field with expensive implants and multidisciplinary health
care delivery, the ideal scenarios for high-value arthroplasty care
include economies of scale, achievable via merging both high-
volume surgeons and high-volume centers. Additional investiga-
tion is needed to determine if the increased value associated with
high-volume surgeons and high-volume hospitals is attributed to
economies of scale or the individual training and experience of the
staff. Furthermore, this study indicates that the volume of care and
level of organizational efficiency that the hospital merits additional
study.
Conclusions
Our study establishes economies of scale in THA by demon-
strating a direct relationship between volume and cost reduction
based on application of SSLR analysis of ROC curves for risk-based
volume stratification using meaningful volume definitions for
low-volume, medium-volume, and high-volume surgeons and
hospitals. High-volume hospitals are performing the largest pro-
portion of THAs; however, low-volume surgeons are performing
2403
the greatest share of these cases, which highlights a potential area
for enhanced value in the care of patients undergoing THA.
Acknowledgments
This research did not receive any specific grant from funding
agencies in the public, commercial, or not-for-profit sectors.
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 The Journal of Arthroplasty 33 (2018) 2524e2529

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Excellent Survival and Good Outcomes at 15 Years Using the

Press-Fit Condylar Sigma Total Knee Arthroplasty
William M. Oliver, LLB (Hons), MRCS a, *, Calum H.C. Arthur, FRCS b,
Alexander M. Wood, MSc, FRCS c, Robert A.E. Clayton, BSc (Hons), FRCS a,
Ivan J. Brenkel, FRCS a, Philip Walmsley, MD, FRCS a
a
Department of Orthopaedic Surgery, Victoria Hospital, Kirkcaldy, Fife, UK
b
Department of Trauma & Orthopaedic Surgery, Royal Infirmary of Edinburgh, Edinburgh, Midlothian, UK
c
Department of Orthopaedic Surgery, Leeds General Infirmary, Leeds, West Yorkshire, UK

a r t i c l e i n f o a b s t r a c t

Article history: Background: We report 15-year survival, clinical, and radiographic follow-up data for the Press-Fit
Received 5 January 2018 Condylar Sigma total knee arthroplasty.
Received in revised form Methods: Between October 1998 and October 1999, 235 consecutive TKAs were performed in 203
5 March 2018
patients. Patients were reviewed at a specialist nurse-led clinic before surgery and at 5, 8-10, and 15
Accepted 19 March 2018
Available online 27 March 2018
years postoperatively. Clinical outcomes, including Knee Society Score, were recorded prospectively at
each clinic visit, and radiographs were obtained.
Results: Of our initial cohort, 99 patients (118 knees) were alive at 15 years, and 31 patients (34 knees)
Keywords:
total knee arthroplasty
were lost to follow-up. Thirteen knees (5.5%) were revised; 5 (2.1%) for infection, 7 (3%) for instability,
implant survival and 1 (0.4%) for aseptic loosening. Cumulative survival with the end point of revision for any reason was
patient-reported outcome measures 92.3% at 15 years and with revision for aseptic failure as the end point was 94.4%. The mean Knee Society
Press-Fit Condylar Sigma implant Score knee score was 77.4 (33-99) at 15 years, compared with 31.7 (2-62) preoperatively. Of 71 surviving
knees for which X-rays were available, 12 (16.9%) had radiolucent lines and 1 (1.4%) demonstrated clear
radiographic evidence of loosening.
Conclusion: The Press-Fit Condylar Sigma total knee arthroplasty represents a durable, effective option
for patients undergoing knee arthroplasty, with excellent survival and good clinical and radiographic
outcomes at 15 years.
© 2018 Elsevier Inc. All rights reserved.

The Press-Fit Condylar total knee arthroplasty (PFC TKA;
Johnson & Johnson Professional, Raynham, MA) has been
commercially available since 1984. Despite a reported 10-year
survivorship between 93% [1,2] and 95% [3], in some series, a
deterioration in implant survival was observed beyond 10 years
postoperatively [4e9].
The Sigma design succeeded the original PFC TKA, arriving on
the UK market in 1997. Novel features included an increased radius
of mediolateral femoral condylar curvature, with a corresponding
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.048.
* Reprint requests: William M. Oliver, LLB (Hons), MRCS, Department of Trauma
& Orthopaedic Surgery, Royal Infirmary of Edinburgh, 51 Little France Crescent,
Edinburgh, Midlothian EH16 4SA, UK.
deepening of the polyethylene insert and modification of the
femoral trochlea creating a deeper groove and a more pronounced
lateral epicondylar ridge [10].
We have previously reported results of this device up to 10 years
postimplantation, demonstrating all-cause survivorship of 95.9%
and survivorship for aseptic loosening of 98.7% [11]. Studies
extending beyond 10 years are scarce [12] but suggest that the
decline in implant survival observed in the original design does not
extend to the current version. By following our cohort out to 15
years postoperatively, we will evaluate whether the PFC Sigma TKA
continues to represent a durable, effective option for patients
undergoing TKA.
Patients and Methods
This device was introduced in our unit in October 1998. Between
October 1998 and October 1999, all patients undergoing unilateral

https://doi.org/10.1016/j.arth.2018.03.048
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 W.M. Oliver et al. / The Journal of Arthroplasty 33 (2018) 2524e2529
primary TKA were included in this study. This unselected, consec-
utive group formed our study cohort and is the same cohort used in
the report of our 10-year results [11]. No other prostheses were
used in the department during the study period, with uni-
compartmental, simultaneous bilateral and revision procedures
excluded from the analysis. A summary of baseline demographic
details and indication for index TKA is shown in Table 1.
In our department, we employ a group of 4 specialist nurses
who review all patients undergoing TKA, and the composition of
this group remained constant throughout the study period. They
were not part of the study team and reviewed all patients under-
going TKA during the study period (not just the study cohort). Pa-
tients were reviewed by our specialist nurses at a preadmission
clinic before surgery and at 5 years, 8-10 years, and 15 years
postoperatively. Data including age, gender, weight, height, medical
comorbidities, and clinical outcome scores were recorded pro-
spectively using a standardized data collection form, from which
data were then entered into the departmental arthroplasty data-
base. Radiographs were also obtained at these appointments.
The operations were performed by 6 different consultant sur-
geons or by trainees under direct supervision. The surgical tech-
nique is as described in our previous results [11]. Specifically, the
decision to resurface the patella was left to the discretion of the
consultant surgeon, and drains were not used routinely. All patients
underwent a standard regime of postoperative care, including
mechanical and chemical thromboprophylaxis with thromboem-
bolic deterrent stockings and subcutaneous low-molecular-weight
heparin. A standardized transfusion protocol was in place during
the study, with a trigger hemoglobin value of 8 g/dL.
Using data entered into the departmental arthroplasty database,
preprogrammed algorithms were used to calculate the Knee Soci-
ety Score (KSS) [13] and Oxford Knee Score (OKS) [14] for all study
patients. The OKS was categorized as “excellent,” “good,” “fair,” or
“poor,” using published thresholds [15].
Weight-bearing short-leg anteroposterior and lateral X-rays
were obtained for all patients who attended their 15-year
follow-up appointment. Coronal plane alignment (femorotibial
valgus angle) was measured, and femoral and tibial components
were assessed for the presence of surrounding radiolucent lines or
osteolytic defects [16]. Images were reviewed by 3 surgeons using
Carestream Picture Archiving Communication Software, all of
whom were blinded to that particular patient's outcome at the time
of X-ray assessment.
A life table was constructed, and cumulative survival rates were
calculated. End points were reoperation for any reason and
component revision for aseptic loosening or mechanical failure. A
“worst-case” survival analysis was also performed, whereby all
knees lost to follow-up were treated as having failed immediately
after their last follow-up appointment. Confidence intervals for
survival rates were calculated using the Rothman method [17,18],
which has been validated for this purpose [19,20]. Where
Table 1
Baseline Patient Details and Indication for TKA.
Age (y) 66.5 (28-91)
Gender (n, %) Male: 100, 49.3%
Female: 103, 50.7%
Weight (kg) 81.4 (43-133)
Height (m) 1.63 (1.39-1.88)
Body mass index (kg/m2) 30.5 (17-49)
Indication for TKA (n, %) Osteoarthritis: 209, 88.9%
Rheumatoid arthritis: 20, 8.5%
Post-traumatic arthritis: 6, 2.6%
TKA, total knee arthroplasty.
2525
appropriate, a paired t test was used to assess statistical significance
of the relationship between 2 continuous variables.
Results
From an original cohort of 203 patients (235 knees), at 15 years
postoperatively, 104 patients (117 knees) had died, leaving 99
patients (118 knees) alive and theoretically available for follow-up.
This equates to a death rate of 3.4% per year. Of the surviving
cohort, 60 patients (76 knees) attended the clinic, 7 patients (7
knees) were contacted by telephone, and 1 patient (1 knee)
responded by a letter. Responses by telephone and letter provided
data for the KSS pain component of the knee score and KSS
function score, as well as OKS; however, a complete KSS knee
score (which includes clinical assessment of alignment, range of
motion, and stability) was unavailable for these patients. Thirty-
one patients (34 knees) did not attend the clinic and were
therefore lost to follow-up. A summary of 15-year follow-up is
shown in Figure 1.
KSS knee scores were available for 76 knees (64.4%) who
attended their final clinic appointment, while pain component
scores and function scores were available for a further 7 knees who
were contacted by telephone (83 knees, 70.3%).
The mean KSS knee score at 15 years postoperatively was 77.4
(33-99), showing little deterioration from the 5-year (84.3, 35-
99) and 10-year (78.8, 10-99) scores. Similarly, the mean pain
component of the knee score was 39.5 (0-50) at 15 years, only
slightly reduced from the 5-year (44.3, 0-50) and 10-year (41.3,
10-50) scores. Clinically, this corresponds to mild knee pain when
climbing stairs. Thirty-two of 83 patients (38.6%) reported no
pain.
In contrast to the KSS knee and pain component scores, the
mean function score at 15 years was 56.4 (5-100), a marked
decrease from the 5-year (80.5, 30-100) and 10-year (68.9, 20-100)
function scores. Postoperative trends in the KSS are shown in
Figure 2.
OKSs were available for 77 knees (65.3%) at 15 years. The mean
OKS was 29.0 (3-48), representing a “fair” outcome. Analysis of
previous results from this cohort (Table 2) indicates a general
decline in OKS from 5 to 15 years postoperatively, with a marked
decrease in the proportion of knees classed as “excellent” and an
associated increase in those classed as “poor”; the proportion of
Fig. 1. Fifteen-year follow-up of PFC Sigma TKA cohort.
2526 W.M. Oliver et al. / The Journal of Arthroplasty 33 (2018) 2524e2529
Fig. 2. Postoperative Knee Society Score following PFC Sigma TKA.
knees in the “good” and “fair” category is relatively constant. Dis-
tribution of postoperative OKS is shown in Figure 3.
Radiographic data were available for 71 knees (60.2%) at the
final review. Of these, 12 knees (16.9%) had radiolucent lines. A
summary of the distribution of radiolucent lines on anteroposterior
and lateral radiographs is shown in Table 3.
Clinically, 5 patients with radiolucent lines had occasional mild
pain (KSS pain component score ¼ 45), and the remainder reported
no pain (KSS pain component score ¼ 50).
One knee (1.4%) had osteolysis on the anteroposterior radio-
graph, which demonstrated a 3-mm erosion in zone 1 and 6-mm
erosion in zone 4 beneath the tibial component.
Of 71 knees, 62 were in valgus, 5 were in neutral (femorotibial
angle ¼ zero degrees), and 4 were in varus alignment. The mean
coronal plane alignment was 4.1 valgus (range, 9 valgus to 5
varus). The alignment of 24 knees (33.8%) was found to be outwith
the recommended range of 7 ± 3 valgus [21]. Seven of these 24
knees (29.2%) demonstrated radiolucent lines. A summary of
radiolucent lines by coronal plane alignment is shown in Table 4.
Overall, 11 patients (13 knees, 5.5%) required a revision pro-
cedure. Five knees (2.1%) underwent a 2-stage revision for deep
prosthetic infection, all within 3 years of their index procedure.
Seven knees (3%) underwent change of polyethylene insert for
coronal plane instability secondary to polyethylene wear. In all
these cases, the femoral and tibial components were found to be
well fixed at the time of surgery. Two patients, both of whom un-
derwent surgery for deep infection in the third postoperative year,
required subsequent revision surgery for reasons other than
infection. One patient developed symptomatic aseptic loosening in
the 10th year following index TKA, requiring a single-stage revision
to a hinged prosthesis; the other patient, who had rheumatoid
arthritis, developed instability with synovitis and underwent
change of polyethylene insert in the 11th year following index TKA.
A summary of patients who underwent revision surgery is shown
in Table 5.
At 15 years postoperatively, survival rate with revision for
any reason as the end point was 92.3% (95% confidence interval
[CI] 84.9-96.2). Fifteenth-year survival rate with revision for
aseptic failure as the end point was 94.4% (95% CI 87.6-97.6). The
Table 2
Postoperative Oxford Knee Score Classification, Following PFC Sigma TKA.
OKS Classification (n, %) 5 y (N ¼ 216) 10 y (N ¼ 131) 15 y (N ¼ 77)
Excellent (42-48) 66, 30.6% 34, 26.3% 9,
Good (34-41) 59, 27.2% 46, 34.1% 24,
Fair (27-33) 49, 22.7% 25, 19.3% 14,
Poor (<27) 42, 19.3% 26, 20.1% 30,
OKS, Oxford Knee Score; PFC Sigma TKA, Press-Fit Condylar Sigma total knee
arthroplasty.
Fig. 3. Postoperative Oxford Knee Score classification following PFC Sigma TKA.
“worst-case” survival rate, in which all knees lost to follow-up
are presumed to have failed immediately following their last
follow-up appointment, was 73.2% (95% CI 63.2-81.3). The life
table and Kaplan-Meier survival curve are shown in Table 6 and
Figure 4.
Discussion
The PFC Sigma TKA represents a durable, effective option for
patients undergoing knee arthroplasty, with excellent survival and
good clinical and radiographic outcomes at 15 years. Since its
introduction, it has become a popular prosthesis in the UK, ac-
counting for 34.4% of primary TKAs in 2016 [22]. The UK National
Joint Registry determines the cumulative risk of revision to be
2.65% at 10 years [22]. Previous data from this unit [11,23,24], and
others [25e27], have shown excellent survival and outcomes for
the fixed-bearing prosthesis up to 10 years postoperatively. Our
analysis has shown continuing longevity of the PFC Sigma TKA up to
15 years postoperatively, which is the longest reported follow-up
for this prosthesis.
In our cohort, 8.1% of patellae were resurfaced at index TKA, and
no patient required revision for patellar resurfacing up to 15 years
postoperatively. This is consistent with all other long-term reports
of the PFC Sigma TKA and contrasts with series relating to its pre-
decessor in which revisions for patellofemoral pain and instability
were described [1,3,6].
The mean 15-year KSS knee score showed very minimal dete-
rioration from 5-year and 10-year scores, and the same was
apparent in the pain component score. In the only other series
assessing KSS beyond 10 years postoperatively, Patil et al [12] re-
ported a mean KSS knee score of 84.4 for 39 knees at a mean 11.8
years, and thus, the mean 15-year score for our cohort (77.4)
compares favorably.
In contrast, we observed a reduction in KSS function score from
80.5 at 5 years, and 68.9 at 10 years, to 56.4 at 15 years. The causes
for this functional decline do not appear to be related to either
pain within or the objective performance of the prosthesis. As has
been postulated, this decline may be an indicator of general
Table 3
Distribution of Radiolucent Lines on AP and Lateral Radiographs.
11.7%
1 Zone 2 Zones 3 Zones 4 Zones
31.2%
18.2% AP only 2 3 0 0
39.0% Lateral only 3 0 1 0
AP and lateral 0 1 1 1
AP, anteroposterior.
 W.M. Oliver et al. / The Journal of Arthroplasty 33 (2018) 2524e2529 2527

Table 4
Distribution of Radiolucent Lines by Coronal Plane Alignment.
Radiolucent Lines (n, %) 7 ± 3 Valgus (N ¼ 47) <4 Valgus (N ¼ 24)
AP only 1, 2.1% 4, 16.7%
Lateral only 2, 4.3% 2, 8.3%
AP and lateral 2, 4.3% 1, 4.2%
No radiolucent lines 42, 89.4% 17, 70.8%
AP, anteroposterior.
activity limitation due to advancing age or comorbidity [28].
Regardless, previous studies have estimated the minimal clinically
important difference in KSS function score to be 34.5 points [21]
and so this 24.1-point deterioration may not be of relevance to
patients.
The mean 15-year OKS was 29, classed as “fair,” indicating a
general decline in OKS from 5 to 15 years postoperatively; this
corresponds with the deterioration in KSS function score and again
may simply reflect age-related restrictions in functional ability and
activities of daily living. The expected reduction in postoperative
OKS over the first 10 years following TKA has been estimated at 4.2
points [29].
Radiographs of 71 knees attending 15-year follow-up demon-
strated nonprogressive radiolucent lines in 16.9%, and radiological
loosening in 1.4% (1 knee). Previous results from this cohort
demonstrated radiolucent lines in 43.1% [11], which suggests a
disproportionate number of those with radiolucent lines at 10
years either died or were lost to follow-up by 15 years. Radiolu-
cent lines did not correlate with pain (mean KSS pain component
score 47.9).
The mean coronal plane alignment was 4.1  valgus, which is
within the recommended range of 7 ± 3  valgus [30]. Interest-
ingly, knees that were “malaligned” appeared more likely to
demonstrate radiolucent lines on 15-year X-rays (29.2%) than
those that were not (10.6%). Owing to the small sample size,
however, this difference was not statistically significant (P ¼
.55).
We identified 13 revision procedures (5.5%) before 15 years
postimplantation, which amounts to 5 additional revisions be-
tween 10 and 15 years postoperatively. One further TKA from the
cohort of 235 knees (0.4%) required revision for aseptic loosening at
15 years postoperatively. This does not appear to represent an
excessive deterioration in implant survival, as was observed for the
original design.
Two patients required a second revision procedure, both after
having undergone 2-stage revision for deep prosthetic infection in
the 3rd year following index TKA. Both patients had recognized
risk factors for infection; both were male [31e33] cigarette
smokers and one had rheumatoid arthritis [31,34,35] and the
other was morbidly obese [33,36] (body mass index 42 kg/m2).
These baseline risk factors, in combination with early revision
surgery itself [37], increase the risk of subsequent revision sur-
gery; however, it is reassuring that neither subsequent revision
was due to infection (indications ¼ aseptic loosening and insta-
bility) and that there was a relatively long time interval between
the first and second revision procedures (86 and 99 months,
respectively). This suggests that their initial revisions for infection
had been effective.
Using an end point of revision for any reason, implant survival in
our cohort was 92.3% at 15 years, and using revision for aseptic
loosening as an end point survival was 94.4%. Before our study, the
longest follow-up for this prosthesis had been a single-surgeon
series of 79 TKAs, in which Patil et al reported 14-year survival of
97% using revision for any reason and 100% using loosening as end
points [12]. Accounting for length of follow-up our results are
comparable, suggesting ongoing durability for this prosthesis and
supporting its continued use.
Previous studies assessing long-term survivorship of the orig-
inal PFC TKA have quoted survival rates from 84.6% [8] to 92.6% [5]
at 15 years; the latter results reported in a single-surgeon series of
139 TKAs in Boston, Massachusetts, where the prosthesis was
designed.
As well as comparing our results with other published series of
the same design, it is important to consider long-term reports of
different designs of condylar knee prosthesis, as the implant
design may confer an advantage in terms of longevity. Schwartz
et al [38] reported 10-year survivorship for 179 third-generation
cruciate-retaining TKAs of 97.7% and 100%, with end points of
revision for any reason and revision for loosening, respectively.
Another report of a mean 11.2-year follow-up for 113 hybrid TKAs
demonstrated a survival rate of 93.8% with revision for any reason
as the end point and 96.5% for revision for loosening as the end
point [39]. A comparative analysis of the Genesis I and II designs
(Smith & Nephew, Memphis, Tennessee) described an overall
survival of 92.4% at 15 years, which compares well with our results
[40]. There are few published TKA series extending into the third
decade, although one series of the Anatomic Graduated Compo-
nent TKA (Biomet, Warsaw, Indiana) at 25-30 years post-
implantation reported overall survival of 94.2% at 25 years and
92.4% at 30 years [41]. At these time points, patients were at
greater statistical risk of dying than undergoing revision surgery;
however, of revisions carried out by this point, the most common
indication was aseptic loosening, with instability being the second
most common.
The principal limitation of our study is the high rate of loss to
follow-up. Thirty-four of 235 knees (14.5%) were lost to follow-up;
this is reflected in our “worst-case” survival rate of 73.8% at 15

Table 5
Revision Procedures, Listed According to the Indication and Time of Revision.

Indication Time of Revision (mo) Age (y) Gender Smoker BMI (kg/m2) Primary Diagnosis Procedure

Infection (mixed) 5 67 Male Yes 25.6 OA Two-stage revision

Infection (Staphylococcus aureus) 9 70 Male Ex 35.2 OA Two-stage revision
Infection (mixed) 13 77 Male Ex 27.2 OA Two-stage revision
Infection (mixed) 26 53 Male Yes 26.9 RA Two-stage revision
Infection (Staphylococcus aureus) 27 68 Male Yes 42.0 OA Two-stage revision
Instability 59 62 Male No 25.1 OA Polyexchange
Aseptic loosening 113 68 Male Yes 42.0 OA Hinged TKA
Instability 119 49 Female Ex 32.3 OA Polyexchange
Instability 123 62 Male No 26.4 OA Polyexchange
Instability, synovitis 125 53 Male Yes 26.9 RA Polyexchange
Instability 126 64 Female Ex 34.5 OA Polyexchange
Instability 128 50 Female No 23.4 OA Polyexchange
Instability 136 74 Male Ex 28.7 OA Polyexchange

BMI, body mass index; TKA, total knee arthroplasty; OA, osteoarthritis; RA, rheumatoid arthritis.
2528 W.M. Oliver et al. / The Journal of Arthroplasty 33 (2018) 2524e2529

Table 6
Life Table for Survival of the PFC Sigma TKA.

Year Number Death LTFU Failure Number Annual Annual Cumulative Cumulative Survival with
at Start at Risk Failure Survival Survival (%) “worst-case” Revision for
Rate (%) Rate (%) survival (%) Aseptic Failure (%)

1 235 6 3 2 230.5 0.9 99.1 99.1 (96.9-99.8) 97.8 (95.0-99.0) 100.0 (98.4-100)
2 224 6 0 1 221 0.5 99.5 98.7 (96.2-99.6) 97.4 (94.4-98.3) 100.0 (98.4-100)
3 217 9 2 2 211.5 0.9 99.1 97.8 (94.7-99.1) 95.5 (91.8-97.6) 100.0 (98.2-100)
4 204 10 0 0 199 0.0 100.0 97.8 (94.6-99.1) 95.5 (91.7-97.6) 100.0 (98.1-100)
5 194 10 1 1 188.5 0.5 99.5 97.2 (93.8-98.8) 94.5 (90.3-96.9) 99.5 (97.1-100)
6 182 5 2 0 178.5 0.0 100.0 97.2 (93.7-98.8) 93.5 (88.9-96.3) 99.5 (97.0-100)
7 175 4 3 0 171.5 0.0 100.0 97.2 (93.6-98.8) 91.8 (86.7-95.0) 99.5 (96.8-100)
8 168 5 3 0 164 0.0 100.0 97.2 (93.4-98.9) 90.2 (84.7-96.6) 99.5 (96.7-100)
9 160 5 4 0 155.5 0.0 100.0 97.2 (93.3-98.9) 87.8 (81.7-92.0) 99.5 (96.7-100)
10 151 4 0 2 149 1.3 98.7 95.9 (91.4-98.1) 86.7 (80.3-91.3) 98.1 (94.4-99.4)
11 145 4 16 4 135 3.0 97.0 93.1 (87.5-96.3) 73.8 (65.8-80.5) 95.2 (90.2-97.7)
12 121 6 0 1 118 0.8 99.2 92.3 (86.0-95.9) 73.2 (64.6-80.4) 94.4 (88.7-97.3)
13 114 9 0 0 109.5 0.0 100.0 92.3 (85.7-96.0) 73.2 (64.2-80.6) 94.4 (88.4-97.4)
14 105 9 0 0 100.5 0.0 100.0 92.3 (85.4-96.1) 73.2 (63.8-80.9) 94.4 (88.1-97.5)
15 96 12 0 0 90 0.0 100.0 92.3 (84.9-96.2) 73.2 (63.2-81.3) 94.4 (87.6-97.6)

LTFU, loss to follow-up; PFC Sigma TKA, Press-Fit Condylar Sigma total knee arthroplasty.

years. Several other studies assessing long-term outcomes of the
original PFC and PFC Sigma TKA have more favorable rates of loss to
follow-up [5e7,12] and therefore better “worst-case” survival,
although all began with cohorts of less than 160 TKAs. Larger co-
horts, such as ours, represent a particular challenge when collating
15-year follow-up data.
Moreover, only 60 of 99 surviving patients (74 of 118 surviving
knees, 62.7%) were reviewed in the clinic, with a further 8 patients
(8 knees) reviewed remotely (by telephone or a letter). This not
only limits the type of outcome data that can be obtained (in
particular the KSS knee score, which requires clinical examina-
tion) but potentially introduces bias. Home visits were not
considered appropriate or practical due to patient comorbidity or
institutionalization or patients having moved away from the
region.
Radiographic follow-up, available for 71 of 76 knees
attending clinic, consisted of short-leg weight-bearing radio-
graphs. Although these X-rays are considered suitable for
assessing TKA alignment in general clinical practice, full-length
(hip-knee-ankle) radiographs are generally preferable in a
research setting [42].
Our cohort of patients was operated upon by a range of sur-
geons, including consultants without a subspecialty interest in
knee arthroplasty and supervised trainees, in a district general
hospital. These results, therefore, are highly applicable to general
orthopedic practice. Our results update previous studies from our
Fig. 4. Cumulative 15-year survival rates for the PFC Sigma TKA.
unit [11,23,24] and continue to confirm excellent survivorship and
good clinical and radiographic outcomes for the PFC Sigma TKA at
15 years postoperatively.
Acknowledgments
The authors would like to thank Anne Simpson, Lorraine
McComiskie, Sherral Wilson, Ian Weir, Richard Buxton, Timothy
Dougall, and Iain Brown. Two authors (I.J.B. and P.W.) have given
paid presentations for the company producing the PFC Sigma
prosthesis. During the study period, the department received
funding for specific research projects, which was paid into a
nondirectional education fund, but none were linked to this
particular study.
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 The Journal of Arthroplasty 33 (2018) 2616e2622

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Other

How Fast Should a Total Knee Arthroplasty Be Performed?

An Analysis of 140,199 Surgeries
Jaiben George, MBBS, Bilal Mahmood, MD, Assem A. Sultan, MD, Nipun Sodhi, BA,
Michael A. Mont, MD *, Carlos A. Higuera, MD, Kim L. Stearns, MD
Department of Orthopedic Surgery, Cleveland Clinic, Cleveland, Ohio

a r t i c l e i n f o a b s t r a c t

Article history: Background: Although previous studies have shown that prolonged operative times can lead to an
Received 7 February 2018 increased risk of complications after total knee arthroplasty (TKA), they only evaluated a few compli-
Received in revised form cations. It is also unclear whether a distinctive operative time exists after which complications increase.
27 February 2018
Therefore, this study was performed to (1) assess whether higher operative time increases the risk of
Accepted 6 March 2018
complications within 30 days of TKA and (2) explore the relationship between operative time and
Available online 13 March 2018
various complications to identify possible operative times where complication rates increase.
Methods: The National Surgical Quality Improvement Project database was queried from 2011 to 2015 to
Keywords:
total knee arthroplasty
identify 140,199 primary TKAs. The effect of operative time (skin-to-skin) on various medical and surgical
complications complications within 30 days was evaluated using multivariable logistic regression models. Spline
operative time regression models were created to further study the relationship between operative time and
infection complications.
large database Results: After adjusting for confounding factors, longer operative times were associated with higher risks of
readmission (P < .001), reoperation (P < .001), surgical site infection (P < .001), wound dehiscence (P < .001),
and transfusion (P < .001). The majority of the complications demonstrated an increase throughout the range
of operative time, with a slightly pronounced increase in the risk of complications when the operative time
was longer than 80 minutes.
Conclusion: Prolonged operative times were associated with an increased risk of a number of important
complications such as readmissions, reoperations, surgical site infections, and wound complications.
Based on our results, an operative time goal of less than 80 minutes is helpful for minimizing these
complications after TKA.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is a highly successful procedure
with more than 650,000 procedures performed annually in the
United States [1]. Despite the high volume and the elective nature of
the procedure, a considerable variation in the operative times is
present due to both patient-related and surgeon-related factors
[2e4]. Prolonged surgical duration can expose the patient to longer
duration of anesthesia which might result in marked hemodynamic
changes [5,6]. Also, if the wound is exposed to the air for extensive
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.012.
* Reprint requests: Michael A. Mont, MD, Department of Orthopedic Surgery,
Cleveland Clinic, 9500 Euclid Avenue, A40, Cleveland, OH 44195.
durations, there is an increased risk of wound contamination and
surgical site infections (SSIs) [7,8]. Moreover, as tourniquets are often
used in TKAs, there are also concerns that longer surgeries might
increase the risk of thromboembolic events [9]. Although the re-
ported incidence of most complications after TKA is as low as 1%-2%,
some complications such as infections and pulmonary emboli are
associated with considerable morbidity and mortality [10e12].
Previous studies have evaluated the factors responsible for
increased operative times [3,4]. However, only a few studies have
evaluated whether prolonged surgeries lead to higher complication
rates with most focusing only on SSIs [7,8]. In addition, these
studies assume that the relationship between operative times and
complications are linear. It is possible that some complications
might have a nonlinear relationship with operative times, with risk
increasing dramatically after a certain time. Although faster sur-
geries are generally preferred, it is important to understand that if

https://doi.org/10.1016/j.arth.2018.03.012
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J. George et al. / The Journal of Arthroplasty 33 (2018) 2616e2622 2617

specific time frames exist, surgeons can aim to perform surgeries Table 1
within that desired time. National Nosocomial Infections Surveil- Mean Operative Time Among Various Demographic Groups.

lance guidelines by Centers for Disease Control and Prevention Variable Percentage of Patients Operative Time P-Value
recommend that the operative time should be lower than the 75th (Total Number ¼ 140,199) (Mean ± SD)
percentile, and the initial cut-off for arthroplasty surgeries estab- Age (y) <.001
lished in 1991 was 3 hours [13,14]. However, recent studies have 18-44 1.2 99.3 ± 29.5
found that operative times have decreased in the past few decades, 45-64 39.4 93.4 ± 27.8
65 59.4 88.6 ± 26.2
suggesting that such thresholds might have to be lowered [8,15,16].
Gender <.001
Moreover, such time points based on the percentiles might be Male 37.7 93.7 ± 27.5
arbitrary, and it is unclear whether they accurately represent Female 62.2 88.7 ± 26.6
increased complication risk. Race <.001
White 78.1 90.9 ± 26.9
Therefore, the objectives of the study were to (1) assess whether
Black 7.2 98.3 ± 28.6
higher operative time increases the risk of complications within 30 Others 14.6 85.2 ± 25.9
days of TKA and (2) explore the relationship between operative ASA classification <.001
time and various complications after TKA to identify possible 1 2.1 89.0 ± 27.4
operative times beyond which complication rates increase. 2 50.1 89.9 ± 26.5
3 46.1 91.4 ± 27.5
4þ 1.6 93.8 ± 28.5
Functional status
Methods Independent 98 90.6 ± 27.0 <.001
Dependent 1.4 96.7 ± 28.0
This study used the American College of Surgeons National Smoker <.001
Surgical Quality Improvement Project (NSQIP) database. Our Yes 8.6 92.4 ± 27.5
No 91.4 90.5 ± 27.0
institutional review board deemed this study exempt from
General anesthesia <.001
approval, as NSQIP is a publicly available database without direct Yes 50.8 93.6 ± 27.4
patient identifiers. NSQIP collects data on preoperative morbidity, No 49.2 87.6 ± 26.3
intraoperative variables, and 30-day outcomes for patients under- SD, standard deviation.
going major surgical procedures and contains well-defined clinical
variables that are prospectively collected by trained clinical re-
viewers [17,18]. The American College of Surgeons routinely audits preoperative comorbidities reported in the NSQIP were recorded for
the NSQIP data to ensure accuracy of the collected data, and it has all the patients.
been previously employed in orthopedics and other surgical sub- Operative time (defined as the time from skin incision to skin
specialties [19e21]. Currently, the NSQIP collects data from more closure) reported in the NSQIP was recorded for each procedure [2,22].
than 600 participating hospitals in North America, which treat a
diverse set of populations [17].
Table 2
The NSQIP database was queried from January 1, 2011 to December Mean Operative Time in Patients Undergoing Primary TKA Based on the Presence or
31, 2015 to identify 151,684 TKAs using the Current Procedural Ter- Absence of Various Comorbidities.
minology code 27447 (arthroplasty, knee, condyle, and plateau;
Comorbidity Percentage of Patients Operative Time P-Value
medial AND lateral compartments with or without patella resurfacing (Total Number ¼ 140,199) (Mean ± SD)
[TKA]). Of these, 4456 bilateral TKAs identified as those with another
Obesity <.001
Current Procedural Terminology code 27447 were excluded. Among Yes 68.8 91.6 ± 27.3
the remaining 147,228 procedures, 11 procedures without an opera- No 30.9 88.6 ± 26.4
tive time were excluded. Some patients had very low and very high Congestive heart failure .451
values for operative times (range 0-1435 minutes). As the validity of Yes 0.3 91.7 ± 27.5
No 99.7 90.6 ± 27.0
these extreme values were unclear, we excluded TKAs with operative
Chronic obstructive .052
times in the bottom (less than 45 minutes, n ¼ 3432) and top 2.5% pulmonary disease
(greater than 175 minutes, n ¼ 3586), leaving 140,199 procedures to Yes 3.7 89.9 ± 27.3
be included in the analysis. Demographic characteristics and No 96.3 90.7 ± 27.0
Diabetes <.001
Yes 18.0 91.5 ± 27.2
No 82.0 90.4 ± 26.9
Dialysis .138
Yes 0.2 93.5 ± 28.8
No 99.8 90.6 ± 27.0
Disseminated cancer .664
Yes 0.1 91.8 ± 29.2
No 99.9 90.6 ± 27.0
Bleeding disorder .018
Yes 2.4 91.7 ± 27.7
No 97.6 90.6 ± 27.0
Corticosteroid use .157
Yes 3.5 91.2 ± 27.8
No 96.5 90.6 ± 27.0
Weight loss .523
Yes 0.1 92.0 ± 26.9
No 99.9 90.6 ± 27.0
Ascites .840
Yes 0.1 91.7 ± 26.8
No 99.9 90.6 ± 27.0

Fig. 1. The histogram showing the distribution of operative times. SD, standard deviation.
2618 J. George et al. / The Journal of Arthroplasty 33 (2018) 2616e2622

Table 3
Comparisons of Operative Time Between Patients With and Without Complications.

30-D Complication Incidence Operative Time (min) (Mean ± SD) Difference (95% CI) P-Value

Complication No Complication

Mortality 0.1% 90.7 ± 28.7 90.6 ± 27.0 0.1 (4.4 to 4.7) .948
Readmission 3.5% 92.7 ± 27.8 90.3 ± 27.0 2.4 (1.6-3.2) <.001
Reoperation 1.1% 96.7 ± 28.3 90.5 ± 27.0 6.2 (4.8-7.5) <.001
Surgical site infections 0.8% 95.5 ± 30.0 90.6 ± 27.0 4.9 (3.2-6.6) <.001
Wound dehiscence 0.2% 99.1 ± 30.9 90.6 ± 27.0 8.5 (4.8-12.2) <.001
Thromboembolic events 1.4% 90.1 ± 26.3 90.6 ± 27.0 0.5 (1.6 to 0.7) .421
Pulmonary complications 0.4% 91.2 ± 26.9 90.6 ± 27.0 0.6 (1.6 to 2.6) .623
Cardiovascular complications 0.4% 91.9 ± 28.2 90.6 ± 27.0 1.3 (1.2 to 3.8) .305
Renal complications 1% 90.7 ± 27.5 90.6 ± 27.0 0.1 (1.3 to 1.6) .860
Systemic complications 0.2% 93.1 ± 27.8 90.6 ± 27.0 2.5 (0.5 to 5.4) .098
Transfusion 7.8% 92.4 ± 29.3 90.5 ± 26.8 1.9 (1.3-2.5) <.001

SD, standard deviation.

The mean operative time for the entire cohort was 91 ± 27 minutes of P < .01 were included as covariates in the multivariable analyses.
(range 45-175). The histogram showing the distribution of operative Therefore, the final multivariable model included the following
times is found in Figure 1. It shows a mild positive skew with a median covariates: age, gender, race, ASA classification, functional status
operative of 87 minutes (interquartile range 70-107). (independent vs partially/totally dependent), smoking status,
Age, gender, race, body mass index, American Society of Anes- anesthesia (general vs others), obesity, chronic obstructive pul-
thesiologists (ASA) score, functional status, type of anesthesia, monary disease, diabetes mellitus, and bleeding disorder. With the
smoking status, and comorbidities were recorded for all the patients. use of multivariable logistic regression analyses, adjusted odds
The mean operative times among different demographic groups are ratios (ORs) along with 95% confidence intervals (CIs) were calcu-
found in Tables 1 and 2. Higher operative times were found in lated to show the change in the odds for a complication with every
younger patients (P < .001), men (P < .001), and blacks (P < .001), and 10-minute increase in operative times.
in those with obesity (P < .001), diabetes (P < .001), and bleeding To explore the pattern of relationship between operative times
disorder (P ¼ .018) (Tables 1 and 2). The incidence of mortality and and complications, times were included as a restricted cubic spline
readmission for any cause within the 30 days of the procedure was term with 4 knots in the logistic regression analysis. Wald statistics
recorded for all the patients. Additionally, the following surgical and were used to assess whether the relationship between operative
medical complications within 30 days were also recorded: reopera- times and complications was nonlinear. Predictive plots of the
tions, SSIs (superficial site infections, deep site infections, or organ site spline regression models were created to graphically assess the
infections), wound dehiscences, venous thromboembolic events relationship between operative times and complications. The pre-
(VTE) (deep vein thromboses or pulmonary emboli), pulmonary dictive plots demonstrate the changes in ORs (the odds of having an
complications (pneumoniae, reintubations, use of ventilators for outcome at a specified operative time compared to the median
more than 48 hours, or failures to wean), cardiovascular complica- operative time) for the entire range of times. In addition to the
tions (strokes, cardiac arrests, or myocardial infarctions), renal com- visual interpretation of the predictive plots, a segmented regression
plications (renal failures, renal insufficiencies, or urinary tract analysis with break point or change point estimation was per-
infections), systemic complications (systemic sepsis or septic shock), formed to identify any possible cut-offs for operative times above
and blood transfusions. All these outcomes were collected by trained which the risk of complications rises steeply. Such break points or
reviewers who communicate with patients by 30-day follow-up let- cut-offs indicate a change in the slope of the relationship between
ters or phone calls, and periodic death searches in public records [17]. risk of a complication and operative time, and were rounded to the
The mean operative times among the various groups were closest 5-minute mark for clinical significance.
compared using t-tests and analyses of variance. Multivariable lo- The following variables had missing values: gender (n ¼ 92), race
gistic regression analyses were performed to evaluate whether (n ¼ 162), anesthesia (n ¼ 15), ASA classification (n ¼ 107), functional
increasing operative times were associated with higher risks of status (n ¼ 938), obesity (n ¼ 357), readmission (n ¼ 2193), reop-
complications. All the demographic variables and comorbidities eration (n ¼ 467), and mortality (n ¼ 1). The missing values were
which showed a difference in operative times at a significance level excluded from the analysis. The level of significance for all analyses
was set at P < .05. Statistical analyses were performed using R soft-
Table 4 ware (version 3.1.3, Vienna, Austria) [23]. Spline regression analysis
Results of Multivariable Regression Models Evaluating the Effect of Operative Time was performed using the “rms” package, while segmented regression
on Various Complications. to identify break points was performed using the “segmented”
30-D Complication Odds Ratioa (95% CI) P-Value package provided with R software [24].
Mortality 1.01 (0.95-1.07) .742
Readmission 1.03 (1.02-1.04) <.001
Reoperation 1.07 (1.05-1.09) <.001
Results
Surgical site infections 1.06 (1.04-1.08) <.001
Wound dehiscence 1.09 (1.04-1.13) <.001 The mean operative time among those with and without compli-
Thromboembolic events 1.00 (0.98-1.01) .781 cations can be found in Table 3. The mean operative time was higher
Pulmonary complications 1.00 (0.97-1.03) .782
in patients with readmission (difference 2.4 minutes, 95% CI 1.6-3.2, P
Cardiovascular complications 1.02 (0.99-1.06) .198
Renal complications 1.01 (0.99-1.03) .185 < .001), reoperation (difference 6.2 minutes, 95% CI 4.8-7.5, P < .001),
Systemic complications 1.02 (0.99-1.07) .211 SSI (difference 4.9 minutes, 95% CI 3.2-6.6, P < .001), wound dehis-
Transfusion 1.03 (1.02-1.04) <.001 cence (difference 8.5 minutes, 95% CI 4.8-12.2, P < .001), and trans-
a
Odds ratio denotes the increase in the odds of the complication with every fusion (difference 1.9 minutes, 95% CI 1.3-2.5, P < .001). On
10 min increase in operative time. multivariable regression, longer operative time was associated with
 J. George et al. / The Journal of Arthroplasty 33 (2018) 2616e2622 2619

Fig. 2. The figure shows the relationship between operative time and (A) mortality, (B) readmission. The approximate threshold (values above which the risk of a complication
increases steeply) for readmission was 70 minutes, while no such change-thresholds could be observed for mortality. The shaded region represents 95% confidence intervals.

higher risk of readmission (coefficient 1.03, 95% CI 1.02-1.04, P < .001),
reoperation (coefficient 1.07, 95% CI 1.05-1.09, P < .001), SSI (coeffi-
cient 1.06, 95% CI 1.04-1.08, P < .001), wound dehiscence (coefficient
1.09, 95% CI 1.04-1.13, P < .001), and transfusion (coefficient 1.03, 95%
CI 1.02-1.04, P < .001). Operative time was not associated with mor-
tality (P ¼ .742), VTE (P ¼ .781), respiratory complications (P ¼ .782),
cardiovascular complications (P ¼ .198), renal complications (P ¼ .185),
and systemic complications (P ¼ .211) (Table 4).
Using spline regression models, the predictive plots showing
the relationship between operative time and complications are
represented in Figures 2-4. Using Wald statistics, wound dehis-
cence (P ¼ .014), VTE (P ¼ .007), renal complications (P ¼ .010), and
transfusion (P < .001) had a nonlinear relationship with operative
time, whereas mortality (P ¼ .652), readmission (P ¼ .483),
reoperation (P ¼ .121), SSI (P ¼ .132), pulmonary complications
(P ¼ .462), cardiovascular complications (P ¼ .747), and systemic
complications (P ¼ .944) had a linear relationship with operative
time. Although readmission, reoperation, and SSI had an overall
linear relationship with operative time, the rate of these compli-
cations appeared to increase when the operative time exceeded
above 75-80 minutes (Figures 2 and 3). Similarly, the risk of
wound dehiscence increased considerably when the operative
time was greater than 75 minutes (Fig. 2). VTE appeared to have a
bimodal relationship with operative time, with the risk decreasing
from 50 to 70 minutes, then increasing from about 70 to 110 mi-
nutes, and finally decreasing afterwards. Transfusion had a U-
shaped relationship with operative time with the trough around
80 minutes (Fig. 4).

Fig. 3. The figure shows the relationship between operative time and different surgical complications: (A) reoperation, (B) surgical site infection, and (C) wound dehiscence. The
approximate thresholds (values above which the risk of a complication increases steeply) were 75 minutes for all the surgical complications. The shaded region represents 95%
confidence intervals.
2620 J. George et al. / The Journal of Arthroplasty 33 (2018) 2616e2622

Fig. 4. The figure shows the relationship between operative time and different medical complications: (A) venous thromboembolic events, (B) pulmonary complications, (C)
cardiovascular complications, (D) renal complications, (E) systemic complications, and (F) transfusion. The approximate thresholds (values above which the risk of a complication
increases steeply) were 70 minutes for VTE and pulmonary complication, 75 minutes for renal and systemic complications, and 80 minutes for transfusion. The shaded region
represents 95% confidence intervals.

Discussion 2%, operative times of some surgeries might be erroneously re-

Although faster surgeries are generally preferred, there is
limited literature on the relationship between TKA operative time
and complications. This study found that prolonged operative times
were associated with increased risk of a number of important
complications such as readmissions, reoperations, and SSIs. Addi-
tionally, we found that a number of complications appeared to have
a pronounced increase in the risk when the operative time was
longer than 80 minutes.
The study has a number of limitations. The accuracy of the re-
sults depends on the data available in the NSQIP database, and such
large databases often lack granularity. Even though data in NSQIP
are collected prospectively with an inter-rater disagreement of only
ported in this database, and some surgeries may have been incor-
rectly labeled as a primary TKA [25]. This study excluded the
outliers in an attempt to limit the influence of such errors. This is
further supported by the near normal distribution of operative
times of the patients included (Fig. 1). Moreover, the use of such a
large database, including a diverse set of patients treated at
different hospitals by a large number of surgeons, makes the
findings of this study generalizable to a wide population. Although
a number of patient comorbidities were adjusted in this study, a
number of other factors such as surgical complexity, implant type,
use of cement, hospital teaching status, hospital size, and so on
might have affected operative times, and could not be evaluated.
Furthermore, the NSQIP does not report functional outcomes which
 J. George et al. / The Journal of Arthroplasty 33 (2018) 2616e2622
are important measures of success of TKA. Despite these limita-
tions, this study provides a comprehensive assessment of the effect
of operative time on various important complications in a large
population.
Wound dehiscence, reoperation, and SSI had the largest ORs
(increase in the odds of complication per unit increase in operative
time) suggesting that they are more likely to be influenced by
operative times. Our findings are in agreement with other studies
that have reported an association with operative time and risk of
complications [8,15]. In a single institution study by Peersman et al
[8], the authors matched 113 patients who developed an SSI to 236
patients without an SSI, and found that patients who developed an
SSI had increased operative times (127 vs 94 minutes, P < .001). In
another study of over 99,000 primary total joint arthroplasties
(TJAs) in the NSQIP database, Duchman et al [15] reported that
wound complications including SSI were significantly increased
when the operative time was greater than 120 minutes. However,
in another study using a community joint registry, Naranje et al [7]
did not find any association between operative time and SSI among
9973 TJAs after adjusting for potential confounding factors. These
findings might be due to inadequate power given the fact that the
incidence of infection was only 0.7% in their study. Although NSQIP
does not provide the reasons for readmission and reoperation, it is
possible that these might have been related to wound-related
complications. The higher risk of transfusion observed in this
study indicate that prolonged operative times might have led to
increased blood loss, a finding similar to that reported in other
studies [26,27].
The cutoff time observed in our study (about 80 minutes) is
lower than the 75th percentile (107 minutes in our study) cut-off
recommended based on the National Nosocomial Infections Sur-
veillance guidelines [13,14]. In another study using the NSQIP
database, Duchman et al [15] found that 120 minutes was the 75th
percentile for operative time of TJAs. Although their study used the
same database as ours, the authors rounded the 75th percentile to
the closest 30-minute interval which might explain why the re-
ported 75th percentile in their study was higher than ours (120 vs
107 minutes). Also, the lower operative times in our study may
have been due to the inclusion of recent year data (operative times
might have decreased with year due to improved techniques), in-
clusion of only knees, and the exclusion of outliers. Although the
majority of the complications had an approximately linear rela-
tionship with operative times, some complications such as VTE and
transfusion had a statistically significant nonlinear relationship.
VTE had a bimodal relationship with operative time. The reasons
for the higher risk of these complications with very low and very
high operative times are unclear given the lack of other relevant
information in the NSQIP database such as VTE prophylaxis agents,
and the use of tourniquet. This nonlinear relationship may also
partly explain the lack of significance for VTE in the multivariable
analysis. Transfusions showed a U-shaped relationship with oper-
ative time, and the reasons for this pattern are unclear given the
lack of information about transfusion threshold, type of trans-
fusion, and so on.
In summary, this study found that prolonged operative times
were associated with an increased risk of a number of important
complications such as readmissions, reoperations, SSIs, and wound
complications. The effect of operative time was greatest on the risk
of wound-related complications. The majority of the complications
demonstrated an increased incidence throughout the range of
operative time, though there appeared to be a slightly pronounced
increase in the risk of complications when the operative time was
longer than about 80 minutes. However, the higher risk of certain
complications may be related to the reasons for longer operative
times which may not have been adjusted for in this study. Despite
2621
the limitations of the NSQIP database, this study helps to improve
the understanding about the potential implications of longer sur-
gery, especially given the growing concerns of increased operative
times with concurrent surgeries, and resident participation. Based
on the results of our study, an operative time goal of less than
80 minutes might be helpful in minimizing TKA complications.
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 The Journal of Arthroplasty 33 (2018) 2496e2501

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Iatrogenic Bone and Soft Tissue Trauma in Robotic-Arm Assisted

Total Knee Arthroplasty Compared With Conventional Jig-Based
Total Knee Arthroplasty: A Prospective Cohort Study and
Validation of a New Classification System
Babar Kayani, MRCS, MBBS, BSc (Hons) a, b, *,
Sujith Konan, MBBS, MD (Res), FRCS (Tr & Orth) a, b,
Jurek R.T. Pietrzak, MB BCh, FCS(SA)Orth a, b,
Fares S. Haddad, FRCS (Ed), Dip Sports Med, FFSEM a, b
a
Department of Trauma and Orthopaedics, University College Hospital, London, United Kingdom
b
Department of Trauma and Orthopaedics, Princess Grace Hospital, London, United Kingdom

a r t i c l e i n f o a b s t r a c t

Article history: Background: The objective of this study was to compare macroscopic bone and soft tissue injury between
Received 15 January 2018 robotic-arm assisted total knee arthroplasty (RA-TKA) and conventional jig-based total knee arthroplasty
Received in revised form (CJ-TKA) and create a validated classification system for reporting iatrogenic bone and periarticular soft
9 March 2018
tissue injury after TKA.
Accepted 15 March 2018
Methods: This study included 30 consecutive CJ-TKAs followed by 30 consecutive RA-TKAs performed by
Available online 27 March 2018
a single surgeon. Intraoperative photographs of the femur, tibia, and periarticular soft tissues were taken
before implantation of prostheses. Using these outcomes, the macroscopic soft tissue injury (MASTI)
Keywords:
bone trauma
classification system was developed to grade iatrogenic bone and soft tissue injuries. Interobserver and
classification Intraobserver validity of the proposed classification system was assessed.
robotic surgery Results: Patients undergoing RA-TKA had reduced medial soft tissue injury in both passively correctible
soft tissue injury (P < .05) and noncorrectible varus deformities (P < .05); more pristine femoral (P < .05) and tibial
total knee arthroplasty (P < .05) bone resection cuts; and improved MASTI scores compared to CJ-TKA (P < .05). There was high
interobserver (intraclass correlation coefficient 0.92 [95% confidence interval: 0.88-0.96], P < .05)
and intraobserver agreement (intraclass correlation coefficient 0.94 [95% confidence interval: 0.92-0.97],
P < .05) of the proposed MASTI classification system.
Conclusion: There is reduced bone and periarticular soft tissue injury in patients undergoing RA-TKA
compared to CJ-TKA. The proposed MASTI classification system is a reproducible grading scheme for
describing iatrogenic bone and soft tissue injury in TKA.
Clinical Relevance: RA-TKA is associated with reduced bone and soft tissue injury compared with con-
ventional jig-based TKA. The proposed MASTI classification may facilitate further research correlating
macroscopic soft tissue injury during TKA to long-term clinical and functional outcomes.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is an established and highly

One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.042.
* Reprint requests: Babar Kayani, BSc (Hons), MRCS, MBBS, Department of
Trauma and Orthopaedics, University College London Hospital, 235 Euston Road,
Bloomsbury, London NW1 2BU, United Kingdom.
effective treatment for end-stage knee osteoarthritis. The proced-
ure is performed in over 90,000 patients per year within the United
Kingdom [1]. The technical objectives of surgery are to replace
diseased bone with artificial implants, restore alignment, preserve
the joint line, balance flexion and extension gaps, and maintain the
normal Q angle for patella tracking. To achieve these objectives,
preservation of the surrounding soft tissue envelope during TKA is
essential [2e7]. Inadvertent injury to the periarticular soft tissue
structures such as the collateral ligaments, posterior cruciate

https://doi.org/10.1016/j.arth.2018.03.042
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 B. Kayani et al. / The Journal of Arthroplasty 33 (2018) 2496e2501
ligament (PCL), or extensor mechanism may compromise post-
operative clinical and functional recovery, reduce stability, and
decrease implant survivorship [2,6e8].
In patients undergoing conventional jig-based total knee
arthroplasty (CJ-TKA), correct alignment and soft tissue tensioning
may be achieved using a measured resection technique or gap-
balancing technique [9e12]. Bone resection is undertaken using
intramedullary or extramedullary alignment guides with a manually
controlled oscillating saw blade. Surgical instruments are often used
to protect supporting ligamentous and neurovascular structures.
Controlled selective or more aggressive soft tissue releases may be
used to balance flexion and extensions gaps. However, manual error
associated with inadvertent soft tissue release during preparation
for implantation or tissue damage from the sawblade is an accepted
risk of the procedure. In many cases, this subtle soft tissue injury is
unnoticed or under-reported [13e19] and its long-term clinical and
functional significance remains undetermined [19].
Recent advances in surgical technology have led to the devel-
opment of robotic-arm assisted total knee arthroplasty (RA-TKA).
This uses preoperative computerized tomography scans to create a
patient-specific computer-aided design model of the knee joint.
The surgeon uses this virtual 3-dimensional model to create a
surgical plan for the desired bone coverage and limb alignment.
Computer software calculates the optimal bone resection window
and implant positioning for implementation of this plan, and an
intraoperative robotic arm helps to execute this surgical plan with a
high level of accuracy. Bone resection is limited to within the
stereotactic boundaries of the predefined haptic bone window,
which conceptually helps to limit bone and periarticular soft tissue
injury [20]. To our knowledge, there are no existing clinical studies
comparing bone and periarticular soft tissue injury in CJ-TKA vs
RA-TKA and no existing classification systems for grading peri-
articular soft tissue injury in TKA. A validated grading system would
help to standardize reporting of bone and soft tissue injury during
TKA and facilitate future studies exploring the impact of bone and
periarticular soft tissue injury on long-term clinical outcomes and
implant survivorship.
The primary objective of this study was to compare intra-
operative bone and soft tissue injury in CJ-TKA vs RA-TKA. We
hypothesized that patients undergoing RA-TKA would have
reduced iatrogenic bone and soft tissue injury compared with
CJ-TKA due to the presence of stereotactic boundaries with robotic-
guided surgery. The secondary objective was to develop a validated
classification system for documenting and researching intra-
operative bone and soft tissue injury during knee arthroplasty.
Materials and Methods
Patient Selection
This prospective cohort study included 60 patients with symp-
tomatic knee osteoarthritis undergoing primary TKA between
January 2016 and July 2017. This included 30 consecutive RA-TKAs
and the preceding 30 consecutive CJ-TKAs before robotic-assisted
TKA was fully introduced into the unit. The treatment group allo-
cated to each patient was decided by the date of the surgery with
operative procedures before September 2016 undergoing CJ-TKA
and operative procedures after this date undergoing RA-TKA. All
operative procedures were performed by the senior author (FSH)
who is fully trained in CJ-TKA and has previously undergone
cadaveric training in RA-TKA. The inclusion criteria for the study
included: patients with knee osteoarthritis; patients greater than
18 years of age; both surgeon and patient agree that TKA is the most
suitable treatment; patient is fit for surgery following review by an
anesthetist and surgeon; patient has surgery performed using
2497
either CJ-TKA or RA-TKA. The exclusion criteria included the
following: patient is unwilling to participate in the study; patient
has diagnosis of inflammatory arthropathy or collagen disorders;
patient undergoing revision TKA for failed unicompartmental
arthroplasty or tibial osteotomy; and patient has surgery per-
formed using an alternative surgical technique (eg, computer
navigation). Written informed consent was obtained from all pa-
tients included in this study. The proposed study was prospectively
reviewed by the hospital board who confirmed further institutional
research ethics board review was not required.
Preoperative Clinical and Radiological Data
Baseline characteristics relating to age, gender, body mass index,
American Society of Anesthesiologists grade, laterality of surgery,
preoperative range of movement, and varus or valgus alignment
with degree of passive correction were prospectively recorded for
each patient. Patients in both study groups had preoperative
anteroposterior and lateral weight-bearing radiographs. In all
patients undergoing RA-TKA, an additional CT scan of the knee joint
was performed. This was used to create a patient-specific
3-dimensional model of the patient's native knee anatomy and
computer software was used to plan optimal bone resection and
implant positioning for the desired bone coverage and limb
alignment.
Surgical Technique
In both treatment groups, a tourniquet was applied but not
inflated unless there were intraoperative concerns regarding he-
mostasis or obtaining a satisfactory bone-cement interface. A
midline skin incision with medial parapatellar approach was used
with preservation of a 3-mm cuff of quadriceps tendon attached to
vastus medialis and a cuff of medial retinaculum to the patella to aid
closure. The anteromedial capsule was released subperiosteally off
the proximal tibia, patella everted, retropatellar fat pad excised, and
anterior cruciate ligament resected. Medical and lateral menisci
were excised, and osteophytes were removed using a bone nibbler
and broad osteotome. In patients undergoing CJ-TKA, extra-
medullary referencing was used to perform the tibial bone resec-
tion. An oscillating sawblade and cutting block were positioned to
perform the tibial resection perpendicular to the anatomical axis of
the tibia in the coronal plan with an anteroposterior slope of 3
in
the sagittal plane. Intramedullary referencing was used for the
femoral resection with a valgus angle of 5-9 degrees as guided by the
preoperative imaging. Blunt Hohmann retractors were used to
protect the soft tissues throughout. Following this, soft tissue re-
leases were performed as required to ensure satisfactory balance of
flexion and extension gaps. All soft tissue releases were recorded. In
patients undergoing RA-TKA, femoral and tibial registration pins
were inserted for the attachment of the femoral and tibial arrays,
and the surgeon-controlled robotic arm was used to execute the
planned bone cuts and guide implant positioning. The robotic arm
had visual, auditory, and tactile feedback to ensure accurate bone
resection within the stereotactic window and limit sawblade action
outside of this field. The degree of accuracy for RA-TKA is 2 degrees/
2 mm. Intraoperative dynamic referencing was used to assess on-
table alignment, stability, and range of motion with live on-screen
measurements. In both groups, the PCL was incised and later
removed with the box cut.
The implants used in both groups were the Triathlon Posterior
stabilized (PS) implant (Stryker, Mahwah, NJ) which consists of a
Triathlon PS femoral component, universal baseplate tibial
component, and polyethylene insert. Patella resurfacing was per-
formed in both treatment groups.
2498 B. Kayani et al. / The Journal of Arthroplasty 33 (2018) 2496e2501
Table 1
Baseline Characteristics for Patients Undergoing RA-TKA and CJ-TKA.
RA-TKA (n¼30) CJ-TKA (n¼30)
Age, y (range) 68.5 (43-84) 69.9 (42-86)
Gender (M/F) 14/16 13/17
BMI (kg/m2) 29.15 ± 4.5 30.68 ± 4.7
Side (left/right) 12/18 16/14
Coronal deformity (mean ± SD) 4.80
± 5.718
3.04
± 7.0

Correctible coronal deformity 15/15 13/17
Sagittal deformity (mean ± SD) 5.75
± 3.9
5.81
± 4.3

ASA grade (mode; range) 2 (1-3) 2 (1-3)
ASA, American Society of Anesthesiologists; BMI, body mass index; CJ-TKA, con-
ventional jig-based total knee arthroplasty; RA-TKA, robotic-arm assisted total knee
arthroplasty; SD, standard deviation.
Baseline Characteristics
There were no differences in baseline characteristics between
the 2 treatment groups in relation to age, gender, body mass index,
American Society of Anesthesiologists score, laterality of surgery,
and preoperative coronal or sagittal plane deformities (Table 1).
Two patients in the CJ-TKA group had coronal deformities that were
not passively correctible. There was no statistical difference in
correctability of coronal plane deformities between the 2 treatment
groups.
Intraoperative Clinical Photographs
Standardized intraoperative photographs with a 100-mm lens
(EF 100 mm f/2.8 L Macro IS USM, Canon Inc., Ohta-ku, Tokyo,
Japan) were obtained following femoral and tibial bone preparation
to assess the iatrogenic bone and soft tissue injury. Five photo-
graphs were taken in each patient to assess the soft tissue condition
within the medial, lateral, anterior (extensor mechanism), and
posterior compartments. All photographs were taken from 1 meter
to enable accurate and clear visualization of the bone and peri-
articular soft tissues whilst ensuring that the sterile surgical envi-
ronment was not compromised. Six blinded fellowship-trained
surgeons were given a tutorial on the proposed classification sys-
tem. Each of the blinded observers individually reviewed the
intraoperative photographs and allocated scores to the each of the 4
zones and an overall grade to each patient. Scores were compared
between observers to assess interobserver reliability. Each of the 6
blinded observers were given the same clinical pictures and asked
to rescore bone and soft tissue injury according to the proposed
classification to determine intraobserver reliability. The use of
photographs allowed documentation and prevented exposure of
the open knee wound to multiple observers.
Classification System
The proposed classification is called the macroscopic soft tissue
injury (MASTI) score. The MASTI classification system is based on
an intraoperative assessment of the soft tissue envelope in TKA. The
classification system divides the knee into the 4 following zones:
medial tibial zone; lateral tibial zones; anterior zone (the extensor
mechanism, patella and quadriceps tendon); and posterior zone.
The tibia is divided into a medial and lateral zone by a horizontal
line from the PCL towards the most prominent point of the tibial
tubercle (Fig. 1). The posterior zone includes the PCL and posterior
capsule, which is most easily evaluated in deep knee flexion. The
zones of the knee are evaluated for iatrogenic soft tissue injury. In
our series, all cases were cruciate substituting prosthesis.
The macroscopic appearances of the soft tissue injuries in each
of the 4 zones are evaluated. There are 6 potential soft tissue
P Value
.912
1
1
.272
.363
.77
.958
1
Fig. 1. Diagrammatic representation of the macroscopic soft tissue injury (MASTI)
score showing tibial plateau in the axial plane.
appearances, and the score designated to each zone reflects the
most severe soft tissue injury within that zone. Different point
values are assigned to the corresponding soft issue macroscopic
appearance for each zone (Fig. 2).
This includes:
6. Uninvolved soft tissue (10 points)
5. Planned soft tissue release (8 points)
4. Soft tissue contusion (7 points)
3. Soft tissue fibrillation (macroscopic incomplete damage)
(5 points)
2. Soft tissue cleavage (3 points)
1. Complete unintentional soft tissue detachment (superficial
medial collateral ligament tear, lateral collateral ligament tear,
partial or full patella tendon tear) (0 points)
Using this classification system, a maximum of 40 points may be
awarded if there is no evidence of iatrogenic soft tissue injury in
any of the 4 zones. If there is complete unintentional soft tissue
detachment in any of the 4 zones, then the patient scores 0 points
for all 4 compartments. The minimum score is therefore zero
points. The grading system for each zone has been weighted to
enable the total score of all 4 zones to accurately reflect the severity
of periarticular knee injury and enable stratification of this infor-
mation into 4 distinct groups (A-D) (Table 2).
Group A (34-40 points) indicates that the periarticular soft tis-
sue envelope is well preserved with mild to no iatrogenic soft tissue
injury in all 4 zones. Group B (25-33 points) indicates that there is
moderate iatrogenic periarticular soft tissue injury with clear soft
tissue injury in at least 2 zones. Group C (24-1 points) indicates
more severe soft tissue injury with iatrogenic soft tissue injury to
least 3 of the 4 zones. Group D (0 points) indicates surgical trauma
or complete disruption that has resulted in defunctioning of the
superficial medial collateral ligament, lateral collateral ligament, or
the extensor mechanism (patella or quadriceps tendon) irre-
spective of the soft tissue appearance in any other corresponding
compartment.
The quality of the femoral and tibial bony surfaces is also
evaluated and used to stratify the soft tissue injury score further.
There are 3 distinct grades for the macroscopic appearance of the
cut femoral and tibial surface. Grades are assigned to the femur
(“F”) and tibia (“T”) based on the most injured part of the bone
cuts. Grade A indicates that the cut bone surfaces are pristine and
unblemished. Grade B indicates that the bony surfaces are
 B. Kayani et al. / The Journal of Arthroplasty 33 (2018) 2496e2501 2499

Table 2
Description of the MASTI Classification System.

MASTI Description of Soft Points Description

Classification Tissue Preservation

Grade A Excellent >34 points Iatrogenic injury to only 1

zone with relative soft
tissue preservation of the
other zones
Grade B Average 25-33 points Minimal iatrogenic injury
to 2 zones with relative
soft tissue preservation of
the other zones
Grade C Poor <24 points Significant iatrogenic soft
tissue injury to 3 zones
Grade D Defunctioned knee 0 Injury to superficial MCL ±
LCL ± extensor mechanism
defunctioning the knee

LCL, lateral collateral ligament; MASTI, macroscopic soft tissue injury; MCL, medial
collateral ligament.

95%. The inference was studied using the chi-square test or Fisher's
exact test, as required. The inference was carried out using t test.
The level of significance was set at P < .05.

Results

MASTI Score

The overall MASTI score was greater in patients undergoing

RA-TKA compared with CJ-TKA (30.85 ± 3.1 vs 27.68 ± 3.9,
respectively, P < .05). Patients receiving RA-TKA had increased
grade A scores (10/30 vs 2/30, P < .05) and reduced grade C scores
(0/30 vs 8/30, P < .05) compared with CJ-TKA. There was no
difference in RA-TKA and CJ-TKA in grade B scores (18/30 vs 20/30,
P ¼ .21) and no patients in either group received grade D scores. The
odds ratio showed RA-TKA was 5.6 times more likely to have a
grade A score than CJ-TKA.

Interobserver and Intraobserver Correlation

There was high interobserver (ICC 0.92 [95% CI: 0.88-0.96],

P < .05) and intraobserver agreement (ICC 0.94 [95% CI: 0.92- 0.97],
P < .05) between the 6 blinded observers in relation to the MASTI
classification system.
Fig. 2. Intraoperative photographs showing soft tissue injury for each grade of MASTI
classification system. No type 6 injuries were observed in this study. LCL, lateral
collateral ligament; MCL, medial collateral ligament. Bone Injury Score

Intraoperative assessment of femoral and tibial bone resections

uneven or were inadvertently injured or damaged when per-
forming the bone cuts. Grade C indicates that repeat bone
resection may be necessary to improve the bony surface condi-
tion and that tibial and/or femoral wedges may be necessary to
restore the joint line.
Statistical Analysis
All the data were analyzed with statistical IBM SPSS (IBM SPSS, V
24, Armonk, NY, IBM Corp) software package. Throughout the
process, a tool for assessing reliability (Cronbach's alpha >0.95) was
used. All the variables were described by inputting the percentages
and the number of cases as categorical variables. The quantitative
variables were described as an average and a standard deviation.
The suitability study was done by calculating the intraclass corre-
lation coefficient (ICC), also denominated the “internal correlation
coefficient” or “reliability coefficient”, with a confidence interval of
followed a similar trend with reduced iatrogenic bone injury scores
in RA-TKA compared with CJ-TKA. The use of RA-TKA was associ-
ated with more pristine type A femoral (30/30 vs 12/30, P < .05) and
tibia (26/30 vs 15/30, P < .05) bone cuts compared with CJ-TKA.
Type B bone cuts were less common in RA-KA for both femur (0/
30 vs 18/30, P < .05) and tibia (4/30 vs 15/30, P < .05) compared to
CJ-TKA. No patients in either group had type C femoral or tibial
bone resection surfaces.
Soft Tissue Injury
In patients with both correctible and noncorrectible deformities,
RA-TKA was associated with reduced medial soft tissue release
compared to CJ-TKA (Table 3). Of note, none of the patients in the
RA-TKA group required complete release of the posterior oblique
ligament and posterior capsule compared with 10 patients in the
CJ-TKA group.
2500 B. Kayani et al. / The Journal of Arthroplasty 33 (2018) 2496e2501
Table 3
Medial Soft Tissue Releases in Study Patients With Correctable and Noncorrectable
Coronal Deformities.
RA-TKA CJ-TKA
Noncorrectable coronal deformity 15 12
Medial zone soft tissue release
None 8 2
<50% 7 5
Complete 0 5
Release of POL and posteromedial capsule
Correctable coronal deformity 15 18
Medial zone soft tissue release
None 3 3
<50% 12 10
Complete 0 5
Release of POL and posteromedial capsule
CJ-TKA, conventional jig-based total knee arthroplasty; RA-TKA,
armeassisted total knee arthroplasty; POL, posterior oblique ligament.
Alignment and Fixed Flexion Deformity (FFD)
In the cohort of patients who underwent RA-TKA, there was no
correlation between preoperative FFD and the proposed MASTI
score (Pearson's coefficient ¼ 0.29, P ¼ .2). The extent of preop-
erative malalignment did not correlate with the proposed MASTI
score (Pearson's coefficient ¼ 0.21, P ¼ .36). The clinical correct-
ability of preoperative malalignment did not have an impact on the
soft tissue classification score (Pearson's coefficient ¼ 0.17,
P ¼ .41). In the group that underwent CJ-TKA, the extent of FFD
weakly correlated with proposed MASTI score (Pearson's
coefficient ¼ 0.35, P < .05). In this group, there was a negative
correlation between the extent of preoperative malalignment and
proposed MASTI score (Pearson's coefficient ¼ 0.73, P < .05).
Discussion
This study showed that RA-TKA was associated with reduced
bone and periarticular soft tissue injury compared with CJ-TKA. The
MASTI classification system had high interobserver and intra-
observer reliability for reporting the extent of iatrogenic bone and
soft tissue injury during TKA. This proposed classification system
may help to standardize reporting of bone and soft tissue injury
during TKA and facilitate further research correlating periarticular
soft tissue injury with different surgical techniques to long-term
clinical outcomes and implant survivorship.
Accurate bone resection, implant positioning, and ligamentous
tensioning are fundamental to achieving well-balanced flexion and
extension gaps in TKA. Suboptimal soft tissue balancing may lead to
increased risk of implant wear, instability, aseptic loosening, and
revision surgery [3,21e25]. However, there is no uniform
consensus on the sequence or extent to which these soft tissue
releases should be performed to achieve balanced flexion and
extension gaps, with some authors suggesting that all TKAs per-
formed without navigation should undergo ligamentous releases,
whereas others suggest that soft tissue balancing may only be
appropriate in 50%-76% of cases [24e26]. In this study, intra-
operative dynamic tracking enabled the surgeon to assess on-table
alignment through the arc-of-motion, stability, range of movement,
and laxity with varus and valgus straining. None of the patients
undergoing RA-TKA required release of the posterior oblique liga-
ment or posteromedial capsule and overall RA-TKA had reduced
medial soft tissue releases compared with those undergoing CJ-
TKA, despite no difference between the 2 groups relating to pre-
operative alignment and passive correctability. In the RA-TKA
group, intraoperative manipulation and modifications to femoral
and tibial bone cuts based on live onscreen changes in alignment
and stability helped to achieve balanced flexion and extension gaps,
without the need for extensive soft tissue releases.
Bone resection in RA-TKA was performed using an oscillating
P Value saw with visual, auditory, and tactile feedback. The sawblade in
RA-TKA was only active within the confines of the stereotactic
<.05 boundaries, which may have helped to better protect the peri-
articular soft tissue envelope compared to the manually controlled
sawblade in CJ-TKA. Our findings are in keeping with a previous
cadaveric study in which 6 blinded observers reported soft tissue
trauma in cruciate-retaining TKAs and found RA-TKA was associ-
<.05 ated with reduced PCL injury, tibial subluxation, and patella ever-
sion compared with CJ-TKA [20]. In our study, there was no gross
ligamentous disruption in either treatment group, and the soft
tissue trauma may be considered subtle subclinical findings, but
previous studies on knee arthroplasty have shown that even
robotic
limited soft tissue releases may promote changes in local and sys-
temic inflammatory responses, leading to increased pain and
delayed postoperative rehabilitation [26e29]. Siebert et al [30]
retrospectively reviewed 70 patients who underwent RA-TKA and
50 who had CJ-TKA and reported that soft tissue swelling was far
less in the former. The authors also reported that sawblade action
confined to the boundaries of the stereotactic window in the ro-
botic group may have helped to better control bone resection and
limit injury to the periarticular soft tissue envelope.
In this study, we found that the conceptual benefits of the ste-
reotactic window in RA-TKA were transferrable to clinical practice
with reduced bone and soft tissue injury compared to CJ-TKA, but
these findings should be interpreted with caution as there is no
existing evidence correlating these periarticular injuries to long-
term clinical results, functional outcomes, or long-term implant
survivorship. Furthermore, patients undergoing RA-TKA had
improved MASTI scores compared to CJ-TKA, but the clinical
significance of the difference in mean scores between the 2 treat-
ment groups is unknown at this stage. Studies have reported
improved accuracy of implant positioning and short-term func-
tional outcomes in RA-TKA compared to CJ-TKA [31e35], and the
results of further higher quality studies comparing clinical
outcomes, patient-reported outcome measures, complications,
cost-effectiveness, and implant survival between the 2 surgical
techniques are still awaited.
The MASTI classification system provides a structured and sys-
tematic approach to reporting bone and periarticular soft tissue
injury during TKA. To our knowledge, this is the only grading sys-
tem for recording periarticular injury in TKA. Despite its short-
comings in these early stages, this objective and validated
classification system assesses a comprehensive range of outcomes
from the soft tissue envelope and stratifies femoral and tibial bone
injury. The high interobserver validity of the classification will also
aid the adoption and integration of this grading system into clinical
practice. The MASTI classification system may be used as a guide to
analyze and record periarticular injury during TKA in more detail;
standardize data collection between treatment centers; correlate
postoperative pain, rehabilitation, and inflammatory response to
the extent of soft tissue releases; and facilitate further research
comparing the invasiveness of different surgical approaches to
long-term clinical outcomes and implant survivorship.
There are several limitations to this study which need to be
considered when interpreting the findings. First, the MASTI score
provides a general grade for bone and soft tissue injury during TKA
with limited information on the state of the individual compart-
ments of the knee joint. Second, the classification system was
constructed using cruciate-sacrificing implants and further modi-
fications may subsequently be required with cruciate-retaining
implant designs. Third, clinical photographs were used for assess-
ment and determination of the grade of soft tissue injury as
 B. Kayani et al. / The Journal of Arthroplasty 33 (2018) 2496e2501
opposed to determining injury at the time of the surgical proced-
ure. Fourth, the impact of this periarticular injury on the systemic
inflammatory response, which can affect postoperative pain, and
early functional recovery was not assessed in this study. Fifth, the
majority of arthroplasty surgeons currently use CJ-TKA and so any
potential benefits of this RA-TKA on bone and soft tissue injury may
be purely academic until further studies correlating these benefits
to long-term clinical outcomes are published.
Conclusion
Patients undergoing RA-TKA had decreased bone and peri-
articular soft tissue injury compared to those undergoing CJ-TKA.
The proposed MASTI classification system had high interobserver
and intraobserver reliability for assessing bone and soft tissue
injury during TKA and may facilitate further research comparing
and correlating the invasiveness of different surgical techniques to
long-term clinical outcomes and implant survivorship.
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 The Journal of Arthroplasty 33 (2018) 2387e2391

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Improved Perioperative Care of Elective Joint Replacement

Patients: The Impact of an Orthopedic Perioperative Hospitalist
Steven J. Fitzgerald, MD *, Terrence C. Palmer, OT/L, MBA, Matthew J. Kraay, MS, MD
Department of Orthopaedic Surgery, Center for Joint Replacement and Preservation, Adult Reconstruction and Joint Replacement, UH Cleveland
Medical Center, Cleveland, Ohio

a r t i c l e i n f o a b s t r a c t

Article history: Background: We developed an orthopedic hospitalist fellowship program for our total joint replacement
Received 10 December 2017 program at a large urban academic medical center. The goal of the program was to improve patient
Received in revised form outcomes, quality, and healthcare value through collaborative perioperative care and improved care
28 February 2018
coordination. This study evaluates the implementation and impact of our modified Hospitalist-
Accepted 13 March 2018
Available online 21 March 2018
Orthopaedic Team Co-management model on quality and performance metrics.
Methods: We reviewed our Quality Institute data using 3 databases for the 16 months before (PreOH)
and 18 months after (PostOH) implementation. Procedural volume was identical during period 1 (1100
Keywords:
total hip arthroplasty
cases) vs period 2 (1119 cases). Metrics included mean LOS (length of stay), % patients discharged home,
total knee arthroplasty mean observed and expected LOS and LOS index, LOS variance, % ICU (intensive care unit) admissions,
hospitalist mean ICU days, % cases with complications, % mortality, 30-day readmission rate, and Hospital Consumer
quality Assessment of Healthcare Providers and Systems scores. Statistical analysis was performed using the
joint replacement software imbedded in the database software.
Results: Statistically significant improvements occurred in multiple performance and quality metrics
including mean hospital LOS for total knee replacement, percentage of total knee replacement patients dis-
charged home, and percentage of patients discharged home for primary total hip arthroplasty, complication
rate, and 30-day readmission rate. Reductions in % ICU admission and ICU LOS were seen but not statistically
significant. HCAPHS scores improved in 6 of 8 categories, and was statistically significant in 3 of 8.
Conclusion: The results of this study demonstrate that the modified Hospitalist-Orthopaedic Team Co-
management model described above improves quality, cost effectiveness, and value for elective total
joint replacement patients in comparison to the traditional consultation only model.
© 2018 Elsevier Inc. All rights reserved.

The hospitalist model has been shown to result in decreased
acute care costs and length of stay (LOS) in many medical and
surgical populations [1e7]. Perioperative care of surgical patients
by hospitalists can be provided in several ways. When hospitalist
care is provided under a “consultation” arrangement, medical
evaluation and treatment is provided based on an “as needed” basis
in response to a change or concern about the patient’s medical
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.029.
This research did not receive any specific grant from funding agencies in the public,
commercial, or not-for-profit sectors.
* Reprint requests: Steven J. Fitzgerald, MD, Department of Orthopaedic Surgery,
Adult Reconstruction and Joint Replacement, UH Cleveland Medical Center, 11100
Euclid Avenue, Cleveland, OH 44106-5043.
condition. This is a reactive strategy to manage potential compli-
cations that develop in the perioperative period. The disadvantage
of this approach to patient care is that this strategy frequently
misses the opportunity to prevent complications, which is espe-
cially important in today’s value-based healthcare environment.
Hospitalist care can also be provided under a “surgical or hos-
pitalist co-management” arrangement. In this situation, the hos-
pitalist is typically involved in medical management of all surgical
patients on a surgical service. This is a more proactive strategy that
provides considerably more opportunity for prevention of com-
plications, improved “rescue” of patients who have developed
complications [5], improved understanding about the needs of the
surgical patient, and increased collaboration between surgeon and
hospitalist. In a value-based healthcare environment, this may be a
more effective way to manage LOS, reduce waste, avoid unnec-
essary testing, and control costs and unnecessary resource utiliza-
tion over the episode of care.

https://doi.org/10.1016/j.arth.2018.03.029
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2388 S.J. Fitzgerald et al. / The Journal of Arthroplasty 33 (2018) 2387e2391

Patients undergoing joint replacement surgery are unique, and
in many ways unlike other surgical patients. Because TJRs are
elective procedures, patients undergoing these procedures should
be in optimal medical condition prior to surgery. Total joint
replacement (TJR) patients are also generally healthy but because
they are frequently elderly they may have multiple medical
comorbidities that affect their risk of perioperative complications.
Joint replacement patients are also at high risk of venous throm-
boembolic complications post-operatively. Due to the considerable
bleeding risks associated with the use of potent anticoagulants
post-operatively, it is essential that hospitalists providing medical
care for elective TJR patients understand that the bleeding risks and
thromboembolic concerns need to be managed in a balanced
manner to provide our patients with a safe surgical outcome.
Perioperative care of the joint replacement patient would be ex-
pected to be enhanced and outcomes improved by a more thorough
understanding of the specific needs of these patients by all pro-
viders caring for them around the time of surgery.
In an attempt to provide our TJR patients with improved peri-
operative medical care, we developed an orthopedic/surgical hos-
pitalist fellowship program for our TJR program at a large urban
academic medical center. This program provided a hospitalist with
in-depth training in TJR surgery, anesthesia, pain management,
surgical critical care, and perioperative medicine. The goal of the
program was to improve patient outcomes, quality, and healthcare
value through better understanding of patient needs, collaborative
perioperative care, and improved overall care coordination.
This dedicated orthopedic hospitalist at our institution works
closely in collaboration with our Center for Perioperative Medicine
which is an anesthesia directed pre-op evaluation process focused
on risk assessment, health optimization, risk mitigation, and
identification of patients “at risk” for adverse outcomes. Proactive
co-management of “at risk” patients by the orthopedic hospitalist is
expected to prevent complications, readmissions, excess days, and
improve value for our patients.
Our current program which is perhaps best described as
a modified Hospitalist-Orthopaedic Team Co-management model
closely resembles the Hospitalist-Orthopaedic Team
Co-management model described by Huddleston et al [8] and the
Surgical Co-management model described by Rohatgi et al [9].
In our program, acute post-operative care by our hospitalist is
provided in collaboration with the orthopedic team (attending surgeon
and resident staff) and our Center for Perioperative Medicine. Patients
identified to be “at risk” during their pre-operative assessment are
closely followed and co-managed by our orthopedic hospitalist, while
other minimal risk patients are managed by our hospitalist on an “as
needed” basis under a more traditional consultation arrangement. We
feel that this approach best directs resources where they are most
effective and needed and minimizes waste and unnecessary care.
The objectives of this study are to assess the impact of a dedi-
cated Perioperative Orthopaedic Hospitalist on value and quality-
related outcomes after elective TJR.
Materials and Methods
We performed a review of our Quality Institute data for all
elective TKRs and total hip arthroplasties (THAs) at a large urban
academic medical center for the 16 months before (PreOH) and 16
months after (PostOH) addition of our dedicated orthopedic hos-
pitalist to our TJR program in August 2012. Perioperative care in the
PreOH group was provided under a typical consultation model with
a hospitalist service at our institution and perioperative care in the
PostOH group was provided by our dedicated orthopedic hospi-
talist under the modified Hospitalist-Orthopaedic Team Co-
management model described above. The period of study was
selected to provide sufficient study size and a realistic estimate of
the impact of this specific change in perioperative care manage-
ment on our program’s performance metrics. The study period was
also selected to coincide with an interval during which no other
major changes in patient care occurred.
Data analyzed came from 3 separate databases maintained by
our Quality Institute during the study period. Patients undergoing
primary TJR typically have more predictable surgical episodes than
the more diverse group of revision TJRs, and as a result we looked at
this group separately from a larger group of all TJRs. One of these
databases (Vizient) contained risk-adjusted data for all patients
undergoing the following International Classification of Diseases,
Ninth Revision procedural codes at our institution during the
study period: 81.51(primary total hip), 81.52 (partial hip), and 81.54
(primary total knee). Another database (Midas STATit) contained
data about all patients admitted with the following diagnosis-
related groups: Medicare Severity Diagnosis Related Groups (MS-
DRG) 469 and 470 (primary TJR with and without major compli-
cation or comorbidity). The third database contained Press-Ganey
Hospital Consumer Assessment of Healthcare Providers and Sys-
tems (HCAHPS) patient satisfaction data for all patients with MS-
DRG 469 and 470 during the study period. Analysis yielded 1100
patients in the PreOH group and 1119 patients in the PostOH group.
There was no statistically significant difference between the 2
groups with respect to mean or median age, gender, percentage of
patients with and without major comorbidities and complications,
or Case Mix Index (CMI) (Table 1). This study was Institutional
Review Board approved.
The following quality and performance metrics were deter-
mined for each group:
1. Mean LOS for primary THA and total knee replacement
(TKR)
2. Percentage of primary THA and TKR patients discharged to
home
3. Mean observed and expected LOS (risk adjusted) and LOS
index for DRG 81.51, 81.52, and 81.54.
4. LOS variance in days
5. % ICU (intensive care unit) admissions for DRG 81.51, 81.52,
and 81.54

Table 1
Comparison of Patient Populations.

Pre-Hospitalist Period Post-Hospitalist Period P-Value Comments

CMI 2.11 2.13 Not significant at P > .05

% Male 36.09% 39.92% Not significant at P > .05
% Female 63.91% 60.08% Not significant at P > .05
% With MCC 1.41% 1.94% Not significant at P > .05
% Without MCC 98.59% 98.06% Not significant at P > .05
Mean age (y) 66.46 67.19 Not significant at P > .05
Median age (y) 67.00 67.50 Not significant at P > .05
% Age over 80 14.01% 14.44% Not significant at P > .05
% Age over 65 59.07% 61.82% Not significant at P > .05

CMI, Case Mix Index; MCC, major complication or comorbidity.

 S.J. Fitzgerald et al. / The Journal of Arthroplasty 33 (2018) 2387e2391 2389

Table 2
Outcomes.

Pre-Hospitalist Period Post-Hospitalist Period P-Value Comments

Mean THA LOS observed (d) 3.39 3.26 Not significant at P > .05
Mean TKA LOS observed (d) 3.36 3.17 Significant at P < .05
Mean LOS expected (d) 3.46 3.38 Not significant at P > .05
% ICU admissions 1.73 1.25 Not significant at P > .05
Mean ICU days 3.63 3.07 Not significant at P > .05
% Cases with UHC complications 2.73 1.52 Significant at P < .05
% Mortality observed 0.27 0.27 Not significant at P > .05
% Mortality expected 0.18 0.16 Not significant at P > .05
% 30-Day readmissions 2.28 1.16 Significant at P < .05
% TKR discharge to home 53.9 59.0 Significant at P < .05
% THR discharge to home 56.8 63.9 Significant at P < .05

UHC, University Health Systems Consortium.

6. Mean ICU days for primary THA and TKR and DRG 81.51,
81.52, and 81.54
7. % Cases with University Health Systems Consortium defined
complications for DRG 81.51, 81.52, and 81.54
8. % Mortality rate (observed and expected based on comor-
bidities) for primary THA and TKR for DRG 81.51, 81.52, and
81.54
9. 30-Day readmission rate for DRG 81.51, 81.52, and 81.54
10. HCAHPS “top box” scores for MS-DRG 469 and 470
Press-Ganey HCAPHS “top box” scores improved in 6 of 8 cate-
gories and statistically significant increases were seen in 3 of 8
categories (overall rating, responsiveness of staff, and hospital
environment) after addition of our dedicated orthopedic
hospitalist.
No significant differences in the other measures were noted
between the 2 groups (Tables 2 and 3).
Discussion

Data analysis was performed using statistical software
embedded within each of the databases. A P-value of <.05 was used
to demonstrate statistical significance in both quality and perfor-
mance metrics in the PreOH and PostOH groups.
Results
Improvements in multiple performance and quality metrics
were seen with addition of a dedicated orthopedic hospitalist to our
TJR program. Mean hospital LOS for primary TKR decreased
significantly from 3.36 to 3.17 days (0.19 days). Percentage of TKR
patients discharged home increased significantly from 53.9% to
59.0%. Statistically significant increase in percentage of patients
discharged home from 58.8% to 63.9% was also seen for primary
THA. Although LOS was reduced by 0.13 days for primary THA, this
difference was not statistically significant.
Analysis of the DRG 81.51, 81.52, and 81.54 database demon-
strated improvements in all measured metrics. Statistically signif-
icant reductions in University Hospitals Consortium defined
complications from 2.73% to 1.52% (P < .05) and reduction in 30-day
readmission rate from 2.28% to 1.16% (P < .05) was seen following
institution of our orthopedic hospitalist program. The mean
decrease in overall LOS of 0.17 days/patient resulted in an estimated
190 fewer acute care hospital days in the post hospitalist group.
Reduction in percentage of patients requiring ICU admission and in
ICU LOS was observed, but did not reach statistical significance
which was most likely related to the relative rarity of these events.
There are few published studies evaluating the impact of hos-
pitalist care models for TJR patients. Duplantier et al [10] performed
a retrospective review of patients treated both before and after
implementation of a universal hospitalist co-management program
for all TJR patients at their institution. They reported a decreased
LOS after implementation of a hospitalist co-management care
model; however, care provided under this co-management
arrangement resulted in more new diagnoses and increased total
cost of care. The authors suggested that this might be due to coding
of these new diagnoses as complications and increased testing
performed by hospitalists. Like our program, their patients were
treated under a hospitalist “consultation” model prior to imple-
mentation of their co-management program. Unlike our hospitalist
program however, every TJR patient, regardless of health status and
risk for perioperative complications, was managed by someone
from a hospitalist “service” post-operatively. In addition, hospitalist
co-management in their study was provided by a diverse service of
providers, rather than a dedicated physician with in-depth training
in management of orthopedic surgical patients and who had a
collaborative relationship with a specific surgical service, as is the
case at our institution. Routine hospitalist co-management of all
patients, including those at low risk for complications, may have
contributed to unnecessary post-operative testing and an increase
in diagnoses with a resultant increased cost of care. The importance
of all caregivers to collaborate and work together in managing
quality, cost, and value is essential in today’s value-oriented
healthcare environment.

Table 3
Patient Satisfaction.

Pre-Hospitalist Period (%) Post-Hospitalist Period (%) % Change (%) P-Value Comments

Overall rating 74.8 80.6 5.8 Significant at P < .05

Communication with nurses 79.3 81.6 2.3 Not significant at P > .05
Responsiveness of hospital staff 58.1 65.7 7.6 Significant at P < .05
Communication with doctors 83.1 85.5 2.4 Not significant at P > .05
Hospital environment 53.1 61.6 8.5 Significant at P < .05
Pain management 82.1 78.0 4.1 Not significant at P > .05
Communication about medications 62.8 60.9 1.9 Not significant at P > .05
Discharge information 95.1 97.1 2.0 Not significant at P > .05
2390 S.J. Fitzgerald et al. / The Journal of Arthroplasty 33 (2018) 2387e2391
Rohatgi et al [9] reported decreased medical complications, LOS,
readmissions, and a substantial decrease in the cost of care in a
diverse population of orthopedic and neurosurgical patients. Unlike
this study, they did not however demonstrate an improvement in
patient satisfaction. The surgical co-management (SCM) hospitalist
model described by them closely resembles the dedicated ortho-
pedic hospitalist program at our institution. Like our dedicated
hospitalist, their SCM hospitalists were dedicated to a single sur-
gical service and provided for their involvement in the pre-
operative medical optimization of the patient. This resulted in a
close collaboration and working relationship with their surgical
service to develop a better understanding of the complications
associated with the TJR patients they co-managed and promoted
“trusting professional” relationships between the hospitalists and
surgical staff. In addition, the presence of the SCM hospitalist on the
acute care unit, like our orthopedic hospitalist, promoted more
rapid response to significant changes in our patient’s medical
condition, participation in multidisciplinary care rounds, and
overall coordination of care and discharge planning.
Huddleston et al [8] evaluated the impact of a hospitalist in a
randomized controlled trial comparing “high risk” elective TJR
patients managed under a collaborative Hospitalist-Orthopaedic
Team co-management model with those managed under a stan-
dard orthopedist managed model with hospitalist care provided by
“consultation” on an as needed basis. In this study, patients
managed under the hospitalist co-management model were more
frequently discharged home with no complications and fewer mi-
nor complications were observed in the co-managed group.
Observed LOS and total acute care costs were the same for both
groups. The authors did not look at skilled nursing facility (SNF)
utilization, readmissions, and other factors impacting on the larger
episode of care cost. Both orthopedic surgeon and nursing staff
preferred the hospitalist co-management model. The 2 different
treatment groups in this study were provided perioperative care in
a similar manner to the PostOH and PreOH groups in our study.
Addition of a dedicated orthopedic hospitalist to our TJR pro-
gram, working in close collaboration with an anesthesia directed
perioperative medicine program, a multidisciplinary patient care
team, and our orthopedic surgical staff resulted in considerable
improvements in quality and value-based performance measures in
this study. Mean hospital LOS for primary TKR decreased signifi-
cantly from 3.36 to 3.17 days (0.19 days) and percentage of patients
discharged home increased significantly from 53.9% to 59.0%. Sig-
nificant increase in percentage of patients discharged home from
56.8% to 63.9% was also seen for primary THA.
This study has several limitations. First, we do not have
detailed comorbidity information about the patients in the PreOH
and PostOH groups to definitively prove that they are similar in
terms of comorbidities, surgical and medical risk. The databases
analyzed for this study were queried using MS-DRGs and
International Classification of Diseases, Ninth Revision procedural
codes and do not contain diagnostic codes for specific patient
comorbidities. In addition, assignment of the MS-DRGs for each
patient relies on accurate coding data within the patient medical
record, which is dependent on charting and coding accuracy.
Both study groups however were large and similar demograph-
ically in numerous ways (Table 1) including CMI, which did not
change significantly over the study period. CMI is a relative value
assigned to a DRG and is dependent on principal and secondary
diagnoses, procedures, age, complexity (comorbidity), and needs.
Although we were not able to match the patient populations
according to specific comorbidities, the CMI does serve as a
surrogate for patient complexity. In addition, our patient exclu-
sion and inclusion criteria were consistent during the entire
period of study.
Another limitation of this study is that the de-identified data
from the 3 unlinked quality databases analyzed in this study do not
provide for costs to be directly linked to specific patients. This
makes it difficult to quantify the financial impact of reduction in
complications, hospital readmissions, ICU admissions, and ICU LOS
seen with addition of our orthopedic hospitalist. Despite this, the
above improvements in quality and performance can be expected
to decrease the episode of care costs significantly. The decrease in
TJR LOS of 0.17 days/case after implementation of our orthopedic
hospitalist program resulted in a projected savings of 190 acute care
hospital days. The cost savings associated with this can be expected
to be significant in a bundled care environment.
Readmissions after TJR represent a considerable source of waste
and inefficiency following TJR since many are preventable. Based on
our known 90-day episode of care costs for TJR patients at our
institution, we know that readmissions accounted for $743 of cost
for each patient episode in 2016. As a result, the 49% reduction in
readmissions (from 2.28% to 1.16%) seen after implementation of
our orthopedic hospitalist program translates to a reduction of
$365 in mean episode of care cost per patient.
Post-acute care in an SNF also adds considerable cost to the TJR
episode of care. In 2016, the mean SNF post-acute care cost for
patients having TJR at our institution was $8134 per patient. As a
result, the 6% increase in patients discharged to home instead of a
post-acute care facility following surgery can be expected to reduce
the mean episode of care cost by $488 per patient.
As mentioned above, we do not have case specific or total episode
costs associated with complications and ICU admissions for the pa-
tients in this study. The significant reduction in complications of 43%
(from 2.73% to 1.52%) and reduction in ICU admissions can be ex-
pected to further reduce episode of care costs for our patients.
Our study is the first to demonstrate a statistically significant
improvement in HCAHPS scores using a modified Hospitalist-
Orthopaedic Team Co-management model. The significant im-
provements in patient satisfaction scores (3 of 8 Press-Ganey
HCAHPS scores) associated with implementation of our orthope-
dic hospitalist program may be expected to reduce reimbursement
penalties for Medicare patients through The Centers for Medicare &
Medicaid Services value-based purchasing program. Finally, sig-
nificant reduction in readmissions can also be expected to reduce
readmission penalties mandated by the Affordable Care Act.
The results of this study demonstrate that the modified
Hospitalist-Orthopaedic Team Co-management model described
above improves quality, cost effectiveness, and value for elective
TJR patients in comparison to the traditional consultation only
model. Key attributes of this program are close collaboration
among hospitalist, orthopedic surgeon, a multidisciplinary ortho-
pedic team, and an anesthesia directed pre-op evaluation program,
as well as a thorough understanding of our patient’s needs by all
care providers. Identification of patients “at risk” for adverse out-
comes at the time of their pre-operative assessment allows for
proactive co-management of “at risk” patients by the orthopedic
hospitalist to prevent complications, readmissions, excess days, and
improve value for our patients.
Our study describes a unique fellowship training program in
collaboration with medicine, anesthesia, and orthopedic surgery that
provided a hospitalist with in-depth training in TJR surgery, anes-
thesia, pain management, surgical critical care, and perioperative
medicine, with the specific goal of increasing quality of care in pa-
tients undergoing elective total joint replacement. Although other
authors have described collaborative hospitalist programs, this is the
first paper in the orthopedic literature to describe a specific training
program for the perioperative care of total joint patients.
As alternative payment models continue to evolve, delivering
high quality care, while simultaneously managing costs and
 S.J. Fitzgerald et al. / The Journal of Arthroplasty 33 (2018) 2387e2391
providing value for our patients, this will not only drive our patient’s
choice of healthcare providers, but also directly impact hospital and
physician reimbursement. At our institution, continued hospitalist
collaboration with a multidisciplinary total joint replacement team
has changed the way we care for our patients and resulted in further
improvements in patient care in response to changes mandated by
the affordable care act and our participation in the Bundled Pay-
ments for Care Improvement initiative.
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[3] Phy MP, Vanness DJ, Melton JL, Long KH, Schleck CD, Larson DR, et al. Effects of
a hospitalist model on elderly patients with hip fracture. Arch Intern Med
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[7] Friedman SM, Mendelson DA, Bingham KW, Kates SL. Impact of a comanaged
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[8] Huddleston JM, Long KH, Naessens JM, Vanness D, Larson D, Trousdale R,
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[9] Rohatgi N, Loftus P, Grujic O, Cullen M, Hopkins J, Ahuja N. Surgical coman-
agement by hospitalists improves patient outcomes: a propensity score
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 The Journal of Arthroplasty 33 (2018) 2423e2427

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Improvement in Depression and Physical Health Following Total

Joint Arthroplasty
Belal A. Tarakji, MD a, Aaron T. Wynkoop, MD a, Ajay K. Srivastava, MD a,
Erin G. O'Connor, PhD b, Theresa S. Atkinson, PhD a, c, *
a
Department of Orthopaedic Surgery, McLaren Flint, Flint, MI
b
McLaren Flint, Flint, MI
c
Department of Mechanical Engineering, Kettering University, Flint, MI

a r t i c l e i n f o a b s t r a c t

Article history: Background: Depression is a common co-morbid condition seen in arthroplasty patients. Pain and
Received 10 November 2017 depression have been understood to influence one another, which may explain why this patient group
Received in revised form experiences higher rates of depression than the general population. Arthroplasty can relieve pain and
15 March 2018
improve function, which may thereby initiate an improvement in the patient’s depressive symptoms.
Accepted 15 March 2018
Available online 27 March 2018
Methods: This retrospective study examined physical and mental domain outcomes of Short Form-36
health-related quality of life questionnaire among 146 patients who underwent primary hip or knee
arthroplasty for osteoarthritis at a single institution during 2001-2004. These patients were classified
Keywords:
outcome
into “depressed/anxious” and “non-depressed” groups based on their pre-operative mental component
depression summary (MCS), with MCS < 42 defining depression. MCS and the subscales from the 36-Item Short-
SF-36 Form Health Survey form expected to be influenced by arthroplasty, Physical Function, Pain, and Role
arthroplasty Physical were examined at 3 months and 1 year post-operative.
TKA Results: At 1 year, 66.7% of the “depressed/anxious” group reported MCS > 42, suggesting improvement
THA of their depressive symptoms. Both groups reported similar improvements in their 36-Item Short-Form
Health Survey subscale scores for Pain and Physical Function. However, the depressed group’s scores
were lower than the non-depressed group’s at all time points.
Conclusion: Arthroplasty significantly improved Physical Function and Pain in depressed patients, while
their depressive symptoms improved. This improvement may be in response to the resolution of physical
symptoms and represents an additional benefit to this elective surgery. Further studies, in larger populations,
are needed to establish patient characteristics associated with non-resolution of depressive symptoms and
the role of mental health interventions to optimize outcomes for hip and knee arthroplasty patients.
© 2018 Elsevier Inc. All rights reserved.

Osteoarthritis (OA) is one of the most prevalent health condi-
tions in the United States, affecting more than 27 million people
according to the National Health Interview Survey [1]. This results
in more than 600,000 knee and 300,000 hip replacement proced-
ures performed each year in the United States to alleviate pain and
restore function to the affected joint [2,3]. By 2030, it is anticipated
that there will be a large increase to 572,000 hip and 3.48 million
knee procedures done annually [4].
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.051.
* Reprint requests: Theresa S. Atkinson, PhD, Department of Mechanical Engi-
neering, Kettering University, Flint, MI 48504.
The pain associated with OA can limit function and quality of
life. Depression is a common co-morbidity in osteoarthritic patients
with chronic pain [5e9]. Although 8% of the overall population is
estimated to suffer from depression [7], 18%-22% of patients
suffering from chronic pain (pain >6 months) report being
depressed [10]. Rathbun et al [8] found that increased depressive
symptoms were associated with increased osteoarthritic pain. In
one group, approximately half of the depressed subjects’ pain was
due to OA [10]. Furthermore, other than the pain from spine OA, the
hip and knee are the most common sites of chronic pain [10].
In a group of 40 knee arthroplasty patients, Blackburn et al [11]
showed that pain and depression scores significantly improved
following surgery. This is consistent with a large study of knee
arthroplasty patients [12] which concluded that knee pain is

https://doi.org/10.1016/j.arth.2018.03.051
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2424 B.A. Tarakji et al. / The Journal of Arthroplasty 33 (2018) 2423e2427
contributory to psychological symptoms. Hawker et al [13] suggest
that hip and knee arthritis pain leads to depression through the
physical limitations imposed by pain. Thus, treatment strategies
that reduce pain might be expected to improve mental health (MH)
measures. A study examining pre-operative hip and knee arthro-
plasty patients found that the groups experienced similar rates of
depression and pain [14]. Perez-Prieto et al [15] found that a
depressed knee patient group experienced net improvement in
Pain and Physical Function (PF) similar to non-depressed. They also
observed improvement in mental component summary (MCS) for
depressed patients exceeding that for the non-depressed group,
with 86% of the depressed group experiencing a resolution of their
depression at 1 year following surgery. Similarly, Duivenvoorden
et al [16] found that anxiety and depressive symptoms decreased
significantly in patients following hip and knee arthroplasty.
Collectively these data suggest that knee and hip arthroplasty’s
ability to resolve pain and functional issues may bring about
reduced depressive symptoms.
Although evaluating depression pre-operatively may be difficult,
several screening tools have been developed to assess for associated
signs and symptoms. The 36-Item Short-Form Health Survey (SF-36)
was developed in the United States and has been shown to be a
reliable and valid measure of general health [17]. The MH and MCS
portions of SF-36 provide a specificity for diagnosis of depression of
92% [18]. It therefore might provide a useful tool for both identifying
depression and documenting arthroplasty outcomes. Although there
are studies that have used the SF-36 to assess patient satisfaction as
well as physical improvements with total knee arthroplasty (TKA),
there is limited literature to suggest that both TKA and total hip
arthroplasty (THA) may not only improve quality of life, but also lead
to significant improvement in MH as well.
Pathologies of the knee and hip are common causes of long-
term pain. Literature suggests a bilateral link between chronic
pain and depression: pain can be a risk factor for depression, and
structural changes alone do not always account for joint pain in
patients with depression [10]. Recognition of a relationship be-
tween joint pain and depression and the ability of arthroplasty to
address both issues can help patients and physicians understand
joint surgery as a means of providing a holistic approach to
improving a patient’s psychological and physical symptoms. This
study looks at changes in both depression as well as function and
pain scores following a knee or hip replacement procedure. The
purpose of this study is to strengthen evidence of arthroplasty
benefits to mental and physical health for depressed patients. The
study will seek to determine whether resolution of depressive
symptoms accompanies improvement in PF and pain.
Methods
Hip and knee arthroplasty patients from a single mid-western
hospital who completed the SF-36 form at 12 months following
surgery (±30 days) from 2010 to 2014 were identified. This group of
260 represents approximately 23% of the arthroplasty patients seen
Table 1
Average MCS Scores ± Standard Deviation.
Pre-Op
Depressed all 35.65 ± 4.48
Knee 36.55 ± 3.89
Hip 33.85 ± 5.19
Non-depressed all 54.43 ± 7.29
Knee 55.00 ± 7.55
Hip 53.04 ± 6.52
at this facility over this time period. Previous studies indicate that
SF-36 scores plateau by 1 year following hip or knee arthroplasty
[19e21], therefore this time point should present changes associ-
ated with surgery. The patient group was further reduced to include
only primary arthroplasty patients with OA as the indication for
joint replacement and who had completed the SF-36 form at each
follow-up visit, resulting in 165 patients. An Institutional Review
Board approved record review resulted in further exclusion of 19
patients, as these cases were revisions, involved inflammatory
condition (ie, rheumatoid arthritis, systemic lupus erythematosus,
etc.), or had demographic data missing from the records. The
resulting dataset included 102 knee and 44 hip patients. Subject
age, gender, body mass index (BMI), and number of co-morbid
conditions were collected in addition to SF-36 responses. Co-
morbid conditions considered were defined following the meth-
odology described by Elixhauser et al [22] in the development of
their co-morbidity index. This patient group was previously
described in a study examining the influence of physical co-
morbidities on arthroplasty outcomes [23].
Patient pre-operative mental state was classified using the pre-
operative MCS from the SF-36. Previous research indicates that
using a cut-off MCS score of 42 provides a screen for depression
with a sensitivity of 71% and specificity of 82% [18]. Patients with
scores less than 42 on their pre-operative SF-36 were placed in the
“depressed” group (36 total: 12 hips and 24 knees), while those
with scores of 42 or higher were placed in the “non-depressed”
group (110 total: 32 hips and 78 knees). Demographics and out-
comes for each group were then examined.
Demographics for the depressed group were compared to those
for the non-depressed group using t-tests test or by applying a
Mann-Whitney test (where data did not meet the normality
requirement, as determined using an Anderson-Darling test for
normality) to identify significant differences (P ¼ .05). When fre-
quency data were analyzed, a Fisher’s exact 2  2 test (P ¼ .05) was
applied.
The MCS scores were compared between the “depressed” and
“non-depressed” groups at 3 months and 1 year (t-test). Mean
changes in scores at 1 year from pre-operative levels and 95th
confidence intervals (CIs) were calculated (paired t-test). The pro-
portion of each group who met the criteria for non-depressed (MCS
> 42) at each follow-up visit was compared between groups using a
Fisher’s exact 2  2 test (P ¼ .05).
As the joint replacement surgery is expected to address issues of
movement and pain, SF-36 subscales associated with these factors
were examined. For each group, pre-operative, 3 months, and 1
year scores for the subscales PF, Role Physical (RP), and Bodily Pain
(BP) data were compared (depressed vs non-depressed). For these
scores the net change was also compared and 95th CIs on the
means provided. These comparisons utilized t-tests (or paired t-
test for within group comparisons), following the method for t-
tests described for the demographic data.
Mean scores for surgery-specific subgroups were calculated and
reported without statistical analysis, as these groups were
3 Mo 12 Mo Change in Score 0-12 Mo
Mean [95th CI]
46.68 ± 13.34 46.41 ± 10.31 10.76 [8.15-13.83]
36.69 ± 10.04 45.97 ± 10.03
48.45 ± 13.58 47.29 ± 11.26
55.68 ± 8.09 55.33 ± 8.72 1.22 [16.84 to 19.27]
56.21 ± 8.49 56.60 ± 7.31
54.37 ± 6.96 52.23 ± 10.99
 B.A. Tarakji et al. / The Journal of Arthroplasty 33 (2018) 2423e2427
Fig. 1. Proportion of each group with MCS < 42 (note: the depressed group was
defined as having MCS < 42 at the pre-operative point).
insufficient in size to achieve a power level of 80% for detecting
minimal clinically significant changes in scores based on surrogate
data from earlier studies [24,25].
Results
Patient demographics in the study groups were compared
including age, gender, BMI, number of total hips vs total knees, and
finally number of co-morbidities. The ages of the patients between
the 2 groups were not found to be significantly different, at 68.9
years (range 44-87, standard deviation 9.8) for the depressed group
vs 67.4 (range 41-91, standard deviation 9.6). The proportion of
male to female patients was also not significantly different between
the groups; 25.0% of the patients were male for the depressed
group and 27.9% were male for the non-depressed group. In
comparing the BMI for the 2 groups, the non-depressed group’s
average of 29.54 was not significantly different from the 29.59 for
the depressed group. Furthermore, the type of surgery was not
significantly different between the groups; total knees accounted
for 33.0% of the total knees in the depressed group vs 28.8% in the
non-depressed group. Finally, the number of co-morbidities in each
group, as measured using the Elixhauser co-morbidity index [13],
was not significantly different between the groups (ie, similar
number of co-morbid conditions); the depressed group average
was 2.78 ± 1.66 vs 2.61 ± 1.60 for the non-depressed group.
The change in MCS between pre-operative level and 12 months
was used to evaluate the patients’ change in mental state. The
scores for the depressed group improved significantly from their
pre-operative level, with a mean change in score of 10.76 (95th CI
8.15-13.83, P < .001; Table 1). In addition, the proportion of the
depressed group with MCS < 42 (indicative of depression)
decreased from 100% to 33.3% at 12 months (P ¼ .0002; Figure 1)
indicating a significant improvement in mental state for the ma-
jority of the group. In contrast, the change in MCS for the non-
depressed group was not significant (Table 1). However, the
Table 2
PF Scores.
Pre-Op
Depressed all 25.93 ± 7.89
Knee 26.43 ± 7.18
Hip 24.94 ± 9.42
Non-depressed all 32.03 ± 8.90
Knee 32.80 ± 8.39
Hip 30.13 ± 9.92
2425
depressed group’s raw scores were significantly lower than those
for the non-depressed group pre-operatively and at 12 months
(Table 1; P < .001, difference in means at 12 months ¼ 9.43 on
average, 95th CI 7.79-10.89). A similar trend was observed in the
surgery type subgroups.
Patients in the depressed group who did not experience an
improvement in their MCS to above 42 points (those who remained
depressed at 12 months) were similar to depressed patients who
did score above 42 at 12 months, although sample size precluded
statistical analysis. Those who remained depressed had pre-
operative mean MCS scores nearly equal to those who improved,
at 35.91 (difference in means 0.02, CI 9.96 to 9.91). They had
similar BMI at 30.25 for the 12-month depressed vs 29.13, and
similar co-morbidity scores of 3.23 vs 2.87. However, those who
remained depressed were younger on average (64 vs 72 years) and
a higher proportion of the depressed knee patients remained
depressed with 10 of 24 (42%) as compared to 3 of 12 hips (25%)
remaining depressed.
The PF subscale of SF-36 changed in a way that was similar to
that of the MCS score. Comparing depressed patients vs non-
depressed, the depressed group pre-operatively was found to
have significantly lower PF scores (difference of 6.09, 95th
CI 6.49 to 5.70, P < .001; Table 2). At 12 months, the depressed
group continued to demonstrate lower PF scores (difference
of 6.99, 95th CI 7.41 to 6.65, P < .001). However, no statistically
significant difference was found between the groups in terms of the
change in score over 12 months with a mean difference of 0.90
between groups (95th CI 5.36 to 3.57, P ¼ .692). Examining pa-
tients receiving TKA showed that depressed patients had lower PF
scores pre-operatively and at 12 months they continued to have
lower PF scores, as compared to non-depressed. Depressed patients
receiving total hips also had lower PF scores pre-operatively and at
12 months, as compared to non-depressed hips.
BP scores also responded in a similar fashion (Table 3), with
depressed patients reporting more pain at each time point. On the
SF-36, lower scores for BP correlate to a higher level of pain. Pre-
operatively, depressed patients had statistically significant lower
BP scores (ie, higher pain, a difference of 3.78, CI 4.09 to 3.47,
P ¼ .013). In this comparison, the negative sign indicates that the
mean BP for depressed patients was lower than that of the non-
depressed. At 12 months, they continued to exhibit lower scores
compared to the non-depressed group of patients (difference in
means 6.92, CI 7.34 to 6.49, P ¼ .001). In comparison, the net
improvement in BP scores was not significantly different: 9.11 (CI
10.79-13.69) for the depressed group compared to 12.24 (CI 6.11-
12.11) for the non-depressed. For TKA, non-depressed patients had
higher pre-operative scores (indicating lower pain) compared to
depressed patients. This trend continued at 12 months. Similarly,
depressed patients undergoing THA had lower average scores
compared to non-depressed, but statistical examination is reported
as these subgroup samples are small.
Finally, the RP subscale, which measures the limitations in
accomplishing work/daily activities, was examined (Table 4). The
3 Mo 12 Mo Change in Score 0-12 Mo
Mean [95th CI]
36.34 ± 10.58 37.68 ± 11.54 11.75 [8.68-14.82]
36.69 ± 10.04 39.41 ± 9.94
35.64 ± 12.03 34.23 ± 14.04
42.53 ± 8.12 44.67 ± 9.24 12.64 [10.89-14.40]
43.08 ± 9.10 45.13 ± 8.46
41.18 ± 8.16 43.55 ± 10.99
2426 B.A. Tarakji et al. / The Journal of Arthroplasty 33 (2018) 2423e2427

Table 3
Bodily Pain.

Pre-Op 3 Mo 12 Mo Change in Score 0-12 Mo

Mean [95th CI]

Depressed all 31.44 ± 6.99 40.14 ± 10.87 40.55 ± 10.88 9.11 [6.11-13.37]
Knee 32.30 ± 6.72 40.79 ± 10.96 41.38 ± 10.64
Hip 29.72 ± 7.49 38.84 ± 11.06 38.91 ± 11.64
Non-depressed all 35.22 ± 7.51 43.75 ± 7.72 47.47 ± 8.87 12.24 [10.79-13.70]
Knee 36.60 ± 7.57 42.99 ± 7.54 47.31 ± 7.86
Hip 31.87 ± 6.30 45.61 ± 7.96 47.87 ± 11.08

depressed patients exhibited lower RP scores compared to non-
depressed patients pre-operatively (difference in means 6.31,
CI 6.74 to 5.88, P < .001), as well as at 12 months post-
operatively (7.29, CI 7.76 to 6.82, P < .001). The net change
in the RP score was not significantly different between the groups,
with a difference in means of 0.98 (CI 5.76 to 3.81, P ¼ .687).
Depressed patients undergoing total knees had lower RP scores
pre-operatively and at 12 months compared to non-depressed
patients. The depressed group undergoing THA also had lower RP
scores pre-operatively and at 12 months.
Discussion
This study examined 146 total joint arthroplasty patients’ peri-
operative mental and physical wellbeing. Pre-operative MCS from
the SF-36 health survey were used to divide the group into
depressed and non-depressed groups with similar demographics.
The MCS in the depressed group significantly improved at 12
months, indicating an improvement in mental state for the ma-
jority of the group. The physical component score and those sub-
scales expected to be addressed with arthroplasty, namely PF, RP,
and BP, demonstrated improvement in both groups as well, indi-
cating that depressed patients saw a similar net increase in scores
as compared to non-depressed patients.
Blackburn et al [11] was perhaps one of the first to suggest that
addressing knee pain is a possible contributor to improving both
mental and physical health. In their prospective study of 40
consecutive patients undergoing TKA, they concluded that pre-
operative anxiety and depression do not predict poor outcomes
in TKA and the incidence of depression decreased after TKA.
Decreased depression rates after arthroplasty were demonstrated
for TKA by Perez-Prieto et al [15] in Spain and by Duivenvoorden
et al [16] in The Netherlands, who also reported similar findings for
hip arthroplasty patients. This study analyzed the effects of
depression in both TKA and THA in a US population and came to a
similar conclusion, suggesting a universality to these findings. In a
review of studies examining the link between depression and knee
pain, Phyomaung et al [24] identified 6 high quality studies that
reported a significant association between depression and knee
pain. Furthermore, knee OA is a common site of chronic pain [10],
which is also associated with depression [7]. These studies suggest
a link between MH and chronic joint pain. The reduction in pain
associated with arthroplasty may therefore contribute to an
improved mental state. Other recent studies indicate that
addressing a patient’s depression pharmacologically can improve
post-operative knee function scores and lower post-operative pain
medication use [25], further supporting the link between MH and
joint pain. These studies suggest that surgical outcomes could be
further improved if orthopedic surgeons would screen arthroplasty
candidates for depressive symptoms and refer them for appropriate
care pre-operatively.
Perez-Prieto et al [15] published the largest study analyzing the
influence of depression on TKA outcomes. Patient outcomes were
measured using the SF-36, the Knee Society Score, and the Western
Ontario and McMaster Universities Arthritis Index. They found that
although depressed patients had lower scores pre-operatively and
post-operatively compared to non-depressed patients, the differ-
ences in “net change” were less drastic between the 2 groups. This
is consistent with the findings in this study which indicate a similar
gain in function and reduction in pain post-arthroplasty for both
depressed and non-depressed groups. This suggests that these re-
sults are reproducible in a different setting and may extend to hip
arthroplasty patients as well.
Examining those patients whose MCS remained below 42 at 12
months (those who remained depressed) indicated that these pa-
tients were on average younger than the others in the depressed
group. The persistence of depression in younger patients may
reflect pain perception, as a study found younger knee arthroplasty
patients experience less pain relief post surgery, as compared to
older patients [26]. Further work to understand this group better is
needed, as the sample size here precluded in-depth analysis.
This study’s retrospective design presents an important limita-
tion to the work, future prospective and larger studies could pro-
vide a stronger basis for the connection between joint arthroplasty
and MH improvements in arthritic patients. This design precluded
efforts to ensure a high level of compliance for completing the SF-
36 survey at all time points. In conjunction with this limitation is
this study’s relatively small sample size, such that surgery-specific
analysis was not employed due to lack of statistical power. Another
significant limitation to this study is in establishing the diagnosis of
depression. A scale specific to depression was not used. However,
Silveira et al [18] demonstrated that an MSC score of less than 42
had a specificity of 82% for the diagnosis of depression. An addi-
tional limitation is that peri-operative treatment of depression (ie,

Table 4
Role Physical.

Pre-Op 3 Mo 12 Mo Change in Score 0-12 Mo

Mean [95th CI]

Depressed all 29.17 ± 9.34 36.99 ± 10.73 39.23 ± 10.81 10.07 [6.76-13.37]
Knee 31.24 ± 9.90 36.65 ± 10.01 39.61 ± 9.86
Hip 25.02 ± 6.69 37.67 ± 12.48 38.49 ± 12.94
Non-depressed all 35.48 ± 10.54 42.52 ± 10.10 46.52 ± 8.92 11.04 [9.10-12.99]
Knee 37.07 ± 10.51 42.66 ± 10.31 46.74 ± 8.51
Hip 31.60 ± 9.73 42.16 ± 9.72 45.98 ± 9.95
 B.A. Tarakji et al. / The Journal of Arthroplasty 33 (2018) 2423e2427
counseling, medication, etc.) was not accounted for in this study.
However, the MCS for depressed patients demonstrated statisti-
cally significant improvement at 12 months, whereas the non-
depressed patients’ MCS remained relatively stable, while both
groups had similar numbers of persons with a depression diagnosis
indicated in their medical records. Furthermore, the majority of the
depressed group did not have depression listed in their medical
records and therefore it is unlikely that MH treatment alone ac-
counts for improvement in their MCS. Finally, a study of the course
of depression in an older population found that after 2 years 61% of
people who were depressed at baseline continued to suffer from
chronic depressive symptoms, despite receiving active treatment
[27]. In this study, over 63% of patients demonstrated improvement
in depressive symptoms, a large effect that exceeds that found in
the aforementioned study and is similar to the figure reported for
TKA by Perez-Prieto et al [15]. This further suggests that treatment
of patient’s chronic pain secondary to OA may contribute to
improvement in MH.
In conclusion, this study suggests that patients who present
for hip and knee arthroplasty with depressive symptoms achieve
gains in both physical health and MH following surgery. Future
studies should examine whether further improvement in surgi-
cal outcomes and reduction in post-operative pain medication
may result if concurrent MH treatment is provided to these
patients.
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 The Journal of Arthroplasty 33 (2018) 2535e2540

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Is Direct Anterior Approach a Credible Option for Severely Obese

Patients Undergoing Total Hip Arthroplasty? A Matched-Control,
Retrospective, Clinical Study
Alexander Antoniadis, MD *, Dimitris Dimitriou, MD, Andreas Flury, MD,
Gregor Wiedmer, MD, Julian Hasler, MD, Naeder Helmy, MD
Department of Orthopaedics and Traumatology, Bürgerspital Solothurn, Solothurn, Switzerland

a r t i c l e i n f o a b s t r a c t

Article history: Background: Severely obese patients present a significant challenge for arthroplasty surgeons because of
Received 2 February 2018 their body habitus. Up to date, there is no clear consensus on the safety of the direct anterior approach
Received in revised form (DAA) in obese patients undergoing total hip arthroplasty. Therefore, the purpose of the present study
10 March 2018
was to determine whether DAA is a credible option in severely obese regarding complication rates,
Accepted 27 March 2018
clinical outcomes, and component positioning.
Available online 11 April 2018
Methods: Obese patients with a body mass index
35 kg/m2 (n ¼ 129) who received total hip arthro-
plasty with DAA in our institution were matched for gender and age with nonobese patients with body
Keywords:
total hip arthroplasty (THA)
mass index  25 kg/m2 (n ¼ 125). The postoperative complications and clinical and radiologic outcomes
obesity were assessed retrospectively.
clinical outcomes Results: The results of this study showed an increased risk of reoperation (relative risk: 4.0), mostly due
direct anterior approach (DAA) to wound infection and dehiscence, in obese than in nonobese patients. The mean Harris Hip Score
complications increased from 50 and 42 preoperative to 95 and 97 at the 1-year follow-up in obese patients and
nonobese patients, respectively. No significant difference was observed regarding the acetabular ante-
version, inclination or leg-length discrepancy, and vertical center of rotation. The horizontal center of
rotation was slightly medialized (4 mm) in the nonobese compared with the obese patients (1 mm).
Conclusion: Obese patients had a higher complication and reoperation rate compared with nonobese
patients. However, these rates were comparable to the rates of the standard, more extensive approaches
presented in the literature. The current data suggest that DAA might be a credible option for obese
patients, with excellent functional and radiographic outcomes.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) is a highly successful surgery in the
treatment of symptomatic osteoarthritis in terms of pain relief,
restoration of function, and improvement of the quality of life [1].
According to current estimations, more than 1 million arthro-
plasties are performed every year worldwide [2]. With the obesity
D.D. contributed equally to this work.
There is no external funding source, or the funding source did not play a role in the
investigation.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.071.
* Reprint requests: Alexander Antoniadis, MD, Department of Orthopaedics and
Traumatology, Bürgerspital Solothurn, Scho €ngrünstrasse 42, Solothurn 4500,
Switzerland.
outbreak that plagues the modern world, it is expected that the
number of THA implanted will increase rapidly as obese patients
require approximately 8.5 times more often a THA compared with
their nonobese counterparts [3]. It is therefore estimated that the
number of obese patients requiring a THA will rise significantly in
the near future.
Over the past years, several techniques for THA have been well
established in the field of orthopedic surgery [4,5]. Recently, there
has been an increasing interest regarding the minimally invasive
procedures in THA. The direct anterior approach (DAA) is gaining
popularity owing to its soft-tissue-preserving nature, the relatively
low risk of dislocation, the accurate placement of the components,
and the excellent functional outcome accompanied by a clinically
significant reduction in postoperative pain and recovery time [6,7].
However, the proximity of the surgical incision to the adjacent
genitalia, the thin anterior thigh skin, and the overlying abdominal

https://doi.org/10.1016/j.arth.2018.03.071
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2536 A. Antoniadis et al. / The Journal of Arthroplasty 33 (2018) 2535e2540
fold, exacerbated in the obese patients (Fig. 1A), has been attributed
to the increased infection rate observed with the DAA [8,9].
Although several studies have shown no significant risk in obese
patients undergoing a THA with a standard approach [10,11], others
have demonstrated an increased rate of postoperative complica-
tions, mostly wound infections [12,13]. However, there is a limited
number of data, regarding postoperative complications in obese
patients undergoing a minimally invasive THA with a DAA [14].
Given the technically challenging nature of the DAA in obese pa-
tients, regarding retractor placement, proper bone preparation, and
accurate component positioning [8,15], owing to the increased fat
tissue envelope around the hip, the DAA may result in an increased
complication rate in this patient group.
Therefore, the purpose of this study was to examine whether
obese patients undergoing minimally invasive THA with the DAA
have an increased risk of perioperative and postoperative compli-
cations, as well as worse functional and radiographic outcomes
compared with their nonobese control group.
Material and Methods
This study was approved by the institutional review board and
the ethical committee. It was conducted entirely at the authors'
institution. The inclusion criteria were adult patients, undergoing
primary THA for symptomatic osteoarthritis (primary or second-
ary), who had completed at least 1-year follow-up at the time of the
data collection.
Fig. 1. (A) Supine position using the AMIS mobile leg positioner. (B) Retraction of abdominal fat using adhesive tapes. (C) Surgical exposure after reposition. (D) Standardized use of
a pain catheter.
Patient Characteristics
From January 2009 to December 2015, a total of 1089 THAs using
the DAA were performed. This is the standard approach in our
institution for all our patients except patients with a Crowe III and
IV dysplasia. A total number of 129 THAs were performed in 118
severely obese patients with a body mass index
35 (35, 56) kg/m2
and were matched for gender and age with 118 nonobese patients
with a body mass index  25 (19, 25) kg/m2 (THA ¼ 125). Baseline
characteristics including preoperative Harris Hip Score (HHS),
comorbidities likely to influence postoperative complications, and
the patients' physical status according to the American Society of
Anesthesiologists (ASA) were recorded [16] (Table 1).
Surgical Technique and Perioperative Care
All the operations were performed in the supine position using
the anterior minimal invasive surgery Mobile Leg Positioner
(Medacta International SA, Castel San Pietro, Switzerland) (Fig. 1A).
In the severely obese patients, the abdominal fat folded over the
iliac crest was retracted using adhesive tapes, for the surgeon to be
in the place to visualize the groin crease during the procedure
(Fig. 1B). Every patient received preoperative antibiotics before skin
incision and for 24 hours postoperatively. All cases were performed
via a standardized minimally invasive DAA (Fig. 1C) [17]. During the
insertion of the acetabular component, intraoperative imaging was
used. The anterior hip capsule was left open for all the procedures.
A pain catheter with bupivacaine 0.5% (49.25 mL), epinephrine 0.5
mg (0.5 mL), and ketorolac 30 mg (1 mL) was inserted inside the hip
 A. Antoniadis et al. / The Journal of Arthroplasty 33 (2018) 2535e2540 2537

Table 1 readmission, and HHS, on every visit. Interviews with patients were
Patient Characteristics, Comorbidities, and Preoperative and Postoperative Func- conducted in the clinic. The clinical examination was performed by
tional Scores.
an orthopedic surgeon, independent to the study, of our clinic in a
Obese (n ¼ 118) Control Significance standardized manner. For the present study, significant complica-
(n ¼ 118) (P Value) tions were considered: dislocation and superficial or periprosthetic
BMI (kg/m2) 37 (3.8) 22 (1.6) .001a infection, according to the criteria of the Musculoskeletal Infection
Age (y) 70 (9.3) 70 (10.3) .66 Society [19]; wound dehiscence, defined as any wound separation
Preoperative Harris Hip Score 50 (8.7) 42 (9.2) .001a
that required additional intervention; considerable blood loss
Postoperative Harris 95 (4.1) 97 (3.2) .07
Hip Score at 1 y requiring transfusion; periprosthetic or greater trochanter fracture,
Follow-up (mo) 40 (6.3) 36 (5.4) 0.4 and component loosening, defined as >2 mm subsidence of the
ASA score .001a component; and circumflex progressive osteolysis at the bone-
1 (n) 0 10 (8%)
component interface [20].
2 (n) 53 (45%) 100 (85%)
3 (n) 64 (54%) 7 (6%)
4 (n) 1 (1%) 1 (1%) Radiologic Measurements
Comorbidities other than obesity .001a
None 56 (47%) 102 (86%) The postoperative x-rays were evaluated by 2 separate ortho-
Diabetes (n) 35 (30%) 3 (3%)
pedic residents blinded to patient's clinical details. The residents
Immunosuppressionb (n) 7 (6%) 8 (7%)
Smoking (n) 7 (6%) 6 (5%) performed the measurements individually and concurred with the
CKD
stage III (n) 31 (26%) 3 (3%) results. Radiographs of each visit were compared with the initial
Values were given as mean and standard deviation.
postoperative radiograph to evaluate for component loosening.
ASA, American Society of Anesthesiologists; BMI, body mass index; CKD, chronic For the preoperative and postoperative radiographs, a stan-
kidney disease. dardized protocol has been applied by holding the lower limbs
a
Indicates statistically significant difference (P < .05). together in a neutral position and the anterior superior iliac spine
b
Immunosuppression: HIV positive, malignancy.
parallel to each other and the x-ray table. On the anteroposterior
view of the pelvis, the leg-length discrepancy was measured, as the
capsule and was then removed on the first postoperative day. A skin perpendicular distance between a line passing through both tear-
suture (Ethilon 3-0, Ethicon, Vienna, Austria) using the Donati drop points medial to the acetabula to the corresponding tip of the
Vertical Mattress technique was used to close the surgical incision lesser trochanter [21]. A positive leg-length discrepancy value was
(Fig. 1D). The wound was then covered with a sterile dressing used when the operated limb was longer than the contralateral
(Comfeel Plus Transparent), and the first dressing change was side. Acetabular inclination and anteversion were defined as the
performed on the second postoperative day. angle between the acetabular axis and the longitudinal axis in the
An anterior minimal invasive surgery experienced surgeon anteroposterior view and the acetabular axis and the coronal axis in
(>100 operations using DAA) performed or supervised all the the lateral view, respectively [22]. The horizontal and vertical
procedures. The implants used in the present study included a center of rotation (CoR) was defined as the distance of the CoR
cementless acetabular component (RM vitamys; Mathys, preoperative to the distance of the CoR postoperative in the hori-
Switzerland or Versafit Cup; Medacta International, Switzerland) zontal and vertical axes, respectively [23]. A negative value indi-
and a cementless femoral stem (Optimys; Mathys, Bettlach, cated that the postoperative CoR was reconstructed more medial
Switzerland or AMIStem Medacta International, Switzerland) with and superior, respectively.
standard or lateral offset according to the preoperative planning.
The blood loss was calculated at the end of the operation from Statistical Analysis
the attending anesthesiologist as the fluid accumulation in the
suction bottle after subtracting the irrigation fluid and the visual Descriptive statistics used frequencies and percentages to present
estimation of the blood absorbed by surgical gauze. the data. All parameters were tested using the Kolmogorov-Smirnov
A standardized transfusion protocol is performed in our clinic test for normality. When the criteria for normality were met, a
according to the guidelines published by the British Committee of 2-tailed paired t test was used. Otherwise, the Wilcoxon signed-
Standards in blood transfusion for acute anemia [18]. The trans- rank test was applied. The relative risk (RR) was calculated to
fusion protocol did not change throughout the study period. The identify whether obese patients have an increased risk of devel-
transfusion threshold was hemoglobin of 10 g/dL in patients oping postoperative complications. For the acetabular inclination
without cardiovascular disease and 7 g/dL in patients with car- and anteversion, intraobserver and interobserver reliabilities of the
diovascular disease. measurements were evaluated with 2 independent blinded ob-
Beginning from the first postoperative day, all the patients fol- servers using single-measure intraclass correlation coefficients
lowed a standardized physical therapy protocol with mobilization (ICC) with a 2-way random-effects model for absolute agreement.
out of bed, progressing from a walker to no assistive devices as The level of significance level was set at a ¼ 0.05. All the statistical
tolerated. Patients were discharged when able to mobilize for daily analyses were performed using SPSS, version 22 software (SPSS
activities safely, pain controlled with oral medications, and were Inc., Chicago, IL).
medically stable.
All patients were treated with Clexane (enoxaparin) 40 mg Results
subcutaneously once daily as deep venous thrombosis prophylaxis.
Power Analysis and Intraobserver and Interobserver Reliabilities

Clinical Evaluation
The patients were followed up clinically and radiographically at
3 months and yearly. Medical records were reviewed, including
outpatient clinic notes, operative reports, hospital records for
The achieved power of the study according to the post hoc po-
wer analysis with a total sample size of 254 hips, medium effect
size, and a ¼ 0.05 was 100%. Intraobserver ICC and interobserver
ICC were 0.95, 0.91 for anteversion and 0.99, 0.98 for inclination,
respectively.
2538 A. Antoniadis et al. / The Journal of Arthroplasty 33 (2018) 2535e2540

Perioperative Complications Table 3

Summary of Complications.

In the severely obese patients, the mean operation duration was Obese Control Relative Confidence
28 minutes longer, the mean blood loss was 150 mL higher, and the (Hips ¼ 129) (Hips ¼ 125) Risk (RR) Interval (CI)
mean hospital stay was 2 days longer than the control group Infection (n) 6 (4.6%) 1 (0.8%)a 5.8 0.7-47.1
(Table 2). The mean total operation duration defined as the time Superficial 3 1 2.9 0.3-27
past from the patient's entrance and exit of the operating room was Deep 3 0 - -
Wound dehiscence (n) 3 (2.3%) 1 (0.8%)a 2.9 0.31-27.6
43 minutes longer in severely obese patients. Six patients in the
Dislocation (n) 1 (0.8%) 1 (0.8%) 0.97 0.14-6.7
severely obese and 2 patients in the control group stayed in the Periprosthetic fracture (n) 1 (0.8%) 1 (0.8%) 0.97 0.14-6.7
intermediate care unit for 1 day postoperatively and then trans- Hematoma needing 3 (2.5%) 2 (2.5%) 1.45 0.24-8.5
ferred to the surgical ward (Table 2). None of the patients had to be revision (n)
Anemia needing blood 0 1 (0.8%) - -
transferred to the intensive care unit postoperatively. One case of
transfusion (n)
intraoperative periprosthetic fracture occurred in each group Reoperation (n) 12 (9.3%) 3 (2.4%) 4.0 1.2-13.8b
(Vancouver B1), respectively, treated with cerclage augmentation, Total complications (n) 15 (11.6%) 7 (5.6%) 2.0 0.86-4.8
by a stable stem, by lengthening the skin incision distally.
RR, relative risk; CI, confidence interval.
a
Indicates the same patient.
b
Complication Rate and Revision Indicates statistically significant difference (P < .05).

At a mean follow-up of 40 months, the total complication and

within the Lewinnek “safe zone” in both groups (Table 4) [24]. No
reoperation rates in severely obese patients were 11.6% (15 hips) and
significant difference was observed in the acetabular anteversion
9.3% (12 hips), respectively (Table 3). A single episode of hip dislocation
between groups (23 in obese, 22 in nonobese). About 62% of the
occurred in one patient (0.8%) treated with a closed reduction in the
acetabular cups were within the Lewinnek “safe zone” in both
emergency department. Infection requiring reoperation occurred in 6
groups (Table 4). No significant differences were observed in leg-
patients (4.6%). Three patients required a soft-tissue revision and
length discrepancy and vertical CoR between groups. The hori-
lavage as well as polyethylene liner exchange, whereas the other 3 only
zontal CoR was slightly medialized (4 mm) in the control group
needed local debridement for a superficial infection. All 6 patients
compared with the obese patients (1 mm) (Table 4).
receive intravenous antibiotics according to the antibiogram, initial
intravenous, and then per os. Wound dehiscence occurred in 3 patients
and was treated with local wound debridement.
Discussion
At a mean follow-up of 36 months, the total complication and
reoperation rates in the control group were 5.6% (7 hips) and 2.4%
The DAA in THA showed excellent outcomes and improved
(3 hips), respectively (Table 3). A single episode of hip dislocation
short-term patient function in several studies [27,28]. Many au-
occurred in 1 patient (0.8%) treated with a closed reduction in the
thors suggest that the choice of surgical approach should be based
emergency department. Two patients had to be revised for a
on patient factors, surgeon preference, and experience [29]. How-
postoperative hematoma, whereas 1 patient for wound dehiscence
ever, there is no clear consensus on which patient factors should be
after a superficial infection.
taken into consideration. Therefore, the purpose of this study was
The obese patients had a significantly increased risk of devel-
to examine the safety of DAA in obese patients undergoing THA
oping postoperative complications requiring a revision (RR: 4.0,
because of symptomatic osteoarthritis, regarding perioperative and
confidence interval: 1.2-13.8).
postoperative complications as well as functional and radiologic
outcomes. The results of the present study showed a significantly
Functional Outcomes increased risk for reoperation due to postoperative complications,
mostly infections and wound dehiscence, in obese patients
Postoperative functional scores improved significantly from the compared with the nonobese control group. The RR for wound
preoperative value in both groups. The mean HHS increased from infection, although increased in the obese patients was not
50 preoperative to 95 at the 1-year follow-up in obese patients. In
the control group, mean HHS increased from 42 preoperative to 97
at the 1-year follow-up (Table 1). Table 4
Radiologic Measurements.

Radiographic Findings Obese Control Significance

(Hips ¼ 129) (Hips ¼ 125) (P Value)

The mean acetabular inclination was similar in both groups (43 Acetabular inclination ( ) 43 (7.1) 42 (6) .64
in obese, 42 in nonobese) with 88% of the acetabular component Within the “safe zone” (n)

113 (88%) 116 (93%)
Acetabular anteversion ( ) 23 (7.3) 22 (7.1) .71
Within the “safe zone” (n) 80 (62%) 79 (63%)
Table 2 Leg-length discrepancy (mm) 0.02 (0.5) 0.04 (0.3) .68
Perioperative Parameters. Horizontal center of rotation (mm) 0.1 (0.5) 0.4 (0.5) .001a
Within the optimal CoR 99 (76%) 74 (59%)
Obese Control Significance
reconstruction
(n ¼ 118) (n ¼ 118) (P Value)
Vertical center of rotation (mm) 0.1 (0.6) 0.25 (1.2) .08
Intraoperative blood loss (mL) 350 (205) 200 (183) .001a
Values were given as mean and standard deviation.
Operation duration (min) 100 (25.7) 72 (21.6) .001a
“Safe zone” for acetabular inclination and anteversion was set at 30-50 and 5-25 as
Total operation duration (min) 150 (33.2) 107 (26.7) .001a
described by Lewinnek et al [24]. A positive leg-length discrepancy value was used
Hospital stay (d) 7.3 (5.6) 5.3 (2.5) .001a
when the operated limb was longer than the contralateral side. A negative value for
IMCU postoperative (n) 6 (5%) 2 (1.7%) .67
the horizontal and vertical center of rotation (CoR) indicated that the postoperative
Values were given as mean and standard deviation. CoR moved medial and superior, respectively. The optimal reconstruction of CoR
IMCU, intermediate care unit. was set at 5 mm according to literature consensus [25,26].
a a
Indicates statistically significant difference (P < .05). Indicates statistically significant difference (P < .05).
 A. Antoniadis et al. / The Journal of Arthroplasty 33 (2018) 2535e2540
statistically significant. The functional and radiologic outcomes
were similar between groups.
Although the complication and reoperation rates in the present
study was higher in the severely obese patients in comparison with
nonobese patients undergoing THA with the DAA, it must be noted
that it was similar to or even lower than the rate reported in the
literature for other surgical approaches. Specifically, Chee et al [30]
using the standard anterolateral approach reported a 22% compli-
cation rate in the obese patients, compared with 5% in the non-
obese patients. Most of the complications were wound infections
and hip dislocations requiring revision occurring in 13% (7 out of
53) and 5.6% (3 out of 53) of the obese patients, respectively.
Similarly, Jameson et al [31] using a posterior and lateral approach
had a 14.5% (62 of 428) of wound infections and 2.3% (10 of 428) of
revision rate. In accordance with the literature, we had 9.3% (12 of
129 hips) of complication and 9.3% (12 of 129 hips) of reoperation
rate . Our reoperation rate might be apparently higher than the
reported studies because we considered wound debridement and
hematoma release as reoperation, contrary to other articles.
To date, only a few studies investigated the wound infection in
obese patients undergoing THA in DAA. Specifically, Purcell et al
[32] reported a 2.5% (5 of 204) of deep infection requiring a revision
(RR of 7.1) and 1.96% (4 of 204) rate of superficial infection (RR 2.1).
In a retrospective control study, Russo et al [14] found a 10% (8 of
79) of wound complication compared with 3% (4 out of 131) in
nonobese patients (RR 3.3, confidence interval: 0.9-10.6, P < .06).
However, their results were not statistically significant. In agree-
ment with the literature, we found a 4.6% of wound infection (3
superficial and 3 deep infections of 129 patients) in obese patients
in comparison to one superficial infection in the nonobese group.
Despite the increased infection rate, the results were not statisti-
cally significant (Table 4). Nevertheless, the increased infection rate
in our cohort may be attributed to anatomical factors and systemic
factors. More specifically, obese patients have an increased fat tis-
sue envelope that requires more in-depth exploration and as a
result, higher shear forces from the retractor compared with the
nonobese patients [8]. Furthermore, the adjacent genital and waist
crease may increase the risk of wound contamination [33].
Regarding the systemic factors, the obese patients in our cohort had
a significantly higher ASA score and far more comorbidities, espe-
cially diabetes mellitus with or without chronic kidney disease
(Table 1), which might have contributed to the higher infection rate
compared with nonobese patients [34].
Only a limited number of studies reported on the clinical out-
comes following DAA in obese patients undergoing THA, and most
of them focused on the wound complications [14,32]. To the best of
the authors' knowledge, the present study is the only cohort to
report both clinical and radiologic outcomes after THA with DAA in
obese patients. At a mean 40 months of postoperative follow-up,
obese patients showed an excellent functional outcome similar to
the nonobese patients with mean HHS of 97 (range: 83-100). Only
one aseptic loosening was reported within 1 year postoperatively
that required revision surgery. The acetabular inclination was
identical in both groups with 90% of the implant falling in the
Lewinnek “safe zone.” Similarly, acetabular anteversion showed no
significant difference between groups with 62% of the implants
within the Lewinnek “safe zone.” However, only one of the obese
patients presented with hip dislocation (anteversion 33 , inclina-
tion 45 ). These data support the fact that stability is likely multi-
factorial, and the ideal cup position for some patients may lie
outside the Lewinnek “safe zone” [35]. Regarding the leg-length
discrepancy and vertical CoR, no significant difference was
observed between groups. In the obese patients, a more accurate
reconstruction of the horizontal CoR was achieved with a mean
medialization of 1 mm (range: 0, 1.06) compared with a mean
2539
medialization of 4 mm (range: 0, 1.6) in the nonobese patients.
Although both means fall in the optimal reconstruction for CoR in
THA reported in literature (within 5 mm from the anatomic loca-
tion) [25,26], more patients in the nonobese group fall outside the
optimal range (Table 4).
This study should be interpreted in light of its potential limita-
tions. The main drawback was the retrospective design. However,
owing to the standardized clinical and radiologic follow-up proto-
col and the excellent documentation by the orthopedic surgeons of
our institution, most of the patient data we needed were available
for the current analysis. Although we matched-control the groups
according to age and gender, there was a significant difference
regarding the ASA score and the comorbidities between groups.
Nevertheless, we acknowledge the fact that it is extremely difficult
to match-control obese patients, as some comorbidities have a
higher prevalence in the obese population, for example, diabetes
mellitus type II [36]. Finally, most of the obese patients included in
our study had ASA scores 2 and 3, meaning that the results of this
study might not be applied in patients with higher ASA score.
In conclusion, the present study is the only available study in
literature reporting both functional and radiologic outcomes, as
well as perioperative complications in severely obese patients un-
dergoing THA with DAA. The results of this study suggest that the
DAA might be a credible option, with excellent functional and
radiographic outcomes in obese patients. Obese patients might
have a significantly higher reoperation rate, mostly due to wound
infections and dehiscence, in comparison to nonobese patients
operated with the DAA. However, the rate is comparable to the
standard, more extensive approaches presented in the literature.
These data imply that obesity alone should not be considered as a
contraindication to DAA in patients undergoing THA by an experi-
enced surgeon. Nevertheless, meticulous care should be taken
perioperatively, and patient comorbidities should be taken into
account, to minimize the risk of wound complications and reop-
erations. The patients should also be informed of the increased risk
for reoperations due to wound infections and dehiscence compared
with the nonobese patients. Finally, obesity is considered a modi-
fied risk factor, and the orthopedic surgeon should advise obese
patients to reduce their body weight before an elective surgery.
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plasty. J Arthroplasty 2015;30:1384e7.
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 Letters to the Editors
to believe that the addition of long-acting to immediate-release bupi-
vacaine would cause more pain. When the administrative decision was
made to reduce the sample size of the study, a one-sided test was
appropriately applied to test whether liposomal bupivacaine provided
better or comparable analgesia compared with bupivacaine HCl.
Hence, the hypothesis was one directional, and a one-sided statistical
test (P value) was fully justifiable [1,2]. In addition, the postsurgical
infiltration with EXPAREL for long-lasting analgesia in total knee
arthroplasty (PILLAR) study used a multilevel, hierarchical model
which inherently addressed the multiple comparison issues; therefore,
a Bonferroni correction would not be necessary or appropriate [3].
Michael A. Mont, MD*
Department of Orthopaedic Surgery
Lenox Hill Hospital
New York, New York
Walter B. Beaver, MD
Department of Orthopaedic Surgery
OrthoCarolina Hip & Knee Center
Charlotte, North Carolina
Stanley H. Dysart, MD
Department of Orthopaedic Surgery
Pinnacle Orthopedics
Marietta, Georgia
John W. Barrington, MD
Department of Orthopaedic Surgery
Joint Replacement Center of Texas
Baylor Medical Center Frisco
Plano, Texas
Daniel J. Del Gaizo, MD
Department of Orthopaedic Surgery
University of North Carolina Hospitals
Chapel Hill, North Carolina
* Department of Anesthesiology
Reprint requests: Michael A. Mont, MD, Department of
Orthopaedic Surgery, Lenox Hill Hospital, 100 E 77th Street, New
York, NY 10075.
References
[1] Knottnerus JA, Bouter LM. The ethics of sample size: two-sided testing and one-
sided thinking. J Clin Epidemiol 2001;54:109e10.
[2] Owen A. The ethics of two- and one-sided hypothesis tests for clinical trials.
Clin Ethics 2007;2:100e2.
[3] Gelman A, Hill J, Yajima M. Why we (usually) don't have to worry about multi-
ple comparisons. J Res Educ Effect 2012;5:189e211.
Letter to the Editor on “Continuous Adductor Canal
Blocks Provide Superior Ambulation and Pain Control
Compared to Epidural Analgesia for Primary Knee
Arthroplasty: A Randomized, Controlled Trial. J Arthroplasty”
To the Editor:
We read with great interest the article by Kayupov et al [1] in
a recent issue of the journal. The authors performed a
DOI of original article: https://doi.org/10.1016/j.arth.2017.11.013.
Financial Support: No funding was sought.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.036.
2695
randomized clinical trial on 145 patients who underwent pri-
mary total knee arthroplasty. Patients were randomized to 3
groups: combined spinal-epidural, spinal þ continuous
adductor canal block, or general þ continuous adductor canal
block. The authors concluded that continuous adductor anal-
gesia provides superior ambulation, lower pain scores, faster
discharge, and greater patient satisfaction when compared
with epidural analgesia for primary total knee arthroplasty.
The authors should be congratulated for performing a well-
designed study on an important topic (eg, acute pain) in
patients undergoing total knee arthroplasty [2,3]. The current
emphasis on the use of multimodal analgesics to enhance re-
covery across many orthopedic procedures makes the topic
timely in perioperative medicine [4,5].
Although the study by Kayupov et al was well conducted,
there are some questions regarding the study that need to be
clarified. First, the dropout imbalance between groups can
alter the study outcomes. It is not explained why the authors
did not perform an intention-to-treat analysis to demonstrate
that the results did not change. Second, Table 2 suggests an
imbalance between the groups for variables that may alter the
outcomes (eg, age and surgical duration). It would be important
to perform a multivariate analysis to demonstrate that the
imbalance on those variables does not affect the study results.
Finally, the authors reported on 5 outcomes in a 3-group study,
but they did not adjust P values (“significance set at <.05”) to
minimize the chance of type I errors due to multiple
comparisons.
We would welcome some comments from the authors as
this would help to further support the findings of this impor-
tant study.
Lucas J. Castro-Alves, MD
Mark C. Kendall, MD*
Rhode Island Hospital
Warren Alpert Medical School of Brown University
Providence, Rhode Island
*
Reprint requests: Mark C. Kendall, MD,
Department of Anesthesiology, Warren Alpert Medical
School of Brown University, 593 Eddy Street,
Providence, RI 02903.
References
[1] Kayupov E, Okroj K, Young AC, Moric M, Luchetti TJ, Zisman G, et al. Continuous
adductor canal blocks provide superior ambulation and pain control compared
to epidural analgesia for primary knee arthroplasty: a randomized, controlled
trial. J Arthroplasty 2017, https://doi.org/10.1016/j.arth.2017.11.013 [Epub ahead
of print].
[2] Khanna A, Saxena R, Dutta A, Ganguly N, Sood J. Comparison of ropivacaine
with and without fentanyl vs bupivacaine with fentanyl for postoperative
epidural analgesia in bilateral total knee replacement surgery. J Clin Anesth
2017;37:7e13.
[3] Sodhi N, Piuzzi NS, Dalton SE, George J, Ng M, Khlopas A, et al. What influence
does the time of year have on postoperative complications following total knee
arthroplasty? J Arthroplasty 2017, https://doi.org/10.1016/j.arth.2017.12.020
[Epub ahead of print].
[4] Bali C, Ozmete O, Eker HE, Hersekli MA, Aribogan A. Postoperative analgesic
efficacy of fascia iliaca block versus periarticular injection for total knee
arthroplasty. J Clin Anesth 2016;35:404e10.
[5] Cip J, Erb-Linzmeier H, Stadlbauer P, Bach C, Martin A, Germann R. Contin-
uous intra-articular local anesthetic drug instillation versus discontinuous
sciatic nerve block after total knee arthroplasty. J Clin Anesth 2016;35:
543e50.
 Letters to the Editors
follow the PICO format (P: participants, I: intervention, C: com-
parison, O: outcomes). The authors state the inclusion criteria
as: “Studies were included in this review if they were random-
ized controlled trials involving at least 20 patients who received
NMES, TENS, or EA following primary TKA”. Additionally, the au-
thors state the review aims to: “address the following questions:
(1) Is NMES effective at improving postoperative muscle strength
after TKA? (2) Are TENS and EA effective at providing analgesia
after TKA? and (3) What should be the ideal parameters and
intervention protocols to maximize the recovery benefits of
each technique?” Surprisingly, the review did not clearly report
the other components of inclusion criteria such as comparison
and outcome measures. Running a systematic review without
full knowledge about the inclusion criteria can lead to problems
with assessing the validity, applicability, and comprehensive-
ness of the systematic review [2].
The authors state that “we conducted this systematic review
to assess the available evidence.” Furthermore, the qualities of
evidence and heterogeneity of the included studies have not
been reported. The authors have ignored other major compo-
nents of a full systematic review. The aim of the systematic re-
view is to assess the quality of included articles and
heterogeneity to disclose the risk of bias and conclude the level
of evidence. The concluded level of evidence is a major part to
provide the research and clinical recommendations. Moreover,
the systematic reviews have to provide the effectiveness of inter-
ventions with the level or quality of included evidence [2]. Thus,
to determine the level of evidence, we believe that adapting the
Grading of Recommendations Assessment, Development and
Evaluation or Physiotherapy Evidence Database approach is
highly recommended and efficient [3,4].
The systematic review is different from other types of literature
reviews. It must provide an explicit, reproducible methodology
and include a systematic search that attempts to identify all
studies that would meet the eligibility criteria [5]. This unique
construction requires the Methods section of a systematic review
to be evaluated much like a quantitative research study. However,
this review has also several troubling flaws in the methods. The
authors reported using PubMed, there was also the opportunity
to use Medical Subject Headings in the search. Using subject head-
ings in addition to keywords is a key point of searching for studies
according to the Cochrane Handbook for Systematic Reviews of In-
terventions [5].
Mohammad Alwardat, PT, PhD*
Neuroscience PhD School
Department of Systems Medicine
University of Rome “Tor Vergata”
Rome, Italy
Mohammad Etoom, PT, PhD
Physical Therapy Department
Al-Isra University
Amman, Jordan
Paola Sinibaldi Salimei, PhD
Department of Biomedicine and Prevention
University of Rome “Tor Vergata”
Rome, Italy
* One or more of the authors of this paper have disclosed potential or pertinent
Reprint requests: Mohammad Alwardat, PT, PhD,
Neuroscience PhD School, Department of Systems Medicine,
University of Rome “Tor Vergata”,
Via Montpellier, 1, 00133, Rome, Italy.
2697
References
[1] Chen Y, Zhang X, Zhu Y, Jia Y, Wang H, Liu Y. Systematic review of three electrical
stimulation techniques for rehabilitation after total knee arthroplasty. J Arthro-
plasty 2018, https://doi.org/10.1016/j.arth.2018.01.070. [Epub ahead of print].
[2] Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred report-
ing items for systematic reviews and meta-analyses: the PRISMA statement.
PLoS Med 2009;6:e1000097.
[3] Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro
scale for rating quality of randomized controlled trials. Phys Ther 2003;83:713e21.
[4] Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al.
GRADE: an emerging consensus on rating quality of evidence and strength of
recommendations. BMJ 2008;336:924e6.
[5] Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of in-
terventions; 2011. p. 10e1. http://handbook.cochrane.org/ [accessed 11.03.18].
Letter to the Editor on “Correlation of the Caprini
Score and Venous Thromboembolism Incidence
Following Primary Total Joint ArthroplastydResults
of a Single-Institution Protocol”
To the Editor:
We have read with interest the manuscript by Bateman et al [1],
which aimed to correlate the Caprini risk score (CRS) with venous
thromboembolism (VTE) incidence following primary total joint
arthroplasty. The CRS is a validated tool created to identify surgical
patients at high risk of VTE occurrence [2]. Ideally, to validate a risk
assessment tool, several factors should be considered: prospec-
tively collected data, unbiased measurement of the tool, under-
stand the risk assessment tool (CRS in this case) as a categorical
variable for the analysis, power the study for the outcome, and
either control or standardize the discrepancy in prophylactic inter-
ventions. Several of those aforementioned steps are missing in this
study, therefore limiting the possibility to draw accurate or reliable
conclusions.
Although recent data have validated a patient-friendly CRS that
was found to be effective and highly accepted among patients and
physicians [3], face-to-face interaction between patient and a
competent health-care professional familiarized with CRS remains
mandatory to prospectively and accurately obtain medical history
and perform a thorough physical examination, which are funda-
mental to obtain a reliable CRS. Such concern is illustrated by Bate-
man, who reported that only 7% of the preoperative CRS were
calculated correctly. This, however, is a misinterpretation of the re-
sults. The 7% reported by the authors is best described as poor inter-
rater reliability of the calculation. This measurement represents the
percentage of agreement between the retrospectively calculated
preoperative CRS done by nurses and a retrospective calculation
of the CRS performed by the authors (calculated Caprini score).
One shall note that this problem has not been observed with CRS
in other publications after adequate staff training [4,5].
In the primary analysis, the authors measured the correlation of
the CRS with VTE occurrence; the poor correlation reported (r2 ¼
0.07) corresponds to the comparison of the 2 different modalities
used to estimate the CRS, rather than the correlation of the CRS
to VTE occurrence. The inter-rater reliability usually reflects the ac-
curacy of data collection methods, and ultimately, the quality of the
analytical outcome of a study [6]. Finally, the CRS best performs as a
categorical score, as recommended in the 2012 American College of
DOI of original article: https://doi.org/10.1016/j.arth.2017.06.042.
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.065.
2698 Letters to the Editors
Chest Physicians VTE prevention guidelines [7], for which the
selected statistics were inadequate.
As expected, authors acknowledge that 93% of the disagreement
in the CRS estimate was explained by the paucity of medical history.
It is important to emphasize that no copy of the form used was pro-
vided in the article nor were the CRS deficiencies in the 93% of pa-
tients documented. Therefore, the main variable of this study was
not and cannot be consider valid. Evidence of such deficiencies
and inaccurate calculation are seen in Figure 1 where “calculated
CRS” has a minimum of 5 points, which would represent an individ-
ual aged less than 40 years, not overweight, and with no comorbid-
ities, which is inconsistent with the typical joint arthroplasty patient
who is at least 50 years, generally with a body mass index of >25 kg/
m2 and other multiple comorbidities [8]. Correct assessment of such
population with CRS would result in scores around 9-12.
The CRS has been linearly correlated with incidence of VTE in
several surgical groups [5,9,10]. Although we agree with authors
that there is indeed a paucity of information regarding CRS and
VTE incidence in orthopedic surgical population, recent data sug-
gest that CRS could indeed predict VTE occurrence in patients un-
dergoing orthopedic surgical procedures [10]. We agree with
authors that orthopedic surgical population possesses a high risk
of VTE occurrence. It is well demonstrated that the use of risks
assessment tools empowers physicians to improve the VTE preven-
tion with measured mortality benefit.
Owing to multiple limitations, including retrospectively
collected data, incomplete documentation of comorbidities, only
inclusion of symptomatic deep vein thrombosis, limited knowledge
of deep vein thrombosis episodes seen in other institutions, and
lack of power, this study [1] cannot provide valid conclusions
regarding performance of CRS in detecting VTE occurrence in joint
arthroplasty patients.
Luis A. Diaz Quintero, MD*
Division of Internal Medicine
Department of Medicine
NorthShore University HealthSystem
Evanston, Illinois
Harry E. Fuentes, MD
Division of Internal Medicine
Department of Medicine
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois
Juan P. Salazar Adum, MD
Division of Internal Medicine
Department of Medicine
NorthShore University HealthSystem
Evanston, Illinois
Alfonso J. Tafur, MD
Division of Vascular Medicine
Department of Medicine
NorthShore University HealthSystem
Skokie, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois
James C. Kudrna, MD
Department of Orthopedic Surgery
University of Chicago Pritzker School of Medicine
NorthShore University HealthSystem
Glenview, Illinois
Joseph A. Caprini, MD
NorthShore University HealthSystem-Emeritus
Skokie, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois
*
Reprint requests: Luis Diaz Quintero, MD, Department of Internal
Medicine, Northshore University Healthsystem, 2650 Ridge
Avenue Room 5315, Evanston, IL 60201.
References
[1] Bateman DK, Dow RW, Brzezinski A, Bar-Eli HY, Kayiaros ST. Correlation of the
Caprini score and venous thromboembolism incidence following primary total
joint arthroplasty-results of a single-institution protocol. J Arthroplasty
2017;32:3735e41.
[2] Caprini JA, Arcelus JI, Hasty JH, Tamhane AC, Fabrega F. Clinical assessment of
venous thromboembolic risk in surgical patients. Semin Thromb Hemost
1991;17(Suppl 3):304e12.
[3] Fuentes HE, Paz LH, Al-Ogaili A, Andrade XA, Oramas DM, Salazar-Adum JP,
et al. Validation of a patient-completed Caprini risk score for venous thrombo-
embolism risk assessment. TH Open 2017;01:e106e12.
[4] Rios LHP, Fuentes HE, Oramas DM, Andrade XA, Al-Ogaili A, Iskander M, et al.
Validation of a patient-completed Caprini risk assessment tool for Spanish,
Arabic, and Polish Speakers. Clin Appl Thromb Hemost 2018;24:502e12.
[5] Hachey KJ, Sterbling H, Choi DS, Pinjic E, Hewes PD, Munoz J, et al. Prevention
of postoperative venous thromboembolism in thoracic surgical patients:
implementation and evaluation of a Caprini risk assessment protocol. J Am
Coll Surg 2016;222:1019e27.
[6] Gregory KE, Radovinsky L. Research strategies that result in optimal data
collection from the patient medical record. Appl Nurs Res 2012;25:108e16.
[7] Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, et al. Pre-
vention of VTE in nonorthopedic surgical patients: antithrombotic therapy
and prevention of thrombosis, 9th ed: American College of Chest physicians
evidence-based clinical practice guidelines. Chest 2012;141(2 Suppl):
e227Se77S.
[8] Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE,
Steiner CA, et al. Prevalence of total hip and knee replacement in the United
States. J Bone Joint Surg Am 2015;97:1386e97.
[9] Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized
venous thromboembolism risk stratification using the 2005 Caprini score to
identify the benefits and harms of chemoprophylaxis in surgical patients: a
meta-analysis. Ann Surg 2017;265:1094e103.
[10] Luksameearunothai K, Sa-Ngasoongsong P, Kulachote N, Thamyongkit S,
Fuangfa P, Chanplakorn P, et al. Usefulness of clinical predictors for preoper-
ative screening of deep vein thrombosis in hip fractures. BMC Musculoskelet
Disord 2017;18:208.
Response to the Letter to the Editor on “Correlation
of the Caprini Score and Venous Thromboembolism
Incidence Following Primary Total Joint
ArthroplastydResults of a Single-Institution
Protocol”
In Reply:
We thank Quintero et al for their critical reading of our manu-
script regarding the relationship between the Caprini risk score
(CRS) and venous thromboembolism (VTE) following total joint
arthroplasty (TJA).
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.065.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.064.
 Letters to the Editors
health conditions; however, we acknowledge that electronic
medical records are prone to human input errors. With that
said, this is a limitation of all studies that perform a retrospective
chart review.
Furthermore, we would like to further clarify how we assessed
acute postoperative pain within the first 48 hours, as we did not
rely on the Press Ganey survey, as per your letter. We determined
first 48-hour post-operative pain intensity using area under the
P
curve (AUC) for visual analog scale (VAS) scores (AUC ¼ [Pain
score  Dtime]), which we included in our methods section [3].
We acknowledge that we did not subdivide patients with
MDD based on various degrees of MDD severity. We understand
your concerns regarding perioperative treatment with antide-
pressants; however, the purpose of this study was to determine
if a diagnosis of MDD influenced postoperative pain and opioid
consumption following TJA. Furthermore, a study conducted by
Kohring et al [4] investigated the role of antidepressant
treatment and outcomes following TJA. They evaluated the
clinical outcomes of depressed patients receiving perioperative
antidepressant treatment (as determined by their active medi-
cation list), depressed patients who were not receiving active
treatment (also determined by the active medication list), and
nondepressed patients. They found that patients who were
actively taking antidepressant medication experienced similar
clinical improvements as nondepressed patients at 1 year post-
operative, whereas depressed patients who were not receiving
treatment did not show a significant difference in functional
outcome scores.
We appreciate your comment regarding acute postoperative
pain intensity. As stated in your Letter to the Editor, the concern
was that pain intensity in the first 3 days following surgery was
not sufficient to completely reflect opioid consumption and pain in-
tensity during the postoperative rehabilitation period. While your
statement is correct, our stated purpose was to assess immediate
postoperative pain intensity and opioid consumption and specif-
ically in the first 48 hours (2 days) following surgery.
We value your comments as they in conjunction with our report
may stimulate further study on this important topic. We hope our
response has addressed your concerns.
Appendix A. Supplementary Data
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.arth.2018.04.022.
Jennifer I. Etcheson, MD, MSa
Chukwuweike U. Gwam, MDa
Nicole E. George, DOa
Sana Virani, MDa
Michael A. Mont, MDb
Ronald E. Delanois, MDa,*
a
Rubin Institute for Advanced Orthopedics
Center for Joint Preservation and Replacement
Sinai Hospital of Baltimore
Baltimore, Maryland
b
Department of Orthopaedics
Lenox Hill Hospital
New York, New York
* based on previous published studies; thus, no ethical approval or patient consent
Reprint requests: Ronald E Delanois, MD, Rubin Institute for
Advanced Orthopedics, Center for Joint Preservation and
Replacement, Sinai Hospital of Baltimore, 2401 West Belvedere
Avenue, Baltimore, MD 21215.
2701
References
[1] Etcheson JI, Gwam CU, George NE, Virani S, Mont MA, Delanois RE. Opioids
consumed in the immediate post-operative period does not influence how pa-
tients rate their experience of care after total hip arthroplasty. J Arthroplasty
2018;33:1008e11, https://doi.org/10.1016/j.arth.2017.10.033.
[2] Gwam C, Mistry JB, Piuzzi N, Chughtai M, Khlopas A, Thomas M, et al. What
influences how patients with depression rate hospital stay after total joint
arthroplasty? Surg Technol Int 2017;30:373e8.
[3] McGraw-Tatum MA, Groover MT, George NE, Urse JS, Heh V. A prospective, ran-
domized trial comparing liposomal bupivacaine vs fascia iliaca compartment
block for postoperative pain control in total hip arthroplasty. J Arthroplasty
2017;32:2181e5, https://doi.org/10.1016/j.arth.2017.02.019.
[4] Kohring JM, Erickson JA, Anderson MB, Gililland JM, Peters CL, Pelt CE. Treated
versus untreated depression in total joint arthroplasty impacts outcomes. J Arthro-
plasty 2018, https://doi.org/10.1016/j.arth.2018.01.065 [Epub ahead of print].
Letter to the Editor on “Impact of Operative Time
on Adverse Events Following Primary Total Joint
Arthroplasty”
To the Editor:
We read with great interest the recent study “Impact of Opera-
tive Time on Adverse Events Following Primary Total Joint Arthro-
plasty” by Bohl et al [1]. The authors evaluated the impact of a 15-
minute extension of operative time on the occurrence of adverse
events following primary total joint arthroplasty, and found pro-
portional and relatively consistent increases in complication risk
with increased operative time. They concluded that “prolonged
operative time increases the risk for multiple postoperative compli-
cations following total joint arthroplasty.” Their efforts are of great
clinical significance and should be applauded. However, we think
this article raised some interesting concerns that should be
clarified.
First, we agree that operative time could be interpreted as a
modifiable factor when evaluating the association between specific
adverse events and the operative times. However, we think the
operative time is more than an independent contributor, but also
a predictor of the risk of adverse events because the operative
time is a single parameter that is determined by multiple variables.
In this study, the authors have detected some patient demo-
graphics, comorbidity, and procedural characteristics that are asso-
ciated with prolonged operative time. In addition, surgeon-related
factors (eg, preoperative design, surgeon volume, tourniquet use)
and hospital-related factors (eg, efficacy of teamwork, hospital vol-
ume, intraoperative management) would also have significant in-
fluence on the operative time. Therefore, operative time
represents a series of heterogeneous parameters to be considered
and compared when focusing on the adverse events, and mini-
mizing operative time is a systematic exploration of optimizing
DOI of original article: https://doi.org/10.1016/j.arth.2018.02.037.
Funding: None.
Author contribution: Xiang-Dong Wu contributed substantially to conception
and design; drafted the article; gave final approval of the version to be published;
and agreed to act as a guarantor of the work. Ke-Jia Hu contributed substantially to
draft the article; gave final approval of the version to be published; and agreed to
act as a guarantor of the work. Mian Tian contributed substantially to draft the
article; gave final approval of the version to be published; and agreed to act as a
guarantor of the work. Wei Huang contributed substantially to conception and
design; revised it critically for important intellectual content; gave final approval
of the version to be published; and agreed to act as a guarantor of the work.
Ethical approval or institutional review board (IRB) approval: This letter was
is required.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.030.
2702 Letters to the Editors
the operative procedures. Duration of operation, or referred to as
operative time, is a hotly debated and insufficiently explained
contributor [2,3] and is more of a predictor of adverse events [4].
Second, the associations between a 15-minute increase in
operative time and the occurrence of adverse events seem to
be largely influenced by the surgeon or hospital volume [5]. Evi-
dence suggests that complex surgical procedures such as joint
arthroplasty can result in improved outcomes when performed
by high-volume surgeons or in high-volume hospitals [6]. It has
been well established that both surgeon volume and hospital vol-
ume have impacts on postoperative complications, higher vol-
ume being associated with improved clinical outcomes [7e9].
Practice makes perfect, high-volume surgeons possess rich expe-
rience, clinical knowledge, and high-level surgical skills, who
tend to be more expertise than low-volume surgeons, and the
operative time would also be significantly reduced [5,10]. Simi-
larly, there is an apparent institutional volume effect within
high-volume hospitals, and the high efficacy teamwork and
availability of dedicated resources would contribute to short-
ening the operative time. Consequently, low-volume hospitals
or low-volume surgeons are associated with higher risk of
adverse events and prolonged operative time. Therefore, apart
from the mechanisms mentioned in the discussion section, the
hospital and surgeon volume would probably be fundamental
causes of increased risk of adverse events. Although the data
related to hospital or surgeon volume were missing, the potential
impact should be highlighted.
Last but not least, how slow is too slow? The study found there
was a consistent increase in relative risk across the spectrum of oper-
ative times, which seemed to indicate that the faster the operation,
the lower the risk of adverse event. However, we totally agree
with the authors that no compromise in surgical technique should
be made to obtain a shorter operative time. According to our experi-
ence, arthroplasty consists of many standardized surgical proced-
ures, which would take some time that could not accelerate
anymore. Thus, we believe there would be minimum operative times
for different types of joint arthroplasties. In addition, other clinical
outcomes (eg, mechanical axis, dislocation rate) were not collected,
and there might be a different association between operative time
and other outcomes. In the future, a possible recommended range
of operative time should be weighed against the clinical outcomes.
Xiang-Dong Wu, MDa
Ke-Jia Hu, MD, PhDb,c
Mian Tian, MDa
Wei Huang, MD, PhDa,*
a section.
Department of Orthopaedic Surgery
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
b work,” and “intraoperative management.” Relatedly, the authors
Department of Functional Neurosurgery, Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai, China
c
Department of Neurosurgery
Massachusetts General Hospital
Harvard Medical School
Boston, Massachusetts
*
Reprint requests: Wei Huang, MD, PhD, Department of
Orthopaedic Surgery, The First Affiliated Hospital of
Chongqing Medical University, No. 1, Youyi Road,
Yuanjiagang, Yuzhong District,
Chongqing, 400016, China.
References
[1] Bohl DD, Ondeck N, Darrith B, Hannon CP, Fillingham YA, Della Valle CJ. Impact
of operative time on adverse events following primary total joint arthroplasty. J
Arthroplasty 2018, https://doi.org/10.1016/j.arth.2018.02.037.
[2] Naranje S, Lendway L, Mehle S, Gioe TJ. Does operative time affect infection rate
in primary total knee arthroplasty? Clin Orthop Relat Res 2015;473:64e9.
[3] Duchman KR, Pugely AJ, Martin CT, Gao Y, Bedard NA, Callaghan JJ. Operative
time affects short-term complications in total joint arthroplasty. J Arthroplasty
2017;32:1285e91.
[4] Peersman G, Laskin R, Davis J, Peterson M, Richart T. Prolonged operative time
correlates with increased infection rate after total knee arthroplasty. HSS J
2006;2:70e2.
[5] Yasunaga H, Tsuchiya K, Matsuyama Y, Ohe K. High-volume surgeons in regard
to reductions in operating time, blood loss, and postoperative complications for
total hip arthroplasty. J Orthop Sci 2009;14:3e9.
[6] Halm EA, Lee C, Chassin MR. Is volume related to outcome in health care? A
systematic review and methodologic critique of the literature. Ann Intern
Med 2002;137:511e20.
[7] Ravi B, Jenkinson R, Austin PC, Croxford R, Wasserstein D, Escott B, et al. Rela-
tion between surgeon volume and risk of complications after total hip arthro-
plasty: propensity score matched cohort study. BMJ 2014;348:g3284.
[8] Katz JN, Losina E, Barrett J, Phillips CB, Mahomed NN, Lew RA, et al. Association
between hospital and surgeon procedure volume and outcomes of total hip
replacement in the United States Medicare population. J Bone Joint Surg Am
2001;83-A:1622e9.
[9] Tsai TC, Joynt KE, Orav EJ, Gawande AA, Jha AK. Variation in surgical-
readmission rates and quality of hospital care. N Engl J Med 2013;369:
1134e42.
[10] Lau RL, Perruccio AV, Gandhi R, Mahomed NN. The role of surgeon volume on
patient outcome in total knee arthroplasty: a systematic review of the litera-
ture. BMC Musculoskelet Disord 2012;13:250.
Response to Letter to the Editor on “Impact of
Operative Time on Adverse Events Following Primary
Total Joint Arthroplasty”
In Reply:
We would like to thank Wu et al [1] for writing a letter to the
editor regarding our manuscript entitled “Impact of Operative
Time on Adverse Events Following Primary Total Joint Arthro-
plasty.” That manuscript used the National Surgical Quality
Improvement Program (NSQIP) to test for independent associations
of operative time with adverse events following total hip and knee
arthroplasty. The major finding in our study was that operative
time was linearly associated with risks for anemia requiring trans-
fusion, wound dehiscence, renal insufficiency, sepsis, surgical site
infection, urinary tract infection, hospital readmission, and
extended hospital stay. This was true even with adjustment for
measured baseline patient characteristics. Wu et al made several
thoughtful observations, to which we respond in the following
First, the authors pointed out that there is the potential for con-
founding by unmeasured variables. Variables they highlighted
include “preoperative design,” “tourniquet use,” “efficacy of team-
pointed out that there is the potential for confounding of results
by hospital and surgeon volume. We fully agree with both of these
critiques. A hypothetical example of the potential confounding that
they highlight is that hospitals and surgeons who complete the op-
erations more quickly might also have better perioperative medical
management programs in place and hence a lower rate of medical
adverse events. As Wu et al point out, if this were the case, then
DOI of original article: https://doi.org/10.1016/j.arth.2018.04.030.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.029.
 The Journal of Arthroplasty 33 (2018) 2694e2703
Contents lists available at ScienceDirect
The Journal of Arthroplasty
journal homepage: www.arthroplastyjournal.org
Letters to the Editors
Letter to the Editor on “Local Infiltration
Analgesia With Liposomal Bupivacaine Improves
Pain Scores and Reduces Opioid Use After Total Knee
Arthroplasty: Results of a Randomized Controlled Trial”
To the Editor:
Mont et al [1] recently reported a statistically significant
decrease in postsurgical pain in patients receiving injections
of liposomal bupivacaine after total knee arthroplasty in the
Postsurgical Infiltration with exparel for Long Lasting Analgesia in
total knee aRthroplasty (PILLAR) study. The claim is incorrect. The
reduction in pain did not reach statistical significance.
Reference 20 describes the statistical analysis plan for the PILLAR
study [2]. According to the prespecified statistical plan: “the sample
size for the study was based on an assumption that 130 subjects per
group would be required to have a 90% power to detect a
0.3 unit
(mg intravenous morphine equivalent) between-group difference in
geometric means for total opioid dose, assuming a common standard
deviation of 0.670 using a 2-group t test with a 0.025 2-sided signifi-
cance level.” This is an entirely appropriate analysis plan. First, the pre-
specified statistical plan stipulates a 2-sided t test, the accepted
standard for randomized controlled trials. Second, the prespecified
plan stipulates a Bonferroni correction for 2 coprimary end points,
again an accepted standard.
In their report of the PILLAR study, the authors state “because
reduction in pain scores was being evaluated between treatment
groups, one-tailed tests were used… Mean (standard deviation)
AUC12-48 of visual analog scale pain intensity scores, the coprimary
efficacy end point, was 180.8 (94.80) with liposomal bupivacaine
and 209.3 (78.97) without liposomal bupivacaine, with a significant
least squares mean treatment difference (
26.88, P ¼ .0381).”
The reported 1-sided significance (P ¼ .0381) is half of the
2-sided significance (P ¼ .076). This is three-fold higher than the
prespecified threshold of 0.025. Thus, the reduction in pain score
was not statistically significant.
The prespecified statistical plan further states: “To control for
type 1 error, total opioid consumption will be tested only if the
comparison of pain intensity (area under the curve of visual analog
scale scores) between the liposomal bupivacaine and control
groups is significant.” However, the paper does exactly what the
prespecified plan prohibits. The authors report and statistically
test total opioid consumption. This propagates the type 1 error in
exactly the manner that the prespecified statistical plan was struc-
tured to avoid.
DOI of original article: https://doi.org/10.1016/j.arth.2017.07.024.
The author of this paper has disclosed potential or pertinent conflicts of inter-
est, which may include receipt of payment, either direct or indirect, institutional
support, or association with an entity in the biomedical field which may be
perceived to have potential conflict of interest with this work. For full disclosure
statement refer to https://doi.org/10.1016/j.arth.2018.03.032.
0883-5403/© 2018 Elsevier Inc. All rights reserved.
Thus, the author conclusions are compromised by 3 consequen-
tial deviations from the prespecific statistical plan:
(1). The authors substituted a 1-sided statistical analysis for the
customary and prespecified 2-sided statistical analysis,
(2). The authors ignored the prespecified Bonferroni penalty for
2 coprimary end points, interpreting their results against a
0.05 alpha level, and
(3). The authors propagated the type 1 error to the analysis of
total opioid consumption, ignoring the prespecified analysis
plan, and rending invalid their finding of a statistically sig-
nificant reduction in opioid consumption.
Steven L. Shafer, MD*
Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University
Stanford, California
*
Reprint requests: Steven L. Shafer, MD, Department of
Anesthesiology, Perioperative and Pain Medicine,
Stanford University School of Medicine, 300 Pasteur Drive,
MC-5640, Stanford, CA 94305-5640.
References
[1] Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration
analgesia with liposomal bupivacaine improves pain scores and reduces opioid
use after total knee arthroplasty: results of a randomized controlled trial. J
Arthroplasty 2018;33:90e6.
[2] Dysart S, Snyder MA, Mont MA. A randomized, multicenter, double-blind study
of local infiltration analgesia with liposomal bupivacaine for postsurgical pain
following total knee arthroplasty: rationale and design of the pillar trial. Surg
Technol Int 2016;30:261e7.
Response to Letter to the Editor on “Local Infiltration
Analgesia With Liposomal Bupivacaine Improves
Pain Scores and Reduces Opioid Use After Total Knee
Arthroplasty: Results of a Randomized Controlled Trial”
In Reply:
The active control treatment arm in this study is local infiltration
analgesia-bupivacaine HCl. The experimental treatment arm is lipo-
somal bupivacaine in addition to bupivacaine HCl. Both analgesics
have been approved by the Food and Drug Administration based on
demonstrated analgesic efficacy. Therefore, there is no scientific reason
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.032.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.033.
 Letters to the Editors
The authors are correct in describing the discrepancy between
“preoperative” and “calculated” scores in our article as poor
inter-rater reliability. However, Quintero et al do not characterize
how we obtained these scores correctly: “preoperative” scores
were collected retrospectively as recorded in the chart. However,
they were determined by preoperative nursing personnel before
surgery (not “retrospectively calculated preoperative CRS calcu-
lated done [sic] by nurses.”). While some suggest adequate staff
training may improve the accuracy of CRS calculation, other
reports, as we cited, have found the model has been poorly
implemented despite institutional training for nurses [1] and
physicians [2]. As stated in our article, according to our institu-
tion's protocol, this score is meant to be reviewed during the
surgical “time-out” and presumably acted upon at the surgeon's
discretion. We highlighted the poor accuracy of preoperative
scores to emphasize that, at our institution, these scores are
not obtained correctly in >90% of cases. Therefore, even if it
contained meaningful information to stratify VTE risk, the
surgeon would be presented with false values. Moreover, the
CRS utterly fails when considered as a categorical variable, as
every TJA patient is automatically considered “highest risk” by
virtue of undergoing “elective major lower extremity arthro-
plasty” (5 points) [3].
We agree that the poor inter-rater reliability reflects the
accuracy of data collection. Our suspicion was that preoperative
scores were not being calculated correctly, which is exactly
why we retrospectively determined them (calculated scores). Fig-
ures 1-3 demonstrate the distribution of preoperative
and calculated Caprini scores for 376 TJA patients. We clearly state,
“the correlation between preoperative and calculated scores was
poor (Fig. 3, r2 ¼ 0.079)” and do not attribute this value to the cor-
relation of the CRS to VTE occurrence. Data regarding the relation-
ship of CRS and VTE are presented in Table 3. We failed to
demonstrate a significant difference in calculated Caprini scores be-
tween patients with and without VTE.
As addressed in our limitations, it is plausible that not all
medical comorbidities were completely documented, poten-
tially leading to underestimation of Caprini scores for some
patients. However, 2 authors (D.K.B. and R.W.D.) independently
reviewed the senior author's history and physical, as well as the
documentation from each patient's primary care physician and/
or subspecialists providing medical clearance for arthroplasty
surgery. It is unlikely that a high number of relevant comorbid-
ities were not captured for the calculated Caprini scores. Both
the preoperative and calculated Caprini scores were determined
based on the table and methodology provided by Caprini [3].
We regret that this was not explicitly stated in our methods.
However, it would be impractical to list the CRS “deficiencies”
(missing items resulting in the discrepancy between preopera-
tive and our calculated scores) for all 376 patients, as Quintero
insists. We concede this to be another limitation. We found the
inaccuracy of nursing staffedetermined preoperative scores was
due to incomplete attribution of medical comorbidities and
technical error in using the model.
We maintain that our calculated scores are an accurate
representation of the CRS for our cohort. Quintero et al present
our minimum calculated score of 5 as evidence of “deficiencies
and inaccurate calculation.” Once again, a careful reading of our
inclusion criteria and our cohort's demographic characteristics
(Table 1) show an age range of 14e93 years. Indeed, we
included 3 patients who were aged less than 40 years and had
no medical comorbidities relevant to the CRS. Therefore, these
patients earned a calculated score of 5 (Figure 3b). The vast
majority of our patients had scores from 7 to 11, in keeping
with the typical TJA patient Quintero et al cite. The fact that
2699
these 3 young, healthy patients undergoing arthroplasty
surgery are still considered “highest risk” by the CRS demon-
strates that this model fails to provide clinically useful risk
stratification for TJA patients.
Several of the limitations Quintero et al present regarding our
study design have been adequately addressed in our manuscript.
We disagree regarding the end point of symptomatic VTE events,
as this is widely considered to be more clinically relevant in the
TJA population [4]. While we acknowledge the CRS has been vali-
dated in other medical and surgical groups, the immediate assign-
ment of “highest risk” to all TJA patients does not empower
physicians to improve VTE prevention. Furthermore, the CRS
scoring methodology attenuates the influence of other potentially
relevant comorbidities by assigning all patients 5 points for under-
going arthroplasty. We welcome the development of an accurate
and agile VTE risk assessment model tailored specifically to identify
higher risk TJA patients.
Dexter K. Bateman, MDa,*
Robert W. Dow, BSa
Andrzej Brzezinski, MDa
Howard Y. Bar-Eli, MDa
Stephen T. Kayiaros, MDb
a
Department of Orthopaedic Surgery
Rutgers Robert Wood Johnson Medical School
New Brunswick, NJ
b
University Orthopaedic Associates
New Brunswick, NJ
*
Reprint requests: Dexter K. Bateman, MD,
Department of Orthopaedic Surgery,
Rutgers Robert Wood Johnson Medical School,
1 RWJ Place, MEB 422A, New Brunswick, NJ 08901.
References
[1] Gharaibeh L, Albsoul-Younes A, Younes N. Evaluation of venous thromboembo-
lism prophylaxis after the introduction of an institutional guideline: extent of
application and implementation of its recommendations. J Vasc Nurs
2015;33:72e8.
[2] Pannucci CJ, Obi A, Alvarez R, Abdullah N, Nackashi A, Hu HM, et al. Inade-
quate venous thromboembolism risk stratification predicts venous throm-
boembolic events in surgical intensive care unit patients. J Am Coll Surg
2014;218:898e904.
[3] Caprini JA. Risk assessment as a guide for the prevention of the many faces of
venous thromboembolism. Am J Surg 2010;199(1 Suppl):S3e10.
[4] Friedman RJ. Optimal duration of prophylaxis for venous thromboembolism
following total hip arthroplasty and total knee arthroplasty. J Am Acad Orthop
Surg 2007;15:148e55.
Letter to the Editor on “Patients With Major
Depressive Disorder Experience Increased Perception
of Pain and Opioid Consumption Following Total
Joint Arthroplasty”
To the Editor:
We would like to congratulate Etcheson et al [1] on publication
of the article entitled “Patients With Major Depressive Disorder
DOI of original article: https://doi.org/10.1016/j.arth.2017.10.020.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.023.
2700 Letters to the Editors
Experience Increased Perception of Pain and Opioid Consumption
Following Total Joint Arthroplasty” on the Journal of Arthroplasty.
The authors have done an excellent job because there is a limited
number of reports investigating the influence of major depressive
disorder (MDD) on postoperative pain intensity and opioid con-
sumption for joint arthroplasty. They also provided arthroplasty
surgeons with some practical advice on dealing with MDD patients.
However, some questions confused us when we were reading the
article.
As we can see from the article, the diagnostic criteria of MDD
are of fundamental significance in the study because they influ-
ence the accuracy of the conclusion. However, neither did the
author provide a definition of MDD nor did they clarify what
kind of information was taken when evaluating MDD. The diag-
nosis of MDD can be established on the grounds of the clinical
records [2] or based on face-to-face surveys [3]. However, we
were not able to know anything about this from the study since
the Press Ganey survey the authors used is merely a quality
measure for patients' hospital experience [4], which is neither
suitable for evaluating MDD nor assessing the acute postoperative
pain. Furthermore, the diagnosis of MDD should be made by the
psychiatrists rather than orthopedic surgeons if more precise
results are to be achieved.
Another big concern of us about the study is the periopera-
tive treatment of MDD. According to the treatment protocol of
the study, no specific antidepression treatments (ADs) were
applied, thus may well leading to more consumption of opioid
drugs. We noticed that the authors did not subdivide the
MDD patients in terms of MDD severity, which we suppose is
a chink in the armor, because the ADs and opioid consumption
among varied severity levels of MDD must be different. Usually,
ADs are effective in severe MDD patients, while, for the mild-to-
moderate degree, the therapeutic effectiveness of placebos is
almost as effective as ADs [5,6]. Hence, it is reasonable for us
to assume that a lack of proper treatment to MDD plays a
confounding role here in this study. If placebos and/or
psychotherapies instead of more opioid are applied to those
mild-to-moderate MDD patients, the results may turn out to
be different.
Last but not least, the authors recorded postoperative pain
intensity for only 3 days, which is not sufficient to reflect the
whole picture of the opioid consumption and pain intensity dur-
ing the postoperative rehab period. In our medical center, MDD
patients with joint arthroplasty are followed up for at least 1
year, and they are also recommended to visit a psychiatrist on
a regular basis, because most of these patients suffer from
central sensitization pain and may consume more opioid after
discharge if MDD is not under well control, or their MDD symp-
toms can be exacerbated by postoperative pain, anxiety, or
nervousness.
We would like to further discuss these important issues
because it is helpful for surgeons to employ strategies for their
practice.
Appendix A. Supplementary Data
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.arth.2018.04.023.
Lingjia Yu, MD, PhDa,1
Ke Xiao, MD, PhDa,1
Danni Chib
Guixing Qiu, MD, PhDa
Xisheng Weng, MD, PhDa,*
a
Department of Orthopaedic Surgery
Peking Union Medical College Hospital
Peking Union Medical College and Chinese Academy of Medical
Sciences
Beijing, China
b
School of Psychology
Massey University
Auckland, New Zealand
*
Reprint requests: Xisheng Weng, MD, PhD, Department of
Orthopaedic Surgery, Peking Union Medical College Hospital,
Peking Union Medical College and Chinese Academy of Medical
Sciences, No. 1 Shuaifuyuan, Beijing 100730, China.
References
[1] Etcheson JI, Gwam CU, George NE, Virani S, Mont MA, Delanois RE. Patients
with major depressive disorder experience increased perception of pain and
opioid consumption following total joint arthroplasty. J Arthroplasty 2018;33:
997e1002.
[2] Rasouli MR, Menendez ME, Sayadipour A, Purtill JJ, Parvizi J. Direct
cost and complications associated with total joint arthroplasty in
patients with preoperative anxiety and depression. J Arthroplasty 2016;
31:533e6.
[3] Compton WM, Conway KP, Stinson FS, Grant BF. Changes in the prevalence
of major depression and comorbid substance use disorders in the United
States between 1991-1992 and 2001-2002. Am J Psychiatry 2006;163:
2141e7.
[4] Tyser AR, Abtahi AM, McFadden M, Presson AP. Evidence of non-response bias in
the Press-Ganey patient satisfaction survey. BMC Health Serv Res 2016;16:350.
[5] Paris J. The mistreatment of major depressive disorder. Can J Psychiatry
2014;59:148e51.
[6] Birnbaum HG, Kessler RC, Kelley D, Ben-Hamadi R, Joish VN, Greenberg PE.
Employer burden of mild, moderate, and severe major depressive disorder:
mental health services utilization and costs, and work performance. Depress
Anxiety 2010;27:78e89.
Response to Letter to the Editor on “Patients With
Major Depressive Disorder Experience Increased
Perception of Pain and Opioid Consumption
Following Total Joint Arthroplasty”
In Reply:
We thank Yu et al for the comments and appreciate the oppor-
tunity to reply. The goal of our study was to help arthroplasty
surgeons identify patients who may experience higher perceived
pain intensity and may be at risk for consuming more opioids in
the immediate postoperative period following lower extremity to-
tal joint arthroplasty (TJA). Furthermore, with patient satisfaction
serving as an important metric in determining reimbursement by
the Centers for Medicare and Medicaid Services under the Hospital
Value-Based Purchasing Program, identifying how specific patient
groups rate their experience of care is important for institutions
and orthopedic surgeons to understand [1, 2].
We recognize and agree that the diagnosis of major depressive
disorder (MDD) is most accurately made by psychiatrists, rather
than orthopedic surgeons. As such, a diagnosis of MDD was deter-
mined by a retrospective chart review to identify patients with a
diagnosis of MDD in their problem list. We rely on health profes-
sionals to maintain this problem list to accurately reflect active
DOI of original article: https://doi.org/10.1016/j.arth.2018.04.023.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.022.
2696
Response to the Letter to the Editor on “Continuous
Adductor Canal Blocks Provide Superior Ambulation
and Pain Control Compared to Epidural Analgesia for
Primary Knee Arthroplasty: A Randomized,
Controlled Trial”
In Reply:
We would like to thank Drs Castro-Alves and Kendall for their
thoughtful inquiry and comments on our article. We agree with
the intent of the suggestions and would like to describe our
motivation as well as include the results of your suggested modifi-
cations, which indicate that our results are robust.
As to the first point, we agree that dropout imbalance between
treatments can certainly affect outcomes, particularly if there is a causal
relationship between treatment and dropout rate. However, we found
no differences in demographics between groups irrespective of the
dropout rate. In addition, all analyses were originally performed as a
per-protocol (PP) and an intent-to-treat (ITT) analysis, but no differ-
ences were found in the resulting interpretations.
For example, here are the main and secondary outcomes as seen in
Table 2:
P values for both PP and ITT:
Ambulation distance PP: P ¼ .0206 ITT: P ¼
Pain scores PP: P ¼ .0094 ITT: P ¼
Procedure length PP: P ¼ .4105 ITT: P ¼
Discharge day PP: P ¼ .0037 ITT: P ¼
Patient satisfaction PP: P ¼ .0009 ITT: P ¼
Based on these results, we can see that the resulting outcomes were
not sensitive to the imbalance in the dropouts. We would like to clarify
that the P value of .0009 as originally reported in Table 2 under the “Pa-
tient satisfaction” outcome is intended only for the comparison of “very
satisfied” vs “not very satisfied” between groups. The percentages of
the other satisfaction ratings were included for completion, but inclu-
sion of the whole set would not change the significance.
As to the second point, we described in the article that neither
age nor surgical duration were statistically significant, so we did
not include them in our original multivariate model. However,
because they do trend toward significance, we factored them into
a new model per your suggestion to allay any concerns. We found
that our groups were still significantly different in our primary out-
comes of ambulation distance with a P value of .018 and for the
model covariates: age (P ¼ .5944), procedure length (P ¼ .0063).
For the pain score outcome, including the covariates once again
gave us similar result with a P value of .0056 for group differences
and covariates: age (P ¼ .5766), procedure length (P ¼ .2095).
Including the covariates improved the strength of our models.
As to the last suggestion; the use of a family-wise or study-wise
control of error inflation is based on our interpretation of the intent
of such adjustments. Taken to either extreme, these adjustments are
obviously overly conservative or overly liberal. We take the position
that accounting for error inflation of tests that are closely related is
reasonable, and as mentioned in the methods section, we use the
Tukey-Kramer method for within model control of error inflation.
We agree that for a set of tests/hypotheses that are related (a fam-
ily of hypotheses), the type I error should be properly controlled [1].
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.036.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.035.
Letters to the Editors
If, for instance, we were looking at ambulation distance, stair climb-
ing, getting up from a chair, or other closely related outcomes we
would apply adjustments such as a stepdown Bonferroni method
to this set of test to control the family-wise error.
In addition, we had 1 primary outcome, which was ambulation
distance. If this outcome was not significant after the first test, we
would not continue examining other outcomes to take its place in
the analysis. Therefore, we use this method as sort of a gatekeeper
to help control for overall type I error in the study. The primary
outcome was indeed significant, and so, we felt that it was appro-
priate to look at the secondary outcomes. Also, we believe it is
important that we do include several secondary outcomes, as these
provides the groundwork for other studies that can investigate
these outcomes in greater depth in further research.
We appreciate your inquiry into our study and hope that
we have been able to address all of your questions and concerns.
Erdan Kayupov, MD, MSE
Department of Orthopaedics
Rush University Medical Center
Chicago, Illinois
Mario Moric, MS
Department of Anesthesiology
Rush University Medical Center
.0220 Chicago, Illinois
.0067
.6272
.0005 Craig J. Della Valle, MD*
.0272 Department of Orthopaedics
Rush University Medical Center
Chicago, Illinois
*
Reprint requests: Craig J. Della Valle, MD, Division of Adult
Reconstructive Surgery, Rush University Medical Center,
Chicago, IL 60612.
Reference
[1] James Hung HM, Wang S-J. Challenges to multiple testing in clinical trials.
Biom J 2010;52:747e56, https://doi.org/10.1002/bimj.200900206.
Letter to the Editor on “Systematic Review of Three
Electrical Stimulation Techniques for Rehabilitation
After Total Knee Arthroplasty”
To the Editor:
Chen et al [1] recently conducted a systematic review that eval-
uated the effectiveness of neuromuscular electrical stimulation
(NMES), transcutaneous electrical nerve stimulation (TENS), and
electroacupuncture (EA) for improving patient rehabilitation after
total knee arthroplasty (TKA). It is encouraging to see how this non-
pharmacological interventions influence the patients after TKA. We
have several comments regarding this review.
The review is reported according to the Preferred Reporting
Items for Systematic Review and Meta-Analysis format, but the
inclusion criteria are ambiguous. The authors do not sufficiently
DOI of original article: https://doi.org/10.1016/j.arth.2018.01.070.
Funding: The authors received no financial support for the research, authorship,
and/or publication of this article.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.034.
 Letters to the Editors
follow the PICO format (P: participants, I: intervention, C: com-
parison, O: outcomes). The authors state the inclusion criteria
as: “Studies were included in this review if they were random-
ized controlled trials involving at least 20 patients who received
NMES, TENS, or EA following primary TKA”. Additionally, the au-
thors state the review aims to: “address the following questions:
(1) Is NMES effective at improving postoperative muscle strength
after TKA? (2) Are TENS and EA effective at providing analgesia
after TKA? and (3) What should be the ideal parameters and
intervention protocols to maximize the recovery benefits of
each technique?” Surprisingly, the review did not clearly report
the other components of inclusion criteria such as comparison
and outcome measures. Running a systematic review without
full knowledge about the inclusion criteria can lead to problems
with assessing the validity, applicability, and comprehensive-
ness of the systematic review [2].
The authors state that “we conducted this systematic review
to assess the available evidence.” Furthermore, the qualities of
evidence and heterogeneity of the included studies have not
been reported. The authors have ignored other major compo-
nents of a full systematic review. The aim of the systematic re-
view is to assess the quality of included articles and
heterogeneity to disclose the risk of bias and conclude the level
of evidence. The concluded level of evidence is a major part to
provide the research and clinical recommendations. Moreover,
the systematic reviews have to provide the effectiveness of inter-
ventions with the level or quality of included evidence [2]. Thus,
to determine the level of evidence, we believe that adapting the
Grading of Recommendations Assessment, Development and
Evaluation or Physiotherapy Evidence Database approach is
highly recommended and efficient [3,4].
The systematic review is different from other types of literature
reviews. It must provide an explicit, reproducible methodology
and include a systematic search that attempts to identify all
studies that would meet the eligibility criteria [5]. This unique
construction requires the Methods section of a systematic review
to be evaluated much like a quantitative research study. However,
this review has also several troubling flaws in the methods. The
authors reported using PubMed, there was also the opportunity
to use Medical Subject Headings in the search. Using subject head-
ings in addition to keywords is a key point of searching for studies
according to the Cochrane Handbook for Systematic Reviews of In-
terventions [5].
Mohammad Alwardat, PT, PhD*
Neuroscience PhD School
Department of Systems Medicine
University of Rome “Tor Vergata”
Rome, Italy
Mohammad Etoom, PT, PhD
Physical Therapy Department
Al-Isra University
Amman, Jordan
Paola Sinibaldi Salimei, PhD
Department of Biomedicine and Prevention
University of Rome “Tor Vergata”
Rome, Italy
* One or more of the authors of this paper have disclosed potential or pertinent
Reprint requests: Mohammad Alwardat, PT, PhD,
Neuroscience PhD School, Department of Systems Medicine,
University of Rome “Tor Vergata”,
Via Montpellier, 1, 00133, Rome, Italy.
2697
References
[1] Chen Y, Zhang X, Zhu Y, Jia Y, Wang H, Liu Y. Systematic review of three electrical
stimulation techniques for rehabilitation after total knee arthroplasty. J Arthro-
plasty 2018, https://doi.org/10.1016/j.arth.2018.01.070. [Epub ahead of print].
[2] Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred report-
ing items for systematic reviews and meta-analyses: the PRISMA statement.
PLoS Med 2009;6:e1000097.
[3] Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro
scale for rating quality of randomized controlled trials. Phys Ther 2003;83:713e21.
[4] Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al.
GRADE: an emerging consensus on rating quality of evidence and strength of
recommendations. BMJ 2008;336:924e6.
[5] Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of in-
terventions; 2011. p. 10e1. http://handbook.cochrane.org/ [accessed 11.03.18].
Letter to the Editor on “Correlation of the Caprini
Score and Venous Thromboembolism Incidence
Following Primary Total Joint ArthroplastydResults
of a Single-Institution Protocol”
To the Editor:
We have read with interest the manuscript by Bateman et al [1],
which aimed to correlate the Caprini risk score (CRS) with venous
thromboembolism (VTE) incidence following primary total joint
arthroplasty. The CRS is a validated tool created to identify surgical
patients at high risk of VTE occurrence [2]. Ideally, to validate a risk
assessment tool, several factors should be considered: prospec-
tively collected data, unbiased measurement of the tool, under-
stand the risk assessment tool (CRS in this case) as a categorical
variable for the analysis, power the study for the outcome, and
either control or standardize the discrepancy in prophylactic inter-
ventions. Several of those aforementioned steps are missing in this
study, therefore limiting the possibility to draw accurate or reliable
conclusions.
Although recent data have validated a patient-friendly CRS that
was found to be effective and highly accepted among patients and
physicians [3], face-to-face interaction between patient and a
competent health-care professional familiarized with CRS remains
mandatory to prospectively and accurately obtain medical history
and perform a thorough physical examination, which are funda-
mental to obtain a reliable CRS. Such concern is illustrated by Bate-
man, who reported that only 7% of the preoperative CRS were
calculated correctly. This, however, is a misinterpretation of the re-
sults. The 7% reported by the authors is best described as poor inter-
rater reliability of the calculation. This measurement represents the
percentage of agreement between the retrospectively calculated
preoperative CRS done by nurses and a retrospective calculation
of the CRS performed by the authors (calculated Caprini score).
One shall note that this problem has not been observed with CRS
in other publications after adequate staff training [4,5].
In the primary analysis, the authors measured the correlation of
the CRS with VTE occurrence; the poor correlation reported (r2 ¼
0.07) corresponds to the comparison of the 2 different modalities
used to estimate the CRS, rather than the correlation of the CRS
to VTE occurrence. The inter-rater reliability usually reflects the ac-
curacy of data collection methods, and ultimately, the quality of the
analytical outcome of a study [6]. Finally, the CRS best performs as a
categorical score, as recommended in the 2012 American College of
DOI of original article: https://doi.org/10.1016/j.arth.2017.06.042.
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.065.
 The Journal of Arthroplasty 33 (2018) 2460e2464

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Liposomal Bupivacaine vs Plain Bupivacaine in Periarticular

Injection for Control of Pain and Early Motion in Total Knee
Arthroplasty: A Randomized, Prospective Study
Jason P. Zlotnicki, MD a, Brian R. Hamlin, MD b, Anton Y. Plakseychuk, MD, PhD b,
Timothy J. Levison, MS b, Scott D. Rothenberger, PhD c,
Kenneth L. Urish, MD, PhD a, b, c, d, e, *
a
Department of Orthopaedic Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA
b
The Bone and Joint Center, Magee Womens Hospital of the University of Pittsburgh Medical Center, Pittsburgh, PA
c
Clinical and Translation Science Institute, Department of Medicine, University of Pittsburgh, Pittsburgh, PA
d
Arthritis and Arthroplasty Design Group, University of Pittsburgh, Pittsburgh, PA
e
Department of Biomedical Engineering, Carnegie Mellon University, Pittsburgh, PA

a r t i c l e i n f o a b s t r a c t

Article history: Background: The use of multimodal pain regimens has been shown to be an effective technique for the
Received 2 February 2018 treatment of postoperative pain after total knee arthroplasty. Periarticular injections, of both short-acting
Received in revised form and long-acting anesthetics, have emerged as an additional method of providing significant improve-
3 March 2018
ment in postoperative pain relief. The purpose of this study is to compare the efficacy of periarticular
Accepted 6 March 2018
injection using long-acting vs short-acting preparations.
Available online 16 March 2018
Methods: A randomized, prospective study of 80 consecutive patients was performed comparing lipo-
somal bupivacaine vs plain bupivacaine periarticular injection. The primary outcomes included pain
Keywords:
total knee arthroplasty
relief, total narcotic usage, and completion of physical therapy goals, specifically range of motion.
liposomal bupivacaine Results: No significant improvements were noted between liposomal bupivacaine and plain bupivacaine
bupivacaine injection groups in overall pain reduction, range of motion, or total narcotic usage. At 24 hours, small
physical therapy statistically significant differences in physical therapy pain scores were noted with liposomal bupivacaine
pain vs plain bupivacaine and control patients, but these differences did not persist at later time points. Both
preparations demonstrated statistically significant improvements in range of motion when compared to
historical controls, but no differences were noted between preparations.
Conclusion: Overall, minimal significant differences were noted between liposomal bupivacaine and plain
bupivacaine at early and late time points. Both preparations of periarticular injection demonstrated su-
periority over control pain regimens but were relatively equivalent to one another in direct comparison.
© 2018 Elsevier Inc. All rights reserved.

Analgesia is a critical postoperative component of total knee
arthroplasty (TKA). Multimodal pain regimens have emerged as an
effective way to treat the various causes of surgical pain and allow
patients’ early return to activity and satisfactory levels of comfort.
Poor control of postoperative pain and high opioid requirements
This study was performed at the Department of Orthopaedic Surgery and Clinical
and Translation Science Institute at the University of Pittsburgh, Pittsburgh, PA.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.014.
* Reprint requests: Kenneth L. Urish, MD, PhD, Department of Orthopaedic Sur-
gery, University of Pittsburgh, 300 Halket, Suite 1601, Pittsburgh, PA 15219.
can delay patient mobilization and physical therapy, prolonging
hospital stay and ultimately decreasing patient satisfaction and
outcomes [1e3]. The numerous side effects and complications of
opioids, a mainstay of conventional TKA pain management, are well
documented [4]. Periarticular injections for the treatment of sur-
gical pain have gained widespread traction as an adjunct to oral and
intravenous pain regimens, with the goal of providing improved
pain control while decreasing the administration of systemic an-
algesics [5,6]. A variety of periarticular injection “cocktails” have
been described and may include local anesthetics, nonsteroidal
anti-inflammatory drugs, steroids, or other locally active agents [7].
The local anesthetics bupivacaine or ropivacaine are an impor-
tant component of TKA periarticular injection. A new slow-release

https://doi.org/10.1016/j.arth.2018.03.014
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J.P. Zlotnicki et al. / The Journal of Arthroplasty 33 (2018) 2460e2464
formulation of liposomal bupivacaine has been introduced with the
potential to improve clinical efficacy of periarticular injections.
However, clinical studies have demonstrated mixed efficacy. There
have been a series of studies suggesting this slow-release formu-
lation of bupivacaine may be superior to standard periarticular
injections [8,9]. In addition, studies have demonstrated pain control
with liposomal bupivacaine to be equivalent to that provided by
intrathecal morphine or femoral nerve block, with less systemic
side effects [9e11]. These latter femoral nerve block comparison
studies document improved early ambulation, higher percentage of
physical therapy milestones met, decreased opiate consumption,
and decreased hospital length of stay with liposomal bupivacaine
preparation [10e12]. Other studies have demonstrated equivalent
or inferior pain control with long-acting liposomal bupivacaine
preparations as compared to short-acting bupivacaine [13e16].
The conclusions drawn from early comparison studies have
been unclear and difficult to apply in clinical practice. Limitations of
these studies include retrospective design and comparisons be-
tween liposomal bupivacaine periarticular injection and a multi-
modal pain regimen cocktail that contains numerous active agents.
In addition, they had limited patient-reported outcome measures.
More recent prospective studies have compared periarticular in-
jection with liposomal bupivacaine to intra-articular bupivacaine
infusion (ON-Q*) and liposomal bupivacaine vs normal bupivacaine
as part of a larger periarticular injection cocktail. In these studies,
no significant differences were noted in narcotic consumption, vi-
sual analog scale pain score, or hospital length of stay [17e19].
Although these studies evaluate secondary “functional” outcomes,
these studies lack the necessary combination of pain control and
objective functional outcome (ie, knee range of motion, total dis-
tance walked).
The goal of the study was to prospectively compare liposomal
bupivacaine to traditional bupivacaine at multiple time points and
patient-reported outcomes. These end points include pain scores,
pain medicine usage, and postoperative range of motion. We hy-
pothesized that long-acting liposomal bupivacaine would provide
better pain relief and achieve increased progress with physical
therapy when compared to traditional bupivacaine preparations
and historical control patients.
Materials and Methods
This prospective, randomized, blinded, institutional review
boardeapproved study enrolled 80 consecutive patients that met
inclusion criteria as set forth by the experimental protocol. Inclu-
sion criteria included cemented primary TKA, ability to receive
regional anesthetic with intrathecal morphine injection, ability to
participate in the institution’s multimodal pain pathway, and no
history of chronic opioid abuse or withdrawal. Multimodal pain
pathway, as defined by our institution, consisted of preoperative
oral dosing of acetaminophen, pregabalin, celecoxib, spinal
administration of bupivacaine and morphine, and postoperative
dosing of oral narcotic, celecoxib, and pregabalin. At the time of
enrollment, the participants were randomized to receive a peri-
articular injection with either plain bupivacaine or liposomal
bupivacaine. Both patients and staff (nursing and physical therapy)
were blinded between the periarticular injection groups. Two pa-
tients were excluded from the liposomal bupivacaine group sec-
ondary to further surgical intervention during the hospitalization
(periprosthetic fracture and acute wound dehiscence). In retro-
spective fashion, 40 consecutive patients who met all the inclusion
criteria before the initiation of the study served as a historical
control. No prestudy power analysis was performed. This was a trial
study where a set number of 40 vials of 20-cc liposomal bupiva-
caine were made available by the health system.
2461
Patients were screened and selected based upon the afore-
mentioned inclusion criteria and were provided written and oral
explanations of the goals of study before obtaining informed
consent. All surgical procedures were performed by 2 fellowship-
trained orthopedic surgeons. Patients received appropriate
medication as set forth by the institutional preoperative multi-
modal pain pathway before initiation of intrathecal medication
and surgery. Once in the operating room, 20 cc of either 0.5% plain
bupivacaine or liposomal bupivacaine was mixed with 70 cc of
normal saline and divided among three 30-cc syringes based upon
the selected randomized group. This accounted for the manufac-
turer instructions, which called for 1 vial (20 cc) of liposomal
bupivacaine to be diluted into 70 cc normal saline for a total
volume of 90 cc. The plain bupivacaine was diluted in the same
fashion so that identical volumes were injected in the operating
room. After completion of bone preparation, 30 cc of the peri-
articular injection was infiltrated into posterior capsule (avoiding
the midline) and the periosteum of the femur and tibia. After
cementation of implants, 30 cc of the periarticular injection was
infiltrated along the arthrotomy including the quadriceps and
patellar tendon. The last 20 cc was injected throughout the sub-
cutaneous layer. A 21-gauge needle was used for the injection and
multiple small injections of the solution were performed at each
of the aforementioned sites. We followed the manufacturer’s
suggested protocol for injection.
Patients experienced routine care as part of the institutional
postoperative multimodal pain and rehabilitation pathways,
including the aforementioned postoperative pain regimen and day
of surgery mobilization with daily continuous passive motion.
Data collected in the perioperative period included de-
mographic(s): age, sex, body mass index (BMI), American Society
of Anesthesiologists (ASA) status, and physical status score. Pain
scores, narcotic usage, and completion of physical therapy goals
including objective reporting of range of motion were recorded as
primary outcomes. All data were reported using summary statis-
tics including means and standard deviations for quantitative
data, and frequencies and percentages for qualitative data. P
values for age and BMI were obtained using F-tests. P values for
ASA and LOS were obtained using Kruskal-Wallis tests. P values for
surgeon, gender, and D/C disposition were obtained using Fisher
exact test. Pain medication usage, physical therapy pain scores, and
range of motion were analyzed using a linear mixed-effects model
controlling for effects of gender and surgeon. Pairwise comparisons
between groups were made using t-tests produced by the model
fits. P values were adjusted using a Bonferroni correction to account
for multiple comparisons. A simple linear regression model was
used to investigate differences in total medication used. Time to
first narcotic was analyzed using Wilcoxon rank sum tests, and P
values were adjusted for multiple comparisons using a Bonferroni
correction.
Results
There were a total of 40 patients in the plain bupivacaine group
who received periarticular injection with plain bupivacaine, 38
patients in the liposomal bupivacaine group who received peri-
articular injection with liposomal bupivacaine, and 40 historical
controls who received no periarticular injection but were enrolled
in the institutional preoperative and postoperative pain pathway.
There were no statistical differences between age, BMI, and ASA
status, but a statistically significant imbalance in gender was noted
(Table 1). Further multivariable analysis demonstrated this gender
imbalance did not alter results.
Postoperative physical therapy pain scores and objective mea-
sure pain scores were obtained at 24- and 48-hour time points, and
2462 J.P. Zlotnicki et al. / The Journal of Arthroplasty 33 (2018) 2460e2464
Table 1
Patient Demographic Characteristics.
Characteristic All (N ¼ 118) Liposomal Bupivacaine (N ¼ 38)
Age, mean (SD) 62.7 (8.5) 63.2 (7.2)
BMI, mean (SD) 35.4 (6.7) 35.5 (7.4)
ASA status, median (IQR) 3 (2-3) 3 (2-3)
Gender, N (%)
Male 42 (64.4) 19 (50.0)
Female 76 (35.6) 19 (50.0)
No significant statistical differences were noted in patient age, BMI, and ASA status, but a statistically significant imbalance in gender was noted (P ¼ .0439).
SD, standard deviation; BMI, body mass index; ASA, American Society of Anesthesiologists; IQR, interquartile range.
objective measurements of flexion/extension were recorded on
postoperative day 1 and at time of discharge. A statistically signif-
icant decrease in pain score during physical therapy was noted
during the first 24 hours in comparison of liposomal bupivacaine
group to controls and liposomal bupivacaine to plain bupivacaine,
but this was not observed at later time points (Table 2). In terms of
motion, a statistically significant improvement in early motion was
noted for both periarticular injection groups as compared to con-
trol. Periarticular injection demonstrated an improvement in
postoperative flexion: 82.7
(liposomal bupivacaine) and 80.0

(plain bupivacaine) compared to 66.4
(controls) on postoperative
day 1. These differences were not observed at later time points, and
there was no statistically significant difference in direct comparison
between liposomal and plain bupivacaine groups (Table 3).
Pain control was assessed by observing total morphine equiva-
lent dosage (MED) between groups (Fig. 1). Average MED required
by patients at time points 0-24 hour, 24-48 hour, and 48-72 hour
and average total MED were recorded and comparison tests were
performed. The only statistically significant difference noted was in
the comparison between liposomal bupivacaine and historical
control patients at the 0-24 hour (early) time point. This significant
difference was not observed at later time points. There were no
differences observed between the liposomal bupivacaine and plain
bupivacaine group in any of the measures of total pain medication
administered. In terms of total MED used within the hospitaliza-
tion, no significant differences were noted.
Discussion
Periarticular injections for the treatment of surgical pain have
gained widespread traction as an adjunct to oral and intravenous
pain regimens, with the goal of providing improved pain control
while decreasing the administration of systemic analgesics [5,6]. In
our prospective, randomized study, periarticular injection, whether
liposomal bupivacaine or plain bupivacaine, resulted in decreased
pain and improved functional performance in early physical ther-
apy as compared to the control group. We could not clinically
differentiate any meaningful difference in pain or functional out-
comes between the liposomal bupivacaine and plain bupivacaine
group. Despite this lack of significance, interesting differences were
seen in both pain medication use and physical therapy
Table 2
Physical Therapy Pain Scores.
Time Physical Therapy Pain Score
LB PB Control
24 h 5.4 6.9 7.3
48 h 3.9 5 5.2
Physical therapy pain scores at both 24 h and 48 h postoperatively were recorded for both treatment groups and historical controls. A significant decrease in pain score during
physical therapy was noted at early time point between the LB group and historical controls, but this was not observed at later time points.
LB, liposomal bupivacaine; PB, plain bupivacaine; C, controls.
Plain Bupivacaine (N ¼ 40) Control (N ¼ 40) P Value
64.3 (8.8) 60.7 (9.0) .1454
35.4 (6.6) 35.2 (6.3) .9773
3 (2-3) 2 (2-3) .0595
14 (35.0) 9 (22.5) .0439
26 (65.0) 31 (77.5)
achievements across all groups (no periarticular injection, tradi-
tional periarticular injection, etc.)
Postoperative pain is a critical component of a successful
arthroplasty. Poor control of postoperative pain and high opioid
requirements can delay patient mobilization and physical therapy,
prolonging hospital stay and ultimately decreasing patient satis-
faction and outcomes [1e3]. In this study, our data demonstrated
decreases in pain medication used at early postoperative time
points with the use of periarticular injection. This effect was sta-
tistically significant for liposomal bupivacaine and as compared to
the control group at up to 24 hours postoperatively, but the effects
after that point were equivocal. Although plain bupivacaine did not
demonstrate statistical significance (P ¼ .06), large, clinically sig-
nificant decreases in pain medication consumption were observed
within this group compared to control group. These findings are
comparable to other findings in the current literature. Surdam et al
and Yu et al demonstrated decreased opiate consumption with
liposomal bupivacaine compared to femoral nerve block [10,11]. In
our study, average pain medicine administered was decreased in
the early time point for liposomal bupivacaine and plain bupiva-
caine groups, showing an early decrease in postoperative pain and
requirement for opiate. Although these results were noted in
multiple time points by Barrington et al, the effect of liposomal
bupivacaine and plain bupivacaine was only realized in the early
time point when compared to control groups [9]. Additionally,
there was no statistically significant difference between the lipo-
somal bupivacaine and plain bupivacaine groups.
Adequate postoperative pain control and avoidance of opiate-
driven systemic side effects allow for earlier mobilization and
more effective physical therapy. Improved early ambulation and a
higher percentage of physical therapy milestones met have been
demonstrated in the literature with liposomal bupivacaine peri-
articular injection [10e12]. In our study, we hypothesized that
liposomal bupivacaine would demonstrate significant improve-
ments in objective knee range of motion values when compared to
plain bupivacaine and control groups. Likewise, these earlier im-
provements in therapy milestones would allow for persistent,
improved motion at discharge. The data revealed that statistically
significant improvements were noted in both pain scores during
physical therapy and objective range of motion at early time point
(0-24 hour) in liposomal bupivacaine vs controls (P < .05).
P Values
LB vs C PB vs C LB vs PB
.005 1.00 .03
.10 1.00 .17
 J.P. Zlotnicki et al. / The Journal of Arthroplasty 33 (2018) 2460e2464
Table 3
Postoperative Range of Motion.
Time Motion Measurement (
)
LB PB
POD#1 Extension 7.6 7.7
Flexion 82.7 80.0
Discharge Extension 5.8 6.2
Flexion 87.2 89.1
Postoperative range of motion data were recorded for both treatment groups and historical controls. A significant improvement in early motion was noted for both peri-
articular injection groups, but these differences were not observed at later time points.
POD, postoperative day; LB, liposomal bupivacaine; PB, plain bupivacaine; C, controls.
Statistically significant improvements in pain control with plain
bupivacaine vs controls at early time point were also observed. In
addition, the improvements seen at early time points did not
persist in comparison to nonperiarticular injection control subjects
at later time points and discharge. This decrease in early physical
therapy pain and improved flexion noted with liposomal bupiva-
caine and plain bupivacaine compared to control support the
notion of improved motion in the early postoperative period with
periarticular injection, but the effect does not appear to be resilient
in comparison to nonperiarticular injection groups.
A cost comparison between the 2 different periarticular in-
jections demonstrated a cost of $2.28 for 20-cc vial of 0.5% plain
bupivacaine vs $285.00 for a 20-cc vial of liposomal bupivacaine,
minus the cost of 70 cc of normal saline that was added to both
substances for dilution. This amounts to an added cost of $282.72 for
liposomal bupivacaine in comparison to plain bupivacaine. This is an
important consideration in an era of value-based orthopedic care
that accounts for both outcome and cost. From the results of our
study, the added cost of liposomal bupivacaine does not improve the
quality of care provided in postoperative pain management.
The collection of objective physical therapy measurements is a
strength of our study. A significant improvement is noted in the early
postoperative motion for both liposomal bupivacaine and plain
bupivacaine periarticular injection. This highlights an inherent
strength of periarticular injection in the postoperative pain regimen;
local anesthesia aimed directly at the soft tissue locations about the
knee can allow patients to achieve greater motion at earlier time
points. This suggests that periarticular injections significantly in-
crease objective physical therapy flexion in early time points. Lipo-
somal bupivacaine was observed to be more effective in reducing pain
during the first 24 hours. However, this effect was not seen at later
time points. This is interesting, as the theorized advantage of lipo-
somal bupivacaine is a prolonged release and analgesic effect due to a
slower, more controlled release of active medication.
Fig. 1. Average morphine equivalent dose (MED)da significant difference in average
MED required at early time point (0-24 h) was noted in comparison of control subjects
and the liposomal bupivacaine group, but this difference did not persist at later time
points.
2463
P Values
Control LB vs C PB vs C LB vs PB
8.5 .45 .79 1.00
66.4 <.0001 <.0001 1.00
4.9 .01 .38 1.00
85.3 1.00 .56 1.00
There were limitations in our study design. First, the use of a his-
torical control group did not allow all groups to be prospective. This
was necessary to allow the liposomal bupivacaine and plain bupiva-
caine groups to be completely blinded. Adding a group that received
no injection into the prospective arm would have introduced bias. The
decision to use 40 consecutive patients who all underwent surgical
intervention before the initiation of the study was aimed at elimi-
nating or limiting any aspect of bias. Second, there were no prestudy
power analyses or sample size calculations performed before execu-
tion of the study. However, it is important to note that a total of 40
vials of 20-cc liposomal bupivacaine were made available to our study
group by health system, and subsequent study size was determined
based on this limit. In addition, no post hoc power analyses were
performed based on results of the study to avoid the introduction of
biased results. Finally, an unexpected but statistically significant
heterogeneity was identified in patient demographics related to male
vs female gender (P < .05). Multivariate analysis demonstrated that
gender was not a statistically significant variable that predicted dif-
ferences in pain scores or functional outcomes.
In TKA, multimodal pain management that includes either
liposomal bupivacaine or plain bupivacaine periarticular injection
as compared to no periarticular injection results in better pain
control as measured by patient-reported outcome scores and
functional assessments. In our study, patients who received lipo-
somal bupivacaine had better pain experience at 24 hours post-
operatively in terms of total MED and pain score during physical
therapy when compared to non-PA control subjects. This benefit
was not observed at later time points nor was it statistically
different than the plain bupivacaine preparation group. Statistically
significant improvements in early postoperative flexion were
observed with the use of periarticular injection, whether liposomal
bupivacaine or plain bupivacaine, compared to historical controls,
but no statistically significant differences were observed between
periarticular injection groups in terms of objective physical therapy
outcome. These findings continue to document the success of
periarticular injection in the treatment of postoperative pain in TKA
and does not support any clinical difference between long-acting
liposomal and standard bupivacaine in periarticular injection.
Acknowledgments
Dr. Kenneth Urish is supported in part by the National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS
K08AR071494), the National Center for Advancing Translational
Science (NCATS KL2TR0001856), the Orthopaedic Research and
Education Foundation, and the Musculoskeletal Tissue Foundation.
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of ANSI/NISO Z39.48-1992 (Permanence of Paper)
 The Journal of Arthroplasty 33 (2018) 2435e2439

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Medial Mobile-Bearing Unicompartmental Knee Arthroplasty in

Young Patients Aged Less Than or Equal to 50 Years
Nicholas J. Greco, MD a, b, c, *, Adolph V. Lombardi Jr., MD, FACS a, b, c, d,
Andrew J. Price, DPhil, FRCS (Tr&Orth) e, Michael E. Berend, MD f,
Keith R. Berend, MD a, b, c
a
Joint Implant Surgeons, Inc., New Albany, OH
b
White Fence Surgical Suites, New Albany, OH
c
Mount Carmel Health System, New Albany, OH
d
Department of Orthopaedics, Ohio State University Wexner Medical Center, Columbus, OH
e
Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science, University of Oxford, Botar Research Centre, Oxford, United
Kingdom
f
Center for Hip and Knee Surgery, St. Francis Hospital, Mooresville, IN

a r t i c l e i n f o a b s t r a c t

Article history: Background: Contemporary research has shown medial mobile-bearing unicompartmental knee
Received 11 February 2018 arthroplasty to be an effective treatment in patients younger than 60 years; however, only one other
Received in revised form study has specifically investigated unicompartmental arthroplasty outcomes in patients 50 years or
21 March 2018
younger. The purpose of this study was to determine the clinical outcomes and survivorship of medial
Accepted 27 March 2018
mobile-bearing unicompartmental arthroplasty in this younger patient population.
Available online 9 April 2018
Methods: A retrospective review of patients undergoing primary unicompartmental knee arthroplasty
using the Oxford partial knee from 2003 to 2014 in a single practice database was performed. Patients
Keywords:
unicompartmental arthroplasty
were included in the study if they were 50 years of age or younger with a primary diagnosis of ante-
medial mobile-bearing arthroplasty romedial osteoarthritis and minimum clinical follow-up of 2 years. Patient clinical outcomes, function,
primary knee arthroplasty and need for revision surgery were assessed.
young patients Results: The study included 340 knees. Average patient age was 46.5 years, and the mean follow-up was
knee 6.1 years. Patients demonstrated significant improvements (P < .05) in range of motion (114.5 v 116.9),
University of California Los Angeles activity score (4.4 vs 5.6), Knee Society clinical (37.3 vs 86.5) and
functional scores (58.8 v 79.8). Overall, 20 patients required reoperation, and the predicted survival rate
was 96% at 6 years and 86% at 10 years. Aseptic loosening occurred in 7 patients at an average of 5.6 years
postoperatively, while 4 patients required conversion to total knee arthroplasty because of arthritic
progression at a mean time of 6.6 years. There were no revision procedures required due to polyethylene
liner wear or breakage.
Conclusion: Medial mobile-bearing unicompartmental arthroplasty should be considered as a treatment
option in patients younger than 50 years of age suffering from anteromedial osteoarthritis of the knee.
© 2018 Elsevier Inc. All rights reserved.

The “Oxford Knee” was first introduced by Goodfellow and
O'Connor in England in 1974 specifically for the treatment of
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.069.
* Reprint requests: Nicholas J. Greco, MD, Joint Implant Surgeons, Inc., 7277
Smith's Mill Road, Suite 200, New Albany, OH 43054.
anteromedial osteoarthritis of the knee [1,2]. It was a descendent of
early unicondylar arthroplasty procedures, but it first introduced
the concept of a fully congruent mobile articulating surface. His-
torically, survivorship has demonstrated to range between 84% and
100% at 10-year follow-up in various studies with 1 study exhibit-
ing 91% implant survivorship at 20-year follow-up [3e5].
Despite these generally successful outcomes, there has
remained constant debate centering on patient indications for the
procedure. Beginning in 1989, the classic article by Kozinn and
Scott detailed contraindications to uniarthroplasty procedures

https://doi.org/10.1016/j.arth.2018.03.069
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2436 N.J. Greco et al. / The Journal of Arthroplasty 33 (2018) 2435e2439
including both disease- and patient-specific criteria which were
based on outcomes from a case series of 100 patients [6]. They
stated that patients exceeding an age of 60 years, weight of 180
pounds, or those extremely physically active heavy laborers were
contraindicated for the procedure given an increased risk for me-
chanical loosening based on their anecdotal evidence. Interestingly,
this philosophy has remained prevalent, as a study of members of
the American Academy of Hip and Knee Surgeons in 2006 cited age
as the most important factor when deciding on treatment of pa-
tients with medial compartment arthritis, an intact anterior cru-
ciate ligament, and mild patellofemoral disease [7].
Multiple investigations have aimed to discredit this thought
process when determining the appropriate indication for a uni-
arthroplasty procedure. Pandit et al [8] showed that the Oxford
phase 3 implant revision rate and cumulative 10-year survival rates
were relatively similar for patients of age less than 60 years, weight
greater than 180 pounds, and those very active patients as
compared with the ideal patients satisfying the Kozin and Scott
criteria. The average age of the cohort less than 60 years old in this
study was 55 years with only a few included patients aged less than
50 years. Similarly, in a study from Heidelberg, Germany, exam-
ining return to activity in young patients following Oxford uni-
arthroplasty, 93% of patients returned to regular activity, and the
revision rate was merely 2.5% at an average age of 55 years in the
study cohort [9].
Even with these encouraging results in relatively young pa-
tients, the optimal treatment of medial compartment arthritic
disease in patients aged less than 50 years remains uncertain. High
tibial osteotomy was previously the primary means of surgical
management in this patient population, although more recent
study of long-term outcomes of this procedure is less promising
[10]. As such, utilization of this procedure has decreased. Arthro-
plasty has become increasingly utilized, but it remains an uncertain
treatment option in this age group as demonstrated by higher
revision rates of both total knee arthroplasty and uni-
compartmental knee arthroplasty demonstrated in multiple reg-
istry studies [11,12]. However, uniarthroplasty results in these
younger patients have scarcely been reported. In a report of the
Australian and Swedish joint registries, the survival rate at 7 years
was reported to be 81% in those patients under 55 years treated
with unicompartmental arthroplasty [12]. The only work studying
uniarthroplasty explicitly in patients younger than 50 years
comprised a cohort of 35 patients from France [13]. The patients
were treated with a fixed-bearing implant, and the operation was
performed through a standard medial parapatellar approach with
patellar eversion in which a 10-year implant survival reported in
2009 was 80.6% in this cohort.
Therefore, the purpose of this research was to scrutinize uni-
arthroplasty outcomes in patients younger than 50 years using a
medial mobile-bearing implant through a minimally invasive
approach. We sought to determine whether unicompartmental
arthroplasty would provide a viable solution for treatment of
medial compartment disease in this patient population, particu-
larly focusing on patients' return to function and whether implant
survival rate was comparable to the previously reported data.
Methods
Patients undergoing primary medial unicompartmental knee
arthroplasty from 2005 to 2015 within a single practice database
were retrospectively reviewed. Surgery was performed by one of
the 4 fellowship-trained joint arthroplasty surgeons. Patients were
included in the study analysis if they were of age less than or equal
to 50 years at the time of surgery. Those who had not completed a
minimum of 2-year clinical follow-up were excluded from the
participants. Furthermore, patients were included if their indica-
tion for surgery was anteromedial osteoarthritis, whereas those
patients with a diagnosis of avascular necrosis of the medial
femoral condyle or tibia were excluded from analysis. All patients
satisfied objective deformity criteria for anteromedial osteoarthritis
of the knee including completion of a valgus stress radiograph to
ensure appropriate correction of the deformity. Demographic data
for each patient were collected and included in the final analysis.
The Oxford partial knee arthroplasty (Zimmer Biomet; Warsaw,
Indiana) was used for all cases in this study. This implant consists of a
flat cobalt-chromium tibial tray with single keel and mobile poly-
ethylene bearing which articulates with a spherical femoral compo-
nent. An assortment of single-peg and twin-peg femoral components
was used in this study depending on the date of surgery. The articu-
lating surface of the polyethylene bearing is concave, and the geom-
etry perfectly matches the sphericity of the femoral component,
while the undersurface of the polyethylene is flat. The surgical pro-
cedure was performed using minimally invasive instrumentation
which allows the implantation without dislocation of the patella.
Postoperatively, the patient underwent a standard 4- to 6-week
course of physical therapy. Patients were evaluated clinically and
radiographically at follow-up appointments at 6 weeks and 1 year
postoperatively and on an annual basis thereafter unless problems
arose.
Clinical outcomes were measured by the Knee Society clinical
score, function score, and University of California Los Angeles ac-
tivity score at each follow-up appointment. Causes of implant
failure and need for revision surgery were also examined.
The goal of the analysis was to determine the change in clinical
function following the surgical procedure and to establish the rate
of revision surgery in this population. Preoperative clinical scores
were compared with the postoperative scores at the most recent
clinical follow-up timepoint. Student's 2-tailed t test was used to
compare the preoperative to postoperative clinical scores with a
standard error set at 5%. Survival rate was calculated from a life
table using revision for any cause as the end point.
Results
A total of 425 primary medial unicompartmental knee arthro-
plasty procedures were performed in patients younger than 50
years during the study period with 340 knees meeting the inclusion
criteria of anteromedial osteoarthritis and 2-year minimum clinical
follow-up. The mean patient follow-up was 6.1 years (range 2-13
years). Average patient age was 46.5 years (range 29-50 years).
Complete demographic data are presented in Table 1.
Clinical parameters and function improved postoperatively after
medial mobile-bearing unicompartmental arthroplasty. Improve-
ment in ROM was small but significant with a preoperative mean of
114.5 (standard deviation 12.4) and postoperative mean of 116.9
Table 1
Demographic Data for Study Population.
Two-Hundred Seventy-Nine Patients (340 Knees)
Male:female 41%:59%
Age (y) 46.5 (29-50)
Height (inches) 67.2 (59-79)
Weight (pounds) 226.2 (115-420)
BMI (kg/m2) 35.2 (18-62)
Insert height (mm) 3.6 (3-7)
Phase III:Twin-Peg 37%:631%
Operative time (min) 59.9 (24-182)
Tourniquet time (min) 38.4 (13-93)
Intraop blood loss (cc) 53.9 (20-300)
Length of stay (d) 1.0 (0-4)
BMI, body mass index.
 N.J. Greco et al. / The Journal of Arthroplasty 33 (2018) 2435e2439 2437

Fig. 1. Knee Society clinical and function scores.

(standard deviation of 11.2) (P ¼ .02); however, the overall objective rate free of revision surgery was estimated to be 96% at 6 years and
clinical parameters showed significant improvement of nearly 50 86% at 10 years postoperatively.
points in the Knee Society clinical score with a preoperative mean of Indications for utilization of unicompartmental arthroplasty
37.3 (standard deviation 13.4) and postoperative mean of 86.5 have evolved over time with continued debate over the ideal pa-
(standard deviation 17) (P < .001). Patients also reported significant tient candidate. In 1989, Kozinn and Scott were among the first to
improvement in functionality following surgery that measured develop disease- and patient-specific criteria for application of
nearly 20 points in the Knee Society function score with a preoper- unicompartmental arthroplasty [6]. They believed that patients
ative mean of 58.8 (standard deviation 16.2) and a postoperative older than 60 years, of weight greater than 180 pounds, and those
mean of 79.8 (standard deviation of 22) (P < .001). Knee Society extremely physically active patients or heavy laborers were rela-
clinical and function scores are presented in Figure 1. Patient activity tively contraindicated for the procedure. These principles stemmed
level also significantly increased as measured by the University of from an unpublished study of 100 consecutive unicompartmental
California Los Angeles activity score (P < .001). Preoperatively, the arthroplasty procedures performed by the author with 10-year
mean score of 4.4 (standard deviation 1.5) categorized patients as follow-up in which 9 of the 13 failures from mechanical loos-
being able to perform mild activity with limitations in activities ening occurred in patients meeting one of these aforementioned
around the house, whereas postoperatively, the mean score descriptions. Other authors have echoed this sentiment when
improved to 5.7 (standard deviation 1.8) which correlates with the indicating patients for the procedure [14]. This ideology has
ability to perform moderate physical activity such as swimming in remained prevalent as shown in a study of members of the Amer-
addition to having no limitations with daily housework. ican Academy of Hip and Knee Surgeons just over 10 years ago [7].
A total of 20 revision surgeries were performed during the
period of the study as presented in Table 2. The most common
cause for revision surgery was aseptic loosening in 7 patients with
an average age of 46.1 years (standard deviation 2.5 years) occur- Table 2
ring at an average of 5.6 years postoperatively (standard deviation Failed Unicompartmental Arthroplasty Cases.
1.6 years). Four patients with a mean age of 47 years (standard Age Time Reason for Revision
deviation 4 years) required conversion to total knee arthroplasty
43 F 0.8 Revised elsewhere
because of arthritic progression at a mean time of 6.6 years
46 F 1.7 Revised elsewhere
following the primary procedure (standard deviation 3.9 years). 48 F 3.4 Revised elsewhere
There were no revision procedures required due to polyethylene 41 F 1.3 Arthritic progression
liner wear or breakage in the study. Of interest, those patients 49 M 6.2 Arthritic progression
49 F 9.5 Arthritic progression
revised at other institutions and those revised for unexplained pain
49 F 9.5 Arthritic progression
were all reoperated on within 3 years of the primary surgery. The 42 M 3.2 Aseptic loosening
cumulative survival rate, using all-cause revision surgery as the end 50 F 6.2 Aseptic loosening
point, was 96% at 6 years and 86% at 10 years as presented in 46 M 4.4 Aseptic loosening
Table 3. 46 M 4.9 Aseptic loosening
46 M 6.2 Aseptic loosening
45 F 6.4 Aseptic loosening
48 F 8.2 Aseptic loosening
Discussion
42 M 0.2 Fall with instability, poly
47 M 2.4 Infection, poly
In our study of patients younger than 50 years of age with 47 M 1.1 Pain
anteromedial osteoarthritis, treatment with medial mobile-bearing 43 F 1.6 Pain
unicompartmental arthroplasty was shown to provide improve- 49 M 2.4 Pain
48 M 0.6 Tibia stress fracture
ment in patient function and clinical parameters. Patient survival
2438 N.J. Greco et al. / The Journal of Arthroplasty 33 (2018) 2435e2439

Table 3
Life Table Analysis Using Revision for Any Reason as End Point.

Interval Number Number Withdrawing Number Number of Proportion Proportion Cumulative Proportion Standard
End Time Entering During Interval Exposed Terminal Events Terminating Surviving Surviving at the Error
Interval to Risk End of Interval

1 340 0 340 1 0 1 1 0
2 339 12 333 2 0.01 0.99 0.99 0.01
3 325 42 304 4 0.01 0.99 0.98 0.01
4 279 38 260 3 0.01 0.99 0.97 0.01
5 238 36 220 1 0 1 0.96 0.01
6 201 46 178 1 0.01 0.99 0.96 0.01
7 154 37 135.5 2 0.01 0.99 0.94 0.02
8 115 19 105.5 3 0.03 0.97 0.92 0.02
9 93 22 82 2 0.02 0.98 0.89 0.03
10 69 26 56 2 0.04 0.96 0.86 0.03
11 41 21 30.5 0 0 1 0.86 0.03
12 20 10 15 1 0.07 0.93 0.8 0.06
13 9 9 4.5 0 0 1 0.8 0.06

In this poll, less than 50% of surgeons felt that unicompartmental
arthroplasty would be indicated for the treatment of a 60-year-old
moderately active patient with isolated medial compartment dis-
ease, an intact anterior cruciate ligament, mild patellofemoral
disease, and less than 7 degrees of varus angulation.
These historical contraindications have been challenged in
recent studies using a medial mobile-bearing unicompartmental
arthroplasty implant. The Oxford surgeons compared outcomes
between those patients who met Kozinn and Scott indications vs
those that did not in a prospective cohort of 1000 Oxford partial
knee arthroplasties [8]. Cumulative 15-year survival rate was
similar between those highly active male patients older than 60
years with weight greater than 180 pounds as compared with those
patients without any of these contraindications (92.7% vs 89.9%).
Furthermore, clinical outcomes were similar or better in the Kozinn
and Scott contraindicated patients [15].
Age has been a specific focus in these studies examining pa-
tient indications for unicompartmental arthroplasty. In this
aforementioned Oxford knee study, when investigating solely the
patient age, those patients younger than 60 years demonstrated
no statistical difference in 15-year revision-free survival rate
compared with those patients older than 60 years (94.8% vs
91.3%); however, they exhibited significantly greater improve-
ment in the Knee Society functional score, Oxford Knee Score, and
Tegner activity score following the surgical procedure [16]. Simi-
larly, in a study of 118 knees in patients less than 60 years treated
with an Oxford phase 3 implant, 93% were able to return to regular
physical activity with only 5 patients requiring revision proced-
ures [9]. Thus, it is believed that disease-specific criteria of ante-
romedial osteoarthritis may be more important in the
determination of a unicompartmental arthroplasty candidate
instead of patient age [17].
Despite these results in a relatively younger patient population,
the treatment of medial compartment disease in patients younger
than 50 years of age has remained uncertain. High tibial osteotomy
had served as the primary means of treatment in these younger
patients as recommended by Kozinn and Scott [18]. In the previ-
ously mentioned American Academy of Hip and Knee Surgeons
member survey, over 50% of respondents stated they would choose
high tibial osteotomy for treatment of a 45-year-old patient in the
same case scenario as opposed to less than 30% who would choose
unicompartmental arthroplasty. However, there has been waning
enthusiasm for the use of high tibial osteotomy in this population,
largely because of the increased difficulty in converting these
osteotomized knees to total knee arthroplasties [19]. In a study by
Cross et al comparing conversion of unicompartmental arthro-
plasty and high tibial osteotomy to total knee arthroplasty, the
complication and reoperation rates of those patients with high
tibial osteotomy was more than twice as large as those patients
with unicompartmental arthroplasty (21% vs 8%; 17% vs 8%) [20].
Furthermore, registry data have called into question the utili-
zation of arthroplasty in younger age groups as evidenced by the
higher cumulative revision rates in these patients [21]. Recent
statistics from the 2017 Australian Orthopaedic Association
National Joint Replacement Registry annual report demonstrate a
revision risk of total knee arthroplasty 8 times greater in patients
younger than 55 years as compared to those older than 75 years
[11]. While unicompartmental arthroplasty has remained as a
viable treatment option in many countries, it has consistently
shown lower overall survival in many registry studies compared
with total knee arthroplasty [22], and in those patients under 55
years of age, the cumulative risk of revision is markedly higher than
those patients aged 55 to 64 years at 7 years postoperatively in both
the Australian and Swedish registries, 19% vs 12% respectively [12].
There is only 1 previous study examining the outcomes of medial
unicompartmental arthroplasty in patients under the age of 50
years. In this study performed in France of 35 consecutive knees
with an average age of 46 years, a standard medial parapatellar
approach with patellar dislocation was performed in 80% of cases
while all patients received a fixed-bearing unicompartmental
implant (Miller-Galante; Zimmer, Warsaw, Indiana) [13]. Patients
demonstrated significant improvement in Knee Society clinical and
functional scores, and 29 of 31 patients were able to return to
previous activities at a mean follow-up of 9.7 years. However, at
this mean follow-up timepoint, the survival rate free of revision
surgery was 80.6% due to 6 revision procedures of which 4 were
due to significant polyethylene bearing wear.
In comparison, our series predicted that survival of 94% at 7
years and 86% at 10 years has improved upon the survival rate of
81% at 7 years for patients younger than 55 years of age in the
Australian and Swedish registries and 80.6% at 9.7 years for patients
younger than 50 years of age from Aix-Marseille University. The
most common reason for revision surgery was aseptic loosening of
either the femoral or tibial component, which was the cause in 7 of
the 20 failures. In this age group, the 10-year survival is lower than
has previously published for the Oxford partial knee in older
patient groups [4,8,16]. This likely reflects the young age of the
patients and is similar to the trends seen in registry data with
higher revision rates in young patients [23].
However, the mobile-bearing design with a congruent articu-
lation reducing contact stress impacted the mode of failure as there
were no revision surgeries due to polyethylene fracture or wear.
Conversely, the fixed-bearing design is likely subject to higher areas
of stress concentration as shown by the need for polyethylene
 N.J. Greco et al. / The Journal of Arthroplasty 33 (2018) 2435e2439
bearing revision in the study by Parratte et al [13]. Mobile-bearing
polyethylene is subject to the risk of dislocation, yet this was not an
encountered problem within our study. Fixation of the Oxford tibial
and femoral components may be an issue in this younger age group
as aseptic loosening was the primary mode of failure.
An interesting finding in this study which has been observed
within larger registry studies is the tendency toward early con-
version of unicompartmental arthroplasty in cases of unexplained
pain. Despite the proven success of unicompartmental arthroplasty
in independent studies, there have been multiple registry studies
demonstrating a slightly lower survivorship of unicompartmental
arthroplasty compared with total knee arthroplasty [23,24]. This
difference is believed to be due to differences in indications, im-
plants, and technical aspects of the procedure such as over-
correction of the deformity which cannot be controlled for in a
large registry collection. Similarly, there is also a difference in
threshold for converting a unicompartmental arthroplasty to a total
knee arthroplasty. Conversion from unicompartmental arthro-
plasty to total knee arthroplasty is technically easier than revision
total knee arthroplasty, and patients demonstrate superior clinical
outcomes and lower complications following conversion; there-
fore, surgeons likely are biased when determining the threshold for
performing a conversion procedure as opposed to revision total
knee arthroplasty [25e27]. This was apparent in our study as there
were 3 patients revised to total knee arthroplasty for unexplained
pain and another 3 revised to total knee arthroplasty by surgeons
not affiliated with the study, and the average time to conversion
was just under 2 years from the index procedure.
The structure of our study is not without limitations beginning
with the retrospective design. A control group was not included in
the analysis for comparison, and instead, the outcomes in our
young patient population were compared with other previous
studies. In addition, there were 4 surgeons included in the study
which predisposes to slight differences in preoperative decision-
making, technical experience, and indications for revision sur-
gery. The mean follow-up was 6 years in our study, and conse-
quently, only 56 patients made it to the 10-year follow-up
timepoint which limited our ability to accurately predict long-term
survival from our data.
Conclusion
Age has historically remained a contraindication for uni-
compartmental arthroplasty since the breakthrough article of
Kozinn and Scott in 1989. Recent examination of the Oxford medial
mobile-bearing partial knee has demonstrated successful results in
patients younger than 60 years of age; however, only one study has
investigated unicompartmental arthroplasty outcomes in patients
50 years or younger. The presented study demonstrates significant
improvement in patient symptoms and function following medial
mobile-bearing unicompartmental arthroplasty in subjects
younger than 50 years of age with a diagnosis of anteromedial
arthritis. At a mean follow-up of 6 years, survival free of revision
surgery was 94%, while the survival rate at 10 years was 86%, which
is better than that previously reported in both registry and single-
center studies. Medial mobile-bearing unicompartmental arthro-
plasty should be considered a viable surgical treatment in young
patients suffering from anteromedial osteoarthritis of the knee.
2439
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 The Journal of Arthroplasty 33 (2018) 2485e2490

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The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Modern Day Bicruciate-Retaining Total Knee Arthroplasty:

A Short-Term Review of 146 Knees
Omar K. Alnachoukati, MS *, Roger H. Emerson, MD, Elizabeth Diaz, PA-C,
Emily Ruchaud, MS, Kwame A. Ennin, MD
Texas Center for Joint Replacement, Plano, Texas

a r t i c l e i n f o a b s t r a c t

Article history: Background: Bicruciate retaining (BCR) implants were first proposed in the 1960s with the polycentric
Received 4 January 2018 knee. Given the technical difficulty of implanting these devices, and the mixed results at the time, the
Received in revised form BCR concept had stalled, until recently. This study seeks to provide a short-term review of the BCR
6 March 2018
implant design, describe patient-reported outcomes, and discuss key aspects to ensure successful im-
Accepted 12 March 2018
plantation of the modern-day BCR implant design.
Available online 17 March 2018
Methods: Between October 2014 and December 2016, the senior author performed 146 primary total
knee arthroplasties using BCR implants. Arthritic knees, with minimal soft tissue damage and an intact
Keywords:
bicruciate retaining
anterior cruciate ligament, were the general indications used for this cohort. All patients implanted with
total knee arthroplasty the BCR device were included in this analysis. One hundred forty-six (100%) BCR knees were available for
patient-reported outcomes follow-up at an average of 12 months (range, 1-33 months) postoperatively.
anterior cruciate ligament Results: Ninety-one percent of respondents reported their knee always or sometime feels normal, with
activity level only 9% of respondents reporting their knee never feels normal. Our study reports 94% of patients re-
ported neutral satisfaction or higher, with only 6% of patients reporting dissatisfaction and 1% reported
being very dissatisfied. Of all 146 BCR devices implanted, there were 2 (1.4%) revisions and 1 (0.7%)
reoperation, a manipulation under anesthesia.
Conclusion: This is the largest consecutive series of BCR total knee arthroplasties using the modern-day
implant design with 1-year follow-up in the United States. The results of our study show great patient-
reported satisfaction, function, and short-term outcomes for patients implanted with the new BCR
design.
© 2018 Elsevier Inc. All rights reserved.

As the incidence of total knee arthroplasty (TKA) continues to
grow exponentially, largely attributed to ageing of the baby boomer
generation, the demand for TKA from patients younger than 65
years of age is also increasing. Dr. Kurtz et al anticipate a 17-fold
increase in the number of TKAs in the 45-54 age category, from
59,077 procedures in 2006 to 994,104 procedures by 2030 [1]. With
the changing population demographic comes a higher set of
expectations and functional demands from TKA patients. Un-
fortunately, several reports have demonstrated that approximately
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.026.
* Reprint requests: Omar K. Alnachoukati, MS, Texas Center for Joint Replace-
ment, 6020 W. Parker Road, Suite 470, Plano, Texas 75093.
18%-20% of patients who undergo TKA are unsatisfied [2] at 1 year
following their TKA [3].
Continuously innovating implant designs and refining surgical
technique promise to improve patient-reported outcomes and
function. Simulating more native knee kinematics may help
improve these metrics. Numerous studies support the notion that
preservation of the cruciate ligaments in TKA preserves more
normal knee kinematics [4e10], contributing to the revitalization of
interest in bicruciate-retaining (BCR) TKA designs.
BCR implants were first proposed in the 1960s with the poly-
centric knee, later modified to the geometric knee. By the 1970s,
Cloutier had improved the BCR design and has reported 82% sur-
vivorship through 22 years [11]. Given the technical difficulty of
implanting these devices, and the mixed results at the time, the
BCR concept had stalled, until recently.
This study seeks to provide a short-term review of the BCR
design, describe patient-reported outcomes, address important

https://doi.org/10.1016/j.arth.2018.03.026
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2486 O.K. Alnachoukati et al. / The Journal of Arthroplasty 33 (2018) 2485e2490
surgical intricacies involved with BCR implantation, and discuss
key aspects in the modern-day BCR implant design.
Patients and Methods
Texas Health Resources Institutional Review Board approved the
study on May 4, 2017, IRBNet #1051698-1. Due to the retrospective
nature of the study, a waiver for informed consent was granted.
Between October 2014 and December 2016, the senior author
performed 146 primary TKAs using BCR implants. Arthritic knees,
bicompartmental or tricompartmental, with minimal soft tissue
damage and an intact anterior cruciate ligament (ACL) were the
general indications used for this cohort. ACLs with some synovial
stripping or appearing lightly frayed were still considered for BCR
TKA. All patients implanted with the BCR device were included in
this analysis. One hundred forty-six (100%) BCR knees were avail-
able for follow-up at an average of 12 months (range, 1-33 months)
postoperatively.
All patient-reported surveys and clinic visits were considered
standard of care. Retrospective data were collected from the elec-
tronic medical record. The patient population comprised of 104
women (71%) and 43 men (29%). The mean age at surgery was 68
(range, 49-82) and mean BMI was 30 (range, 20-40). Eighty-two
patients involved the right knee and 65 patients the left knee.
All TKAs were performed through a medial parapatellar
approach with the BCR implant design, Vanguard XP Total Knee
System (Zimmer Biomet, Warsaw, IN). The femur was cut at 5
of
valgus with 3
of external rotation. On the tibial side, special
instrumentation was used to protect the tibial island and recreate
anatomic slope, per manufacturer recommendations. Trialing of
components then took place to ensure cortical contact medially and
laterally, ensuring maximal implant contact on the tibia. Once trial
components and soft tissue balancing were determined to satis-
faction, bony surfaces were prepared for cementation. Third-
generation cementation technique was used, cleaning the bone
thoroughly with pulse lavage, vacuum mixing of cement, and
pressurized injection with cement gun. A drill was used to perforate
the tibia, while components were heated slightly by washing with
warm saline. A perforator tool was introduced toward the end of
the study to help standardize tibia perforation. One batch of cobalt
cement in the early mixed phase, within 1 minute, was pressurized
into the tibia with a cement gun and then the tibial base plate
placed followed by the femoral component, further pressurized by
placing the knee in extension and held. Cement was applied to both
the bone and the implants, ensuring components were dry before
application. The knee was maintained in extension while the
cement set up. There was no movement of the components or the
knee until the cement had fully cured. Significant releasing of major
soft tissues (medial/lateral collateral ligaments, ACL/posterior cru-
ciate ligament [PCL]) was avoided, unless absolutely warranted.
Lateral retinacular release and/or popliteus release occurred as
necessary.
All BCR TKAs included in this analysis were the first in a
consecutive series of cases using the BCR implant at our practice
after the implant became available to our practice. The results
represent our initial experience with the modern BCR implant
design.
Patients were followed 4 weeks, 6 months, 1 year, and every
year after the first year postoperatively. Follow-up consisted of
establishing the American Knee Society Score (AKSS), the new Knee
Society Knee Score (KSKS) short form, the University of California at
Los Angeles (UCLA) activity score, and obtaining anteroposterior
and lateral radiographs. Range of movement was assessed with the
patient supine, measuring from the lateral side by placing a 12-inch
goniometer in a line from the greater trochanter to the lateral
Table 1
Clinical Outcome Measures.
Variable Preop Postop P Value
ROM 116 (14) 121 (9) .0002
KSS function 58 (18) 89 (14) 0
KSS total 48 (20) 96 (6) 0
UCLA 4 (2) 6 (1) .0005
Values represented as mean (SD).
Preop, preoperative; Postop, postoperative; ROM, range of motion; KSS, Knee So-
ciety Score; UCLA, University of California at Los Angeles activity score; SD, standard
deviation.
femoral condyle and thence to lateral malleolus [12]. Range of
motion (ROM) was used to quantify the maximum arc of knee
mobility by expressing the full passive knee flexion and extension
motion that could be obtained during clinical examination.
Patient-reported outcomes were assessed using the AKSS, KSKS,
and UCLA activity score. The AKSS is a validated total knee rating
system. It is subdivided into a knee score which rates the knee joint
and a functional score which rates the patient’s ability to walk and
climb stairs (both scores have a maximum of 100 points) [13]. The
KSKS short form is a condensed version of the KSKS long form that
was introduced in 2012 which has been shown to be a valid and
reliable instrument for measuring the outcome of TKA. The short-
form version of the KSKS is a responsive patient-reporting tool
for assessing both patient function and satisfaction after TKA [14].
The short form provides a brief measure for 3 domains of the long
form and can be used for monitoring patient outcome after TKA in
research studies or clinical practice [14]. The UCLA activity score
was chosen for this study because of its reliability, high completion
rates, ability to delineate between high-impact and low-impact
sports, and popularity within the orthopedic community [15e17].
Additionally, the UCLA activity score has a strong positive correla-
tion with average steps per day, a known predictor of bearing
surface wear [18,19]. The preoperative score closest to surgery and
the most recent postoperative score were used in each case in this
study.
Research staff conducted chart reviews and were not involved
in patient care. Records were reviewed for both surgical and
nonsurgical complications. Implant labels were confirmed to
verify BCR TKA component details and to determine bearing
thickness mismatching between medial and lateral condyles.
Surgical operative notes were reviewed to determine soft tissue
balancing and ligament releasing. One hundred twenty-five (86%)
AKSS surveys, 87 (60%) KSKS surveys, and 80 (55%) UCLA scores
were completed and collected postoperatively at the most recent
follow-up visit.
Student 2-tailed t-tests were used to determine statistical sig-
nificance for comparisons between preoperative and postoperative
patient-reported outcome measures (PROMs) and ROM. An alpha of
.05 was used for all comparisons. Statistical analysis and graphs
were prepared using Microsoft Excel macros (Microsoft, Redmond,
WA) and SPSS (IBM Statistics version 23; IBM Corporation, Armonk,
NY).
Results
AKSS and UCLA scores are displayed in Table 1. Patient reports of
knee feeling normal and satisfaction (based on KSKS) post-TKA are
displayed in Figure 2 and Figure 1, respectively. Patients were asked
what activities they participated in (based on KSKS) and reported
road cycling, swimming, golfing, distance walking, gardening,
dancing, ballet, stretching exercises, racquet sports, aerobic exer-
cises, and stationary biking.
 O.K. Alnachoukati et al. / The Journal of Arthroplasty 33 (2018) 2485e2490 2487

Fig. 1. KSKS Satisfaction Question Results. Results shown are based on question #11 on
the KSKS. KSKS, Knee Society Knee Score; KSS, Knee Society Score; CI, confidence
interval.

Fig. 3. Clustered 3D bar graph of tibial bearing combinations used. Graph represents
Of all 146 BCR devices implanted, there were 2 (1.4%) revisions all tibial bearing combinations used with the BCR implant. Mismatched bearings are
and 1 (0.7%) reoperation, a manipulation under anesthesia (MUA). represented in green and matched bearings are represented in blue.
The first revision patient reported a painful prosthesis and very
limited ROM of 84
in clinic, 8 months after the initial surgery.
tibial components. Finally, a single patient reoperation was
Intraoperatively, it was noted the patient had arthrofibrosis, more
required for a patient who reported restricted ROM of 75
and a
specifically a cyclops lesion, with a fixed flexion deformity and
painful knee prosthesis. She was manipulated under anesthesia and
limited ROM. Both the femoral and tibial components were
reported improved outcomes following reoperation.
securely fastened to the bone and were difficult to remove. There
Thirty-nine of 146 (27%) knees were treated with mismatched
were no signs of wear of the tibial polyethylene. The patient re-
bearing thicknesses on the medial to the lateral condyle in the same
ported some mild allergy to metals, and upon analysis, was shown
knee. Mean lateral bearing size was 9.5 (standard deviation, 0.69)
to be mildly reactive to nickel, and was converted to a titanium
and mean medial bearing size was 9.0 (standard deviation, 0.70).
posterior-stabilized implant 9 months after primary surgery. There
Implanted bearing combinations are displayed in Figure 3.
were no signs of infection or effusion. The second revision patient
Nine of 146 (6.2%) knees had a minor fracture of the tibial island,
had reported a symptomatic knee in clinic and upon review of the
occurring intraoperatively while cementing/manipulation of the
patient’s X-rays, there was a radiolucent line in the lateral side of
tibial tray. Although not part of the product surgical technique,
the tibial tray and the tibial component had slightly subsided. Of
these were fixated with a 50-mm cancellous screw. Fracturing of
note, the tibial tray was slightly undersized, leaving roughly 7.7 mm
the tibial island occurred in the beginning of the series but did not
of lateral bone on the tibia uncovered. The knee was revised with a
occur toward the end of the series.
revision knee system, which incorporated a stemmed femoral and
Ninety-six (66%) knees did not require any significant soft tissue
releasing. The popliteus tendon was released in 33 (23%) knees, and
a lateral retinacular release occurred in 13 (9%) knees. One knee
required releasing the lateral collateral ligament, 2 knees required
releasing of the medial collateral ligament, and 1 knee required
iliotibial band release.

Discussion

Once thought of as a procedure for the elderly, TKA indications

and demographic populations continue to expand to more active
and younger patients. With this demographic shift comes a higher
demand for outcomes and overall satisfaction. Implants that allow
for the retention of the ACL have been hypothesized to enhance the
feeling of normality after TKA, through close restoration of native
kinematics. The BCR TKA concept was pioneered over 40 years ago,
but the idea has since made a resurgence, with a fresh take-on
innovation in both surgical approach and implant design.
The majority of patients who undergo TKA have their ACL
sacrificed, regardless of the condition the ligament is in, under-
mining the anatomic importance related to functional kinematics.
Fig. 2. KSKS “Normal” Question Results. Results shown are based on question #10 on The ACL has been shown to be the primary restraint to anterior
the KSKS. tibial displacement [20,21]. In cadaveric lab studies, BCR implants
2488 O.K. Alnachoukati et al. / The Journal of Arthroplasty 33 (2018) 2485e2490
have been shown to preserve the natural knee anterior-posterior
laxity, while PCL-retaining (PCR) implants do not [22], corrobo-
rating with previous in vivo clinical investigations [6] that BCR
implants had more natural tibiofemoral kinematics than those with
PCR TKA did during treadmill gait and stair stepping. Numerous
studies report PCR implant’s inability to restrict posterior tibial
translation [5,22,23]. Optimally, femorotibial contact should load
the tibial tray near the midline tibia throughout ROM [5]. Stiehl et al
[5] report posterior condylar contact is less likely with the BCR TKA.
Surgeon-derived outcome assessments are adequate in-
struments commonly used to determine patient success, judging
for factors such as pain and ability to perform activities of daily
living; however, PROMs provide a less bias grading outcome
assessment. Numerous reports have demonstrated that approxi-
mately 20% of patients who undergo TKAs are unsatisfied [2,24].
Our study reports 94% of patients reported neutral satisfaction or
higher, with only 5% of patients reporting dissatisfaction and 1%
reported being very dissatisfied when asked “How satisfied are you
with your knee function while performing light household activ-
ities” 1 year postoperatively, demonstrating a significant
improvement from previously documented PROMs following TKA.
Our results, demonstrating patient satisfaction after BCR TKA, are
consistent with several studies [6,8,25,26,27].
The preservation of both cruciate ligaments in TKA has been
shown to preserve more normal knee kinematics [4e10], which
may explain the higher satisfaction among our patient cohort. In a
national multicenter study conducted by Nam et al [3], 66% of re-
spondents reported their knee to feel “normal” 2.6 years following
TKA using various novel designs including cruciate-retaining,
gender-specific, high flex, and rotating-platform designs. Our
study accounts 91% of respondents reported their knee always or
sometime feels normal, with only 9% of respondents reporting their
knee never feels normal, at an average of 12.8 months post-
operatively. The retention of both cruciate ligaments may enhance
the feeling of normality when compared to “standard” implants as
patients often have a preference for one knee prosthesis over
another [25]. In a study conducted by Pritchett [25], he found that
patients who underwent bilateral staged TKAs (inserting a different
implant in each knee) were more likely to prefer retention of their
ACL and PCL or substituting with a medial pivot prosthesis.
Retaining proprioception following TKA could contribute to
feeling of normality in the knee joint, especially in BCR implants
[11,25,26,33]. Baumann et al [28] found that proprioceptive func-
tion in BCR arthroplasty is not only comparable to uni-
compartmental knee arthroplasty but also demonstrated increased
balance ability for preserving both cruciate ligaments as compared
to sacrificing both cruciate ligaments in TKA. Preserving the ACL
could lead to this “normal” feeling as anatomic studies have shown
that specifically, the ACL contains a considerable number of pro-
prioceptive nerve cells [29]. Following TKA surgery, patient
participation in moderate activities was the most commonly re-
ported activity level for the BCR patient cohort. Patients reported
participating in activities such as golfing, swimming, distance
walking, road cycling, and dancing. Retention of both cruciate lig-
aments correlates with greater proprioception and thus further
retention of native kinematics, allowing improved participation in
activities of daily living and potentially explaining our results of
greater patient satisfaction.
Added soft tissue balancing and a relatively smaller operating
field make implanting the BCR implant more technically
demanding. Compared to a cruciate-sacrificing arthroplasty,
anatomic positioning with a precise reconstruction of the joint line
and ligamentous tension is even more important to achieve natural
knee kinematics [30]. The retention of cruciate ligament insertion
points into the tibia leave only a bony base for seating of the tibial
component, leading to reports of bone island fractures by early
adopters [31]. Nine knees (6%) in our study had a bone island
fracture intraoperatively, the pearls of our careful balancing of the
flexion and extension gaps with the spacer guides in the instru-
mentation provided. Part of this balancing is achieving anatomic
tibial slope which again is facilitated by the instrumentation. The
surgeon needs to avoid undermining the island with the oscillating
saw, which will weaken the island bone, and knee extension is to be
achieved by removing bone not by stretching the posterior soft
tissues. Forced extension with the components in place could pull
off the island. Although not part of the product surgical technique,
but unlike the developers who converted the knee to a traditional
TKA [32], the senior surgeon seated the fracture with a 50-mm
cancellous screw (Fig. 4). None of these patients have experi-
enced complications, setbacks, or limited ROM.
The modern BCR design concept is to fit the implant to the pa-
tient, not fit the patient to the implant. Extensive soft tissue
releasing and bone cuts are techniques that should be avoided. Pelt
et al [32] describe their BCR implantation technique to include
releasing the collateral ligament, and further releasing the medial,
lateral, and PCL soft tissues. The majority of patients in our study
did not undergo extensive soft tissue releasing, with only 3 (2%)
knees requiring release of the collateral ligament and no PCL
releasing.
Adequate cementation remains of the utmost importance to the
survivability of the BCR implant design given the lack of implant to
bone contact surface area, the inability to fully subluxate the tibia
anteriorly to provide optimum visualization, and enhanced
cementation difficulty. Tibial component fixation is one of the
largest concerns with the BCR design. One patient (0.7%) was
revised for tibial loosening in our study. Pelt et al [32] report 30% of
their BCR TKAs having radiolucent lines, an 11% reoperation rate,
and a 5% revision rate while our site reports 0.7% reoperation rate,
1.4% revision rate, and more than twice the sample size (66 vs 146)
with the same implant. The variability of outcomes between sur-
geons using the same implant could be due to the larger sample
size at our site, or an altered surgical technique. An example of two
different cementation outcomes, following the same procedure, are
shown in Figure 5. In a separate analysis conducted by the sponsor,
Fig. 4. X-ray of tibial island fracture fixed with 50-mm cancellous screw on BCR knee.
Anteroposterior and lateral X-ray of tibial island fracture that was fixed with a 50-mm
cancellous screw.
 O.K. Alnachoukati et al. / The Journal of Arthroplasty 33 (2018) 2485e2490
Fig. 5. Images of BCR knees with varying cement quality. Image on the left represents BCR knee with excellent cement technique, consisting of uniform 3þ mm cement mantle and
full periprosthetic coverage. Image on the right represents the same implant consisting of thin cement mantle on tray due to a lack of pressurization.
5 different surgeons were asked to submit twenty X-rays of the BCR
implant, preferably at 1 year post-TKA. None of the submitted cases
reviewed displayed excellent postoperative cement mantles of
uniform 3þ mm cement penetration and full periprosthetic
coverage, and in total, only 33% of patients had no radiolucencies.
These results suggest less than optimal cementation techniques,
which may explain some post-operative difficulties that were re-
ported by other authors. Appropriate sizing to ensure maximal
tibial coverage, tibial component positioning, and cementation
remain the most pivotal stages of BCR device implantation.
The only other revision occurred after the patient reported very
limited ROM and poor flexibility of the knee 8 months post-
operatively. Upon intraoperative inspection of the capsule, it was
determined the patient had developed a cyclops lesion. Cyclops
lesions are an anteriorly localized form of arthrofibrosis, most
typically seen following ACL reconstruction. Klaassen et al [33] have
reported 2 cases of cyclops lesions in 3 knees following BCR TKA,
stressing careful preservation of the ACL from any injury intra-
operatively and kinematically sound implant alignment as factors
to help prevent undue strain on the ACL.
Mismatching of medial and lateral bearings was a frequent
method used to help balance soft tissues without needing to
perform excessive soft tissue releasing. Twenty-seven percent of
implanted knees had tibial bearings mismatched, with respect to
bearing thickness. This concept allows the surgeon to further
customize the implant by adjusting not only thickness but also
constraint in the pursuit of more normal knee kinematics and
retention of functional anatomy and allowing the surgeon to avoid
extensive ligament releases and/or bone recuts.
Strengths of this study include having the largest patient
cohort for modern-day BCR TKA patients, documenting 100%
follow-up postoperatively, while also incorporating patient-
reported outcomes into the analysis. A weakness of the study
was the inability to collect patient-reported outcome scores for
every patient postoperatively. Although it must be noted that the
manufacturer’s recommendations suggest the presence of an
intact ACL as an indication for BCR TKA, this could be interpreted
as a possible selection bias. The investigator’s theory behind the
BCR TKA was that it provides an alternative for patients who have
an intact ACL and PCL, and no longer having to sacrifice key
structures in the native knee anatomy. In practice, the continuum
2489
would go from UKA < BCR TKA < cruciate-retaining TKA <
posterior-stabilized TKA, progressing from one implant to the
next being correlated with disease progression.
To the best of our knowledge, this is the largest reported
consecutive series of BCR TKAs using the modern-day implant
design with 1-year follow-up in the United States. The results of our
study show great patient-reported satisfaction, function, and short-
term outcomes for patients implanted with the new BCR design.
Acknowledgments
We thank Texas Health Presbyterian Hospital of Plano for their
support of this work.
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 The Journal of Arthroplasty 33 (2018) 2506e2511

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Morphological Patterns of Anterior Femoral Condylar Resection in

Kinematically and Mechanically Aligned Total Knee Arthroplasty
Jung-Taek Kim, MD a, Jun Han, MD, PhD b, Quan Hu Shen, MD a, c,
Sung Won Moon, MD a, Ye-Yeon Won, MD a, *
a
Department of Orthopedic Surgery, Ajou University School of Medicine, Ajou Medical Center, Suwon, Korea
b
Department of Orthopeadics, YanBian University School of Medicine, Jilin, China
c
Department of Orthopeadics, First people's hospital of Suqian city, Jiangsu, China

a r t i c l e i n f o a b s t r a c t

Article history: Background: “Grand-piano sign” has been used as a popular benchmark to facilitate correct rotational
Received 30 December 2017 alignment during total knee arthroplasty (TKA). The purpose was to quantitatively determine morpho-
Received in revised form logical patterns on anterior femoral resection in mechanically aligned (MA) and kinematically aligned
19 March 2018
(KA) TKA.
Accepted 27 March 2018
Available online 9 April 2018
Methods: Computed tomography scans of 60 TKA candidates were reconstructed into 3D models. Femurs
were virtually cut with a 3D imaging program using various anterior flange flexion angles (AFFAs) of 3
,
5
, and 7
. The anterior femoral resection was performed parallel to the surgical epicondylar axis, at an
Keywords:
knee
external rotation and internal rotation of 3
relative to surgical epicondylar axis for MA-TKA, and parallel
arthroplasty to the cylindrical axis, at an external rotation and internal rotation of 3
to cylindrical axis for KA-TKA.
mechanically aligned The ratio of vertical distance from the anterior margin of distal femoral resection to the most prox-
kinematically aligned imal peak of each medial and lateral condyle of anterior femoral resection was defined as AC/BC ratio.
grand-piano sign Results: The mean ratios of AC/BC were 0.57, 0.60, and 0.63 respectively, according to 3
, 5
, and 7
of
computer simulation AFFA with standard MA-TKA method and were 0.73, 0.74, and 0.76, respectively, according to 3
, 5
, and
7
of AFFA with standard KA-TKA method. The AC/BC ratios of malrotated planes were significantly
different from those of both standard MA- and KA-TKAs (P-values < .01).
Conclusion: Surgeons can accessorily use the quantifying method for anterior femoral resection intra-
operatively to ensure correct rotational alignment of femoral resection in both mechanically and kine-
matically aligned TKA.
© 2018 Elsevier Inc. All rights reserved.

Rotational malalignment of the femoral component affects
mediolateral stability and patellar tracking [1e3]. A significant
force imbalance on tibial tray, aseptic loosening, instability, poly-
ethylene wear, and/or dislocation of the patella can result from
malrotation of the femoral component as well, and it is one of the
most important factors causing or contributing to the need for
surgical reintervention [4e6].
Since the first description about a “grand-piano sign” by Insall
[7], it has been used as a popular benchmark to facilitate correct
rotational alignment during mechanically aligned total knee
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.063.
* Reprint requests: Ye-Yeon Won, MD, Department of Orthopedic Surgery, Ajou
University School of Medicine, Ajou Medical Center, 164, World cup-ro, Yeongtong-
gu, Suwon-si, Gyeonggi-do 16499, South Korea.
arthroplasty (MA-TKA), the prevailing philosophy for TKA. Cui et al
[8] have provided quantitative measurements of anterior condylar
resection morphology for a conventional TKA technique.
In conventional MA-TKA, surgical epicondylar axis is the “gold
standard” for rotational alignment of femoral component [4,9]. A
new strategy for alignment, kinematically aligned (KA) TKA,
emerged and aimed to restore the anatomy of the prearthritic knee.
As clinical results of KA-TKA were better than conventional MA-TKA,
KA-TKA was getting popular [10]. The cylindrical axis drawn from
sagittal contours of both condyles sets the orientation of anterior
condylar resection surface for KA-TKA. The difference between these
2 techniques may result in different femoral resection surfaces.
The posterior condylar axis serves as a surrogate for the cylin-
drical axis in clinical practice [11]. Manual cutting guides, oscil-
lating saws, and estimation for the thickness of worn cartilage can
result in surgical errors of the unequal resection of both medial and

https://doi.org/10.1016/j.arth.2018.03.063
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J.-T. Kim et al. / The Journal of Arthroplasty 33 (2018) 2506e2511 2507

lateral condyles, which may be associated with the error of the
rotational malalignment [11e13].
Quantitative anatomical study of morphologic patterns of
anterior femoral condylar resection surface can provide reliable
intraoperative sign for correct rotational alignment in conventional
TKA [8]. However, there has been no quantitative study evaluating
morphological patterns of anterior femoral condylar resection
surface in KA-TKA.
We hypothesized that patterns of anterior femoral condylar
resection surface with KA-TKA could also provide a reliable intra-
operative sign to facilitate correct rotational alignment, although
the patterns in KA-TKA differ from those appreciated in MA-TKA.
Thus, the purpose of the present study was to quantitatively
investigate clear, discernable, and reproducible patterns of anterior
femoral condylar resection surface by simulating surgical proced-
ures of MA-TKA and KA-TKA and determine whether identified
patterns could be used as an intraoperative index to facilitate
proper rotational alignment for each technique.
Material and Methods
Preoperative Imaging Evaluations
Preoperative imaging evaluation for TKA obtained at our insti-
tution consisted of scanogram anteriorposterior with weight-
bearing views and computed tomography (CT) scanning. On sca-
nograms, the mean angle between the mechanical axis of the femur
and tibia was 8.9
varus (range, 1.0
-22.6
varus). Preoperative CTs
were scanned using a 64-slice CT scanner (Brilliance 64, Philips,
Israel) or 128-slice CT scanners (Somatom definition flash and edge,
Siemens, Germany). Scanning parameters were as follows: 120 kV,
300 mAs, 64 * 0.625 mm, rotation time: 0.75; slice thickness: 1 mm
around knee joints, 3 mm otherwise.
A CT scan with the coverage of knee joint, both proximal one-
fourth of the femur, and distal one-fourth of the tibia was coun-
ted as an appropriate scan.
CT scans were imported to special medical imaging software
(Xelis software, version 1.0.2.2; INFINITT, Seoul, Korea) to create
three-dimensional (3D) reconstruction models. The software was
used to simulate femoral resection of TKA and measure distances
described in the following section.

Patients
The present study was approved by the institutional review
board of our institution. This study retrospectively reviewed the
medical records and radiographic images of consecutive 74 patients
with primary degenerative arthritis who underwent total knee
arthroplasties during the period from January 2014 to August 2014.
All the arthroplasties were performed by 1 senior surgeon. Three
patients with severe damage to subchondral bone and 11 patients
with a history of retained metal implants in or around knee joints
were disqualified. The mean age of the remaining 60 patients was
71.3 years (range, 61-85 years). Of these 60 patients, 12 were male
and 48 were female.
Virtual Surgery
In consideration of various implant designs commercially
available, virtual TKA was planned under the premise of implants
with 3
, 5
, and 7
of flexion built-in between the anterior cutting
plane and the intramedullary guide placed at the longitudinal axis
of the distal femur (Fig. 1, Table. 1). The angle of flexion built-in was
termed as anterior flange flexion angle (AFFA). All procedures were
simulated using the instruments which guides distal femoral
resection before anterior femoral resection. To simulate femoral
resection in MA-TKA, the whole femoral model was loaded and
realigned in a mechanical coordinate system.

Fig. 1. Virtual femoral resection was performed in mechanically aligned total knee arthroplasty and kinematically aligned total knee arthroplasty. (A) Distal femoral resection of
standard mechanically aligned total knee arthroplasty. Distal femur was cut (dashed line) perpendicular to the mechanical axis (solid line) with 7 mm of cutting thickness. (B) Distal
femoral resection of standard kinematically aligned total knee arthroplasty. Distal femur was cut parallel to the cylindrical axis (solid line). The distal femoral resection surface was 7
mm above the distal tangential plane of the cylinder (dashed line).
2508 J.-T. Kim et al. / The Journal of Arthroplasty 33 (2018) 2506e2511

Table 1 parallel to the cylindrical axis (Fig. 1B) [13,25]. To simulate

The Anterior Flange Flexion Angles of Various Total Knee Arthroplasty Designs. incorrect rotational alignment in KA-TKA, 2 anterior femoral
Total Knee Arthroplasty Model Manufacturer Anterior Flange Flexion Angle resection planes were also reconstructed in ER and IR of 3
relative
Vanguard Biomet 3

to cylindrical axis (CA).
Legion Smith & Nephew 3

Medial-Pivot Knee Wright 3
Measurements
Gemini II LINK 3

Genesis II/Anthem Smith & Nephew 3

Scorpio NRG Stryker 4
The morphology of the anterior femoral resection surface was
Attune Depuy 5
quantitatively measured from the surgeon's view for easy appli-
NexGen/Persona Zimmer 5
cation of data. On the anterior femoral resection plane, vertical
Lospa Corentec 5
distances from the distal resection margin (line C) to the most
Triathlon Stryker 7

proximal cutting margin of medial (point A) and lateral (point B)
condyles were measured. The ratio of the vertical distance from the
line C to the medial peak over the one to the lateral peak (AC/BC)
Taking the usage of intramedullary rod in conventional TKA was calculated (Fig. 3A). If there was no discernible peak on a
procedures into consideration, the longitudinal axis was set medial condyle, the inflection point was selected as point A
perpendicular to the mechanical axis (connecting the center of the (Fig. 3B).
femoral head and the middle of the intercondylar notch) on the All the measurements on the analysis were made by 1 ortho-
coronal plane and perpendicular to distal femoral axis in sagittal pedic surgeon. Another orthopedic surgeon measured in 20
plane [14] (Fig.1A, Fig. 2A). The surgical epicondylar axis connecting randomly selected surfaces to assess interobserver reliability of
the medial sulcus with the lateral epicondyle was set as 0-degree measurements. Intraclass correlation coefficient (ICC) of interob-
rotation [15]. server reliability was 0.86 which was indicative of excellent
The maximum resection thickness from the distal condyle of the agreement.
femoral model was 7 mm to simulate 9-mm thick resection for
substituting the corresponding region of the femoral component Validation
condyle considering a mean articular cartilage thickness of 2 mm
[16]. The kerf thickness of saw was moot as procedures were To validate the reliability of the simulation study, an additional
virtual. study was performed to compare results from simulation to those
The simulated anterior femoral resection plane was flexed 3
, 5
, obtained from actual femoral resection [8]. As 3 femurs were avail-
and 7
relative to the anatomical axis of the distal femur and par- able, we planned to perform a femoral resection of KA-TKA (1 in the
allel to the surgical epicondylar axis (SEA) [4,9,17] (Fig. 2). To standard method and 2 in malrotated methods) with the in-
simulate incorrect rotational alignment in MA-TKA, 2 anterior struments of Persona (Zimmer, Warsaw, IN), which has 5
of AFFA.
femoral resection planes were reconstructed on the 3D imaging After CT scanning of cadaveric femurs, CT scans were reconstructed
program in external rotation (ER) and internal rotation (IR) of 3
into 3D models and virtually resected with methods described
relative to SEA. previously. Actual resection of standard KA-TKA was performed in
To simulate the femoral resection in KA-TKA, the whole the same manner as described previously [13]. One in malrotated
femoral model was reloaded and realigned in a kinematic coor- method was resected in 3 degree internally rotated to the standard
dinate system [18e23]. The cylindrical axis was determined by the plane while the other was resected in 3 degree externally rotated to
best fitting circle drawn on a kinematic sagittal section of both the standard plane. Measurements of resection surfaces were made
medial and lateral femoral condyles [24]. The distal femoral with a digimatic caliper (Mitutoyo Co., Kanagawa, Japan) and
resection was simulated by drawing a plane parallel to the cylin- compared with values of virtually resected surfaces (Fig. 4).
drical axis and perpendicular to the distal femoral axis (Fig. 1B, Fig
2A) [25]. The distal femoral resection surface was 7 mm above the Statistics
distal tangential plane of the cylinder in accordance with the
rationale explained previously. The anterior femoral resection was Statistical analysis was performed using the IBM SPSS Statistics
3
, 5
, and 7
flexion to the anatomical axis of the distal femur and software package (IBM SPSS Statistics 21, SPSS IBM, NY). To

Fig. 2. A 2D CT image and 3D model in image software during a virtual procedure. (A) The longitudinal axis of the femur (white line), a line drawn through the midline of the distal
femur. The cutting planes were presented on the sagittal plane as lines flexed 3
(....), 5
(—), and 7
(-.-) relative to longitudinal axis of the femur. (B) The anterior resection plane
with 5
flexed relative to the longitudinal axis seen in oblique view.
 J.-T. Kim et al. / The Journal of Arthroplasty 33 (2018) 2506e2511 2509

Fig. 3. The morphology of anterior femoral condylar resection was measured quantitatively. (A) If a peak was discernible in each condyle, the distance from the most proximal point
of anterior condylar resection surface in both condyles to the margin of distal femoral resection was measured. Point A, the most proximal point of the anterior bone cut on the
medial condyle; point B, the most proximal point of the anterior bone cut on the lateral condyle; line C, resection margin of distal femur; AC: vertical distance from point A to line C;
BC: vertical distance from point B to line C. (B) If there was no discernible peak on a medial condyle, the inflection point was selected as point A.

compare differences in ratios according to changes in rotational
alignment of resection plane, paired t test was used. The ratios of 3
resection surfaces of each anterior flange flexion angle were
compared in pairs. To address the issue of multiple comparisons, a
Bonferroni correction was applied. For validation of simulation
compared to actual bone resection, ICC was calculated [26,27].
Results
The mean ratios of AC/BC were 0.57, 0.60, and 0.63, respectively,
according to 3
, 5
, and 7
of AFFA with standard MA-TKA method.
For rotationally malaligned anterior resection surface, the ratios
were 0.69, 0.70, and 0.73 at 3
IR and 0.49, 0.51, and 0.55 at 3
ER
relative to SEA, respectively, according to 3
, 5
, and 7
of AFFA
(Table 2). The AC/BC ratios of malrotated planes were significantly
different from those of standard rotational alignment (all the P
values were less than .01).
The mean ratios of AC/BC were 0.73, 0.74, and 0.76, respectively,
according to 3
, 5
, and 7
of AFFA with standard KA-TKA method.
In rotationally malaligned anterior resection surface, the mean ra-
tios were 0.86, 0.89, and 0.90 at 3
IR and 0.61, 0.63, and 0.65 at 3

ER relative to CA, respectively, according to 3
, 5
, and 7
of AFFA
(Table 3). The AC/BC ratios of malrotated planes were significantly

Fig. 4. Similar cutting surface morphologies produced by virtual bone cut (upper row) and the actual bone cut (lower row) in a cadaver's distal femur. (A) External rotation 3
to the
cylindrical axis, (B) parallel to the cylindrical axis, and (C) internal rotation 3
to the cylindrical axis.
2510 J.-T. Kim et al. / The Journal of Arthroplasty 33 (2018) 2506e2511

Table 2
AC/BC Ratios Produced by Anterior Bone Cuts With Various Anterior Flange Flexion Angles and Rotational Angles in MA-TKA.

Mechanically Aligned Total Knee Rotation Relative to The Surgical Epicondylar Axis P Value
Arthroplasty
IR3 Parallel ER3 IR3 to SEA ER3 to SEA


Anterior flange flexion angle 3 0.69 ± 0.09 0.57 ± 0.08 0.49 ± 0.07 <.01 <.01
5
0.70 ± 0.09 0.60 ± 0.08 0.51 ± 0.08 <.01 <.01
7
0.73 ± 0.08 0.63 ± 0.09 0.55 ± 0.05 <.01 <.01

IR3, internal rotation 3
; ER3, external rotation 3
; MA-TKA, mechanically aligned total knee arthroplasty; SEA, surgical epicondylar axis.

different from those of standard rotational alignment (all the P
values were less than .01).
For validation test, ICC was 0.92 which was well within the
range of excellent reliability. This indicates that our CT
imageebased resection simulation method reflects the actual bone
resection (Table 4).
Discussion
The present study performed quantitative analysis of the con-
ventional index called “grand-piano sign” for proper rotational
alignment. In MA-TKA, despite change in the method of measure-
ment, the AC/BC ratios were 0.57, 0.60, and 0.63, respectively, ac-
cording to 3
, 5
, and 7
of AFFA. In KA-TKA, the AC/BC ratios were
0.73, 0.74, and 0.76, respectively, according to 3
, 5
, and 7
of AFFA.
A femoral anterior resection surface is inherently placed in a
conspicuous place. It is easily visualized during TKA procedure. This
might be why the “grand-piano sign” has been used as a marker for
an auxiliary indicator for correct rotational alignment of femoral
condylar resection, even though it has not been quantitatively
defined as such. As KA-TKA procedure gains popularity, there has
been a predictable demand for standardized description of femoral
anterior resection surface patterns to satisfy challengers who are
familiar with and in favor of conventional grand-piano sign in MA-
TKA. To the best of our knowledge, anterior condylar femoral
resection surface in KA-TKA has not been quantitatively assessed
yet. Thus, we performed the present study to provide quantitative
information about anterior condylar femoral resection surface
shape in KA-TKA. It can serve as a path guide to facilitate correct
rotational alignment in both MA-TKA and KA-TKA.
The AC/BC ratios of anterior resection surface parallel, at ER, and
at IR of 3
to CA were significantly different with different AFFAs in
KA-TKA as well (Table 2). The AC/BC ratio of anterior resection
surface with standard CA was 0.73, 0.74, and 0.76, respectively,
according to 3
, 5
, and 7
of AFFA. A remote value from this would
alarm the surgeon to check the rotational alignment of femoral
resection.
Cui et al [8] have evaluated discernable patterns of anterior
femoral resection surface by measuring the vertical distance
between the most proximal point and the line connecting the most
distal point of resection surface of both condyles. The axis for mea-
surement was defined as a line perpendicular to the line connecting
most distal points of both condyles. Thus, a substantial difference can
be drawn from a small positional change of the most distal points
even if resection surface shape does not have significant change [28].
Although the previous method provided intuitive information for
patterns of anterior femoral resection surface, measurements were
at risk of being sensitive to the changes of the most distal points of
both condyles. Another limitation of the previous measurement was
that the anterior femoral resection follows distal femoral resection in
a majority of TKA procedures. After distal femoral resection, the most
distal points often cannot be identified on the femur, hindering
intraoperative appliance of quantitative information. Thus, we
assumed the anterior margin of distal femoral resection plane as the
measurement axis to provide a consistent and relatively reliable
reference line for intraoperative information. This would, in turn,
make it easier for surgeons to apply these data for assessing the
anterior femoral resection surface.
The aim of KA-TKA is to restore prearthritic knee by assuming
that knees flex and extend on a single cylindrical axis. The cylin-
drical axis is drawn based on the best fitting circles to sagittal
sections of both condyles [24]. By resecting distal and posterior
femoral condyles and replacing them with the same thickness of
implants, restoration of the cylindrical axis can be achieved.
However, available “off-the-shelf” TKA implants are limited.
Therefore, anterior femoral resection should be determined by
implant shape and the resection plane of distal and posterior
condyles. The limitation in restoring diverse prearthritic knee with
a restricted number of TKA implants was another reason why we
performed this study. Our results demonstrate that there still is a
pattern of anterior resection surface shapes, although the formulaic
design of implants has been shown to be inadequate to address all
possible anatomical variability of the distal femur [19]. The un-
derstanding of the difference in anterior resection surface would
serve as a path guide to facilitate correct rotational alignment to the
adopters of KA-TKA and provide a new insight to the surgeons who
prefer MA-TKA as well.
The difference in ratio between MA-TKA and KA-TKA arises from
2 sources. The first is from the difference in distal femoral resection
planes. Whereas the distal femoral condyles were resected perpen-
dicular to the mechanical axis of femur according to the principle of
MA-TKA, the distal femoral cuts were made parallel to CA according
to the principle of KA-TKA. The second is from the difference in
rotational alignment. Eckhoff et al [19] have demonstrated that the
difference between the cylindrical axis and the transepicondylar axis
in the 3D space is not negligible. We did not compare which one was
superior as the role of the resection surface because an intra-
operative indicator was the focus of the present study.

Table 3
AC/BC Ratios Produced by Anterior Bone Cuts With Various Anterior Flange Flexion Angles and Rotational Angles in KA-TKA.

Kinematically Aligned Total Knee Rotation Relative to The Surgical Epicondylar Axis P Value
Arthroplasty
IR3 Parallel ER3 IR3 to CA ER3 to CA


Anterior flange flexion angle 3 0.86 ± 0.10 0.73 ± 0.08 0.61 ± 0.07 <.01 <.01
5
0.89 ± 0.08 0.74 ± 0.09 0.63 ± 0.08 <.01 <.01
7
0.90 ± 0.09 0.76 ± 0.08 0.65 ± 0.07 <.01 <.01

CA, cylindrical axis; IR3, internal rotation 3
; ER3, external rotation 3
; KA-TKA, kinematically aligned total knee arthroplasty.
 J.-T. Kim et al. / The Journal of Arthroplasty 33 (2018) 2506e2511
Table 4
Comparison of Morphological Measurements From Virtual and Actual Bone Cuts.
Kinematically Aligned TKA Real Resection Virtual Resection
AC BC AC/BC AC BC

Knee Surg Sports Traumatol Arthrosc 2017.
Internal rotation 3 37.48 40.52 0.92 43.52 43.48
Neutral 31.86 35.87 0.89 27.34 30.47
External rotation 3
24.52 45.27 0.54 25.28 44.79
Intraclass correlation coefficient ¼ 0.92.
TKA, total knee arthroplasty.
We acknowledge that our study has several limitations. The
present study conducted a simulation of femoral resection. Three-
dimensional simulation of the anterior resection surface has a
strong strength in that multiple scenarios can be tested on the same
subject for paired comparison which cannot be provided by actual
bone cutting. Although the validity of this study can be questioned,
CT scan is better suited for imaging hard tissue than magnetic
resonance imaging which is better suited for imaging of soft tissue.
Thus, we conducted bone-cutting simulation based on CT scanning.
To close the potential gap between actual and virtual circum-
stances, validation test was performed to calculate ICC as well.
Our patients were limited to those with varus knee deformity.
As most TKA candidates have slight varus hip-knee-ankle angle,
these results cannot be applied to patients with valgus or dysplastic
femoral deformity. Therefore, our results should be interpreted
cautiously as several reports have reported racial differences in
knee anatomy. More studies are needed to determine specific
values of morphometric parameters of anterior femoral condylar
resection surface for each race.
As the simulation was based on CT scans, the thickness of
cartilage was uniformly assumed as 2 mm. Therefore, we assumed
that 7-mm thickness resection in virtual surgery was equal to 9-
mm thickness resection in real surgery [11].
Conclusion
Surgeons can accessorily use the quantifying method for pat-
terns of anterior resection surface intraoperatively to ensure that
correct rotational alignment of femoral resection is obtained in
both mechanically and kinematically aligned TKA.
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 The Journal of Arthroplasty 33 (2018) 2440e2448

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Multimodal Clinical Pathway With Adductor Canal Block

Decreases Hospital Length of Stay, Improves Pain Control,
and Reduces Opioid Consumption in Total Knee Arthroplasty
Patients: A Retrospective Review
Terry A. Ellis II, MD a, b, *, Hassan Hammoud, MD a, b, Philip Dela Merced, MD a, b,
Nishankkumar P. Nooli, MD a, b, Farhad Ghoddoussi, PhD a, Joshua Kong, BS a,
Sandeep H. Krishnan, MD a, b
a
Department of Anesthesiology, Wayne State University School of Medicine, Detroit, MI
b
Department of Anesthesiology, St. Joseph Mercy Oakland Hospital, Pontiac, MI

a r t i c l e i n f o a b s t r a c t

Article history: Background: Total knee arthroplasty volume is increasing significantly in the United States. Reducing
Received 21 November 2017 hospital length of stay may represent the best method for accommodating expanding volume and
Received in revised form reducing costs. We hypothesized that tailoring a clinical pathway to facilitate early ambulation would
5 March 2018
decrease costs and resource utilization.
Accepted 17 March 2018
Available online 27 March 2018
Methods: We conducted a sequential before-and-after study of total knee arthroplasty patients after a
phased implementation of a clinical pathway that includes multimodal oral analgesic protocols, adductor
canal nerve block, and standardized day of surgery ambulation protocols. Primary outcomes measured
Keywords:
total knee arthroplasty
were hospital length of stay, total opioid consumption, total antiemetic use, and perioperative pain scores.
multimodal clinical pathway Results: Two hundred ninety-five patients were divided into 3 sequential cohorts. Cohort 1 received
adductor canal block spinal anesthesia, femoral nerve block, and was not placed into postop day 0 ambulation therapy. Cohort
femoral nerve block 2 received spinal anesthesia, adductor canal block, and postop day 0 ambulation therapy. Cohort 3
hospital length of stay received spinal anesthesia, adductor canal block, postop day 0 ambulation therapy, and standardized oral
postoperative opioid consumption multimodal analgesic protocol. Cohort 3 had significantly reduced hospital length of stay. Cohorts 2 and 3
postoperative pain control had significantly less opioid consumption. Cohort 3 had significantly less total ondansetron consumption
compared with cohort 1. Cohort 3 had significantly reduced average pain scores compared with cohort 1.
Conclusion: The data demonstrate that tailored clinical pathways designed to facilitate early ambulation
can reduce hospital length of stay, reduce opioid consumption, reduce antiemetic use, and improve pain
control. The results establish that refined clinical pathways can assist in improving care while increasing
value to patients, providers, and systems.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is one of the most common
elective surgical procedures in the United States [1,2]. Costs asso-
ciated with TKA surpassed 11 billion dollars per year in the United
States in 2005, and institutional expense increases related to TKA
Disclosures: No grants, no sponsors, and no funding sources provided direct or
indirect financial support to the research work contained in the manuscript.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.053.
* Reprint requests: Terry A. Ellis II, MD, St. Joseph Mercy Oakland Medical Office
Building, 44555 Woodward Avenue, Suite 308, Pontiac, MI 48341.
have exceeded revenue growth for the past 2 decades [3,4]. As
expense increases associated with total joint arthroplasty (TJA)
programs have outpaced reimbursement, hospitals remain
dependent upon cost control to effectively deliver care to this
expanding number of patients [4,5]. Attempts to contain costs
through educational efforts, voluntary practice guidelines, and drug
and implant cost-control measures have produced varying levels of
success [4e9]. Reducing hospital length of stay may represent the
most significant potential cost savings mechanism in TKA as
measured by both hospital costs and patient charges [4,7].
Multimodal clinical pathways (MCPs) are clinical care practices
developed by multidisciplinary groups within an institution to

https://doi.org/10.1016/j.arth.2018.03.053
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448
create optimal regimens of care regarding the sequence, timing,
and interventions by surgeons, anesthesiologists, nurses, and other
staff for a particular diagnosis or procedure. MCPs address vari-
abilities in clinical practice by having providers agree prospectively
on a common regimen of interventions which, based on evidence
demonstrating efficacy, do not negatively impact outcomes [10]. A
number of studies have demonstrated success in using an MCP to
decrease hospital length of stay for patients undergoing TJA
without negatively impacting clinical outcomes [10e14].
A major component of MCP regimens in TKA is facilitation of
early patient participation in rehabilitation efforts. It has been
shown that early participation in rehabilitation can decrease hos-
pital length of stay, improve outcomes, and decrease complications
[13e17]. To encourage early rehabilitation efforts, the adductor
canal block and adductor canal catheter block (ACB) have become
popular alternatives to femoral nerve block, femoral nerve catheter
blocks (FNBs), and epidural catheter blocks and infusions for
postoperative analgesia in patients undergoing TKA [18e20].
Studies demonstrate that ACB results in less quadriceps weakness
than FNB while providing equally efficacious analgesia [19e21].
While the magnitude of fall risk and risk reduction due to the
regional anesthetic technique chosen has been debated in the
literature, reducing quadriceps weakness may allow earlier and
more complete participation in rehabilitation exercises [16e22].
Previous studies of MCP have mainly been designed to evaluate
the effect of individual interventions; however, those results
potentially underestimate the full impact of a fully evolved MCP
[11]. We sought to evaluate the impact of sequential revisions to our
MCP for TKA by analyzing outcomes during a phased imple-
mentation spanning a 36-month period. The first phase was a
change from FNB to ACB for postoperative analgesia concomitant
with the addition of postoperative day (POD) 0 ambulation and
rehabilitation therapy regimen. The next phase added a standard-
ized oral multimodal analgesic (OMA) to the MCP regimen. We
retrospectively analyzed 3 cohorts of patients who underwent TKA
during this phased implementation, comparing hospital length of
stay, pain control, total opioid consumption, and total antiemetic
medication consumption during hospitalization.
Patients and Methods
We analyzed the impact of a tailored MCP for TKA patients over
3 time periods comparing 3 sequential cohorts drawn from our
own TKA population. Before the implementation of this fully
evolved MCP within our institution, no standardized oral OMA
protocol existed. Patients were preferentially provided neuraxial
anesthesia for surgery, and FNB was carried out in the recovery
room for postoperative analgesia. Postoperative analgesia was
managed by individual surgeon preference, as were ambulation
and rehabilitation protocols. Faced with these varying practices, our
TJA program was tasked with developing a revised MCP with the
goal of improving pain control, reducing hospital length of stay, and
reducing costs by standardizing multiple best practice processes.
The team revised the MCP based on published peer-reviewed
literature, validated practice models, and previous practice experi-
ence [10e17,19,22e31]. A fully evolved MCP pathway was imple-
mented which includes a standardized preemptive OMA protocol
incorporating concurrent administration of oral gabapentin (300
mg), celecoxib (200 mg), acetaminophen (1 g), and oxycodone (10
mg). Intraoperatively, spinal anesthesia with bupivacaine (10-15 mg)
is used as the primary anesthetic in all cases except those which
convert to general anesthesia due to failure of neuraxial anesthesia
or in patients with contraindications. Intraoperative opioid use is
avoided. TKA patients are provided with ACB in the immediate
postoperative period using bupivacaine (0.25% 30 mL),
2441
buprenorphine (300 mcg), and dexamethasone (4 mg). Post-
operative pain is managed with an OMA protocol that includes
extended release oxycodone (10-20 mg every 12 hours), immediate-
release oxycodone (10 mg every 4-6 hours as needed), gabapentin
(300 mg every 8 hours for 72 hours), celecoxib (200 mg per day for
72 hours), and acetaminophen (1 g every 8 hours for 72 hours).
Intravenous (IV) opioids are reserved for severe breakthrough pain
during the postoperative period. Ambulation and rehabilitation
therapy are started on POD 0 and continue through discharge.
Table 1 describes the day of surgery regimen for TKA patients.
After the institutional review board approval, the medical re-
cords of 338 patients undergoing primary TKA were retrospec-
tively reviewed. Patient records were selected by the date of
surgery for 3 sequential cohorts during the phased implementa-
tion of the MCP guiding their hospitalization. For each cohort,
charts were reviewed using convenience sampling until approxi-
mately 100 patients meeting the inclusion criteria were identified.
Cohort 1 included 99 patients treated during a 3-month period
starting 6 months before implementing revisions to the MCP.
These patients received spinal anesthesia, FNB for postoperative
analgesia, and were not placed into POD 0 ambulation or reha-
bilitation therapy protocols. Cohort 2 included 99 patients whose
charts were selected during a 3-month period starting 6 months
after the implementation of the first phase of clinical pathway
revision. These patients received spinal anesthesia, ACB, and POD
0 ambulation and rehabilitation therapy protocols. Cohort 3 con-
sisted of 97 patients whose charts were selected from a 3-month
period starting 6 months after the implementation of the second
phase of clinical pathway revision. These patients were cared for
using the fully evolved MCP that included the addition of a stan-
dardized OMA protocol (see Table 1).
A total of 43 patients were excluded from the initial records
screened. Twenty-three patients received ketamine intra-
operatively and were excluded to avoid ketamine's potential con-
founding effect. Eleven patients either refused to participate with
the OMA protocol or received preoperative oral analgesics before
Table 1
St. Joseph Oakland Mercy Total Joint Multimodal Anesthesia Protocol.
Preoperative Gabapentin 300 mg PO
Celecoxib 200 mg PO
Acetaminophen 1 g PO
Oxycontin 10 mg PO
Intraoperative THA/TKA: Spinal anesthesia preferred using
10-15 mg bupivacaine
Dexamethasone 10 mg IV at the start of the
case, ondansetron 4 mg IV at the end of the
case.
Intra-articular/periarticular Injection per
orthopedic surgeon
Postanesthesia care unit (PACU) TKA: adductor canal nerve block in PACU
immediately after surgery.
TKA: consider adductor canal nerve catheter
for patients with chronic pain, high opioid
usage, or intolerance to opioids.
Avoidance of IV opiates if possible
Postoperative Oxycontin 10-20 mg Q12 hrs
Oxycodone 10 mg Q4-6 hrs PRN
Gabapentin 300 mg PO Q8 for 72 h
Celecoxib 200 mg PO Daily for 72 h
Acetaminophen 1 g PO Q8 for 72 h
IV opioid for severe breakthrough pain only
IV, intravenous; PO, per os; TKA, total knee arthroplasty; THA, total hip arthroplasty.
2442 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448

the implementation of the standardized OMA protocol and were
excluded from the study. Four patients were excluded from the
study because they received ACB as part of their treatment before
the implementation of the revised MCP. Finally, 3 patients were
excluded because they underwent knee revision surgery rather
than primary TKA, and 2 patients were excluded because of their
American Society of Anesthesiologists (ASA) classification of 4.
Patient demographics including age, gender, body mass index,
and ASA classification were collected for all patients, and the co-
horts were analyzed to ensure similitude. Patients with chronic
pain and those with chronic opioid dependence were included in
the study as they were equally distributed among the cohorts.
Both preoperative and postoperative verbal analog pain scores
(VAS; 0, no pain to 10, worst pain imaginable) were collected for
each patient from the electronic medical record. All pain scores
were collected with a minimum of 1 VAS recorded during each
nursing shift (8 hours). Mean pain scores were reported as calcu-
lated from all assessments made during hospitalization. Perioper-
ative medication consumption totals were collected from the
electronic medical record. All opioid, acetaminophen, ketorolac,
and antiemetic medication administered to each patient were
collected. At our institution, ondansetron is the first-line antiemetic
agent used. Patients with refractory nausea were treated with
promethazine and/or droperidol.
Total opioid consumption for all patients in this study was
converted to oral morphine equivalents to facilitate comparison.
The following conversion equivalents were used: 5 mg morphine
(per os [PO]) ¼ 5 mg hydrocodone (PO) ¼ 3.3 mg oxycodone
(PO) ¼ 1.25 mg hydromorphone (PO) ¼ 0.25 mg hydromorphone
(IV) ¼ 0.02 mg fentanyl (IV) ¼ 1.67 mg morphine (IV, intramus-
cular [IM], subcutaneous [SC]) ¼ 50 mg tramadol ¼ 50 mg
meperidine (PO) ¼ 12.5 mg meperidine (IV/IM/SC) ¼ 33.33 mg
codeine (PO) ¼ 20 mg codeine (IV/IM/SC) based on the recom-
mendations by http://www.globalrph.com/narcotic.cgi. While the
conversion of opioid dosing to morphine equivalents is chal-
lenging due to the lack of consistency among conversion plat-
forms, this had a minimal impact on our study because all 3
cohorts were retrospectively converted for comparison only.
Statistical Analysis
The primary outcome of the investigation was hospital length of
stay, total opioid consumption (oral morphine equivalents), and the
average postoperative pain score. The secondary outcomes
included total antiemetic medication consumption, total acet-
aminophen consumption, and total ketorolac consumption. All
outcomes were analyzed as continuous variables except for the
incidence of administration of the antiemetic drugs, which was
treated as a categorical variable.
Demographic data were analyzed using t tests, chi-square tests,
and Fisher exact tests, as appropriate. The statistical differences
between the 3 cohorts for the continuous data were determined
first using a 1-way analysis of variance, and then, the Fisher least
significant difference (LSD) post hoc test was performed to
compare the statistical difference between the mean values of the 3
cohorts. For the categorical data, the statistical difference was
determined using Pearson c2, followed by Yates's continuity
correction and the Fisher exact probability test. A P value of less
than .05 was considered to be statistically significant. Data are re-
ported as mean ± standard error of mean or mean ± standard de-
viation (SD). All the data were analyzed using IBM SPSS, version 19
(IBM Corporation, Armonk, NY).
Results
This retrospective chart review analyzed 295 charts of patients
undergoing primary TKA. Patients were divided into 3 sequential
cohorts based upon the MCP guiding their hospital course. Patient
demographics and perioperative data are presented in Table 2.
There was no significant difference between the 3 cohorts with
respect to gender, body mass index, and ASA classification. The
average age of the patients in cohort 3 was 3.5 years younger than
the average age of the patients in the other 2 cohorts (see Table 2
and Fig. 1).
Preoperative pain score acts as a positive control variable for the
study demonstrating that there was no selection bias between the
convenience sampled cohorts. There was no significant difference
between cohorts for this variable (F (2, 291) ¼ 0.905, P ¼ .406; see
Table 3 and Fig. 1B).
Table 3 summarizes the hospital length of stay, preoperative
pain score, average postoperative pain score, incidence of anti-
emetic consumption for each cohort, and incidence of in-hospital
fall after TKA. Table 4 summarizes medications consumed by the
patients, including total opioid, acetaminophen, ketorolac, and
ondansetron use. Table 5 summarizes the incidence of other com-
plications experienced by the 3 cohorts.

Table 2
Patient Demographics and Perioperative Data.

Cohort 1 (N ¼ 99) Cohort 2 (N ¼ 99) Cohort 3 (N ¼ 97) P Values

Cohort 1 vs Cohort 2 Cohort 1 vs Cohort 3 Cohort 2 vs Cohort 3

Gender
Male 45 (45) 39 (39) 44 (45) .471 1.00 .590
Female 54 (55) 60 (61) 53 (55)
Age (y)
All 69.3 ± 10.7 69.5 ± 9.7 66.0 ± 9.2 .895 .021a .010a
Male 70.5 ± 10.2 68.6 ± 8.5 64.5 ± 9.6 .355 .005a .041a
Female 68.3 ± 11.1 70.1 ± 10.4 67.3 ± 8.7 .378 .594 .124
BMI (kg/m2)
All 32.3 ± 7.3 32.4 ± 7.2 33.1 ± 7.2 .939 .461 .505
Male 30.6 ± 6.2 31.7 ± 6.3 32.6 ± 6.8 .420 .169 .575
Female 33.7 ± 7.8 32.8 ± 7.7 33.5 ± 7.6 .540 .894 .630
ASA I 3 (3) 3 (3) 4 (4)
ASA II 48 (48) 39 (39) 52 (54)
ASA III 48 (48) 57 (57) 41 (42) .655 .740 .578
ASA IV 0 (0) 0 (0) 0 (0)

Values are expressed as mean ± SD or number (% of patients).

ASA, American Society of Anesthesiologists; BMI, body mass index; SD, standard deviation.
a
P value <.05 is considered to be statistically significant.
 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448 2443

Fig. 1. Boxplots of the (A) age, (B) American Society of Anesthesiologists (ASA) classification, and (C) body mass index (BMI, kg/m2) of the participating patients for the 3 cohorts.
The solid line in the middle of the box represents the median. The box represents the middle 50% and the whiskers represent top and bottom 25%. The circles represent mild outliers
and the stars, the extreme outliers.

Hospital Length of Stay
There was a significant difference between the 3 cohorts with
respect to the length of stay (F (2, 292) ¼ 349.4, P < .001, u ¼ 0.838
[large effect size]). Post hoc comparisons (LSD) revealed that the
length of stay was significantly decreased (P < .001) for cohort 2
(M ¼ 3.26, SD ¼ 0.58) when compared to cohort 1 (M ¼ 3.89, SD ¼
0.38). The length of stay was significantly decreased for cohort 3
(M ¼ 2.12, SD ¼ 0.44) in comparison to both cohort 1 (P < .001) and
cohort 2 (P < .001; see Table 3 and Fig. 2A).
Pain Control
Analysis of variance analysis overall did not show a significant
effect of the type of treatment the patients received on the average
postoperative pain scores (F (2, 292) ¼ 2.954, P ¼ .054, u ¼ 0.114
[small effect size]), but post hoc comparisons (LSD) revealed that
the average postoperative pain score was significantly decreased
(P ¼ .016) in cohort 3 (M ¼ 3.18, SD ¼ 1.16) in comparison to cohort
1 (M ¼ 3.55, SD ¼ 1.07). There was a tendency toward reduction in
average postoperative pain scores between cohorts 1 and 2 (M ¼
3.37, SD ¼ 1.01); however, this difference was not statistically sig-
nificant. There was also a reduction in average pain scores between
cohorts 2 and 3; again however, this difference was not statistically
significant (see Table 3 and Fig. 2C).
Incidence of Antiemetic Drug Administration
There was a significant association between the type of treat-
ment patients received and the incidence of antiemetic drug
administration. There was a significant reduction in the incidence
of antiemetic drug administration in cohort 2 in comparison to
cohort 1 (Pearson c2 ¼ 9.86, P ¼ .002, 34% vs 57%, respectively).
There was also a significant reduction in the incidence of antiemetic
drug administration in cohort 3 in comparison to cohort 1 (Pearson
c2 ¼ 15.35, P < .0001, 29% vs 57%, respectively). There was a
reduction in the mean value of antiemetic drug administration in
cohort 3 in comparison to cohort 2, but this reduction was not
statistically significant (Pearson c2 ¼ 0.68, P ¼ .410, 29% vs 34%,
respectively; see Fig. 2D).
There was also a significant effect of the type of treatment that
the patients received on the total ondansetron consumption (F
(2,292) ¼ 3.356, P ¼ .036, u ¼ 0.125 [small effect size]). Post hoc
comparisons (LSD) revealed that total ondansetron consumption
was significantly decreased (P ¼ .014) for cohort 3 (M ¼ 2.06,
standard error [SE] ¼ 0.44) in comparison to cohort 1 (M ¼ 3.66,
SE ¼ 0.49). Although the mean value of total ondansetron
2444 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448

Table 3
Primary Outcome Data.

Cohort 1 (N ¼ 99) Cohort 2 (N ¼ 99) Cohort 3 (N ¼ 97) P Values

Cohort 1 vs Cohort 1 vs Cohort 2 vs

Cohort 2 Cohort 3 Cohort 3

Length of stay (d)

All 3.89 ± 0.38 3.27 ± 0.58 2.12 ± 0.44 0.000a 0.000a 0.000a
Male 3.87 ± 0.40 3.13 ± 0.52 2.09 ± 0.47 0.000a 0.000a 0.000a
Female 3.91 ± 0.35 3.35 ± 0.61 2.15 ± 0.41 0.000a 0.000a 0.000a
Pain score (preop)
All 1.31 ± 2.21 1.68 ± 2.57 1.75 ± 2.50 .288 .199 .843
Male 0.71 ± 1.25 1.38 ± 2.28 1.43 ± 2.43 .091 .082 .930
Female 1.81 ± 2.68 1.87 ± 2.75 2.01 ± 2.55 .919 .704 .779
Pain score (postop, avg)
All 3.55 ± 1.07 3.37 ± 1.01 3.18 ± 1.16 .227 .020a .214
Male 3.36 ± 1.15 3.17 ± 0.89 3.05 ± 1.17 .422 .214 .589
Female 3.71 ± 0.99 3.50 ± 1.07 3.29 ± 1.15 .272 .041a .306
Incidence of antiemetic drug administration
All 56 (57) 34 (34) 28 (29) .003a 0.000a .502
Male 22 (49) 9 (23) 6 (14) .027a 0.000a .406
Female 34 (63) 25 (42) 22 (42) .037a .043a .862
Incidence of in-hospital fall
All 5 (5) 0 (0) 0 (0) .059 .059 1.00
Male 1 (2) 0 (0) 0 (0) 1.00 1.00 1.00
Female 4 (7) 0 (0) 0 (0) .047a .11 1.00

Values are expressed as mean ± standard deviation or number (% of patients).

a
P value <.05 is considered to be statistically significant.

consumption for cohort 2 (M ¼ 2.42, SE ¼ 0.44) was reduced in for cohort 3 was reduced in comparison to cohort 2, this reduction
comparison to cohort 1, this reduction was not statistically signif- was not statistically significant (P ¼ .269; see Table 4 and Fig. 3A).
icant (P ¼ .062). There was no significant difference (P ¼ .560) be-
tween cohorts 2 and 3 (see Table 4 and Fig. 3D). Total Acetaminophen and Ketorolac Consumption

There was a significant effect of the type of treatment received

Total Opioid Equivalent Consumption
There was a significant effect of the type of treatment patients
received on total opioid consumption expressed in oral (mg)
morphine equivalents (F (2, 292) ¼ 11.448, P < .001, u ¼ 0.257
[medium effect size]). Post hoc comparisons (LSD) revealed that total
opioid consumption was significantly decreased (P ¼ .001) for cohort
2 (M ¼ 120.7, SE ¼ 14.4) in comparison to cohort 1 (M ¼ 182.5, SE ¼
16.3). Similarly, total opioid consumption was significantly
decreased (P < .001) for cohort 3 (M ¼ 94.1, SE ¼ 10.0) in comparison
to cohort 1 (P < .001). Although the mean total opioid consumption
on total acetaminophen consumption (mg) (F (2, 292) ¼ 17.397, P <
.001, u ¼ 0.316 [medium effect size]). Post hoc comparisons (LSD)
revealed that total acetaminophen consumption was significantly
decreased (P < .001) for cohort 2 (M ¼ 3112.1, SE ¼ 177.1) in com-
parison to the cohort 1 (M ¼ 4209.3, SE ¼ 217.2). Similarly, total
acetaminophen consumption was significantly decreased (P < .001)
for cohort 3 (M ¼ 2675.3, SE ¼ 174.9) in comparison to cohort 1 (P <
.001). Although the mean total acetaminophen consumption for
cohort 3 group was reduced in comparison to cohort 2, this
reduction was not statistically significant (P ¼ .106; see Table 4 and
Fig. 3B).

Table 4
Medication Usage.

Cohort 1 (N ¼ 99) Cohort 2 (N ¼ 99) Cohort 3 (N ¼ 97) P Values

Cohort 1 vs Cohort 1 vs Cohort 2 vs

Cohort 2 Cohort 3 Cohort 3

Total opioid oral morphine equivalent (mg)

All 182.5 ± 16.2 120.7 ± 14.0 94.1 ± 10.0 .004a .000a .246
Male 165.4 ± 14.7 107.0 ± 13.2 106.4 ± 18.6 .004a .013a .979
Female 196.6 ± 27.3 129.6 ± 21.6 83.9 ± 10.1 .052 0.000a .067
Total acetaminophen (mg)
All 4209 ± 217 3112 ± 177 2675 ± 175 0.000a 0.000a .079
Male 4268 ± 314 3133 ± 252 2760 ± 276 .006a 0.000a .319
Female 4161 ± 305 3098 ± 245 2605 ± 228 .007a 0.000a .143
Total ketorolac (mg)
All 27.3 ± 3.3 25.9 ± 2.6 30.0 ± 2.6 .742 .513 .262
Male 19.0 ± 4.1 29.6 ± 4.2 29.7 ± 3.4 .073 .047a .993
Female 34.2 ± 4.8 23.5 ± 3.3 30.3 ± 3.8 .063 .524 .176
Total ondansetron (mg)
All 3.66 ± 0.49 2.42 ± 0.44 2.06 ± 0.44 .062 .016a .561
Male 2.76 ± 0.52 1.64 ± 0.55 1.27 ± 0.69 .142 .087 .680
Female 4.41 ± 0.78 2.93 ± 0.64 2.72 ± 0.56 .139 .080 .800

Values are expressed as mean ± standard error or number (% of patients).

a
P value <.05 is considered to be statistically significant.
 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448 2445

Table 5
Incidence of Postoperative Complications.

Type of Events Group 1 (291) Group 2 (319) Group 3 (387) P Values

Number Percent Number Percent Number Percent Group 1 vs Group 1 vs Group 2 vs

Group 2 Group 3 Group 3

Death 2 0.7% 1 0.3% 0 0.0% .608 .184 .452

Deep vein thrombosis (DVT) 3 1.0% 1 0.3% 3 0.8% .352 1 .631
Emergency department visit 21 7.2% 19 6.0% 28 7.2% .624 1 .546
(without inpatient hospitalization)
Hematoma 2 0.7% 1 0.3% 1 0.3% .608 .580 1
Joint space infection 1 0.3% 1 0.3% 1 0.3% 1 1 1
Other return to the OR for total 6 2.1% 5 1.6% 11 2.8% .765 .624 .316
jointerelated events
(not previously reported)
Pulmonary embolism 0 0.0% 1 0.3% 0 0.0% 1 1 .452
Readmission 9 3.1% 13 4.1% 13 3.4% .665 1 .690

Values are expressed as either absolute number (number) or percentage (percent) of that type of incidence from among the total number of patients in the specific group.
P value < .05 is considered to be statistically significant. Group 1, group 2, and group 3 are in the order the patients who have gone through knee surgery in 6-month intervals
from January 1, 2013 to June 30, 2013; October 1, 2014 to March 31, 2015; and December 1, 2015 to May 31, 2016, respectively. Patients for the study groups cohort 1, cohort 2,
and cohort 3 were selected from among the patients of group 1, group 2, and group 3 time intervals, respectively.

Fig. 2. Boxplots (A) of the hospital length of stay (LOS), (B) preoperative pain score, and (C) the average postoperative pain score. The solid line in the middle of the box represents
the median. The box represents the middle 50% and the whiskers represent top and bottom 25%. The circles represent mild outliers and the stars, the extreme outliers. (D) The
percentage of the incidence of postoperative administration of antiemetic drugs in the three cohorts.
2446 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448

Fig. 3. Boxplots of (A) total opioid (oral morphine equivalent, mg), (B) total acetaminophen (mg), (C) total ketorolac (mg), and (D) total ondansetron (mg) consumption by patients
in each cohort. The solid line in the middle of the box represents the median. The box represents the middle 50% and the whiskers represent top and bottom 25%. The circles
represent mild outliers and the stars, the extreme outliers.

There was no significant effect of the type of treatment on total
ketorolac consumption. (F (2, 292) ¼ 0.542, P ¼ .582; see Table 4
and Fig. 3C).
Complications
There were 5 reported in-hospital falls for patients in cohort 1
and 0 reported in-hospital falls in either of cohorts 2 and 3 (see
Table 3).
There was no statistically significant difference between the 3
cohorts in the incidence of the following postoperative complica-
tions: death, deep venous thrombosis, pulmonary embolus, infec-
tion, perioperative complications, reoperation, hardware failure,
joint dislocations, hospital readmissions, and emergency room
visits without readmission (see Table 5).
Discussion
Multiple studies have demonstrated the efficacy of MCP and
OMA in standardization of patient care, improved outcomes, and
reduced costs [10e13,23e26,32,33]. Despite increased imple-
mentation of MCP regimens, a significant number of patients have
continued to experience inadequate postoperative pain relief.
Postoperative pain poses an obstacle to rehabilitation efforts and
hospital discharge, leading to increased costs [23e26,32]. Pain
control following TKA has been historically based on oral opioids,
patient-controlled intravenous opioid analgesia, or epidural in-
fusions [23,32]. Adverse effects commonly encountered with these
modalities are associated with significantly increased length of
hospital stay and cost of care [23,27,28]. Patient-controlled intra-
venous opioid analgesia and epidural infusions can require
frequent adjustments, limit ambulation, have significant side ef-
fects, and may not be appropriate for all patients. These short-
comings, combined with an increased understanding of pain
physiology, have prompted development of novel MCP regimens
[10e13,23,24,32,33]. During the past 2 decades, there has been a
rapid increase in peer-reviewed literature, including prospective
randomized trials, demonstrating the efficacy of multimodal ap-
proaches over opioid-based analgesia [13,23,29,32]. These studies
show that patient education, preemptive oral analgesics, stan-
dardized anesthetic care, and regional anesthetic techniques for
postoperative analgesia enable earlier participation in rehabilita-
tion efforts, improve pain control, reduce opioid consumption, and
decrease hospital length of stay after TKA [10e13,23,32].
This before-and-after study has demonstrated that each phase
of implementation of the tailored MCP regimen resulted in
 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448
statistically significant reductions in hospital length of stay. The
initial phase of implementation included the change to ACB
combined with POD 0 ambulation and rehabilitation protocols.
These changes were implemented together as they are closely
intertwined. Studies have shown that early mobilization in pa-
tients who are status after TKA or total hip arthroplasty can result
in reduced length of stay without an increase in negative out-
comes [30]. The ability to ambulate on POD 0, however, is often
related to muscle strength and pain level. Literature has shown
that ACB results in less quadriceps weakness than FNB while
providing similar analgesia [19e21]. In fact, a 2017 meta-analysis
of randomized controlled trials comparing ACB to FNB in TKA
confirmed that ACB provided pain relief and total opioid con-
sumption that was comparable to FNB, while having improved
quadriceps sparing, better range of motion in the knee, and
decreased fall risk [31]. Also in 2017, Thacher et al [34] found that
ACB reduced the incidence of knee buckling and falls during
physical therapy when compared to FNB in TKA. This initial phase
of implementation resulted in an average reduction in hospital
length of stay of 0.62 days. The second phase of implementation
was the addition of the standardized OMA protocol to the MCP.
Studies have shown that OMA can decrease postoperative opioid
requirements, increase participation in therapy, and reduce length
of stay [35]. The addition of the OMA protocol to the MCP resulted
in a total average reduction in hospital length of stay of 1.79 days
when compared to patients treated before the implementation of
the revised MCP.
This study also demonstrated the additive effects of the MCP on
reducing opioid consumption. The implementation of the revised
MCP resulted in a statistically significant decrease in total opioid
consumption. It is worthwhile to note that there was an approxi-
mately 50% reduction in total opioid consumption between cohort
1 and cohort 3. This reduction in opioid use was also accompanied
by a statistically significant decrease in acetaminophen consump-
tion following the implementation of the MCP. Ketorolac usage
increased slightly during the implementation phases; however, its
overall utilization increase was not statistically significant. The
ability of the MCP to reduce opioid consumption may be of
particular importance as we attempt to combat the opioid crisis
that our country currently faces. In addition, reduction in overall
medication administration including acetaminophen and opioids
may lead to decreased hospital costs.
The implementation of the revised MCP resulted in a signifi-
cant decrease in the incidence of antiemetic administration. None
of the MCP regimens in this study included scheduled antiemetic
medication. There was a 44% decrease in ondansetron adminis-
tration between cohorts 1 and 3. It is also significant to note that
there was no use of second-line antiemetic agents in either cohort
2 or cohort 3. This significant decrease in medication utilization
offers a potential for reduced hospital costs in this patient
population.
Our results also demonstrate the additive effect of the fully
evolved MCP on improving postoperative pain control. The first
phase of implementation resulted in a reduction in VAS reported by
patients; however, this reduction was not statistically significant.
The second phase of implementation resulted in statistically sig-
nificant reductions in VAS reported by patients. This is an encour-
aging result when considering the statistically significant reduction
in opioid consumption. It would appear that the MCP used for
cohort 3 was able to improve pain control and reduce reliance upon
opioids.
Of obvious concern to health-care systems is reducing the
incidence of postoperative complications that would offset any
savings achieved by reducing the hospital length of stay. This is
especially true as systems advance toward payment paradigms
2447
that do not reimburse for costs associated with those complica-
tions. Our institution participates in both the Anesthesia Perfor-
mance Improvement Reporting Exchange and Michigan
Arthroplasty Registry Collaborative Quality Initiative. We exam-
ined event data that are submitted to both the Anesthesia Per-
formance Improvement Reporting Exchange and Michigan
Arthroplasty Registry Collaborative Quality Initiative to evaluate
the incidence of complications experienced by each of the cohorts.
There was no statistically significant difference increase in the
incidence of any of these complications among the 3 cohorts. This
suggests that the fully evolved MCP was successful in significantly
reducing hospital length of stay without a concomitant increase in
complications. This reduction would represent a significant cost
savings opportunity for TJA programs that adopt similar MCP
regimens.
This study did not specifically address a comparison of FNB to
ACB as it was not designed to do so; however, the statistically sig-
nificant reduction in the number of in-hospital falls is particularly
encouraging in the face of the early ambulation and rehabilitation
protocols. Our results indicate that changing from FNB to ACB
tailored to facilitate POD 0 ambulation and rehabilitation efforts
can be done without increasing pain scores or complications. Our
results are consistent with other studies that demonstrate preser-
vation of quadriceps strength with ACB that allows POD 0 ambula-
tion and rehabilitation therapy [19,21].
An issue that our investigators noted during the study was the
inconsistency in collection of VAS data from patients. While
nursing protocols dictate the documentation of the pain score once
per shift, there was a wide variation in the total number of
assessment scores documented between patients. We used the
average pain score as calculated using the total number of docu-
mented assessments for each patient, but our data could have been
affected to a minor extent by the high variability in the total
number of documented VAS assessment scores.
One potential defect in our sequential before-and-after study is
our use of historical controls in looking at sequential cohorts, which
frequently is among the features of before-and-after studies. There
are also inherent biases that are associated with before-and-after
studies [36]. We are, thus, hesitant to attribute the noted im-
provements to any single intervention within the fully evolved
MCP. Future randomized studies may be necessary to ascertain this.
What we can conclude is that the process of development of a fully
evolved MCP and its implementation can introduce significant
improvements in care and value.
Our results demonstrate a significant opportunity for cost sav-
ings and system resource utilization reduction that may offer
important benefit to the health-care systems as the massive in-
crease in TKA volume burdens the system of the future. We were
able to demonstrate a reduced hospital length of stay, better pain
control, and a reduction in opioid utilization that was directly
related to alterations in care pathways tailored to facilitate early
ambulation. Our results are consistent with the findings of studies
showing the efficacy of single interventions but further demon-
strate the additive benefits experienced with phased imple-
mentation of a fully evolved MCP. Future studies comparing the
safety of FNB to ACB could be of further benefit to systems devel-
oping MCP that involve POD 0 ambulation and rehabilitation
therapy.
Acknowledgments
The authors would like to thank Saint Joseph Mercy Oakland
Hospital, Pontiac, Michigan, and especially the Information Tech-
nology Department for their assistance in this study. They would
also like to thank the SJMO Department of Orthopedic Surgery for
2448 T.A. Ellis II et al. / The Journal of Arthroplasty 33 (2018) 2440e2448
their significant support and assistance. They would like to indi-
vidually thank Karen Wilde and Dr. Safa Kassab for their support
and assistance with this project.
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 The Journal of Arthroplasty 33 (2018) 2541e2545

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

No Difference in Major Complication and Readmission Rates

Following Simultaneous Bilateral vs Unilateral Total Hip
Arthroplasty
Mina W. Morcos, MD, MSc, Adam Hart, MD, FRCSC, John Antoniou, MD, FRCSC,
Olga L. Huk, MD, FRCSC, David J. Zukor, MD, FRCSC, Stephane G. Bergeron, MD, MPH *
Department of Orthopedic Surgery, McGill University, SMBD-Jewish General Hospital, Montreal, Quebec, Canada

a r t i c l e i n f o a b s t r a c t

Article history: Background: Simultaneous bilateral total hip arthroplasty (THA) is an attractive option for patients with
Received 12 January 2018 osteoarthritis as it requires a single anesthetic and hospitalization. Nonetheless, serious concerns remain
Received in revised form over the perioperative safety and rate of hospital readmission. The purpose of the present study was to
2 March 2018
compare the rate of 30-day major complications and hospital readmissions between patients undergoing
Accepted 17 March 2018
simultaneous bilateral vs unilateral THA using the National Surgical Quality Improvement Program
Available online 27 March 2018
database.
Methods: The National Surgical Quality Improvement Program database was queried from 2011 to 2015
Keywords:
bilateral
inclusively to identify all cases of elective, primary simultaneous bilateral THA and match them to a
hip arthroplasty control group of unilateral THA cases. A multivariable regression analysis was then used to assess the
readmission relationship of simultaneous bilateral vs unilateral THA on major complications and readmissions.
NSQIP Results: A total of 575 bilateral THA patients were matched to 2290 unilateral THA patients using a 4:1
major complication ratio based on age, sex, and American Society of Anesthesiologists scores. Bilateral THA patients were
more likely to undergo general anesthesia (77% vs 58.7%, P < .0001), required more postoperative
transfusions (29.2% vs 15.9%, P < .0001) and were more often discharged to a rehabilitation facility rather
than home (39.4% vs 20.8%, P < .0001). However, the adjusted odds of a major complication (odds ratio ¼
0.72, 95% confidence interval [0.41-1.24], P ¼ .24) and 30-day readmission (odds ratio ¼ 0.67, 95% con-
fidence interval [0.38-1.19], P ¼ .17) were similar between the 2 groups.
Conclusion: Although patients who underwent simultaneous bilateral THA were more likely to be dis-
charged to a rehabilitation facility and required significantly more perioperative transfusions compared
to those undergoing unilateral THA, the odds of a 30-day major complication and readmission were
similar between groups.
Level of Evidence: III
© 2018 Elsevier Inc. All rights reserved.

The demand for primary total hip arthroplasty (THA) has been
growing steadily over the last decade and approximately 42% of
patients undergoing THA suffer from bilateral hip osteoarthritis
[1,2]. It is estimated that between 16% and 35% of patients will
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.050.
* Reprint requests: Stephane G. Bergeron, MD, MPH, Department of Orthopedic
Surgery, SMBD-Jewish General Hospital, Room E-003 3755 Co ^ te St-Catherine Road,
Montreal, Quebec, Canada H3T 1E2.
require contralateral THA within 1 year of the first hip arthroplasty
[3e5]. Consequently, the option of performing simultaneous
bilateral THA is becoming an increasingly attractive option for
appropriately selected patients.
Potential advantages of simultaneous bilateral THA include a
single anesthetic procedure, shorter total hospital stay, and faster
recovery time [6e9]. Several studies have also demonstrated
similar complication rates between simultaneous bilateral THA and
staged THA, as well as improved cost-effectiveness in favor of
simultaneous bilateral THA compared with staged bilateral THA
[10e13]. However, concerns remain over the perioperative safety of
simultaneous bilateral THA given the findings of other studies
showing longer operative time, increased blood loss, and need for

https://doi.org/10.1016/j.arth.2018.03.050
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2542 M.W. Morcos et al. / The Journal of Arthroplasty 33 (2018) 2541e2545

transfusion, as well as increased rates of infection, thrombosis, and Table 1

pulmonary embolism [14,15]. Unfortunately, most studies are Baseline Characteristics of 2865 Patients Undergoing Unilateral and Bilateral THA.

limited by a small sample size, lack of a reliable control group, and Baseline Characteristic Unilateral Bilateral P Value
inherit selection bias. The move towards bundled payments in the (n ¼ 2290) (n ¼ 575)
United States further amplifies concerns of performing simulta- Demographic characteristic
neous bilateral THA due to the potentially higher rate of perioper- Age, mean (±SD) 57.6 (±11.8) 57.4 (±12.0) .80
ative complications and unplanned hospital readmissions. Sex .93
Female (%) 1156 (50.5%) 289 (50.3%)
The purpose of this study was to compare the perioperative
Male (%) 1134 (49.5%) 286 (49.7%)
outcomes between patients undergoing simultaneous bilateral THA Smoker
vs unilateral THA using the National Surgical Quality Improvement Current smoker (%) 404 (17.6%) 89 (15.5%) .24
Program (NSQIP) database. The NSQIP database is a prospective, Nonsmoker (%) 1886 (82.4%) 486 (84.5%)
Past medical history
multicenter database that is well suited to compare perioperative
Hypertension (%) 1045 (45.6%) 232 (40.4%) .024
outcomes between simultaneous bilateral and unilateral THA. The Diabetes (%) 200 (8.7%) 29 (5.0%) .003
primary outcome sought to compare the 30-day major complica- COPD (%) 68 (3.0%) 11 (1.9%) .20
tion rate, whereas the secondary outcome evaluated the 30-day CHF or dyspnea (%)a 113 (4.9%) 20 (3.5%) .15
unplanned hospital readmission rate following simultaneous History of steroid use (%)b 58 (2.5%) 30 (5.2%) .002
Preoperative laboratories
bilateral and unilateral THA.
Creatinine (mg/dL), mean (±SD) 0.90 (±0.49) 0.88 (±0.43) .21
BUN, mean (±SD) 17.0 (±8.1) 16.8 (±11.4) .73
Methods Hematocrit, mean (±SD) 40.8 (±4.1) 41.1 (±4.1) .22
Platelets, mean (±SD) 249 (±69.9) 253 (±68.3) .21
The NSQIP database is a risk-adjusted, validated, outcome-based Operative characteristics
ASA classification .98
program collecting data on patients undergoing major surgical 1 216 (9.4%) 54 (9.4%)
procedures. This database includes information on patient charac- 2 1396 (61%) 349 (60.7%)
teristics such as demographics, comorbidities, and perioperative 3 661 (28.9%) 167 (29%)
variables, as well as 30-day postoperative complications and 4 17 (0.7%) 5 (0.9%)
Anesthesia <.0001
readmission rates [16]. Variables are collected prospectively by
Regional (%) 946 (41.4%) 132 (23%)
surgical clinical reviewers for 30 days postsurgery even if a patient General (%) 1342 (58.7%) 443 (77%)
is discharged from the hospital [17]. The data are internally audited, Length of surgery (minutes), 99.5 (±48.1) 160.7 (±64.8) <.0001
and the disagreement rate is less than 2% [18]. There are over 750 mean (±SD)
participating centers and more than 90% are located within the Transfusion (intraop and up to 364 (15.9%) 168 (29.2%) <.0001
72 h after surgery)
United States [19]. Discharge <.0001
All patients undergoing elective primary unilateral and simul- Home (%) 1812 (79.2%) 348 (60.6%)
taneous bilateral THA between 2011 and 2015 inclusively were Rehab (%) 477 (20.8%) 226 (39.4%)
included in this study. Patients were identified using the Current Length of stay (d), mean (±SD) 3.2 (2.5) 3.1 (2.6) .36
Procedural Terminology code 27130, and simultaneous bilateral ASA, American Society of Anesthesiologists; SD, standard deviation; THA, total hip
procedures were defined as bilateral THAs performed under a arthroplasty; COPD, chronic obstructive pulmonary disease; CHF, congestive heart
single anesthetic on the same day. The exclusion criteria included failure; BUN, blood urea nitrogen.
a
CHF or dyspnea includes a history of congestive heart failure or dyspnea at rest
infection, malignancy, fracture, and emergency procedures. We or on moderate exertion.
identified a total of 575 patients with primary simultaneous bilat- b
Patients who required regular oral or intravenous corticosteroid for a chronic
eral THA from the NSQIP database after applying the previously medical condition within 30 d before THA.
mentioned inclusion and exclusion criteria. Bilateral THA patients
were then matched to a control group of unilateral THA patients
performed during the same time interval. Approximate string intubation, ventilator dependency >48 hours, and death [20e23]. A
matching was used with a 4:1 matching ratio based on age, gender, readmission consisted of any unplanned readmission to any hos-
and American Society of Anesthesiologists (ASA) scores (the ASA pital within 30 days of surgery even if the hospital differed from
score is a physical status classification system used for risk strati- where the THA was performed.
fication of operative risk at the time of a surgical procedure). This
matching algorithm identified a matched control group of 2290 Statistical Analysis
unilateral THA patients.
Patient baseline characteristics included demographics, medical Preoperative patient variables between the simultaneous bilat-
comorbidities, preoperative laboratories, and operative variables eral THA group and unilateral THA group were compared using a 2-
(Table 1). The type of anesthesia was grouped into either regional or sample t test for continuous variables, Fisher's exact test for binary
general anesthesia, while blood transfusion was defined as any variables, or chi-square test for multiple categorical variables.
transfusion within 72 hours from surgery. Patient disposition Continuous variables are expressed as mean ± standard deviation,
postoperatively was considered home if they returned to their while categorical variables are reported as absolute values and
preoperative primary residence, while all other patients were dis- percentages. Unadjusted 30-day major complication and read-
charged to a rehabilitation center, skilled or unskilled care facility, mission rates were calculated using the same methods.
other facility not considered home, or separate acute care facility. Multivariable logistic regression analysis was performed to
Any variable that had a completion rate less than 80% was excluded model the independent effect of bilateral vs unilateral THA on the
from the statistical analysis. A major postoperative complication 30-day risk of having a major complication or readmission after
was defined according to previously published studies using NSQIP controlling for all other confounders. Independent risk factors from
and included at least one of the following: deep wound infections, Table 1 were included in the baseline model because these were
pneumonia, sepsis, pulmonary embolus, acute renal failure believed to be potential confounders in the relationship of the type
requiring dialysis, cerebrovascular accident, cardiac arrest, of THA and risk of major complication or readmission. Variable
myocardial infraction, return to operating room, unplanned thought to be unlikely true confounders were removed from
 M.W. Morcos et al. / The Journal of Arthroplasty 33 (2018) 2541e2545 2543

subsequent models while also assessing for any interaction terms. Table 3
The stability of future models was evaluated by comparing the chi- Multivariable Logistic Regression Model Assessing Independent Predictors on
30-Day Major Complications After Primary Unilateral and Bilateral THA.a
square likelihood ratio, Akaike information criterion, and 2 log L
to previous models. A final model was chosen for both major Variable Adjusted Odds P Value 95% Confidence
complication and readmission according to its ability to best pre- Ratio Interval

dict either outcome after bilateral and unilateral THA. SAS software Total hip arthroplasty
(version 9.3; SAS Institute, Cary, NC) was used for all statistical Bilateral 0.72 .24 0.41-1.24
Unilateral 1.0 (reference)
analyses.
Age 1.02 .06 1.0-1.04
Sex
Results Male 1.19 .44 0.76-1.85
Female 1.0 (reference)
Smoker
A total of 575 primary simultaneous bilateral THA patients were Current smoker 1.63 .06 0.98-2.71
identified and matched to 2290 patients treated with unilateral Nonsmoker 1.0 (reference)
THA. Patient baseline and perioperative characteristics between Past medical history
both groups are reported in Table 1. The bilateral THA group con- Hypertension 1.31 .24 0.84-2.05
Diabetes 0.74 .44 0.34-1.59
sisted of fewer patients with diabetes (5% vs 8.7%, P ¼ .003) and
COPD 0.61 .44 0.17-2.14
hypertension (40.4% vs 45.6%, P ¼ .024), while bilateral THA pa- CHF or dyspnea 1.48 .35 0.65-3.34
tients were more likely to have a history of steroid use (5.2% vs 2.5%, Steroid use 1.35 .57 0.47-3.89
P ¼ .002). Simultaneous bilateral THA patients were more often Preoperative laboratories
performed under general anesthesia (77% vs 58.7%, P < .0001), had Hematocrit 1.02 .53 0.96-1.07
ASA classification
longer surgical times (160.7 vs 99.5 minutes, P < .0001), and 1 1.0 (reference)
required a higher rate of postoperative transfusion (29.2% vs 15.9%, 2 0.95 .9 0.4-2.22
P < .0001). Finally, patients in the bilateral THA groups were more 3 1.4 .47 0.56-3.48
likely to be discharged to a rehabilitation facility (39.4% vs 20.8%, 4 N/A .99 N/A
Anesthesia
P < .0001).
Regional 0.95 .8 0.62-1.45
Postoperative complications and the 30-day rate of readmission General 1.0 (reference)
are summarized in Table 2. The unadjusted rate of major compli- Length of surgery 1.005 .0005 1.002-1.007
cations was similar between both groups: 4.0% in the bilateral THA ASA, American Society of Anesthesiologists; N/A, not applicable; THA, total hip
group vs 3.7% in the unilateral THA group (P ¼ .71). The unadjusted arthroplasty; COPD, chronic obstructive pulmonary disease; CHF, congestive heart
rate of 30-day hospital readmission was also nonsignificant be- failure.
a
tween the bilateral and unilateral groups (3.5% vs 3.7%, P ¼ .9). Multivariable model performed on a total of 2685 patients undergoing unilat-
eral and bilateral THA (180 patients were excluded for missing values).
After controlling for potential confounders, the multivariable
logistic regression analysis showed similar odds of having a major
complication after simultaneous bilateral compared to unilateral
THA (odds ratio ¼ 0.72, 95% confidence interval [0.41-1.24], P ¼ .24) Discussion
(Table 3). There was also no difference in the odds of being read-
mitted within 30 days following bilateral THA compared to The purpose of this study was to compare the 30-day major
unilateral THA (odds ratio ¼ 0.67, confidence interval [0.38-1.19], complication and hospital readmission rates in 2865 patients
P ¼ .17) (Table 4). undergoing simultaneous bilateral and unilateral THA. After
adjusting for differences in baseline characteristics, we found that
simultaneous bilateral THA had similar odds of major complica-
tions and readmission rates compared to unilateral THA. One of the
Table 2
Thirty-Day Complication Rate and Readmission Rate Following Unilateral and main concerns of performing simultaneous bilateral THA is the
Bilateral THA. potential increase in major complications. There are conflicting
reports in the literature regarding the safety of bilateral THA. Older
Unadjusted Results Unilateral Bilateral P-Value
(n ¼ 2290) (n ¼ 575) studies have reported a high rate of overall complications, namely
thromboembolic events after simultaneous bilateral procedures
Major complication rate (%) 84 (3.7%) 23 (4.0%) .71
Death 7 (0.3%) 0 (0%) .36
[24,25]. However, improvements in anticoagulation prophylaxis
Return to OR 48 (2.1%) 9 (1.6%) .51 have significantly reduced the rate of both deep venous thrombosis
Deep wound infection 13 (0.6%) 7 (1.2%) .10 and pulmonary embolism [9,26,27]. A more recent retrospective
Pneumonia 4 (0.2%) 3 (0.5%) .15 unmatched cohort study by Glait et al [28] examined the New York
Pulmonary embolus 2 (0.1%) 1 (0.2%) .49
State database between 1990 and 2010 to compare unilateral THA
Acute renal failure (requiring 1 (0.04%) 0 (0%) 1.0
postoperative dialysis) and bilateral THA. The authors found an increase in pulmonary
Cerebrovascular accident 2 (0.1%) 1 (0.2%) .49 embolism and deep vein thrombosis rates in bilateral THA group
Cardiac arrest 2 (0.1%) 0 (0%) 1.0 although the mortality rate was similar between groups. Other
Myocardial infarction 4 (0.2%) 1 (0.2%) 1.0 authors have also shown no difference in the risk of major com-
Sepsis 7 (0.3%) 4 (0.7%) .25
Unplanned intubation 4 (0.2%) 0 (0%) .59
plications. Kim et al [7] found no difference in major and minor
Ventilator dependency >48 h 2 (0.1%) 0 (0%) 1.0 complications in 978 patients treated with 1-stage bilateral total
Minor complication rate (%) 35 (1.5%) 10 (1.7%) .71 hip arthroplasty compared to patients undergoing unilateral THA.
Superficial wound infection 15 (0.7%) 5 (0.9%) .58 When compared to 2-stage procedures, simultaneous bilateral THA
Urinary tract infection 16 (0.7%) 5 (0.9%) .59
has been shown to have equal or fewer complication rates [29,30].
Deep vein thrombosis 5 (0.2%) 0 (0%) .59
30-d readmission rate (%)a 80 (3.7%) 20 (3.5%) .90 Aghayev et al [29] reported fewer systemic complications after 1-
stage procedures compared with 2-stage bilateral THA within 6
THA, total hip arthroplasty; OR, operation room.
a
Readmission rate calculated using 2733 patients (4.6% missing patients): 2163
months and 2-stage THA between 6 months and 5 years. However,
unilateral THA (94.5%) and 570 bilateral THA (99.1%). most of these studies suffer from methodological limitations such
2544 M.W. Morcos et al. / The Journal of Arthroplasty 33 (2018) 2541e2545

Table 4 minimize the chance of a type II error but grouping all major
Multivariable Logistic Regression Model Assessing Independent Predictors on complications as previously described in other studies using
30-Day Readmission Rates Following Primary Unilateral and Bilateral THA.a
NSQIP after THA.
Variable Adjusted Odds Ratio P Value 95% Confidence
Interval

Total hip arthroplasty Conclusion

Bilateral 0.67
Unilateral 1.0 (reference) .17 0.38-1.19 Using a multicenter database, we found no difference in the
Age 1.02 .05 1.0-1.04 rates of 30-day major complications or unplanned readmissions
Sex
between simultaneous bilateral and unilateral THA. The majority of
Male 1.42
Female 1.0 (reference) .11 0.92-2.19 patients undergoing bilateral THA were young (average age was 57
Smoker years) and healthy with minor comorbidities (ASA score 1 or 2).
Current smoker 1.59 Given that both procedures were found to have a low rate of
Nonsmoker 1.0 (reference) .09 0.93-2.73
complications and readmissions, simultaneous bilateral THA ap-
Steroid use 1.25 .71 0.38-4.14
Preoperative laboratories pears to be a safe and attractive option for low-risk patients
Creatinine 1.08 .63 0.78-1.51 suffering from bilateral hip arthritis.
ASA classification
1 1.0 (reference)
2 0.6 .12 0.31-1.15 References
3 0.4 .02 0.18-0.85
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concerns of higher readmission rates. Few studies have sought to tiveness of one-stage versus two-stage bilateral total hip replacement. Or-
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[11] Reuben JD, Meyers SJ, Cox DD, Elliott M, Watson M, Shim SD. Cost comparison
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NSQIP showing similar readmission rates. Therefore, surgeons similar complication rates to unilateral total hip arthroplasty. J Arthroplasty
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should not be discouraged from performing simultaneous THA over [14] Berend ME, Ritter MA, Harty LD, Davis KE, Keating EM, Meding JB, et al.
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of the study design. Owing to the administrative nature of the bilateral total hip arthroplasty: perioperative risk comparison. J Arthroplasty
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[17] NSQIP. Data collection, analysis and reporting. http://site.acsnsqip.org/program-
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cation. Despite these limitations, the NSQIP database is a high- [18] NSQIP. American College of Surgeons National Surgical Quality Improvement
quality database that is regularly audited. It contains an exten- Program. http://www.facs.org/quality-programs/acs-nsqip?. [Accessed March
2017].
sive list of perioperative variables and postoperative complica-
[19] American College of Surgeon's National Surgical Quality Improvement Pro-
tions making it a useful database to measure health outcomes gram User guide for the 2011 participant use data file. 2012. https://www.
following joint arthroplasty. Another limitation of this study is facs.org/~/media/files/quality%20programs/nsqip/ug12.ash.
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discharge within 2 days following total hip or knee arthroplasty does not
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of any study with a retrospective design. We attempted to 2016;98:1419e28.
 M.W. Morcos et al. / The Journal of Arthroplasty 33 (2018) 2541e2545
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 The Journal of Arthroplasty 33 (2018) 2341e2343
Contents lists available at ScienceDirect
The Journal of Arthroplasty
journal homepage: www.arthroplastyjournal.org
Editorial
Opioids in Total Joint Arthroplasty: Moving Forward
Americans consume about 80% of the world’s prescription opi-
oids despite constituting less than 5% of the global population [1].
According to the Center for Disease Control and Prevention, 91
Americans die every day from opioid overdose (including prescrip-
tion opioids and heroin) and this number is expected to increase
[2]. Among patients on chronic prescription opioids, it is estimated
that 1 in 550 will die from opioid-related causes [3]. The question
for total joint arthroplasty (TJA) surgeons is how to reduce opioid
use in our patients during the perioperative period.
There are a number of critical issues related to pain manage-
ment after TJA that clearly require further study. These include
(1) identifying patients who are at risk of having increased pain
and opioid consumption postoperatively, (2) developing effective
strategies to wean patients off narcotics preoperatively and estab-
lishing clear postoperative guidelines to avoid prolonged opioid
use, and (3) enhancing patient outcomes by optimizing periopera-
tive analgesia protocols to limit or even eliminate opioid require-
ment postoperatively. In this issue of the Journal of Arthroplasty,
Namba et al [4] retrospectively reviewed an arthroplasty registry
and identified the opioid prescription patterns of 23,726 patients
who had unilateral primary total knee arthroplasty (TKA). Surpris-
ingly, 60% of patients had used opioids in the year before surgery
and 42% were using opioids 3 months after surgery. The authors
noted factors associated with prolonged opioid use that had been
previously reported in the literature including female gender,
depression and anxiety, substance abuse, and young patient age.
The authors also identified previously unreported risk factors for
opioid use including black race, diabetes mellitus, congestive heart
failure, hypertension, and liver disease. Patients with cardiac or
liver disease may not be able to use anti-inflammatory and acet-
aminophen so opioids may be their only option for pain relief.
The authors recommended trying to avoid the use of opioids preop-
eratively or weaning patients off of these medications before
surgery [4].
Three other studies recently published in the Proceedings of the
Annual Meeting of the American Association of Hip and Knee Sur-
geons also focused on the impact of preoperative opioid use on
postoperative opioid use and outcomes. Bedard et al [5] performed
a retrospective review of 17,695 patients who underwent primary,
unilateral total hip arthroplasty (THA) using a private insurance
database. The authors found that opioid prescription use within 3
months preceding surgery was associated with increased risk of
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.06.004.
https://doi.org/10.1016/j.arth.2018.06.004
0883-5403/© 2018 Elsevier Inc. All rights reserved.
early revision hip arthroplasty. Using the same database, Politzer
et al [6] retrospectively reviewed 66,950 patients who underwent
primary TKA and found that among those who consumed opioids
preoperatively, 34.8% went on to become chronic users compared
to only 5% of opioid-naïve patients. In a retrospective matched-
cohort study assessing the effect of preoperative opioid use on
post-TKA opioid prescriptions and outcomes, Hernandez et al [7]
showed that preoperative opioid users were more likely to require
opioid refills and manipulation under anesthesia for arthrofibrosis.
In today’s healthcare environment, there is an increased focus
on patient satisfaction after surgery as patient satisfaction scores
could impact physicians’ reimbursement in the future. Recently,
Etcheson et al [8] examined the influence of postoperative opioid
consumption and 7 different Press Ganey domains in THA patients.
In this retrospective review of 322 THA patients, the authors noted
that overall Press Ganey patient satisfaction scores were not
affected by postoperative opioid consumption. The results suggest
that with new pain protocols, opioid prescriptions can be reduced
without negatively impacting patient satisfaction. Finally, it would
be useful to have a tool to identify patients who are at risk of prob-
lems with pain management after TJA. Nickel et al [9] were
awarded the 2017 James A. Rand Young Investigator’s Award at
the Annual Meeting of the American Association of Hip and Knee
Surgeons for their study assessing a novel method to identify pa-
tients at increased risk of prolonged narcotic consumption after
surgery. An algometer was used to apply pressure at either the
medial epicondyle (TKA) or iliac wing (THA) in addition to the ipsi-
lateral olecranon until the pressure sensation became painful. The
authors found negative correlation between the pain threshold
measurement and postoperative opioid use. In the future, objective
tools to identify those at risk of increased narcotic consumption are
needed as current methods are subjective, imprecise, and some-
times inconsistent.
Developing strategies to limit opioid use after surgery and to
successfully wean patients off these drugs after TJA is essential.
When opioid therapy is necessary, orthopedic practices should
set standardized protocols and policies to control and limit opioid
use postoperatively. If a patient is going to receive a prescription
for an opioid after surgery, the joint arthroplasty surgeon and his/
her team should send a consistent message to the patient that
they will be receiving the medication for a short duration. There
should be consensus practice restrictions on prescription size
with 2 prescriptions for smaller amounts preferred over a single
large prescription [10] because postoperative prescription opioids
often go unused, unlocked, and undisposed, which can pose a po-
tential for opioid misuse [11]. At least 16 states now have statutory
limits on first opioid prescriptions ranging from 3 to 14 days [12].
Orthopedic surgeons who practice in those states have had to learn
2342
to manage pain associated with acute trauma and surgical proced-
ures with limited-duration prescriptions. This requires seeing pa-
tients in the office more frequently than was the routine practice
before the legislative limits. This also requires educating the mid-
level providers who do routine postoperative visits that the goal
is to minimize opioid use and that if opioids are refilled at the first
postoperative visit, this should typically be for a reduced tablet
strength, longer interval between doses, and shorter duration of
therapy. The mid-level providers should also be educated that pa-
tient requests for continued or increased opioid requirement at
the first postoperative visit is a potential postoperative complica-
tion, just like a postoperative infection, and the patient should be
evaluated by the operating surgeon. Persistent use of opioids
beyond 90 days after TKA has been shown to be an independent
risk factor for revision surgery [13]. Providing the patient with writ-
ten information that explains the practice's pain prescription proto-
col before surgery or at the initial patient encounter would facilitate
this discussion. Lemay et al [14] found that patients who received
preoperative pain management information reported less pain,
had greater use of nonopioid pain strategies, and had better func-
tion at 6-month follow-up. Unfortunately, 44% of patients reported
that they did not receive information related to pain management
or the information was not helpful.
Orthopedic surgeons continue to pursue protocols to optimize
pain management strategies after TJA including the use of nerve
blocks, periarticular injections, and nonopioid analgesics [15e19].
In this issue of the Journal of Arthroplasty, Ellis et al [20] report on
their institutional experience with multimodal analgesia. The au-
thors retrospectively reviewed 295 patients undergoing primary
TKA who were divided into 3 sequential cohorts: (1) use of femoral
nerve block with delayed ambulation, (2) use of adductor canal
block with day of surgery ambulation, and (3) use of adductor canal
block with day of surgery ambulation and a standardized oral
multimodal analgesic protocol. All 3 cohorts received spinal anes-
thesia. Both cohorts 2 and 3 had reduced postoperative opioid con-
sumption. Cohort 3 also had a significant reduction in postoperative
pain scores, incidence of antiemetic drug administration, and
length of stay in group 3. This study demonstrates that anesthesia
techniques and perioperative pain protocols can impact postopera-
tive opioid use and functional outcomes after TJA. Randomized tri-
als are needed to evaluate the efficacy of these pain protocols and it
is essential that future studies assess the impact of these protocols
on postoperative opioid use beyond the hospital discharge.
The American Academy of Orthopaedic Surgeons (AAOS) has
demonstrated a commitment to combating the opioid epidemic.
The AAOS is participating in the American Medical Association
Take Force for Opioid Use and has launched a public service adver-
tisement campaign to raise awareness of the dangers of the opioid
epidemic. In addition, the AAOS revised statement on “Opioid Use,
Misuse, and Abuse in Orthopaedic Practice” provides orthopedic
surgeons with several important strategies to facilitate appropriate
management of musculoskeletal pain [21]. The fundamental mes-
sage is that healthcare providers should limit opioid use for preop-
erative, nonsurgical, and chronic pain patients. The AAOS statement
also emphasizes that any new approach to pain management
requires a cultural shift from opioids as primary pain treatment
to one that takes into account individual patient circumstances
with a goal of identifying stressors and ineffective coping strategies
[21]. This statement is a call to arms for all arthroplasty surgeons to
truly commit to limiting perioperative opioid use.
Elimination of preoperative use of opioids should be considered
a modifiable risk factor and strategies to limit postoperative opioid
use are essential. Surgeons need to collaborate with other health-
care providers to develop programs to wean patients off of these
drugs both preoperatively and postoperatively. Finally, patient
Editorial
education tools need to be created to teach patients the risks asso-
ciated with opioid use and the negative impact on the outcomes of
their TJA. Clinical researchers of hip and knee arthritis, and hip and
knee arthroplasty need to design and implement prospective
studies, using the strategies outlined in this editorial, to determine
whether orthopedic surgeons and other healthcare providers are
making an impact on markedly reducing opioid use in this popula-
tion of patients [22]. In addition, orthopaedic surgeons need to
develop a culture in their practices, with their patients, and their
individual healthcare teams that it takes a team approach to
address this opioid epidemic and that we are there as fellow
team members to help them (patients) help themselves and help
us with this issue.
Mohamad J. Halawi, MD*
Department of Orthopaedic Surgery
University of Connecticut Health Center
Farmington, Connecticut
Jay R. Lieberman, MD
Department of Orthopaedic Surgery
Keck School of Medicine of University of Southern California
Los Angeles, California
*
Reprint requests: Mohamad J. Halawi, MD, Department of
Orthopaedic Surgery, University of Connecticut Health Center, 263
Farmington Avenue, Farmington, CT 06030.
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 Editorial
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2343
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 The Journal of Arthroplasty 33 (2018) 2595e2604

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

Outcomes of Articulating Spacers With Autoclaved Femoral

Components in Total Knee Arthroplasty Infection
Daniel E. Goltz, BS *, E. Grant Sutter, MD, MS, Michael P. Bolognesi, MD,
Samuel S. Wellman, MD
Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC

a r t i c l e i n f o a b s t r a c t

Article history: Background: In 2-stage revision of total knee arthroplasty (TKA) infection, articulating antibiotic spacers
Received 21 January 2018 show similar eradication rates and superior range of motion compared with static spacers. This study
Received in revised form evaluated infection control and other outcomes in articulating spacers with an autoclaved index femoral
14 March 2018
component.
Accepted 20 March 2018
Methods: We reviewed 59 patients who underwent 2-stage treatment of TKA infection using articulating
Available online 30 March 2018
antibiotic spacers with an autoclaved femoral component with at least 2-year follow-up (mean: 5.0
years) from spacer placement. Reinfection was defined as any subsequent infection; recurrence was
Keywords:
autoclaved femoral component
defined as reinfection with the same organism, need for chronic antibiotics, or conversion directly to
infection amputation/arthrodesis.
articulating antibiotic spacer Results: Nine patients (15%) experienced a recurrence and 22 patients (37%) experienced a reinfection.
revision total knee arthroplasty Incidence of diabetes mellitus was significantly higher in patients who became reinfected. Other
2-stage revision comorbidities, revision history, prior spacer, or presence of virulent organisms did not predict infection
recurrence. Forty-seven spacers underwent reimplantation, 6 (13%) of these went on to above-knee
amputation, 6 (13%) received another 2-stage procedure, and 3 (6%) underwent subsequent irrigation
and debridement. Three patients (5%) proceeded directly from spacer to above-knee amputation (2) or
arthrodesis (1). Nine spacers (15%) in 7 patients were retained indefinitely (mean: 3.4 years), with overall
good motion and function.
Conclusion: Accounting for methodology, articulating spacers with autoclaved femoral components
provide similar infection control to previous reports. Most patients with reinfection grew different or-
ganisms compared with initial infection, suggesting that some subsequent infections may be host
related. Some patients retained spacers definitively with overall good patient satisfaction.
© 2018 Elsevier Inc. All rights reserved.

Approximately 450,000 total knee arthroplasties (TKAs) are

One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.059.
This research was approved by the institutional review board for work involving
human subjects prior to initiation of study.
This research did not receive any specific grant from funding agencies in the
public, commercial, or not-for-profit sectors.
* Reprint requests: Daniel E. Goltz, BS, Duke University School of Medicine, Mary
Duke Biddle Trent Semans Center for Health Education, Duke University Medical
Center Greenspace, Durham, NC 27710.
performed annually in the United States, and this number is ex-
pected to increase to almost 3.5 million by 2030 [1]. Periprosthetic
joint infection (PJI) is a devastating complication, and though it
only occurs in 1-2% of TKA cases [2e4], the potential overall
magnitude provides impetus for effective treatments to reduce
morbidity and cost. A 2-stage protocol involving debridement and
prosthesis resection followed by delayed reimplantation was first
proposed by Insall et al [5]. This technique was soon refined by the
addition of a temporary antibiotic spacer [6,7] and minimum 6-
week course of parenteral antibiotics between stages, a combi-
nation that is currently considered the gold standard in treatment
of chronic PJI [8].

https://doi.org/10.1016/j.arth.2018.03.059
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2596 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604

Spacers made from antibiotic-laden cement serve not only as a static spacer was based on surgeon judgment, considering factors
mechanism for local drug delivery but also to maintain joint space such as degree of bone loss and history of a failed articulating
and minimize ligament contracture between stages. These were spacer.
initially formed as static (block) constructs with limited range of Patients were classified by McPherson systemic host grade [23],
motion (ROM). Although generally effective at infection control American Society of Anesthesiologists (ASA) score, and comorbid
[6,9,10], static spacers suffer from bone loss, instability, and difficult conditions including diabetes mellitus (n ¼ 19, 32%), smoking (n ¼
exposure during second-stage surgery [11], in addition to compli- 8, 14%), rheumatoid arthritis (n ¼ 5, 8%), and chronic steroid use
cations resulting from prolonged immobility (venous thrombo- (n ¼ 5, 8%). Thirty-six cases (61%) presented after a prior revision
embolism and poor capsular healing) [7,12]. Spacers with surgery, including 27 (46%) for infection. Twelve (20%) of the prior
articulating components were introduced to address these con- revisions treated for infection involved an antibiotic implant of
cerns. Although articulating spacers have not conclusively been some type (10 spacers, 1 antibiotic-coated nail, 1 with antibiotic
shown to have superior infection control compared to static con- beads). These data are summarized in Table 1.
structs, they have increased in popularity as comparison studies The diagnosis of infection and decision to perform surgery was
have shown them to have superior postoperative ROM, less bone made by the senior authors. The majority of patients were diag-
loss, and better patient-rated function [12e18]. Some recent nosed by the presence of positive cultures from either preoperative
guidelines now recommend limiting use of static spacers to certain joint aspiration or intraoperative tissue and fluid samples. In 16
patient subgroups, such as those with large bone defects or a dis- cases (27%), cultures were negative, and infection was diagnosed by
rupted extensor mechanism [19]. the presence of a deep draining sinus tract or a combination of
Several categories of articulating spacers currently exist. elevated inflammatory markers including erythrocyte sedimenta-
Cement-on-cement spacers can be handmade, molded, or pre- tion rate, C-reactive protein, synovial white blood cell count,
fabricated. Metal-on-polyethylene constructs include a femoral polymorphonuclear differential cell count, gross purulence
component that can be either prefabricated, new, or autoclaved and encountered within the joint, and positive intraoperative histo-
recycled. A recent systematic review found no significant difference pathologic tissue evidence of acute inflammation. Fellowship-
in final outcomes between these types [20], making the autoclaved trained infectious disease specialists were also involved in the
technique an attractive, cost-effective option. First described by
Hofmann et al [21], the femoral component is removed, sterilized,
and reinserted along with a new polyethylene liner, all fixed by Table 1
Descriptive Statistics of Demographic Profiles and Comorbidities Stratified by
antibiotic-laden cement. The successful outcomes reported in this Whether Patients Did or Did Not Experience Reinfection.
study may have eased fears that maintaining the metallic compo-
nent would serve as a new nidus for infection. The follow-up study Overall (n ¼ 59) No Reinfection Reinfection P Value
(n ¼ 37) (n ¼ 22)
involving 50 patients [22] remains the largest to date, and over the
past 10 years, the literature has been limited both in terms of cohort Follow-up (y) 5.0 ± 2.4 4.8 ± 2.3 5.1 ± 2.7 .826
Age at first stage (y) 61.0 ± 10.0 61.0 ± 10.2 60.8 ± 10.1 .790
size and often follow-up. There are also limited data on patients
Gender (M:F) 29:30 15:22 14:8 .086
with retained spacers. BMI 34.4 ± 9.0 32.6 ± 7.5 37.4 ± 10.6 .098
Therefore, we sought to determine (1) the recurrence and Primary at outside 50 (85%) 32 (86%) 18 (82%) .630
reinfection rates of articulating spacers with autoclaved femoral hospital
components in patients with a diverse comorbidity profile and Preoperative clinical .750
status
surgical history, (2) whether there are any specific patient factors Primary 23 15 8
significantly associated with reinfection, and (3) whether patients Aseptic revisiona 9 4 5 .282
who retain their spacers indefinitely as functional knee implants Revision for infection 27 18 9 .914
demonstrate acceptable outcomes. Prior antibiotic 12 6 6 .383
implantb
I&D þ liner 15 12 3 .109
Patients and Methods exchange only
ASA score .325
After the institutional review board approval, we retrospectively 2 15 11 4
reviewed all TKAs treated at our institution for chronic deep 3 43 26 17
4 1 0 1
infection using articulating antibiotic spacers with autoclaved McPherson systemic .175
femoral components between January 2005 and November 2015. host
All cases were performed by one of the 2 fellowship-trained grade
arthroplasty surgeons (M.P.B. and S.S.W.). During this time, 84 A 15 11 4
B 35 22 13
articulating spacers were placed. Of the 84 total articulating spacers
C 9 4 5
with autoclaved femoral components, 59 cases in 55 patients met Tobacco abuse 8 (14%) 4 (11%) 4 (18%) .424
the inclusion criteria of at least 2-year follow-up from spacer Diabetes 19 (32%) 7 (19%) 12 (55%) .005
placement. Average follow-up in this cohort was 5.0 years from Virulent organism 8 (14%) 6 (16%) 2 (10%) .501
spacer placement (range: 2-10.5 years), including 29 men and 30 Months between stages 5.6 ± 5.3 4.3 ± 3.0 7.8 ± 7.2 .080
(n ¼ 47)
women. Average age was 61 years (range: 27-81 years), and body Range of motion
mass index (BMI) was 34 kg/m2 (range: 21-63 kg/m2). In our cohort, Spacer (prior to 84 ± 25 86 ± 24 79 ± 27 .512
43 knees (73%) contained posterior-stabilized and 16 (27%) con- second stage)c
tained cruciate-retaining components. Elapsed time between first- Most recent follow-up 100 ± 22 101 ± 23 97 ± 21 .475
and second-stage procedures averaged 5.6 months (0.5-24.1 Means and standard deviations are reported, and P values were calculated either
months). As a major tertiary referral center, 50 of 59 knees (85%) from chi-square test or Wilcoxon rank-sum test.
presented to our institution after undergoing prior surgery at an ASA, American Society of Anesthesiologists; BMI, body mass index; I&D, irrigation
and debridement.
outside hospital. During the study period, other forms of articu- a
Excludes arthroscopy and manipulation under anesthesia.
lating spacers were not used at our institution. In this time, 22 b
Includes spacer, beads, or antibiotic nail.
c
block-type static spacers were performed. The decision to use a Excludes retained spacers.
 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604 2597

care of all patients in this cohort, including preoperative evaluation
and postoperative antibiotic regimen. For the purposes of our
retrospective analysis of organism presence, in equivocal culture
results with either rare colonies or broth-only growth, a specific
culture result was considered positive if infectious disease spe-
cialists targeted the organism with the antibiotic regimen. Virulent
organisms were defined per previous reports as methicillin-
resistant Staphylococcus aureus or methicillin-resistant Staphylo-
coccus epidermidis [24,25] (Table 2).
All patients underwent a similar first-stage surgical protocol. A
medial parapatellar approach was used through the previous inci-
sion and arthrotomy. Patellar tendon banana peel, posteromedial
release, and quadriceps snip were used to facilitate exposure when
indicated. All components and any remaining bone cement were
removed with care taken to minimize bone loss. The femoral
component was subsequently cleaned of any residual cement and
autoclaved. A thorough irrigation and debridement (I&D) of bone
and soft tissue was performed using bacitracin-impregnated solu-
tion and a complete synovectomy, taking care to spare the collateral
ligaments. Antibiotic cement impregnated with a combination of
vancomycin, gentamicin, and/or tobramycin was mixed for the
tibial and femoral components and chosen based on surgeon
preference if preoperative cultures were unknown. If known, the
antibiotic regimen was tailored to individual culture results. Dosing
varied between 1-3 g vancomycin, 160-240 mg liquid gentamicin,
and/or 2.4-3.6 g tobramycin with each 40 g cement package. The
cement was used to fix a new tibial polyethylene insert ranging
from 8 to 14 mm in thickness and the original sterilized femoral
component (Fig. 1).
Patients underwent physical therapy starting the day of sur-
gery with passive ROM exercises and were allowed touchdown
weight bearing. All patients underwent at least 6 weeks of
parenteral antibiotics as directed by an infectious disease
specialist. This was typically followed by an antibiotic holiday of
3-4 weeks during which the patient was monitored for signs of
persistent infection. During this time, inflammatory markers
were trended. If persistently elevated, arthrocentesis was
performed. If markers normalized in the presence of clinical
improvement, then reimplantation was discussed, considering
the patient's general comorbidities, activity level, and goals.
Often, the interval between first- and second-stage procedures
was extended because patient function and satisfaction was
adequate to allow longer healing and recovery times between
surgeries. In some cases, a supportive patient-centered discus-
sion revealed satisfaction with the spacer such that reimplanta-
tion was postponed indefinitely.
Reimplantation with a new total knee prosthesis took place only
after careful intraoperative evaluation, during which the joint was
examined for purulence, and frozen tissue samples were evaluated
by pathologists for acute inflammation. Any evidence of continued
infection led to I&D with placement of repeat spacer, otherwise
cultures were sent, and new total knee components were implan-
ted. Patients underwent outpatient physical therapy and were
subsequently followed up in clinic at 2-week, 6-week, 3-month,
and 1-year intervals.
For the purposes of this study, recurrence was narrowly defined
through a set of parameters that represent index spacer failure and
reflect spacer efficacy at controlling initial infection, whereas
reinfection represents a broad inclusion of all infection following
placement of the index spacer:
Recurrence
- Infection with 1 organism in common with first-stage culture
- Spacer exchanged for new spacer with 1 organism in common
with first-stage culture
- Cultures were negative at both first-stage and subsequent
infection or spacer exchange
- Spacer converted directly to above-knee amputation (AKA) or
arthrodesis with any organism
- Reimplantation or retained spacer but need for chronic sup-
pressive antibiotic regimen
Reinfection
- Any recurrence, as defined previously
- Any other infection subsequent to index spacer placement

Table 2
Overall Cohort Microorganism Frequencies.
Statistical Analysis
Organisma Number of Patients

Gram (þ) Descriptive statistics were gathered for cohort variables,

Coagulase-negative Staphylococcus (sensitive) 9 including frequencies, means, and standard deviations. Differences
Methicillin-sensitive Staphylococcus aureus 7 between categorical variables were tested for significance using the
Methicillin-resistant Staphylococcus aureusc 5 chi-square test. Continuous variables were first determined to be
Coagulase-negative Staphylococcus (resistant)c 3
Enterococcus (ampicillin sensitive) 3
parametric or nonparametric using the Shapiro-Wilk test. Para-
Peptostreptococcus 2 metric variables were evaluated using the 2-tailed t test, whereas
Viridans group Streptococcus 2 nonparametric variables were tested using the Wilcoxon rank-sum
Unspecified gram (þ) cocci 2 test. Kaplan-Meier analysis was used to calculate cohort survival,
Staphylococcus lugdunensis 2
and univariate Cox proportional hazard regression assessed for any
Group B Streptococcus 1
Streptococcus pneumoniae 1 effect certain covariates had on reinfection risk. Bonferroni
Group G beta hemolytic Streptococcus 1 correction was performed for multiple testing on any variables
Gram () reaching statistical significance. Testing was considered significant
Pseudomonas aeruginosa 3 at P values < .05, and all statistical analyses were performed using R
Escherichia coli 2
Serratia marcescens 1
version 3.3.3 (R Foundation, Vienna, Austria).
Proteus mirabilis 1
Stenotrophomonas maltophilia 1 Results
Klebsiella pneumoniae 1
Fungal
In our cohort of 59 cases with minimum 2-year follow-up, 9
Candida 1
Other patients (15%) experienced an infection recurrence (Fig. 2). Of
Negative cultureb 16 these, 3 patients underwent second-stage reimplantation and
a
Includes preoperative and intraoperative cultures.
subsequently had infection recurrence with at least one organism
b
Five patients overall were on chronic antibiotics and 3/5 had negative cultures. in common with first-stage cultures. Two patients attempted
c
Denotes resistant organisms. reimplantation but were judged to have persistent infection and
2598 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604
Fig. 1. Representative anteroposterior radiograph of a patient who underwent bilateral placement of articulating spacers with an autoclaved femoral component, polyethylene tibial
insert, and antibiotic-laden cement for chronic TKA infection.
thus underwent I&D with spacer exchange, with intraoperative
samples eventually growing at least one organism in common with
the first-stage cultures. Three patients were unable to clear their
initial infection and went directly from spacer to AKA (2) or fusion
(1). One patient who has retained the spacer indefinitely is
currently maintained on chronic antibiotics and therefore was
considered a recurrence despite this patient being very satisfied
with the spacer implant. These culture data are summarized in
Table 3.
At the final follow-up, 22 of 59 cases (37%) had experienced a
reinfection (including the 9 recurrences noted previously) (Fig. 2).
Overall Kaplan-Meier 2-year survival free of reinfection was 75%
(95% confidence interval: 64%-87%) (Fig. 3). Average time to rein-
fection was 1.7 years (range: 0.1-6.0) (Table 3) including 7 patients
who experienced a reinfection at greater than 2 years from place-
ment of the spacer. Forty patients were directly reimplanted after
spacer placement and 7 more underwent reimplantation after one
or more I&Ds with spacer exchange (80% overall). Of these 47 pa-
tients who underwent reimplantation, 6 (13%) eventually had an
AKA, 6 (13%) received another 2-stage procedure, and 3 (6%) went
on to I&D with liner exchange. Cultures at the time of spacer
placement grew a virulent organism in 8 cases. Two of these
experienced a reinfection, and in both cases, a different organism
was cultured, including another virulent organism in one case
(resistant coagulase-negative Staphylococcus followed by
methicillin-resistant Staphylococcus aureus). When comparing
posterior-stabilized and cruciate-retaining constructs, no signifi-
cant difference was observed between these implant geometries
for either recurrence (P ¼ .241) or reinfection (P ¼ .234).
In patients who subsequently underwent second-stage reim-
plantation, average ROM was significantly greater at most recent
follow-up after reimplantation (100 , range: 40 -130 ) compared
to ROM with the spacer in place (83 , range: 25 -125 , P < .01). One
patient experienced hyperextension instability with the articulat-
ing spacer in place and was subsequently revised to a static spacer
before reimplantation.
When comparing patients who sustained reinfection to those
who did not, the rate of diabetes mellitus was significantly higher in
patients who became reinfected (55% vs 19%, P < .005) with a
hazard ratio of 4 (P < .01) (Table 1). This variable survived a Bon-
ferroni correction for multiple testing at a level of n ¼ 10. No sig-
nificant differences were found in follow-up, age, gender, BMI,
presence of virulent organisms, ROM, or other comorbidities. The
proportion of patients with prior revision surgery (including prior
antibiotic implant) was not significantly higher in patients with
reinfection compared to those without. Seventy-five percent of
patients were either McPherson B/C or ASA 3/4, but neither was
significantly associated with reinfection.
Of the 59 cases, 9 articulating spacers (15%) in 7 patients were
retained indefinitely over an average of 3.4 years (range: 2.5-5.2).
Of the 9 retained spacers, 5 were used to treat a primary TKA
infection, 2 had a prior revision for noninfectious reasons, one had a
prior retrograde femoral antibiotic nail, and another had a prior 2-
stage procedure in the contralateral knee. Six were in McPherson
type B patients, while the remaining 3 were type C. Average ROM at
most recent follow-up was 114 (range: 90 -125 ), with an average
subjective pain score of 2.9 of 10. Following placement of the index
spacer, at the time of this study, no patients required further
 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604 2599

Fig. 2. Outcomes diagram including stratification by recurrence and reinfection cohorts.

surgery on the operative knee(s) for infection. Five of 7 patients
were ambulatory including 4 who used a cane and 1 patient with
bilateral spacers who did not use an assistive device.
Of the 22 static spacers performed during the study period, 14
had the requisite 2-year follow-up (mean: 5.5 years). Of these 14
cases, 11 (79%) presented having had a prior revision, 8 of which
were prior 2-stage procedures. McPherson scores were not
significantly different between patients in whom static spacers
were used compared to articulating spacers. Eleven patients (79%)
eventually underwent reimplantation. Nine patients (64%) expe-
rienced a reinfection, with 3 of these (21%) considered a recur-
rence based on culture data. With the numbers available, the
higher rate of reinfection trended toward significance when
compared to the articulating spacers (P ¼ .066), and rates of
recurrence were not statistically different between the 2 groups
(P ¼ .575).
2600 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604

Table 3
Organism Profiles in Notable Patient Groups, Including Culture Results Either Before Spacer Placement or Cultures Drawn Intraoperatively as Well as Culture Profile at
Reinfection.

Clinical Course Spacer Placement Reinfection Years From Spacer Placement

Reimplanted (n ¼ 11) Negative MSSA 1.95

MSSA CNS, Staphylococcus lugdunensis 2.09
Pseudomonas MSSA 2.87
Group G Streptococcus, MSSA 0.96
Peptostreptococcus
Peptostreptococcus CNS 0.96
MSSA MSSA 0.48
Enterococcus faecalis, MRSA Enterococcus faecalis 1.81
CNS (resistant) MRSA 4.40
Positive frozens, no cultures drawn Negative 3.90
Negative Negative 4.09
MSSA Bacteroides fragilis 5.98
Spacer exchange before reimplantation CNS Negative 0.44
(n ¼ 7) Negative Negative 2.47
Pseudomonas, CNS Pseudomonas 0.42
MSSA Negative 1.04
CNS Negative 0.69
Streptococcus pneumoniae Negative 0.23
Klebsiella pneumoniae Candida parapsilosis 0.36
Above-knee amputation MSSA Negative 0.61
Proteus, E coli, MSSA Proteus, E coli, Pscudomonas, 0.05
Enterococcus faecium
Fusion Serratia marcescens Enterococcus faecalis 0.40
Retained spacers MRSA (chronic antibiotics for lumbar 3.34
osteomyelitis)
Group B Streptococcus 4.56
Unspecified gram (þ) cocci 4.22
CNS 5.21
Streptococcus viridans 2.85
Enterococcus faecalis 2.67
Negative 2.60
Negative 2.60
Negative 2.49

Only first-stage cultures are available for the retained spacer cohort. Recurrences (including culture negatives) are bolded. Time between spacer placement and reinfection also
noted.
CNS, coagulase-negative Staphylococcus; MSSA, methicillin-sensitive Staphylococcus aureus; MRSA, methicillin-resistant Staphylococcus aureus.

Discussion initial and subsequent surgeries for infection to be recurrences.

This was also the case for patients who experienced no clinical
Multiple studies have shown that a 2-stage revision protocol has improvement with their spacer and proceeded directly to AKA or
moderate to good success in treating chronic PJI after TKA, espe- fusion without reimplantation, regardless of organism profile.
cially given the morbidity and long-term management challenges Furthermore, we assert that spacer efficacy cannot be fully
associated with this complication [7,11,12]. Our goal was to evaluate
the efficacy of articulating antibiotic spacers with an autoclaved
femoral component as closely and conservatively as possible,
considering culture data and host factors, including comorbidities
and surgical history.
Our study demonstrated an infection recurrence rate of 15%,
with an overall reinfection rate of 37% (inclusive of recurrences).
We defined recurrence and reinfection separately by using or-
ganism profiles, which offer insight into whether an index spacer
successfully controlled initial infection. Prior studies offer a broad
range of outcome measures regarding successful infection treat-
ment regimens involving antibiotic spacers. To better clarify the
efficacy of the given treatment, we sought to focus on the success
of the index spacer itself, including outcomes prior to second-
stage reimplantation, a challenge that has been alluded to in
prior work [26]. The Delphi international consensus in 2013
established reporting guidelines, but describes outcomes only
after reimplantation [27]. Therefore, in our cohort, the Delphi
criteria may not have captured patients who required redebride-
ment before reimplantation (an event we considered a spacer
failure) and may also not have recognized success of long-term
retention of the spacer. In addition, cultures may not always
detect all organisms present, and so, in the present study, we Fig. 3. Kaplan-Meier survival analysis of reinfection cohort, including 95% confidence
conservatively defined instances with negative cultures in both intervals.
 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604 2601

Table 4
Current Literature on Outcomes of Articulating Spacers With Sterilized Femoral Components.

Authors Year Cohort Size Reported Reported Reported Average Minimum 2-y 1st to 2nd Spacer ROM at Final Notes
Reinfectiona Reinfection Ratea (%) Follow-Up (y)b Follow-Up Stage (mo) ROM Follow-Up

Nodzo et al [28] 2017 39 8 21 4.4 e 2.7 e e Excluded patients with

prior surgery for infection
Chen et al [29] 2016 10 2 20 2.7 Yes 4.4 81 95 Excluded 1 spacer that was
retained for patient
preference
Lee et al [30] 2015 20 1 5 2.4 Yes 5.8 72 113 Excluded patients who did
not undergo
reimplantation
Classen et al [31] 2014 23 3 13 3.9 No 6.0 68 105 Three spacers converted to
arthrodesis because of
large bone defects
Kim et al [32] 2013 20 2 10 1.8 No 3.3 98 103
Choi et al [17] 2012 14 4 29 3.6 No 6.0 82 100 Not stratified by new (6) vs
autoclaved (8) femoral
component spacers
Four patients retained
spacers indefinitely
without 2nd stage
Kalore et al [33] 2012 15 2 13 6.1 Yes 4.9 79 94 Three patients remaining
on chronic antibiotics were
not considered
reinfections
Excluded patients who did
not undergo
reimplantation or with a
history of prior antibiotic
implant
Pietsch et al [34] 2009 33 3 9 3.9 Yes e 83 100
Anderson et al [35] 2009 25 1 4 4.5 Yes 2.5 107 112
J€
amsen et al [14] 2006 24 2 8 2.1 No 5.6 89 104 Four patients requiring
redebridement between
stages were not considered
reinfections
Two patients retained
spacers indefinitely
without 2nd stage (patient
preference)
Huang et al [36] 2006 21 1 5 4.4 Yes 4.8 85 98
Cuckler [37] 2005 44 1 2 5.4 Yes e 110 112
Hoffman et al [22] 2005 50 6 12 6.2 Yes 2.8 85 100 Includes all 26 patients
from the 1995 study [21]
Four patients remaining on
chronic antibiotics were
not considered
reinfections
One patient died prior to
reimplantation (unrelated
causes)
Emerson et al [13] 2002 22 2 9 3.8 Yes e e 108 Excluded McPherson type
C patients

ROM, range of motion.

a
Variable reporting criteria between studies.
b
Starting time point for follow-up often not recorded.

evaluated under chronic antibiotic use, and so, these patients are
also considered recurrences, regardless of clinical course.
Our overall reinfection rate (37%) is higher compared with most
prior reports focusing on articulating spacers with autoclaved
femoral components (Table 4) [13,14,17,22,28e37]. However, the
methodology and definitions used in these studies vary widely and
highlight the difficulty in comparing results across studies. For
€msen
example, in a cohort of 24 patients with resterilized spacers, Ja
et al [14] reported 2 reinfections after reimplantation, but also had
6 total redebridements before second stage. In our study, these
would be considered at least reinfections (an effective rate of 33%)
and in some cases in which the organism profiles were identical,
recurrences as well. Gomez et al [26] first described this reporting
trend between stages, observing as much as a 15%-27% drop in
reported success rates in some studies when including these pa-
tients who are effectively treatment failures before reimplantation,
although some of these studies involved hip spacers as well.
Further underscoring the variability in approaches to spacer out-
comes, Kubista et al [38], in a series of 368 cases, considered
redebridement to be a risk factor for subsequent infection rather
than an outcome. Classen et al [31] reported 3 reinfections in a
cohort of 23 patients (13%) but also detailed 3 additional patients
who proceeded directly from first stage to arthrodesis. In their
study, Kalore et al [33] reported overall infection control of 87%, but
this dropped to 67% when they excluded patients in whom sup-
pressive antibiotics were used. Similarly, Hofmann et al [21,22] did
not include 4 patients on suppressive antibiotics as recurrences in
their original and follow-up series. Inclusion criteria also play an
important role in reporting reinfection rates. Nodzo et al [28] and
Kalore et al [33] excluded patients with a history of prior antibiotic
implant or surgery for infection, while Emerson et al [13] excluded
any patients with a MacPherson type C comorbidity profile. Chen
2602 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604
et al [29], Kalore et al [33], and Lee et al [30] excluded all patients
who retained their spacer without undergoing reimplantation.
Under our study's reporting criteria, reinfection rates in the broader
literature then range from 2% to over 30%. In addition, nearly one-
third of these studies lack a minimum 2-year follow-up, which may
also preclude observation of late infections (Table 4). Based on this
analysis, we believe our reinfection rate to be comparable to pre-
vious studies and that our results may more accurately reflect the
outcome of the specific spacer studied.
In our study, we were unable to provide direct comparisons
between articulating spacers with autoclaved femoral components
because cement-on-cement articulating spacers are not used at our
institution. Nodzo et al [28] reported 140 articulating antibiotic
spacers divided into 3 cohorts (prefabricated, hand-made mold,
and autoclaved) and did not observe a significant difference in
infection control (P ¼ .54). In a meta-analysis, Spivey et al [20]
directly compared reinfection rates among the different articulat-
ing constructs in 34 studies. The authors found no significant dif-
ference among metal-on-polyethylene (8%) and handmade (10%),
prefabricated (4%), or molded (8%) cement-on-cement articulating
spacers (P ¼ .68). They too found a large variation in reinfection
rates across the studies included in the analysis.
Our study did identify a small cohort of static spacers performed
during the study time. We found a trend toward increased rein-
fection rate compared to our articulating spacers, though this
recurrence rate did not reach statistical significance. Though the
difference is large (64% vs 37%), it is likely that our study is too
underpowered to show a statistically significant difference, as only
14 static spacers met the inclusion criteria. However, at our insti-
tution, static spacers are reserved for patients with significant bone
loss or who have previously failed articulating spacers, and there-
fore, selection bias also likely plays a role. Other authors have also
directly compared articulating spacers with their static counter-
parts. In a 2014 systematic review, Pivec et al [39] examined 48
studies and found average reinfection rates of 10% in static con-
structs compared with 8% in articulating cohorts (P ¼ .35), although
this increased to over 11% in articulating groups when restricting to
medically complex patients. The study by Voleti et al [8] showed
similar results (static: 12%, articulating 7%; P ¼ .2). However, a
systematic review by Guild et al [18] did show a significant differ-
ence (static: 14%, articulating 8%; P ¼ .003).
Some early comparison studies reported static spacer cohorts
with follow-up often nearly twice as long as their newer articu-
lating counterparts [13,14,17,39], with many of these studies
showing higher reinfection rates in static spacers. This may be due,
in part, to an extended time to complication exposure from longer
follow-up. Most prior studies following articulating spacers with
autoclaved femoral components do not specify follow-up start
time. Those that specify typically initiate follow-up at reimplanta-
tion, whereas our study begins at spacer placement. Beginning
follow-up at spacer placement enabled us to better characterize
specific spacer success and failure throughout the clinical course
and to evaluate retained spacers as a means for definitively treating
infection. This emphasis on the clinical course of the spacer itself, in
addition to postreimplantation outcomes, is similar to recent
literature [26]. Though this contributes to the longer follow-up time
in our study, when starting from reimplantation, our follow-up
remains longer than most previous studies. The time interval be-
tween first and second stages averaged 5.6 months in our study,
slightly longer the average interval found in previous studies of 4.4
months (Table 4) and in general longer than the requisite time
needed between stages for standard antibiotic treatment and hol-
iday. The decision to perform reimplantation was based on patient
goals and satisfaction with the spacer. This increased interval
allowed for further local and systemic recovery from a large surgery
before the additional large insult of reimplantation surgery. We
think that this longer interval speaks to the functional efficacy of
the articulating spacer design.
In our cohort, average ROM was 83 with spacer and 100 at
most recent follow-up after reimplantation, a difference that
reached significance and closely matched the average seen in the
broader literature of 85 and 103 , respectively (Table 4). This re-
flects an advantage articulating constructs hold which has been
consistently demonstrated both in individual studies and system-
atic analyses [18,39]. Prior concerns regarding spacer instability
were not observed in this study, as only 1 patient (1.7%) in our
cohort required revision for hyperextension instability, similar to
results seen in the next largest cohort study of these spacers [22].
Previous investigations of antibiotic spacers have sought to
identify patient risk factors associated with reinfection. Age, BMI,
thyroid disease, lymphedema, antibiotic type, polymicrobial
infection, resistant organism, operative time, and others have all
shown an association with reinfection after 2-stage procedure
[33,38,40,41]. To our knowledge, our study is the first to demon-
strate an association with diabetes. The exact mechanism of this
association is not clear; however, the impaired healing potential
and favorable local and systemic environment for bacterial growth
likely contribute. We did not find an association between virulent
organisms and reinfection. However, this may have been due to the
smaller sample size in our cohort, compared with prior studies that
have demonstrated a link investigating other spacer types [24,42],
though this remains controversial [10,43]. Culture-negative in-
fections made up 27% of our cohort, a level consistent with the
broader literature, which reports culture-negative frequencies
ranging from 14% to nearly 30% [22,35e37].
Compared with other studies of these spacers, our cohort had a
higher rate of both prior revision surgery, including patients with
prior antibiotic implants for infection and patient comorbidities.
More than 60% of patients presented with prior surgery, with 20%
having had a prior 2-stage procedure or antibiotic implant of some
kind. In contrast to other studies, prior revisions are rarely reported
and typically range from 0% to 18% [13,21,29,31], and in some
studies, prior 2-stage treatment is considered a criterion for
exclusion [33]. In addition, 75% of our cohort was either McPherson
B/C or ASA 3/4. Most studies do not report McPherson grades and
those that do typically include healthier overall cohorts or may
exclude more severe type C patients from their cohort [13,44]. A
notable exception is Cuckler [37], who reported a patient cohort
with similar McPherson grade distribution. This study found a
lower overall infection rate (2%) than the present study, although it
also did not report patients with prior revision.
Use of articulating spacers with autoclaved femoral components
allows for tangible cost savings compared with new or prefabricated
prostheses. Kalore et al [33] in 2012 reported a cost difference of
nearly $2000 by autoclaving and recycling the femoral component
compared to using a new component. This compares favorably to data
from our institution, where new femoral components typically cost at
least $2000. In another study, Nodzo et al [28] showed a statistically
significant cost savings from using an autoclaved femoral component
($3764) compared to a prefabricated implant ($4825) or commercial
mold ($5439). Although prior work has shown autoclaved femurs to
have comparable infection control compared with other methods
[20,33], skepticism may persist. Recent work, however, has shown
that autoclaving results in not only complete prosthesis sterility but
also eradication of virtually all residual biofilms [45,46]. Despite this
evidence of its safety, the authors acknowledge the potential chal-
lenges of using this technique due to perceived risk and that its use
may be limited by prohibitive policies in some regions.
We also report encouraging functional results for a small cohort
of one-stage spacers retained indefinitely for an average of 3.4
 D.E. Goltz et al. / The Journal of Arthroplasty 33 (2018) 2595e2604
years. Although retained articulating spacers have been reported as
early as 2006 in limited cohorts [14,47], few have since studied this
option. Gomez et al in 2015 reported 72 cases with retained
spacersd2 of these were due to patient preference, 15 were unfit
for surgery, and the remainder were lost to follow-up or deceased
prior to second stage. In 2017, Petis et al [48] reported a cohort of 34
retained knee spacers, 12 of which were articulating. Of these, 5
were medically unfit for surgery and 7 were retained by patient
preference. They also observed a relatively high rate of complica-
tions (44%), which we did not observe in our cohort.
Our study does have several limitations. First, it is a retro-
spective review and subject to associated biases common to
these studies. Despite the relatively large cohort compared to
previous studies, our patient cohort was still limited, and some
differences may not have been observed because of the lack of
statistical power. Our cohort was also heterogeneous; however,
this difficulty is inherent in this patient population given their
often complex surgical and medical history. In addition, nearly all
patients in our cohort were treated before the release of
Musculoskeletal Infection Society consensus definitions for PJI
[49], but diagnosis of infection did conform to standards
accepted at that time. Although collected for a subset of patients,
we did not feel we had an adequate sample of validated patient-
reported outcomes to report with confidence. Finally, as dis-
cussed previously, though we also studied our static spacer
cohort during the study interval, we did not investigate other
types of articulating spacers as our arthroplasty team was not
using metal-on-cement with new femoral components nor
cement-on-cement articulating spacers during this time.
Despite these limitations, to the best of our knowledge, our
work stands as the largest cohort study of articulating spacers with
autoclaved femoral components to date, with an average follow-up
of 5 years. Our results show this technique to have similar infection
control to that reported in the prior literature when accounting for
diverse reinfection criteria with widely variable reported reinfec-
tion rates. We also report one of the largest cohorts of retained
articulating spacers. These patients had good overall outcomes,
satisfaction, and functionality, suggesting that retained articulating
spacers are a viable option as a definitive functional knee implant in
the appropriate patient population.
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 The Journal of Arthroplasty 33 (2018) 2449e2454

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Patient Factors Associated With Prolonged Postoperative Opioid

Use After Total Knee Arthroplasty
Robert S. Namba, MD a, *, Anshuman Singh, MD b, Elizabeth W. Paxton, MA c,
Maria C.S. Inacio, PhD d
a
Southern California Permanente Medical Group, Irvine, California
b
Southern California Permanente Medical Group, San Diego, California
c
Kaiser Permanente, Surgical Outcomes and Analysis, San Diego, California
d
South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

a r t i c l e i n f o a b s t r a c t

Article history: Background: Pain persists in a moderate proportion of patients after total knee arthroplasty (TKA).
Received 7 February 2018 Identifying patient factors that are associated with persistent pain may lead to improved care.
Received in revised form Purpose: The purpose of the study was to identify preoperative factors associated with increased opioid
23 March 2018
prescriptions after TKA.
Accepted 27 March 2018
Available online 9 April 2018
Methods: A retrospective cohort study of TKAs in an integrated health-care system (January 2008-
December 2011) was conducted. The number of opioid prescriptions per 90-day period after TKA
(up to 1 year), was the outcome of interest. Patient risk factors that were evaluated included de-
Keywords:
prolonged use
mographics, pain prescriptions, comorbidities, and chronic pain conditions. Multivariable Poisson
opioids regression models were employed.
patient risk factors Results: The median age for 23,726 patients was 67 years. Before surgery, 60.0% used opioids. Three
preoperative months after surgery, 41.2% of patients continued using opioids. Factors associated with greater opioid
total knee arthroplasty use included: younger age (odds ratio [OR] ¼ 0.83, 95% confidence interval [CI] 0.82-0.84 per 10-year
postoperative increase), liver disease (OR ¼ 1.11, 95% CI 1.06-1.16), preoperative nonsteroidal anti-inflammatory drug
use (OR ¼ 1.09, 95% CI 1.07-1.10), anxiety (OR ¼ 1.05, 95% CI 1.03-1.08), substance abuse (OR ¼ 1.03, 95%
CI 1.00-1.06), diabetes mellitus (OR ¼ 1.03, 95% CI 1.01-1.05), preoperative opioid use (OR ¼ 1.04, 95% CI
1.04-1.04), back pain (OR ¼ 1.23, 95% CI 1.18-1.127), congestive heart failure (OR ¼ 1.16, 95% CI 1.06-1.27),
depression (OR ¼ 1.14, 95% CI 1.09-1.18), fibromyalgia (OR ¼ 1.10, 95% CI 1.02-1.18), hypertension (OR ¼
1.06, 95% CI 1.02-1.10), nonspecific chronic pain (OR ¼ 1.06, 95% CI 1.02-1.10), black race (OR ¼ 1.17, 95% CI
1.12-1.23), and chronic lung disease (OR ¼ 1.05, 95% CI 1.01-1.10).
Conclusion: Several preoperative factors were associated with prolonged opioid use after TKA, and their
identification can assist providers guide pain management. Avoidance or weaning of preoperative opi-
oids should be considered.
© 2018 Elsevier Inc. All rights reserved.

Narcotic management for persistent pain after total knee
arthroplasty (TKA) has not been fully examined. There have been
extensive analyses with perioperative pain management [1,2], but
This research did not receive any specific grant from funding agencies in the
public, commercial, or not-for-profit sectors.
The work was performed at Kaiser Permanente, Surgical Outcomes and Analysis
and the South Australia Health and Medical Research Institute.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.068.
* Reprint requests: Robert S. Namba, MD, Southern California Permanente
Medical Group, 6670 Alton Parkway, Irvine, CA 92646.
long-term opioid use after TKA has been poorly studied. The ma-
jority of pain typically resolves by 3 months after a TKA procedure
[3]. However, a subset of TKA patients has persistent pain [4,5],
report poor patient-reported outcome measurements [6], and
continue to take opioids 12 months or more after surgery [7,8].
Patient factors associated with intermediate- and long-term
opioid usage after TKA include female gender, younger age,
depression, and anxiety [8]. However, prior studies may have
under-reported opioid use after TKA because of reliance upon pa-
tient and surgeon reporting. The goal of this study was to identify
the use of opioids up to 1 year after TKA. Another goal was to
evaluate factors associated with greater number of opioid

https://doi.org/10.1016/j.arth.2018.03.068
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2450 R.S. Namba et al. / The Journal of Arthroplasty 33 (2018) 2449e2454
prescriptions in the year after TKA surgery using a community
registry linked with comprehensive pharmacy data. Some factors
may be modifiable before TKA surgery, but knowledge of non-
modifiable factors may help to manage patient and surgeon ex-
pectations of postoperative opioid use.
Methods
Study Design and Setting
A retrospective cohort study of patients who underwent TKA
procedures between January 01, 2008 and December 31, 2011 at
Kaiser Permanente was conducted. Kaiser Permanente is an inte-
grated health-care system with over 10 million members
throughout the United States [9]. In this study, owing to the avail-
ability of data, only the Southern California, Northern California,
and Hawaii regions, which account for of 8.2 million members,
were included. This patient population has largely been shown to
be demographically and socioeconomically representative of the
geographical region it covers [10,11].
Data Sources
This study used the Kaiser Permanente's Total Joint Replace-
ment Registry (TJRR) and electronic medical records (EMRs) as data
sources. Data between the 2 systems were linked using unique
patient identifiers. The TJRR identified the TKA procedures, patient
characteristics, and patient comorbidities. Information on the
TJRR's coverage, processes, validation, and available data has been
published [12,13]. In brief, this surveillance tool for elective joint
arthroplasty procedures was established in 2001 and reported a
95% voluntary participation in 2011 [13]. The EMR used for this
study is an Epic-based product that was rolled out in 2004 and was
fully implemented in all Kaiser Permanente regions in 2008. The
EMR's pharmacy module identified the medication utilization of
the study subjects. In addition, the EMR's inpatient and outpatient
encounters modules identified patient characteristics and history
not included in the TJRR, which were ascertained using Interna-
tional Classification of Diseases, 9th revision, Clinical Modification,
codes (ICD-9-CM).
Study Sample
The study sample included unilateral primary TKA cases in adult
patients (ie, age  18), without any other elective hip or knee
arthroplasty procedure within 365 days. Only patients having a
surgery for osteoarthritis and without a history of cancer, identified
using ICD-9 codes 140.*-208.*, except 173.* for pain related to
cancer [14] and the specific Elixhauser comorbidities [15] of lym-
phoma, metastatic cancer, solid tumor without metastastis in the
year before surgery, were included. Patients without complete 1-
year follow-up (3% of cases because they died or were lost to
follow-up before the end of the study period) were not included in
the final sample.
Outcome of Interest
The number of opioid prescriptions per 90-day period surgery
up to a year postsurgery was the outcome of interest. Using phar-
macy records, only opioids that were actually dispensed to the
patients were included. Owing to the natural progression in post-
operative recovery and varying expected use of opioid over time,
the number of prescriptions per each 90-day period post-
operatively (ie, days 1-90, 91-180, 181-270, and 271-360) was
evaluated separately.
Exposure of Interest
The preoperative patient risk factors investigated were age,
gender, body mass index (BMI), opioid-related comorbidities, other
medical comorbidities, history of musculoskeletal chronic pain,
history of other types of chronic pain, and preoperative history of
opioid and nonsteroidal anti-inflammatory drug (NSAID) use. The
TJRR was used to identify patient age, gender, BMI, and medical
comorbidities. Medical comorbidities were classified using the
Elixhauser comorbidity algorithm [15,16] and included hyperten-
sion, chronic pulmonary disease, hypothyroidism, deficiency ane-
mia, renal failure, fluid and electrolyte disease, valvular disease,
rheumatoid arthritis/collagen, other neurological disorders,
congestive heart failure, liver disease, coagulopathy, pulmonary
circulation disease, weight loss, paralysis, acquired immunodefi-
ciency syndrome, peptic ulcer disease/bleeding, and diabetes.
Opioid-related comorbidities and history of chronic pain were
identified using inpatient and outpatient encounters in the year
before their joint surgery recorded in the EMRs using a published
ICD-9-CM coding algorithm [14]. Opioid-related comorbidities that
were investigated included anxiety, bipolar disease, depression,
opioid dependency, post-traumatic stress disorder, and substance
abuse. Nonspecific chronic pain conditions were also studied,
including general chronic pain, migraines, tension headache,
abdominal pain, hernia, kidney/gall stones, menstrual pain, neu-
ropathy, and temporomandibular pain. Chronic musculoskeletal
pain conditions were studied and included back pain, neck pain,
fibromyalgia, arthritis, carpal tunnel, limb-extremity pain, pain in
joint, “other” chronic musculoskeletal pain, fractures and contu-
sions, costochondritis, and intracostal muscle injury. Nonspecific
chronic pain was evaluated as a single factor due to the infrequency
of these events in these patients, but history of chronic musculo-
skeletal pain was evaluated as individual factors.
Statistical Analysis
Descriptive statistics were used to describe the study sample
and the number of preoperative and postoperative opioid pre-
scriptions for the cohort. Poisson regression models, with random
surgeon effects, were used to evaluate the association of the ex-
posures of interest with the number of opioid medications per 90-
day postoperative period. Odds ratios (ORs) and 95% confidence
intervals (CIs) from multivariable models are presented. All vari-
ables were evaluated as binary indicators of conditions except for
the continuous variables age (per 10-year increments) and BMI (per
5 unit (kg/m2) increments). Missing data were handled using
multiple imputations. Twenty imputed data sets were created, and
Rubin's rules for aggregating parameter estimates and variances
were used [17]. Collinearity was checked using tolerance values (all
values >0.10), and outliers were reviewed. The alpha level chosen
for statistical significant was 0.05, and tests reported are 2 sided.
SAS 9.2 (SAS Institute, Cary, NC) was used for all analyses.
Patient Involvement
No patients were involved in the design of this study, involved in
developing the outcome measures, nor were they involved in the
conduct of the study. There are no plans to disseminate the results
to study participants.
Results
Of the 23,726 TKA patients, 62.9% (n ¼ 14,907) were females,
and their median age was 68 years (interquartile range 61-75). The
majority of the patients were white (65.9%, n ¼ 15,638), and 54.5%
 R.S. Namba et al. / The Journal of Arthroplasty 33 (2018) 2449e2454 2451

Table 1 Table 1 (continued )

Study Sample Characteristics.
Total Knee Arthroplasty
Total Knee Arthroplasty
N (%)
N (%)
Tension head 124 0.5
Total 23,726 100.0 TMD/TMJ 77 0.3
Age, y, median (IQR) 68 61-75 Menstrual 20 0.1
Gender Preoperative NSAID use 11,877 50.1
Females 14,907 62.9
BMI, body mass index; IQR, interquartile range; NSAID, nonsteroidal anti-
Race
inflammatory drugs; PTSD, post-traumatic stress disorder; TMD/TMJ, temporo-
White 15,638 65.9
mandibular joint disorders.
Hispanic 3837 16.2 a
Include other, multi, and Native American.
Black 2171 9.2 b
Chronic musculoskeletal pain (CMP): back pain, neck pain, fibromyalgia, arthritis,
Asian 1530 6.5
carpal tunnel, limb-extremity pain, pain in joint, "other" CMP, osteoarthritis, fractures
Othera 415 1.7
and contusions, costochondritis and intracostal muscle injury. Nonspecific chronic
Unknown 135 0.6
pain: general chronic pain and migraines, tension headache, abdominal pain, hernia,
BMI category, kg/m2
kidney/gall stones, menstrual pain, neuropathy, temporomandibular.
<30 10,747 45.3
30-35 7204 30.4
35 5750 24.2 (n ¼ 12,954) were obese (BMI  30 kg/m2). In the year before total
Unknown 25 0.1 hip arthroplasty, 50.1% (n ¼ 11,877) of the patients had at least one
BMI, kg/m2, median (IQR) 30.6 27.0-34.8 prescription for NSAIDs and at least 60.0% (n ¼ 14,234) had a pre-
Opioid useerelated comorbidities
scription for opioids. The most prevalent opioid-related comor-
Anxiety 2575 10.9
Depression 2266 9.6 bidities in this cohort were anxiety (10.9%, n ¼ 2575), depression
Substance abuse 1498 6.3 (9.6%, n ¼ 2266), and substance abuse (6.3%, n ¼ 1498). The most
Bipolar 201 0.9 prevalent medical comorbidities included hypertension (61.4%, n ¼
Dementia 149 0.6
14,564) and diabetes (28.4%, n ¼ 6741). Of the total cohort, 88.9%
Opioid dependency 129 0.5
PTSD 84 0.4 (N ¼ 21,085) had a history of musculoskeletal chronic pain, and
Medical comorbidities 13.6% (n ¼ 3228) had a history of nonspecific chronic pain (see
Hypertension 14,564 61.4 Table 1 for detailed patient characteristics).
Diabetes 6741 28.4 Postoperative opioid use decreased in the year after surgery. In the
Chronic pulmonary disease 3675 15.5
first 90 days after surgery, 92.7% (n ¼ 21,993) of patients had a pre-
Hypothyroidism 3003 12.7
Deficiency anemia 2550 10.8 scription for opioids dispensed. During days 91-180, 42.1% (n ¼ 9993) of
Renal failure 2106 8.9 patients were still taking opioids, followed by 32.2% (n ¼ 7638) in days
Fluid and electrolyte disorders 1294 5.5 181-270, and 30.4% (n ¼ 7218) in days 271-360. The median number of
Peripheral vascular disease 984 4.2
prescriptions for patients on opioids was 3 in the first 90 days after
Valvular disease 762 3.2
Rheumatoid 646 2.7
surgery and reduced to 2 per 90-day period afterward (Table 2).
arthritis/collagen vascular disease The number of preoperative prescriptions for opioids (OR range
Other neurological disorders 750 3.2 1.04-1.09) and NSAIDs (OR range 1.04-1.09) was associated with
Congestive heart failure 688 2.9 higher number of postoperative opioid prescriptions in every
Chronic blood loss anemia 560 2.4
period after TKA. Younger patient age was also associated with
Liver disease 507 2.1
Coagulopthy 415 1.8 higher number of opioid prescriptions (ranging from 9% to 17%
Pulmonary circulation disease 196 0.8 reduction on odds of more prescriptions per 10-year increase in
Weight loss 142 0.6 age) in every time period after surgery. Female patients had a
Paralysis 117 0.5
higher number of prescriptions than male patients in days 91-180
Acquired immune 12 0.1
deficiency syndrome
(OR ¼ 1.07, 95% CI 1.04-1.10) and 181-270 (OR ¼ 1.05, 95% CI 1.02-
Peptic ulcer disease  bleeding 6 0.0 1.09) after surgery. In every time period, Asian patients had lower
Unknown 2741 11.5 odds of opioid prescriptions compared with white patients
History of chronic (ranging from 10% to 38% lower odds of prescriptions). Black pa-
musculoskeletal painb
tients had a higher number of prescriptions after the first 90 days
Any 21,085 88.9
Osteoarthritis 19,711 83.1 (OR range 1.08-1.17) and Hispanics in days 91-180 (OR ¼ 1.12, 95% CI
Arthritis 20,568 86.7 1.08-1.17) and 181-270 (OR ¼ 1.05, 95% CI 1.00-1.10). Higher BMI
Joint pain 3686 15.5 was associated with a lower number of opioid prescriptions in the
Back pain 2754 11.6
first 90 days after surgery (OR ¼ 0.97, 95% CI 0.97-0.98) but higher
Neck pain 660 2.8
Fibromyalgia 381 1.6
number in days 181-270 (OR ¼ 1.02, 95% CI 1.01-1.03) and 271-360
Limb-extremity pain 210 0.9 (OR ¼ 1.01, 95% CI 1.01-1.04).
Other chronic 168 0.7 In regard to patient comorbidities, the following were consis-
musculoskeletal pain tently (ie, at all time periods) associated with a higher number of
Carpal tunnel 237 1.0
opioid prescriptions: anxiety, depression, substance abuse, dia-
Fractures and contusions 242 1.0
Costochondritis 27 0.1 betes, rheumatoid arthritis, and liver disease. AIDS was associated
and intracostal muscle injury with a lower number of opioids prescriptions in every time period.
History of nonspecific In regard to history of chronic pain, patients with back pain, fi-
chronic painb bromyalgia, and nonspecific chronic pain all had higher number of
Any 3228 13.6
Neurological 1682 7.1
prescriptions days 91-180, 181-270, and 271-360 after surgery but
General chronic pain 805 3.4 not in the first 90 days. During the same time period, patients with
Abdominal 444 1.9 carpal tunnel, dementia, and joint pain had lower odds of opioid
Migraines 332 1.4 prescriptions (see Table 3 for detailed information on the associa-
Kidney/gall stones 153 0.6
tions between all risk factors and opioid use).
2452 R.S. Namba et al. / The Journal of Arthroplasty 33 (2018) 2449e2454
Table 2
Opioid Utilization Before and After Total Knee Arthroplasty.
Opioid Usersa Total, N Whole Cohort Patients With at
Least 1
Prescription
Min-Max Median Min-Max Median
(IQR) (IQR)
1 y Preoperative 14,234 (60.0) 72,716 0-66 1 (0-4) 1-66 3 (1-7)
1 y Postoperative 22,247 (93.8) 127,832 0-68 3 (2-7) 1-68 4 (2-7)
Days 1-90 21,993 (92.7) 73,961 0-25 3 (1-4) 1-25 3 (2-4)
Days 91-180 9993 (42.1) 21,388 0-24 0 (0-1) 1-24 2 (1-3)
Days 181-270 7638 (32.2) 16,579 0-15 0 (0-1) 1-15 2 (1-3)
Days 271-360 7218 (30.4) 15,904 0-18 0 (0-1) 1-18 2 (1-3)
Data comprise the number of patients with prescriptions, total number of pre-
scriptions, range and median number of opioid prescriptions per patient.
IQR, interquartile range.
a
Patients who had a prescription during this time period or had a prescription in
the previous time period that carried over to the included time period.
Discussion
Persistent pain after TKA is not uncommon. Only 87% of pa-
tients were satisfied with pain relief 5 years after TKA in 1 report
[18], and 19.8% of patients continued to have pain 1 year after
TKA in another [4]. In a systematic review, up to 34% of TKA
patients reported long-term unfavorable chronic pain [5]. In a
prospective observational study, one in 8 patients reported
moderate-to-severe pain 1 year after TKA [3]. Patient factors
associated with increased pain after TKA were reported to
include female gender, younger age, anxiety, and depression
[4,7]. Risk factors for poor satisfaction, but not necessarily opioid
use risk factors, after TKA included female gender, diagnosis
other than osteoarthritis, patient age less than 65 years, and
American Society of Anesthesiologists grade 3 compared with
American Society of Anesthesiologists grade 1 [4,7].
Prolonged use of narcotics after surgery is also not uncommon.
In a cohort of 39,140 patients who underwent major elective sur-
gery, 3.1% continued to use opioids for more than 3 months [19].
Risk factors for prolonged opioid use after nonarthroplasty surgical
procedures were intrathoracic surgical procedures, young age, low
socioeconomic status, diabetes, heart failure, pulmonary disease,
and use of antidepressant drugs. In a series of 145 patients, over
28% of patients treated operatively for musculoskeletal trauma
continued to take opioids 1 to 2 months after injury [20]. Using
patient questionnaires, prolonged opioid use was associated with
catastrophic thinking and symptoms of depression and post-
traumatic stress disorder [20].
Prolonged use of narcotics specifically after TKA surgery has
been previously reported. In a cohort of 6346 TKA patients, 14% of
patients were preoperative narcotic users, and 6% overall,
continued to use opioids 12 months after TKA [7]. However, only
1.4% used narcotics 2 years after TKA in another study [8]. In a
recent study using claims data, 7% of knee or hip arthroplasty pa-
tients used opioids over 1 year after surgery [21]. The rates of
prolonged opioid use were much higher in our study. We observed
that 42% of patients continue to use opioids 3 months after surgery;
32%, 6-9 months after surgery; and 30%, 9-12 months after. Our
findings may reflect the accuracy of using pharmacological data in a
closed integrated health-care system, which has full capture of
patient's pharmaceutical and other patient encounters. Prior
studies reporting on opioid use relied on patient reporting which
may be subject to responder and response bias, that is, variable
response rates and variability due to patient comprehension and
willingness to report on these types of behaviors [8]. Another
investigation involved a clinical trial of a specific knee implant with
surgeon reporting and may have been subjected to under-reporting
[7]. In addition, patients may have received narcotic prescriptions
from other health care provided, which were unknown to the
treating surgeon.
Prior opioid use, before surgery was also high in our series,
with 60% of patients having been prescribed opioids in the year
before TKA. This amount is similar to the 58% reported by in-
vestigators analyzing insurance claims data on 16,527 patients
[22]. Our finding that preoperative opioid use was associated with
prolonged postoperative narcotic use is in agreement with prior
reports [7,23].
After the first 3-month postoperative period, increased opioid
use was associated with patient factors that have been previously
reported (for prolonged opioid and NSAID use): female gender,
depression and anxiety, preoperative NSAID use, substance abuse
and young patient age, and post-traumatic stress syndrome [8,20].
Higher comorbidity scores, back pain, rheumatoid arthritis, fi-
bromyalgia, migraines, smoking, and benzodiazepine use were
identified as predictors for persistent opioid use [21]. Previously
unreported patient risk factors for opioid use identified in our
study included: black race/ethnicity, diabetes mellitus, hyper-
tension, AIDS, congestive heart failure, and liver disease. It is
acknowledged that though these factors were statistically asso-
ciated with increased opioid use, some of the weaker associations
may not be clinically significant. Although diabetes mellitus has
been reported to be a risk factor for increased pain after total joint
arthroplasty [24], the higher risk of more opioid use of only 6%
observed in our study may not be clinically significant. The 17%
higher risk of black patients getting more prescriptions vs white,
however, may be clinically significant. Conditions such as
congestive heart failure and liver disease may require prolonged
opioids due to the lack of other options, because anti-
inflammatory medications, or acetaminophen, are contra-
indicated in these patients. Lower opioid use after the first 90 days
was associated with increased age, Asian race, and dementia. A
diagnosis of generic chronic joint pain was also associated with
lower opioid use but may have involved resolution of arthritic
pain of the operated knee.
It is acknowledged that opioid prescription dispensing may not
reflect actual use of the narcotic. But dispensing of these medica-
tions in different groups of patients was likely reflective of the
varying use of these medications as well in these difference groups.
In addition, the opioids may have been used for pain in other body
sites than the knee which was replaced. In this exploratory study,
we focused on identifying risk factors for excessive prescription
dispensing and tried to address the limitation of not knowing what
the medication was prescribed for by adding history of other
painful condition and chronic painerelated conditions in our
analysis and hopefully removing some of the effect of these con-
ditions on the estimates of the other risk factors. It is possible that
for some of the low prevalence factors that we evaluated, we may
not have detected associations with the outcome of interest due to
the smaller sample. Finally, we also acknowledge as a limitation of
this study our inability to evaluate other possible risk factors for
greater opioid prescription dispensing such as surgeon/prescriber
preferences, patients psychological and social characteristics, and
patients' function and other surgery-related physical improve-
ments/complications.
Our study strengths included the use of a TJRR that collects
prospective data [12] on a regionally representative sample of pa-
tients and surgeons, assuring high data integrity and generaliz-
ability of our findings [10,11]. This study also leveraged, several
independent sources of information within an integrated health-
care system's EMR to obtain a comprehensive clinical and utiliza-
tion pattern history of our patient cohort, which was also a strength
of this study. The integrated health-care system used for this study
 R.S. Namba et al. / The Journal of Arthroplasty 33 (2018) 2449e2454 2453

Table 3
Preoperative Patient Characteristics Associated With Number of Postoperative Opioid Prescriptions per 90-d Increments Postoperatively and Number of Periods This Risk
Factor Is Associated With Number of Prescriptions.

Risk Factor Days 1-90 Days 91-180 Days 181-270 Days 271-360 Na

OR (95% CI) P Value OR (95% CI) P Value OR (95% CI) P Value OR (95% CI) P Value

Preoperative number of opioid prescriptions 1.04 (1.04-1.04) <.001 1.08 (1.08-1.08) <.001 1.09 (1.09-1.09) <.001 1.09 (1.09-1.09) <.001 4
Preoperative NSAID use 1.09 (1.07-1.10) <.001 1.06 (1.03-1.09) <.001 1.07 (1.03-1.10) <.001 1.04 (1.01-1.08) .011 4
Female vs male 1.01 (0.99-1.02) .500 1.07 (1.04-1.10) <.001 1.05 (1.02-1.09) .005 1.03 (1.00-1.07) .092 2
Age (per 10-y increment) 0.83 (0.82-0.84) <.001 0.86 (0.84-0.87) <.001 0.91 (0.89-0.93) <.001 0.91 (0.89-0.93) <.001 4
Race
Asian vs white 0.90 (0.87-0.94) <.001 0.81 (0.75-0.88) <.001 0.62 (0.56-0.68) <.001 0.65 (0.59-0.72) <.001 4
Black vs white 1.02 (0.99-1.04) .247 1.17 (1.12-1.23) <.001 1.12 (1.06-1.18) <.001 1.08 (1.02-1.14) .009 4
Hispanic vs white 0.99 (0.97-1.01) .511 1.12 (1.08-1.17) <.001 1.05 (1.00-1.10) .039 1.02 (0.98-1.07) .343 2
Other vs white 1.08 (1.02-1.14) .007 1.09 (0.98-1.21) .098 0.97 (0.86-1.10) .612 0.94 (0.82-1.06) .308 1
BMI (per 5 point increment) 0.97 (0.97-0.98) <.001 1.00 (0.99-1.01) .882 1.02 (1.01-1.03) .007 1.02 (1.01-1.04) .001 3
Comorbidities
Anxiety 1.05 (1.03-1.08) <.001 1.11 (1.06-1.15) <.001 1.08 (1.03-1.13) .001 1.09 (1.05-1.14) <.001 4
Bipolar 0.85 (0.79-0.91) <.001 0.85 (0.76-0.96) .006 0.98 (0.87-1.11) .800 0.88 (0.77-1.00) .050 2
Depression 1.02 (0.99-1.04) .220 1.14 (1.09-1.18) <.001 1.20 (1.15-1.26) <.001 1.17 (1.12-1.23) <.001 3
Opioid dependency 0.95 (0.89-1.02) .192 0.65 (0.58-0.72) <.001 0.57 (0.51-0.64) <.001 0.55 (0.49-0.62) <.001 3
PTSD 1.01 (0.90-1.12) .921 1.00 (0.85-1.19) .964 1.16 (0.97-1.38) .103 1.44 (1.22-1.69) <.001 1
Substance abuse 1.03 (1.00-1.06) .032 1.23 (1.17-1.29) <.001 1.27 (1.20-1.33) <.001 1.28 (1.21-1.35) <.001 4
Diabetes 1.03 (1.01-1.05) <.001 1.06 (1.03-1.10) <.001 1.04 (1.01-1.08) .020 1.07 (1.04-1.11) <.001 4
AIDS 0.58 (0.44-0.76) <.001 0.41 (0.28-0.59) <.001 0.34 (0.23-0.50) <.001 0.37 (0.26-0.53) <.001 4
Deficiency anemia 0.98 (0.96-1.01) .129 1.01 (0.96-1.06) .783 1.04 (0.99-1.10) .138 1.06 (1.00-1.12) .044 1
Rheumatoid arthritis 0.95 (0.90-0.99) .031 1.10 (1.01-1.20) .026 1.20 (1.09-1.31) <.001 1.25 (1.15-1.36) <.001 4
Chronic blood loss anemia 1.00 (0.94-1.06) .894 0.97 (0.87-1.09) .627 0.89 (0.79-1.02) .094 0.89 (0.78-1.01) .083
Congestive heart failure 0.96 (0.92-1.01) .137 1.16 (1.06-1.27) .002 1.24 (1.13-1.36) <.001 1.20 (1.09-1.33) <.001 3
Chronic lung disease 1.02 (1.00-1.04) .056 1.05 (1.01-1.10) .014 1.06 (1.01-1.11) .020 1.06 (1.00-1.11) .033 3
Coagulopthy 0.99 (0.93-1.05) .742 1.05 (0.93-1.19) .414 1.09 (0.95-1.25) .219 1.19 (1.05-1.35) .008 1
Hypertension 1.01 (0.99-1.03) .372 1.06 (1.02-1.10) .002 1.09 (1.04-1.14) <.001 1.09 (1.04-1.14) .001 3
Hypothyroidism 1.01 (0.99-1.04) .273 1.00 (0.95-1.05) .931 1.01 (0.96-1.06) .764 0.99 (0.94-1.05) .858
Liver disease 1.11 (1.06-1.16) <.001 1.24 (1.13-1.36) <.001 1.24 (1.12-1.38) <.001 1.17 (1.04-1.3) .007 4
Fluid and electrolyte 1.01 (0.98-1.05) .568 1.04 (0.98-1.11) .208 1.07 (0.99-1.14) .074 1.04 (0.96-1.12) .310
Disorders
Other neurological disorders 0.95 (0.91-1.00) .029 1.07 (0.99-1.15) .094 1.13 (1.04-1.22) .005 1.19 (1.10-1.29) <.001 3
Paralysis 0.89 (0.80-0.99) .038 0.87 (0.72-1.04) .128 0.81 (0.65-1.01) .058 0.86 (0.69-1.06) .152
Peripheral vascular disease 1.02 (0.98-1.06) .342 1.07 (0.99-1.16) .071 1.09 (1.01-1.18) .032 1.12 (1.03-1.22) .008 2
Pulmonary circulation 1.00 (0.91-1.09) .926 1.03 (0.87-1.23) .729 0.95 (0.76-1.19) .669 0.96 (0.78-1.17) .667
Disorder
Renal failure 0.95 (0.93-0.98) .003 1.04 (0.98-1.10) .255 1.07 (1.00-1.15) .056 1.05 (0.98-1.12) .166 1
Peptic ulcer disease bleeding 1.07 (0.75-1.53) .700 1.04 (0.62-1.77) .873 1.07 (0.61-1.87) .815 1.17 (0.69-2.00) .552
Valvular disease 0.95 (0.91-1.00) .040 1.02 (0.93-1.13) .662 1.00 (0.89-1.12) .983 1.06 (0.95-1.18) .313
Weight loss 0.93 (0.83-1.04) .178 1.00 (0.81-1.23) .983 1.07 (0.85-1.35) .574 1.01 (0.80-1.28) .910
History of chronic pain
Arthritis 0.99 (0.95-1.04) .818 1.00 (0.91-1.09) .911 1.06 (0.95-1.17) .295 1.07 (0.96-1.18) .210
Back pain 1.01 (0.99-1.04) .229 1.23 (1.18-1.27) <.001 1.33 (1.27-1.38) <.001 1.35 (1.29-1.41) <.001 3
Carpal tunel 0.96 (0.89-1.03) .248 0.84 (0.74-0.95) .005 0.85 (0.74-0.97) .020 0.75 (0.65-0.87) <.001 3
Costochondritis and intracostal muscle injury 1.34 (1.09-1.66) .006 1.46 (1.05-2.04) .025 1.03 (0.69-1.56) .873 0.93 (0.60-1.44) .754 2
Dementia 0.94 (0.86-1.03) .162 0.87 (0.76-0.99) .036 0.68 (0.58-0.80) <.001 0.72 (0.62-0.85) <.001 3
Fibromyalgia 1.03 (0.98-1.08) .301 1.10 (1.02-1.18) .016 1.11 (1.02-1.21) .014 1.15 (1.06-1.25) .001 3
Fractures and contusions 0.91 (0.85-0.98) .010 1.01 (0.91-1.12) .886 0.98 (0.87-1.10) .678 0.96 (0.85-1.08) .475 1
Joint pain 0.96 (0.94-0.98) <.001 0.94 (0.91-0.98) .002 0.95 (0.91-0.99) .008 0.94 (0.90-0.98) .003 4
Limb-extremity pain 1.03 (0.96-1.11) .434 1.00 (0.89-1.12) .986 0.99 (0.87-1.12) .837 1.01 (0.89-1.15) .840
Neck pain 0.99 (0.95-1.03) .528 1.04 (0.97-1.11) .246 1.09 (1.01-1.17) .019 1.11 (1.03-1.19) .007 2
Osteoarthritis 1.02 (0.98-1.06) .436 1.07 (0.99-1.15) .096 1.08 (0.99-1.18) .094 1.06 (0.97-1.16) .170
Other musculoskeletal pain 0.97 (0.87-1.08) .570 1.09 (0.92-1.29) .324 1.15 (0.96-1.38) .128 1.14 (0.95-1.36) .157
Nonspecific chronic pain 1.00 (0.98-1.03) .801 1.06 (1.02-1.10) .002 1.09 (1.05-1.14) <.001 1.08 (1.04-1.13) <.001 3

BMI, body mass index; CIs, confidence intervals; NSAID, nonsteroidal anti-inflammatory drugs; OR, odds ratio; PTSD, post-traumatic stress disorder.
a
Number of 90-d periods where this is a significant risk factor.

allowed us to capture information from not only the TJRR but also
the inpatient and outpatient records of patients as well as their
prescription and dispensing history. Another strength was our
ability to evaluate the actual medication dispensing and not only
medication prescriptions of interest, which increased our certainty
that these medications were actually procured by patients after
prescription and more likely consumed. In addition, the captured
nature of the integrated health-care system population increases
the likelihood of complete capture of medications dispensed
because these patients have no incentive to obtain the medications
in a pharmacy outside of the system, where the cost of the medi-
cations would be higher than in-house. The integrated health-care
system use of unique patient identifiers, which can be used to link
patient information, decreased our risk of data handling bias and
bad record linkage between data sources. The careful and dedicated
monitoring of patients' attrition (ie, using the Social Security
Administration and EMR system) assisted this study in identifying
possible lost to follow-up and accounting for them properly in our
analysis.
Narcotic prescription drugs have high potential for abuse, and
physicians have been challenged with close monitoring of patients
who are given these medications. Identification of factors associ-
ated with prolonged opioid use after TKA may assist the surgeon in
recognizing higher risk patients before surgery.
2454 R.S. Namba et al. / The Journal of Arthroplasty 33 (2018) 2449e2454

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 The Journal of Arthroplasty 33 (2018) 2428e2434

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Patients With Poor Baseline Mental Health Undergoing

Unicompartmental Knee Arthroplasty Have Poorer Outcomes
Graham Seow-Hng Goh, MBBS, MRCS (Edin) *,
Ming Han Lincoln Liow, MBBS, MRCS (Edin), MMed (Ortho),
Hee-Nee Pang, MBBS, FRCS (Edin), Darren Keng-Jin Tay, MBBS, FRCS (Edin),
Ngai-Nung Lo, MBBS, FRCS (Edin), FAMS, Seng-Jin Yeo, MBBS, FRCS (Edin), FAMS
Department of Orthopaedic Surgery, Singapore General Hospital, Singapore, Singapore

a r t i c l e i n f o a b s t r a c t

Article history: Background: The relationship between mental health and outcomes of unicompartmental knee arthro-
Received 28 January 2018 plasty (UKA) remains unclear. Poor preoperative mental health may be caused by pain and functional
Received in revised form limitations associated with knee arthritis. We aimed at (1) investigating the effect of preoperative mental
16 February 2018
health on early outcomes and (2) assessing whether mental health improves after UKA.
Accepted 19 February 2018
Available online 26 February 2018
Methods: Prospectively collected registry data of 1473 medial UKAs performed at a single institution in
2007-2014 were reviewed. Linear regression was used to determine improvement in mental health up to
2 years according to preoperative Short-Form 36 Mental Component Summary (MCS). Patients were
Keywords:
knee arthroplasty
stratified into low MCS (<50, n ¼ 579) and high MCS (50, n ¼ 894). The Knee Society Knee Score (KSKS),
unicompartmental Function Score (KSFS), Oxford Knee Score (OKS), Short-Form 36, satisfaction, and expectation fulfilment
outcomes were compared at 6 months and 2 years.
satisfaction Results: The mean preoperative MCS was 41.2 in low MCS group and 58.6 in high MCS group (P < .001). The
mental health high MCS group had higher KSKS, KSFS, OKS, and Physical Component Summary, and a greater proportion of
SF-36 patients were satisfied and had expectations fulfilled at 6 months and 2 years (P < .05). However, the low MCS
group demonstrated greater improvement in KSKS, KSFS, and OKS (P < .05). Lower preoperative MCS score
was predictive of greater improvement in MCS (coefficient ¼ 0.662, R ¼ 0.602, P < .001).
Conclusion: Patients with poor mental health benefit from greater improvements in their mental health
and knee function after UKA, but also have a greater dissatisfaction.
© 2018 Elsevier Inc. All rights reserved.

Unicompartmental knee arthroplasty (UKA) is an accepted op-
tion for treatment of unicompartmental knee arthritis [1].
Compared to total knee arthroplasty (TKA), UKA has been shown to
allow blood loss reduction, preservation of bone stock, lower
perioperative morbidity, shorter hospital stay, improved range of
motion, and maintenance of native gait kinematics due to cruciate
ligament preservation [2e5]. Improvements in surgical techniques,
implant design, and adherence to defined surgical indications have
resulted in favorable clinical outcomes [6]. These experiences may
account for the rapidly rising implantation of UKA in the United
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.074.
* Reprint requests: Graham Seow-Hng Goh, MBBS, MRCS (Edin), Department of
Orthopaedic Surgery, Singapore General Hospital, 20 College Road, Academia, Level 4,
Singapore 169865, Singapore.
States, which accounted for 8% of all knee arthroplasties performed
in 2005 compared to 2.5% in 1999 and has been increasing in fre-
quency at triple the rate of TKA [7]. With the rapidly increasing
economic burden of UKA, patient selection for this elective surgery
has gained importance.
While UKA has demonstrated high satisfaction rates of 83% to
92% when compared to TKA, a subset of patients have lower post-
operative improvement in pain, physical functioning, health-
related quality of life (HRQoL), and remain dissatisfied with the
results of their UKA [8e10]. There are concerns that presurgical
mental health may influence postsurgical outcomes after joint
arthroplasty. Preoperative psychological attributes such as cata-
strophizing state, poor self-efficacy, poor coping skills, and coex-
isting emotional illnesses have been shown to predict
unsatisfactory patient outcomes [11e14]. Several articles have
examined the relationship between preoperative mental health
status and outcomes after TKA [15e18]. Patients with psychological

https://doi.org/10.1016/j.arth.2018.02.074
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434
distress, depression, anxiety, or poor mental health before surgery
had poorer functioning, quality of life, and satisfaction 1 year after
surgery [19e21]. Lingard and Riddle found that poor preoperative
mental health assessed on the Short-Form 36 (SF-36) was associ-
ated with less improvement in the Western Ontario and McMaster
Universities Osteoarthritis (WOMAC) score 2 years after TKA [22].
While most of the articles have found that poor mental health
preoperatively has been associated with inferior outcomes after
TKA [11e21], no similar studies have been performed for UKA.
The contribution of mental health on patient outcomes and
satisfaction after UKA still remains unclear. To our knowledge, only
1 small series (37 patients) assessing the impact of mental well-
being on UKA has been published [23]. Little is known regarding
the possible associations between the presence of preoperative
psychological distress and patient-reported outcomes measures
after UKA. Furthermore, no study to date has analyzed the effect of
preoperative mental health on satisfaction. The effect of UKA on
mental health is also not well defined: Is poor preoperative mental
health driven by the pain and functional limitations associated with
knee arthritis and thus improves after UKA postoperatively? Given
the established relationship between mental health and patient
satisfaction after TKA [24], an investigation of the impact of mental
health on patient satisfaction following UKA is warranted, partic-
ularly for its potential as a screening tool for candidates of UKA or as
a predictor of dissatisfaction after surgery.
The primary aim of this study was to assess the effect of pre-
operative mental health on the early outcomes (measured by
surgeon-driven objective scales, patient-reported outcome mea-
sures, health-related quality of life, and patient satisfaction) after
UKA in a large cohort followed over a minimum of 2 years. The
secondary aim was to assess whether mental health improves after
UKA. Our hypothesis was that psychological factors play an
important role in determining clinical outcome scores and mental
health will improve after UKA.
Methods
We conducted a review of prospectively collected registry data
of 1473 medial UKAs performed between 2007 and 2014 at a single
tertiary institution. This study was exempted by our institutional
review board as no patient-identifiable data were used. All patients
had completed 6-month and 2-year follow-up appointments with
outcome assessment. The surgical indications of patients who un-
derwent medial UKA consisted of the following: (1) isolated medial
compartment osteoarthritis (OA); (2) an intact anterior cruciate
ligament based on clinical and intraoperative assessments; (3)
flexion contracture < 10 , and (4) >90 of tibiofemoral flexion [1].
The presence of anterior knee pain and preoperative Kellgren and
Lawrence grade III-IV of the lateral or patellofemoral compartments
was considered as surgical contraindications for medial UKA. Pa-
tients with a history of complex knee surgery, trauma, inflamma-
tory arthropathy, and simultaneous bilateral UKA were excluded.
The majority of UKA surgeries were performed by the 2 senior
authors. All UKA surgeries were performed using the limited par-
apatellar approach without patella subluxation under a tourniquet.
The surgical aim was to achieve an equal flexion-extension gap. All
patients received either of 2 cemented fixed-bearing UKA implants:
the PFC Sigma (DePuy, Johnson & Johnson Professional Inc, Rayn-
ham, MA) or Zimmer Uni Knee (Zimmer Inc, IN). The surgical
technique was performed in accordance with the manufacturer's
surgical instrumentation guide.
An independent healthcare professional performed the preoper-
ative and postoperative assessment of all patients. All the patients
had preoperative range of motion, surgeon-driven objective scales
such as the Knee Society Score (KSS), patient-reported functional
2429
Table 1
Evaluation of Patient Satisfaction and Expectation Fulfilment.
Score Patient Satisfaction Stratification
1 Excellent Satisfied
2 Very good
3 Good
4 Fair Dissatisfied
5 Poor
6 Terrible
Score Patient expectation Stratification
1 Yes, totally Fulfilled
2 Yes, almost totally
3 Yes, quite a bit
4 More or less Not fulfilled
5 No, not quite
6 No, far from it
7 No, not at all
outcomes such as the Oxford Knee Score (OKS), and a HRQoL mea-
sure such as the SF-36 health survey. The SF-36 consisted of 8 sub-
scales: Physical functioning, Social functioning, Role-Physical, Bodily
Pain, Mental Health, Role-Emotional, Vitality, and General Health.
Summary scores were developed to aggregate the most highly
correlated subscales and simplify analyses without substantial loss of
information. In this study, the medical outcome study approach
proposed by Ware et al [25] was used to derive 2 higher-order
summary scores: Physical Component Summary (PCS) Score and
Mental Component Summary (MCS) Score. These 2 summary scores
were found to account for between 80% and 85% of the reliable
variance of the standard 8 subscales. They have good validity in
discriminating among clinically meaningful groups, as well as high
internal consistency and test-retest reliability estimates when used
in a general population [26]. The PCS and MCS have been reported
using norm-based scoring (mean ¼ 50, standard deviation ¼ 10) in
nearly all published studies to date [26]. In the present study, we
therefore used the preoperative MCS to dichotomize the cohort into
2 groups (below average mental health, indicating possible psycho-
logical distress, ie, low MCS < 50; above average mental health, ie,
high MCS  50) to allow for categorical analysis. This has previously
been used to assess the general population at risk and MCS < 50 has
been shown to indicate psychological distress [12,19,22,27].
The proportion of patients who met the minimal clinically
important difference (MCID) for the OKS and PCS was also recorded.
The MCID represented half of the standard deviation of the difference
between the preoperative and postoperative outcome scores for the
study cohort, which is an accepted methodology [28]. The calculated
MCID for our cohort of patients was 4 for the OKS and 6.2 for the PCS.
Patients who had outcome scores that met the MCID were deemed to
perceive a meaningful improvement in functional outcome and
HRQoL. All outcome scores were evaluated again at 6 months and 2
years postoperatively, together with an assessment of the patient's
fulfilment of expectations and overall satisfaction with the outcome
of surgery. Expectation and satisfaction scores were recorded using a
7-level and 6-level Likert scale, respectively, with higher scores
indicating poorer results, similar to a scale used in previous studies
[19]. We further stratified the scores into satisfied/unsatisfied or
expectations fulfilled/unfulfilled (Table 1).
Power analysis was performed before the conduct of this study.
To detect an MCID of 5 points in OKS from a baseline score of 18
with a standard deviation of 5, a sample size of at least 23 patients
in each group would be required to achieve a power of 0.95. To
detect a difference of 10 points in KSS knee score from a baseline
mean score of 80 with a standard deviation of 13, a sample size of at
least 28 patients in each group would be required to achieve a
power of 0.80. These calculations were made for a 2-sided test with
2430 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434

Table 2 Table 3
Patient Demographics (N ¼ 1473). Comparison of Clinical Outcomes at Different Time Intervals.

Measure MCS < 50 MCS  50 (N ¼ 894) P Value Outcome Measure MCS < 50 MCS  50 P Value
(N ¼ 579) (N ¼ 579) (N ¼ 894)

Age (y) 61.5 ± 8.7 62.9 ± 8.5 .002 Comparison at 6 mo

Gender Knee Society Knee Score (KSKS) 84.6 ± 13.5 87.2 ± 11.2 <.001
Female 82.6% 70.2% <.001 Knee Society Function Score (KSFS) 74.0 ± 18.1 78.9 ± 16.7 <.001
Male 17.4% 29.8% Oxford Knee Score (OKS)a 20.6 ± 6.4 18.5 ± 4.9 <.001
Body mass index (kg/m2) 27.3 ± 4.5 26.8 ± 4.3 .045 SF-36 PCS 47.8 ± 10.0 49.7 ± 8.2 <.001
Implant SF-36 MCS 52.1 ± 10.1 57.8 ± 8.0 <.001
DePuy 19.2% 21.8% .239 Comparison at 2 y
Zimmer 80.8% 88.2% KSKS 85.5 ± 13.9 87.4 ± 12.3 <.001
Range of motion 128 ± 15.8 129 ± 12.3 .185 KSFS 76.1 ± 17.9 81.8 ± 16.8 .005
Preoperative clinical outcomes OKSa 18.9 ± 5.9 17.2 ± 4.7 <.001
Knee Society Knee Score 41.7 ± 16.9 46.1 ± 16.7 <.001 SF-36 PCS 49.4 ± 10.3 50.8 ± 8.0 .003
Knee Society Function Score 54.6 ± 15.7 62.8 ± 16.1 <.001 SF-36 MCS 51.2 ± 11.2 57.6 ± 8.5 <.001
Oxford Knee Scorea 36.3 ± 7.6 30.7 ± 7.0 <.001 Comparison of the change in scores
SF-36 PCS 34.4 ± 11.4 36.2 ± 10.5 .002 KSKS 43.8 ± 20.7 41.3 ± 20.3 .025
SF-36 MCS 41.2 ± 7.7 58.6 ± 5.8 <.001 KSFS 21.4 ± 18.9 19.0 ± 18.8 .014
OKSa 17.4 ± 8.4 13.5 ± 7.3 <.001
P values <.05 are indicated in bold.
SF-36 PCS 15.0 ± 13.4 14.7 ± 11.5 .584
MCS, Mental Component Summary; PCS, Physical Component Summary.
a SF-36 MCS 10.0 ± 12.0 1.0 ± 9.6 <.001
Lower is better.
P values <.05 are indicated in bold.
MCS, Mental Component Summary; PCS, Physical Component Summary.
a
a type I error of 0.05. All continuous data were expressed in terms of Lower is better.

mean and standard deviation of the mean. Statistical analyses were

performed using the SPSS 20.0 (SPSS Inc, Chicago, IL) software
package. Linear regression was used to determine improvement in
mental health at 6 months and 2 years after UKA according to
preoperative MCS scores. The Student t-test was used to compare
the high and low MCS groups for quantitative variables such as age,
body mass index, and clinical scores. Categorical data such as the
proportion of patients who were satisfied or had attained MCID
were analyzed using the Pearson chi-square test. One-way analysis
of variance was used to compare preoperative, 6-month, and 2-year
MCS scores in both groups. We defined statistical significance at the
5% (P  .05) level.
Results
Patient Demographics
Patient demographics are detailed in Table 2, demonstrating
poorer clinical outcomes and generic physical well-being in the low
MCS group (n ¼ 579) vs the high MCS group (n ¼ 894). The mean
preoperative MCS was 41.2 ± 7.7 in the low MCS group and 58.6 ±
5.8 in the high MCS group (P < .001). Of note, there was no overlap
in standard deviations between the mean MCS of each group.
Effect of Preoperative Mental Health on Outcomes
The high MCS group performed better than the low MCS group
in the KSKS, KSFS, OKS, and PCS at 6 months and 2 years (P < .05;
Table 3). However, the low MCS group demonstrated a greater
improvement in KSKS (P ¼ .025), KSFS (P ¼ .014), and OKS (P < .001)
compared to the high MCS group. Using proportion analysis, we
also found that the low MCS group had a higher proportion of
patients who achieved the MCID for OKS at 6 months (91.7% vs
87.6%, P ¼ .013) and 2 years (95.2% vs 91.9%, P ¼ .019). On the other
patients in the high MCS group had their expectations fulfilled, vs
88.4% in the low MCS group (P ¼ .002).
Impact of UKA on Mental Health
Significant MCS improvements in low MCS group were noted at
6 months and 2 years (Fig. 1). The low MCS group demonstrated
MCS improvement by 10.9 points from 41.2 to 52.1 at 6 months (P <
.001) and continued to remain at 10.0 ± 12.0 above its baseline
value at 2 years (P < .001). In contrast, a significant decrease in MCS
of 1.0 ± 9.6 points from 58.6 to 57.6 was noted in the high MCS
group (P ¼ .003; Fig. 2), although the MCS scores remained signif-
icantly higher than the low MCS group up till 2 years post-
operatively (P < .001; Table 3). Lower preoperative MCS score was
predictive of greater improvement in MCS at 6 months
(coefficient ¼ 0.691, R ¼ 0.650, P < .001) and 2 years
(coefficient ¼ 0.662, R ¼ 0.602, P < .001) postoperatively (Fig. 3).
Discussion
The relationship between mental health and outcomes after UKA
is complex, as the organic functional limitations of knee arthritis are
likely to contribute to poorer mental health. This study has shown
that a patient's preoperative mental health affects the outcome of
UKA. Patients with poor mental health had poorer pain relief and
physical functioning postoperatively. However, the absolute
improvement in surgeon-driven (KSS) and patient-reported (OKS)
Table 4
Attainment of the MCID at Different Time Intervals.
Outcome 6 mo 2y
Measure
MCS < 50 MCS  50 P Value MCS < 50 MCS  50 P Value

hand, there was no difference in PCS improvement between the 2 MCID for OKS 91.7 87.6 .013 95.2 91.9 .019
groups (P ¼ .584), and the proportion of patients who achieved the attained (%)
Not attained (%) 8.3 12.4 4.8 8.1
MCID for PCS at 6 months (P ¼ .602) and 2 years (P ¼ .223) was
MCID for PCS 68.9 70.2 .602 72.5 75.4 .223
similar (Table 4). In terms of subjective outcomes, the high MCS attained (%)
group also had a greater proportion of patients who were satisfied Not attained (%) 31.1 29.8 27.5 24.6
and had their expectations fulfilled at 6 months and 2 years P values <.05 are indicated in bold.
(Table 5). At 2 years, 95% of patients in the high MCS group were MCID, minimal clinically important difference; MCS, Mental Component Summary;
satisfied, vs 90.2% in the low MCS group (P ¼ .003), while 93.9% of OKS, Oxford Knee Score; PCS, Physical Component Summary.
 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434 2431

Table 5 mental health) demonstrated greater improvements in KSS and

Satisfaction and Fulfilment of Expectations at Different Time Intervals. OKS when compared to the high MCS group. To comprehensively
Outcome 6 mo 2y address the question as to how suitable it is to advise such patients
Measure
MCS < 50 MCS  50 P Value MCS < 50 MCS  50 P Value
to undergo UKA, the concept of MCID was also studied. Patients
who had outcome scores that met the MCID were deemed to
Satisfied (%) 85.1 92.1 .002 90.2 95.0 .003
perceive a meaningful improvement in functional outcome and
Dissatisfied (%) 14.9 7.9 9.8 5.0
Expectations 84.1 90.2 .010 88.4 93.9 .002 HRQoL. Our study found that at 2 years, both groups of patients
fulfilled (%) with or without mental disability easily arrive at all those mini-
Expectations 15.9 9.8 11.6 6.1 mums (95% in the low MCS group; 92% in the high MCS group),
not fulfilled (%)
indicating that even patients with poor mental health have signif-
P values <.05 are indicated in bold. icant clinical benefit after UKA surgery.
MCS, Mental Component Summary. The results of this study parallel those in other studies that
show significant differences in patient-reported outcomes
disease-specific scores were greater than in patients with higher following TKA between patients with psychological distress and
baseline mental health, whereas the improvement in their global those without it [15e18]. Lingard and Riddle conducted a cohort
physical health (SF-36 PCS) was comparable. Patients with mental study of 952 patients and found that patients who had mental
disability also had a significant improvement in their mental health disability (MH-SF-36 less than 50) had slightly worse pain but
postoperatively. Despite the greater improvement in the disease- similar function at 2 years following TKA as measured using the
specific scores and improvement in their mental health, patients WOMAC [22]. The authors also highlighted a similar proportion
with mental disability had a lower rate of satisfaction and expecta- achieving MCID between dichotomized distressed and non-
tion fulfilment after their UKA at 2 years. distressed patient groups. Vissers et al [29] conducted a systemic
We found that 39% of the patients in our study were categorized review of 19 studies investigating the psychological factors that
as mentally distressed at baseline (as defined by an SF-36 Mental influence the outcome in patients after TKA or total hip arthro-
Component Summary of less than 50) [26]. These patients had plasty. In 17 of these studies, the clinical follow-up was shorter
significantly poorer scores on measures of pain, function, and than 1 year. The authors concluded that poorer preoperative
quality of life. However, when we examined the change in mea- mental health measured with SF-12 or SF-36 and pain cata-
sures from one period to the next, low MCS group patients (poorer strophizing are the most important factors for a poorer outcome

Fig. 1. Change in MCS in low MCS group.

2432 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434
Fig. 2. Change in MCS in high MCS group.
after TKA. The above studies, however, are predominately on the
results of TKA, and very few studies have investigated the effect of
preoperative mental health on pain and functional outcomes after
UKA. Walton and Newman in a small series of 37 patients un-
dergoing UKA found that preoperative MCS had a significant ef-
fect on 24-month rWOMAC (B ¼ 0.217, standard error ¼ 0.089,
P ¼ .016) such that reduced mental well-being was associated
with a worse outcome. The authors also reported a mean rWO-
MAC of 28 in patients with MCS < 40 compared to 17 in those with
MCS > 60 at 2 years postoperatively [23]. While previous studies
have shown that patients with poorer mental health before TKA
have significantly worse outcomes at 2 years postoperation
[15e18], we have shown that this finding is also applicable to
UKA.
However, no significant difference was observed for the
change in PCS, which is a generalized physical score. The pro-
portion that attained MCID for PCS was also similar between the
groups. This would suggest that poor preoperative mental health
affects a patient's disease-specific score but not their generalized
physical score. This observation is similar to that observed by
Walton and Newman [23] with a high correlation (coefficient ¼
0.43, P < .001) between preoperative SF-12 MCS and OKS but no
correlation between SF-12 MCS and the global physical score
(coefficient ¼ 0.023, P ¼ .813). Clement et al [19] also demon-
strated a diminished improvement in SF-12 PCS in patients with
mental disability, which was defined as MCS < 50. The reason for
the observed improvement in the disease-specific but not the
generalized physical scores according to mental health is not
clear, but might be related to the subjective interpretation of the
scores by the patient with a differing mental attitude. Patients
with mental disability, despite having their knee pathology
addressed and an improvement in their KSS and OKS, may remain
negative in their overall perception of their physical health.
Our study examined the absolute change between preoperative
and postoperative SF-36 MCS scores. We found that patients clas-
sified preoperatively as being psychologically distressed had a
substantial improvement (10.0), whereas patients who were psy-
chologically nondistressed had a slight loss (1.0). The overall
percentage of distressed patients also declined from 39% at baseline
to 26% at follow-up. This finding suggests that UKA reduced the
prevalence of psychological distress in this population, likely
because of a reduction in physical dysfunction associated with joint
OA and pain relief achieved by their UKA, as evident from their
improved disease-specific scores. It is possible that one reason for
lower preoperative mental health in these patients was driven by
knee arthritis. In addition, the use of analgesia preoperatively may
have impaired their mental health, as opioid use is associated with
depressive symptoms [30]. Several authors [19,31,32] have noted
an improvement in the mental health of patients undergoing TKA,
hypothesizing that pain before surgery might lead to depression
and thus undergoing knee arthroplasty would improve depression
and pain. Lingard and Riddle also showed that preoperatively dis-
tressed patients recover their mental function rapidly after surgery
[22]. In the study on UKA by Walton and Newman [23], however,
 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434
Fig. 3. Association between preoperative MCS and change in MCS.
SF-12 scores were not repeated postoperatively in order to assess
any recovery of MCS following surgery. The results of the study
confirm our second hypothesis that mental health improves in
patients undergoing UKA with reduction in pain and disability.
Literature on satisfaction rates after UKA in patients with mental
disability is limited. Preoperative depression has been shown to be
an independent predictor of dissatisfaction after TKA [17]. As pre-
viously described in the literature, patients who had lower SF-36
mental health scores were less likely to be satisfied after surgery
or feel that their preoperative expectations were met [33]. A recent
study on UKA also found that poorer preoperative and post-
operative MCS was associated with patient dissatisfaction at 2 years
postoperatively [34]. These findings are consistent with our study,
as despite a similar improvement in their general physical health
and a greater improvement in their mental health, there was a
lower rate of satisfaction and expectation fulfilment in those with
mental disability. This may be related to their preoperative ex-
pectations, as patients with depressive symptoms have greater
preoperative expectations of TKA that are not achieved post-
operatively [35]. Higher patient satisfaction could be attributed to a
more positive preoperative mental state, which may be linked to
better social support as well as greater willingness and motivation
to undergo physiotherapy postoperatively. Lee et al [34] further
suggested that because postoperative MCS was significantly asso-
ciated with patient dissatisfaction, a patient's mental state should
play a larger role not only in preoperative counselling but also in
postoperative management.
2433
The strength of our study lies in the large sample size and
availability of long-term data at a minimum of 2 years after surgery.
All cases were performed in a single high-volume institution with
standardized nursing and physiotherapy regimes.
Several limitations of this study must be noted. Firstly, although
our study was conducted within a single tertiary healthcare insti-
tution, varying surgical techniques by various surgeons as well as
varying choice of implant may introduce heterogeneity in the
observed outcomes. However, only fixed-bearing implants were
used in this study. Secondly, our study did not account for medical
comorbidities or preoperative radiographic deformity that could
have confounded the present findings. Thirdly, we only assessed
outcome at 2 years postoperatively, but whether these results will
persist, improve, or deteriorate remains uncertain, and further
longer-term studies would be needed to confirm whether the dif-
ferences we have demonstrated persist. Fourthly, our measure of
psychological distress was based on the SF-36 MCS. Although the
SF-36 is a well-validated construct about general mental well-being
that covers psychological symptoms described by other disease-
specific questionnaires, such as depressive and anxiety symp-
toms, it is not designed to diagnose specific mental health disor-
ders. The fact that the patients in this study all faced significant pain
and disability with their OA may have biased upward our finding of
psychological distress. For this group of patients, a category cutoff
of 50 for the SF-36 MCS might be too high. However, several other
studies have used a similar cutoff on the SF-36 MH or MCS to
identify psychological distress or emotional health issues in joint
2434 G.S.-H. Goh et al. / The Journal of Arthroplasty 33 (2018) 2428e2434
arthroplasty patients [11,12,22]. Lastly, although we managed to
confirm our second hypothesis that mental health improves with a
decrease in pain and disability after UKA, we have not analyzed the
psychological histories of the patients; hence, it cannot be inferred
from these data that OA has caused the reduction in preoperative
MCS score. Further studies are warranted to support such a
hypothesis.
The results of this study indicate that the relationship between
mental health and outcome is at least bidirectional, with UKA
leading to significant improvements in mental health status,
whereas worse preoperative mental health status is a predictor of
relatively worse outcomes after UKA. While it appears that patients
with poorer preoperative mental health have worse self-perceived
outcomes in terms of poorer function, greater pain, and lesser
quality of life preoperatively and up to 2 years postoperatively, their
rates of improvement were at least equal to or greater than patients
with higher baseline mental health and a high rate of patient
satisfaction was still achieved. These results may be viewed as
encouraging, and it is possible to conclude that UKA might be
advisable in patients with poor baseline mental health due to the
improvement in the quality of life and function demonstrated. The
results of our study reinforce the importance of perioperative care
with regard to the patient's mental state. Screening for psycho-
logical distress using the simple mental health assessment tool
used in the present study could easily become part of the preop-
erative workup in every orthopedic practice including surgeons
performing UKA. To date, many spine centers have already incor-
porated a psychological screening and subsequent treatment in
their spine surgery programs [36]. The impact of any mental
disability on perceived outcome can be discussed with the patient
preoperatively. In the case of a psychological state at risk for a
poorer clinical outcome, the patient could undergo a specific psy-
chological preoperative treatment to optimize results after UKA.
Customized exercise programs, behavioral support, and modifica-
tion of their expectations of UKA could simultaneously help to
improve satisfaction, self-efficacy, and the mood of the patient.
Additional studies are required to determine whether actively
treating emotional health in patients with poor baseline mental
health will improve their outcomes after knee arthroplasty.
Acknowledgments
The authors would like to acknowledge our physiotherapist
colleague Ms. Chong Hwei Chi for assisting us in the preoperative
and postoperative assessments of the patients.
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 The Journal of Arthroplasty 33 (2018) 2455e2459

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Periarticular Ropivacaine Cocktail Is Equivalent to Liposomal

Bupivacaine Cocktail in Bilateral Total Knee Arthroplasty
Jonathan R. Danoff, MD, Rahul Goel, MD, R. Andrew Henderson, MD, James Fraser, MD,
Peter F. Sharkey, MD *
Rothman Institute, Thomas Jefferson University, Philadelphia, Pennsylvania

a r t i c l e i n f o a b s t r a c t

Article history: Background: This study compares the effectiveness of 2 commonly used periarticular injection formu-
Received 13 November 2017 lations: liposomal bupivacaine and bupivacaine (EXP) and ropivacaine, epinephrine, ketorolac, and
Received in revised form clonidine (ROP) in patients undergoing bilateral total knee arthroplasty or unicompartmental knee
13 February 2018
arthroplasty.
Accepted 20 February 2018
Methods: Twenty-six total knee arthroplasty patients (52 knees) and 3 unicompartmental knee
Available online 6 March 2018
arthroplasty patients (6 knees) undergoing simultaneous, bilateral arthroplasty were randomized to
receive periarticular injections in a blinded fashion. Even birth year patients were selected for PAI of EXP
Keywords:
total knee arthroplasty
in the right knee and ROP in the left knee. This was reversed for odd birth years. Visual analog scale pain
periarticular injection scores for each knee and patient perceived difference in knee functional recovery were recorded during
pain control physical therapy, throughout the hospitalization.
liposomal bupivacaine Results: There was no difference in visual analog scale pain scores between the EXP and ROP injected
Exparel knees at any time point during the first 2 days after surgery. Postoperative pain scores averaged 41.9 mm
ropivacaine (range 0-100 mm) for EXP and 43.1 mm (range 0-100 mm) for ROP. Patients were unable to detect a
difference in the functional recovery between their knees on postoperative day 0, 1, or 2. No compli-
cations as a result of either periarticular injection occurred.
Conclusion: Periarticular injections of EXP and ROP are equally effective after knee arthroplasty and
patients do not appreciate differences between knees as determined by pain score or perceived func-
tional recovery during the first 2 days after bilateral knee arthroplasty. This study demonstrates that a
liposomal bupivacaine injection does not add an incremental benefit for pain control compared to a less
expensive injection formulation.
© 2018 Elsevier Inc. All rights reserved.

Innovative techniques in achieving pain control after total knee
arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA)
have been introduced over the past several years. Multimodal pain
control including oral medication, periarticular injections, and
peripheral nerve blockade has facilitated rapid recovery protocols,
improved patient outcomes, and decreased complications [1e5].
Some surgeons employ periarticular injections to decrease
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.083.
* Reprint requests: Peter F. Sharkey, MD, Rothman Institute, 925 Chestnut Street,
Philadelphia, PA 19107.
postoperative pain, sometimes referred to as “cocktails,” they differ
in medication formulation, volume, injection location, and cost.
It is important to investigate the differences in periarticular
injection protocols to identify the most cost-effective regimens.
Commonly used injection medications combined in a cocktail
include bupivacaine, ropivacaine, liposomal bupivacaine,
epinephrine, ketorolac, clonidine, and morphine [2,3,5e7]. Often
these are diluted to a volume of 50-100 mL total with injectable
normal saline. Two popular cocktails are liposomal bupivacaine and
bupivacaine (EXP) and ropivacaine, epinephrine, ketorolac, and
clonidine (ROP) [2]. Liposomal bupivacaine is purported to provide
prolonged pain relief via controlled delivery from liposomes
[8e12]. Some reports have demonstrated that liposomal bupiva-
caine may decrease postoperative pain and hospital length of stay
compared to peripheral nerve blockade [4]. However, over the past
several years, investigators studying arthroplasty populations of

https://doi.org/10.1016/j.arth.2018.02.083
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2456 J.R. Danoff et al. / The Journal of Arthroplasty 33 (2018) 2455e2459
Fig. 1. Injection of a periarticular cocktail into the: (A) posterior capsule and posterior cruciate ligament prior to implant cementation; (B) medial collateral ligament and the
periosteum of the femur; and (C) medial retinaculum and deep medial collateral ligament around the tibia.
unilateral TKA or UKA have not identified clinical advantages
favoring the EXP periarticular injection [3,6]. This is despite
liposomal bupivacaine being significantly more expensive than
most other formulations.
Comparing outcomes across studies is difficult due to the innate
differences between study protocols, injection protocols, and
outcome measures evaluated. To our knowledge, no prior study has
compared pain control between 2 different periarticular injection
protocols injected into each knee in patients undergoing simulta-
neous, bilateral TKA or UKA. This comparison theoretically allows
patients to directly contrast perceived differences in pain control
between knees and offers additional information as patients serve
as their own internal control for baseline pain perception, pain
medication requirements, anesthesia type, and postoperative
speed of recovery.
Thus, this study was conducted to investigate pain control
between knees in patients undergoing simultaneous, bilateral TKA
or UKA for whom one knee was injected with EXP and the other
with ROP. It is hypothesized that patients would be unable to detect
a difference in pain control between the 2 knees.
Materials and Methods
This is a double-blinded (subject and observer), prospective
consecutive case series of 26 TKA (52 knees) and 3 UKA (6 knees)
patients undergoing simultaneous, bilateral knee arthroplasty
performed between December 2016 and May 2017 by a fellowship-
trained arthroplasty surgeon. Both TKA and UKA patients were
included as the senior surgeon utilizes the same surgical exposure
and periarticular injection protocol for both TKA and UKA cases.
The comparison in this study was between knees, rather than
analyzing the maximum visual analog scale (VAS) improvement
achieved using the different injection cocktails. Per the senior
surgeon's standard intraoperative protocol, patient birth year was
used to randomize one knee to receive EXP and the other ROP. Even
birth year patients were injected with EXP in the right knee and
ROP in the left knee. This was reversed for odd birth years, and
patients were blinded to the injection cocktail laterality. Patients
were included in the study if they were preoperatively diagnosed
with osteoarthritis and underwent simultaneous, bilateral TKA or
UKA. Patients were excluded in this study if they were initially
indicated for a bilateral knee arthroplasty, but the second knee
operation was aborted due to intraoperative medical concerns (0
patients) or patients with postoperative complications that would
confound outcomes (one patient, who sustained a vascular injury
and was excluded from the study). Fourteen patients were female
and 15 were male, average body mass index was 30.4 and (range
23.63-38.26), and average age at the time of surgery was 62.9 years
(range 41.45-77.04 years).
All operations were performed in a single center in a
standardized fashion, according to the senior surgeon's protocol.
Anesthesia was induced by a trained anesthesiologist using
sedation and spinal anesthesia. Peripheral nerve blockade was not
utilized in any of these cases. All operations were performed using a
nonpneumatic tourniquet (HemaClear; OHK Medical Devices,
Grandville, Michigan). A cruciate-retaining total knee (LOSPA;
Corentec, Seoul, Korea) was implanted bilaterally in 14 patients and
a cruciate-retaining total knee (Triathlon; Stryker, Mahwah, New
Jersey) was implanted bilaterally in 11 patients. One patient was
implanted with a Zimmer Tivanium cruciate-retaining knee (Nex-
gen, Zimmer, Warsaw, Indiana). The 3 partial knee arthroplasty
patients received a fixed bearing unicompartmental knee arthro-
plasty (Triathlon Partial Knee Resurfacing; Stryker, Mahwah, New
Jersey). The medial parapatellar approach was used in all cases, and
 J.R. Danoff et al. / The Journal of Arthroplasty 33 (2018) 2455e2459
Fig. 2. VAS pain scores compared between ROP and EXP periarticular injections during the postoperative period.
the patella was not resurfaced in any patient. Standard intra-
medullary alignment tools were used to facilitate the femoral cuts,
and an extramedullary guide was used for the proximal tibia cut.
Two periarticular knee injection cocktails were used in the
surgeon's protocol. The EXP cocktail consisted of 20 mL (266 mg)
liposomal bupivacaine (Exparel, Pacira Pharmaceuticals, San Diego,
CA) and 30 mL of 0.25% bupivacaine diluted with 50 mL normal
saline to a total volume of 100 mL. The ROP cocktail included 5 mg/
mL (50 mL) ropivacaine, 1 mg/mL (0.5 mL) epinephrine, 30 mg/mL
(1 mL) ketorolac, and 0.1 mg/mL (0.8 mL) clonidine, diluted to a
volume of 100 mL with 47.7 mL normal saline. Both cocktails have
previously been described and proven efficacious in the literature
[2,5]. The ROP cocktail was prepared by the in-hospital pharmacy
the morning of the operation. While the surgeon was not blinded to
the medication to be injected, efforts were made by the operating
room team to avoid reminding the surgeon at the time of the
injection as to the contents of the syringe or patient's birth
year. The surgeon used a 21-gauge needle to inject the medication
into the soft tissues surrounding the knee including 10 mL each into
the medial and lateral posterior capsule and 10 mL into the
posterior cruciate ligament (Fig. 1A). Fifty milliliter was evenly
distributed throughout the medial and lateral soft tissues/collateral
ligaments/gutters (Fig. 1B and C), including the periosteum of the
femur/tibia, and 20 mL was injected into the subcutaneous tissues
[2]. After the periarticular injection was complete, pulse irrigation
was used to irrigate the knee joint to remove extravasated fluid and
thus avoid potential chondrotoxicity.
All patients received the same preoperative and postoperative
multimodal pain management protocol. Two hours before surgery,
400 mg of celecoxib and 975 mg of acetaminophen were admin-
istered via oral route to the patients. Tranexamic acid 1000 mg was
intravenously administered before surgery and repeated following
tourniquet release. An additional 3000 mg of tranexamic acid was
2457
injected intra-articularly after capsular closure in combination with
1000 mg of vancomycin in 100 mL of normal saline. Intravenous
antimicrobial prophylaxis was administered preoperatively per
protocol. Postoperatively, the pain control regimen included oral
acetaminophen 975 mg every 8 hours and intravenous ketorolac 30
mg every 8 hours. Tramadol of 50 mg and oxycodone of 10 mg were
administered on an as needed basis for breakthrough pain. All
patients received 81 mg of generic aspirin every 12 hours for 30
days for thromboembolism prophylaxis. No specific restrictions
were placed on the patients for range of motion and physical and
occupational therapy was initiated the same day of surgery after
resolution of the neuraxial anesthesia. Patients were admitted for a
minimum of 2 days after which time they were discharged to home
or to an acute rehabilitation facility. Per the senior surgeon's
protocol, VAS pain scores were recorded during physical therapy
sessions the evening of surgery (POD0-PM), and on postoperative
days (PODs) 1 and 2 in the morning (AM) and again in the afternoon
(PM). Furthermore, the postoperative patient care team recorded in
the medical record the patient's subjective descriptions comparing
differences between each of their knee's functional recovery and
assessed rate of recovery between the 2 knees. All observers were
blinded to the injection type laterality.
Patient outcomes for this study were retrospectively reviewed
by a blinded investigator, and the protocol for this study was
approved by our center's institutional review board. The primary
outcome was VAS pain score and secondary outcomes included
differences in rate of recovery and knee preference overall as were
any complications secondary to the periarticular injection.
A power analysis demonstrates that a minimum of 32 samples
per group would provide adequate power to identify a difference in
VAS score of 18 mm assuming a standard deviation of 20 mm. These
calculations were performed using a b ¼ 0.8 and P < .05.
Assumptions for these calculations were based on previously
2458 J.R. Danoff et al. / The Journal of Arthroplasty 33 (2018) 2455e2459
reported values of minimally clinical important differences in the
VAS score [13]. Outcomes were statistically compared using
chi-squared test or Fisher's exact test and study t-testing using SPSS
Statistics for Windows, version 22.0 (Armonk, New York) using
with statistical significance set to P < .05. A post hoc analysis was
performed indicating that sufficient power was reached with 29
samples per group with the cohort standard deviation of values of
27.6 mm.
Results
Overall, no statistically significant difference in VAS pain scores
between knees was detected comparing the EXP and ROP knees at
any time during the hospital stay (POD0-PM [delta ¼ 0.33; P ¼ .58],
POD1-AM [delta ¼ 0.04; P ¼ .95], POD1-PM [delta ¼ 0.11; P ¼ .86],
POD2-AM [delta ¼ 0.47; P ¼ .54] and POD2-PM [delta ¼ 0.28;
P ¼ .82]). Postoperative pain scores averaged 41.9 mm (range 0-100
mm) for EXP and 43.1 mm (range 0-100 mm) for ROP. As seen in
Figure 2, the mean VAS pain score ranged on average 1.9-5.8 cm
throughout the hospital stay overall.
Subjective functional recovery was not found to be different
between knees throughout the hospitalization, on POD0-PM
(P ¼ .27), POD1-AM (P ¼ 1), POD1-PM (P ¼ .22), POD2-AM (0.44),
and POD2-PM (0.16).
Further analysis was conducted comparing the TKA and UKA
cohorts, separately. Overall, bilateral UKA patients reported more
pain than TKA patients across all time points, with VAS pain score in
the ROP group averaging 56.1 mm (range 9.3-84.0 mm) vs 43.7 mm
(range 20.2-51.3 mm), among UKA and TKA cases, respectively, and
average VAS pain scores in the EXP group averaging 62.3 mm
(range 13.3-75.3 mm) vs 44.9 mm (range 23.4-54.2 mm), among
UKA and TKA cases, respectively. Despite being underpowered to
measure a difference within either TKA or UKA cohorts, at no time
point was a statistically significant difference measured between
TKA knees on POD0-PM (P ¼ .12), POD1-AM (P ¼ .59), POD1-PM
(P ¼ .34), POD2-AM (0.19) and POD2-PM (0.55) or between UKA
knees on POD0-PM (P ¼ .47), POD1-AM (P ¼ .36), POD1-PM
(P ¼ .34), and POD2-AM (0.39).
No adverse events such as foot drop, skin necrosis, falls, deep
vein thrombosis, wound drainage, or any other complication as a
result of the periarticular injections occurred.
Discussion
Given recent focus for maximizing postoperative pain relief
following knee arthroplasty, as well as efforts to reduce cost of care
in total joint arthroplasty, this study sought to compare 2 popular
periarticular injection protocols in simultaneously performed,
bilateral TKA and UKA patients. Both EXP and ROP cocktails have
been previously shown to be successful in controlling pain after
knee arthroplasty, but controversy exists over whether one injec-
tion type is more effective than the other [2]. The ability to use the
patient as their own internal controls strengthens this study's
ability to detect differences in outcomes between knees.
In this study, we found that patients were unable to detect VAS
pain score differences or improved functional recovery outcomes
between their knees, despite each being injected with a different
cocktail. Other published reports investigating cocktail formulations
in unilateral TKA and UKA patient cohorts have reported results
similar to ours and have not shown a difference in pain control be-
tween less expensive bupivacaine or ropivacaine formulations
compared with liposomal bupivacaine [3,6,7]. In fact, one study by
Bagsby et al [3] reported that the liposomal bupivacaine group
demonstrated less pain relief, required more medication use, and
higher antiemetic requirement compared to a cocktail of
ropivacaine, morphine and epinephrine. Another study by
Alijanipour et al [6] failed to identify differences in Knee Society
Scores or patient satisfaction comparing liposomal bupivacaine to
bupivacaine with epinephrine. This study also found no difference
between the 2 groups in terms of narcotic medication use or nausea
within the first 96 hours after surgery or even 4- to 6-week
complication rates and functional outcomes.
The total cost of the ROP medication cocktail at our facility
($25.98 USD) per knee was 82% of the cost of EXP ($315 USD).
Considering that the EXP cocktail failed to show superior outcomes
in this investigation, this additional cost is not justified.
Surgeons employing periarticular injections must be careful to
perform these injections in a safe manner and avoid exceeding the
toxicity limits for these injectable medications. Some tricks that are
employed are to always drawn the syringe plunger in reverse
before injecting to avoid accidental intravascular injections. Also,
being conscious regarding the dosage maximums for these
medications is of paramount importance. Springer et al [14]
demonstrated that periarticular injections of liposomal bupiva-
caine mixed in a cocktail of 0.25% bupivacaine 30 cc with
epinephrine, and 10 cc normal saline did not exceed toxic limits
when the full-dose cocktail was employed in each knee during
simultaneous bilateral total knee arthroplasty. The same full-dose
ropivacaine cocktail, however, cannot be used in simultaneous
bilateral total knee arthroplasty as the dosage used in the cocktail,
described previously, is based on the toxicity limit for a 70 kg
patient. Thus, use of this medication must be divided in half
between knees (50 cc administered per knee) if this cocktail is
utilized in simultaneous bilateral total knee arthroplasty. As stated
previously, no patients exhibited adverse toxicity reactions utilizing
the ropivacaine cocktail in one knee and the liposomal bupivacaine
cocktail in the other knee during the course of this study.
This study has a number of limitations, including the fact that
pain score outcomes were limited to analysis for the first 48 hours
after surgery. It is the senior surgeon's protocol to discharge
patients to home or subacute rehabilitation hospitals on POD2 if
they are medically optimized and we did not obtain pain scores or
evaluate recovery differences after hospital discharge. Nonetheless,
the lack of difference between the 2 injection formulations during
the first 48 hours after surgery is significant since pain is usually
most acute during this time period. We also chose to combine TKA
and UKA patients in a single cohort, which may create confounding
outcomes. While the 2 procedures differ in terms of bone cuts and
ligament sacrificing, the senior surgeon's protocol is to perform the
same surgical exposure for both cases, resulting in the same
amount of soft-tissue dissection, with the exception that the
anterior cruciate ligament is maintained in the UKA cases. While
this may affect total VAS pain score, the primary outcome from the
study was difference in VAS pain score between knees, and in this
case, the compared knees underwent the same surgical procedure.
Thus, the type of knee surgery was controlled between comparison
groups for baseline outcomes, even though distinct operations
were included. Further, as discussed previously, although under-
powered, differences were unable to be detected between EXP and
ROP knees for TKA and UKA cases, despite more pain being expe-
rienced overall in UKA cases. In addition, we did not employ
peripheral nerve blockade in our postoperative cases included in
this study cohort. Some surgeons employ femoral nerve or
adductor canal blockade using single-shot blocks or continuously
dosed catheters, to augment pain control in the postoperative
period [1]. No patients in this study had this additional modality
employed as a means of pain control, and thus, the outcome of this
study cannot be applied to clinical scenarios in which surgeons
choose to employ peripheral nerve blockade and periarticular in-
jections concomitantly. Further, the outcome data in this study did
 J.R. Danoff et al. / The Journal of Arthroplasty 33 (2018) 2455e2459
not include pain medication usage as comparisons were between
knees, and thus, oral medication consumption would affect both
knees equally. It is possible that those patients experiencing more
pain in one knee would request more pain medication such that
their overall pain level would be reduced. However, the main
objective of this study was not to compare overall pain relief but
rather patient subjective perception of pain and functional recovery
in each of their 2 knees. If one knee was more painful than the
other, then this study was designed to detect it, regardless of the
patient's overall pain medication intake. Finally, we did not record
knee range of motion or muscle strength during the course of this
study as it was felt that these outcomes were unreliable within
48 hours from surgery. Instead, secondary outcomes recorded of
the patient's subjective outcome of which knee is recovering faster
were utilized as a surrogate for muscle strength and range of
motion recovery.
In conclusion, this study suggests that the liposomal bupiva-
caine cocktail does not add an incremental benefit for pain
management relative to a low-cost generic alternative. Given the
existing desire to reduce costs, while improving or maintaining
outcomes, the use of liposomal bupivacaine as an injection cocktail
after knee arthroplasty does not appear justified. Future research is
required to define the optimal periarticular medication dosage and
medication combinations that provide maximal pain relief and
cost-effectiveness as part of multimodal protocols.
References
[1] Koh HJ, Koh IJ, Kim MS, Choi KY, Jo HU, In Y. Does patient perception differ
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[2] Dalury DF, Lieberman JR, MacDonald SJ. Current and innovative pain man-
agement techniques in total knee arthroplasty. J Bone Joint Surg Am 2011;93:
1938e43.
[3] Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus tradi-
tional periarticular injection for pain control after total knee arthroplasty.
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[4] Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal
bupivacaine) to manage postoperative pain in unilateral total knee arthro-
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[5] Kelley TC, Adams MJ, Mulliken BD, Dalury DF. Efficacy of multimodal peri-
operative analgesia protocol with periarticular medication injection in total
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[6] Alijanipour P, Tan TL, Matthews CN, Viola JR, Purtill JJ, Rothman RH, et al.
Periarticular injection of liposomal bupivacaine offers No benefit over stan-
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controlled trial. J Arthroplasty 2017;32:628e34.
[7] Klug MJ, Rivey MP, Carter JT. Comparison of intraoperative periarticular in-
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[8] Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-
ranging study comparing wound infiltration of DepoFoam bupivacaine, an
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analgesia in total knee arthroplasty. Knee 2012;19:530e6.
[9] Ranade VV. Drug delivery systems. 1. site-specific drug delivery using lipo-
somes as carriers. J Clin Pharmacol 1989;29:685e94.
[10] Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine
in orthopedic surgery. Am J Orthop 2015;44:111e7.
[11] Lonner J. Role of liposomal bupivacaine in pain management after total joint
arthroplasty. J Surg Orthop Adv 2014;23:37e41.
[12] Singh PM, Borle A, Trikha A, Michos L, Sinha A, Goudra B. Role of periarticular
liposomal bupivacaine infiltration in patients undergoing total knee
arthroplasty-a Meta-analysis of Comparative Trials. J Arthroplasty 2016;32:
675e88.
[13] Stauffer ME, Taylor SD, Watson DJ, Peloso PM, Morrison A. Definition of
nonresponse to analgesic treatment of arthritic pain: an analytical literature
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scale. Int J Inflam 2011;2011:231926.
[14] Springer BD, Mason JB, Odum SM. Systemic safety of liposomal bupivacaine in
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97e101.
 The Journal of Arthroplasty 33 (2018) 2605e2612

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

Periprosthetic Joint Infection With Fungal Pathogens

Timothy S. Brown, MD a, Stephen M. Petis, MD a, Douglas R. Osmon, MD b,
Tad M. Mabry, MD a, Daniel J. Berry, MD a, Arlen D. Hanssen, MD a,
Matthew P. Abdel, MD a, *
a
Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota
b
Department of Internal Medicine, Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota

a r t i c l e i n f o a b s t r a c t

Article history: Background: Although there is abundant information about bacterial periprosthetic joint infections
Received 20 November 2017 (PJIs), there is a notable paucity of information about fungal PJIs. The goals of this study are to describe
Received in revised form the patient demographics, diagnostic findings, and treatment results of fungal PJIs after total joint
5 February 2018
arthroplasty.
Accepted 2 March 2018
Available online 13 March 2018
Methods: We identified 31 fungal PJIs (13 total hip arthroplasties and 18 total knee arthroplasties) in 31
patients treated between 1996 and 2014. This represented 0.9% of the 3525 PJIs treated at our institution
during this time period. Candida species accounted for 81% of infections. The mean patient age at
Keywords:
periprosthetic joint infection
diagnosis of fungal PJI was 68 years. Mean follow-up after initiation of treatment was 4 years.
atypical periprosthetic joint infection Results: In the total hip arthroplasty cohort, survivorship free from all-cause revision or implant removal
fungal periprosthetic joint infection was 44% at 2 years. Survivorship free from reinfection was 38% at 2 years. Mean Harris hip score was 27
candida infection at final follow-up.In the total knee arthroplasty cohort, survivorship free from all-cause revision was 70%
fungal pathogens at 2 years. Survivorship free from reinfection was 76% at 2 years. Mean Knee Society scores were 36 at
final follow-up.
Conclusion: Fungal PJIs are rare (0.9% of diagnosed PJIs). Survivorship free of all-cause revision or implant
removal was very low in the hip group (44% at 2 years), but slightly better in the knee group (70% at 2
years). Moreover, clinical outcomes were poor with high perioperative complication rates. Improved
treatment regimens are needed for this unsolved clinical problem.
© 2018 Elsevier Inc. All rights reserved.

The contemporary incidence of periprosthetic joint infection
(PJI) ranges from 0.3% to 2.9% [1,2] following primary total hip
arthroplasty (THA), and 0.9% to 2% [3,4] following primary total
knee arthroplasty (TKA). The most commonly isolated organisms in
PJI are gram-positive bacteria, with staphylococcal species ac-
counting for more than 50% of cases [1,5]. Gram-negative and
polymicrobial infections are less common [1].
Fungal PJI is considered atypical, reportedly accounting for
approximately 1% of PJIs [6]. The current literature is comprised
mostly of case reports and small case series, with only approximately
85 cases documented over the last 40 years [7]. No series is larger
than 31 cases, and these were included from 6 large referral centers
[7]. Although several treatment options for fungal PJI have been
described, definitive literature is lacking due to the nature of these
case reports and small case series [5,8e25]. Some studies have
advocated antifungal suppression alone [25], while others have
recommended debridement with implant retention [10,11,17,20] or
2-stage exchange arthroplasty [5,9,15,16,22e24].
The goal of this series is to report on a large number of fungal
PJIs treated at a single institution. The specific aims are to describe
the clinical characteristics, clinical outcomes, implant survivorship,
and complications experienced by patients treated for fungal PJIs.

One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect, Patients and Methods
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.003.
Our institution's total joint registry was used to identify all pa-
* Reprint requests: Matthew P. Abdel, MD, Department of Orthopedic Surgery, tients treated for a fungal PJI following THA or TKA between 1996
Mayo Clinic, 200 First Street SW, Rochester, MN 55905. and 2014. Patients were included if they were older than 18 years of

https://doi.org/10.1016/j.arth.2018.03.003
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2606 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612

age and a fungal organism was isolated on either synovial fluid or spacer insertion prior to referral to our center. The treatment of
tissue culture during the treatment of a PJI. Exclusion criteria fungal PJI in this cohort, at our institution, included 3 patients with
included cases where a fungal organism was identified, but was irrigation, debridement, component retention, and modular poly-
deemed to be a contaminant by both the orthopedic surgeon and ethylene exchange (IDPE), 3 patients with 2-stage exchange, 3 pa-
orthopedic infectious disease specialist. Institutional board tients with resection arthroplasty, 2 patients with antibiotic-loaded
approval was obtained prior to initiation of the study. cement spacer insertion and spacer retention, and 2 patients
treated with long-term antifungal suppression after a fungal
Diagnosis of Fungal Periprosthetic Joint Infection organism was cultured at the time of the second stage (reimplan-
tation) of a 2-stage exchange infection treatment protocol. A mean
True fungal PJIs and contaminants were determined after a dose of 150 mg (range 100-250) of amphotericin B was incorpo-
thorough review of the patient's history, physical examination, rated into each batch of cement for the 4 patients who had a spacer
serology, tissue pathology, and speciation of synovial and operative inserted as part of a 2-stage exchange protocol. Three of these
cultures. Those patients who did not clinically meet the criteria for patients had amphotericin B laden cement at the time of reim-
PJI but had one positive culture with a fungal organism were plantation [28,29], with a mean dose of 83 mg (range 50-150). Six
carefully evaluated. All patients had evaluation with an infectious patients received chronic antifungal suppression. Four patients
disease expert. If no antifungal treatment was initiated, and clinical were treated with fluconazole 400 mg daily, and 2 patients were
notes from infectious disease and orthopedic surgery both deter- treated with fluconazole 200 mg daily.
mined the fungal result to be a contaminant, the patient was
excluded from the analysis. The majority of these cases determined
that contaminants were single intraoperative cultures showing a Fungal PJI After TKA
fungal pathogen on one culture in the setting of a presumed aseptic
revision arthroplasty. We determined the number of patients In the TKA cohort, the mean age was 69 years (range 50-92), 56%
satisfying criteria for PJI outlined by the Musculoskeletal Infection of the patients were female, and the mean body mass index was 29
Society (MSIS) [26]. We staged the patients according to the clas- kg/m2 (range 23-35) (Table 1). Three patients died and 5 were
sification system described by McPherson et al [27]. The number of revised prior to 2 years of follow-up. The remaining TKA cohort had
previous surgical procedures involving the affected joint prior to a mean follow-up of 4.2 years (range 2.3-7.2) from the time of
identification of the fungal PJI was recorded. We also determined fungal PJI diagnosis.
how many of these procedures included treatment for PJI prior to Patients underwent a mean of 4 procedures (range 0-10) from
identification and treatment of a fungal organism. the time of their primary TKA procedure to diagnosis of fungal PJI.
There were 17 THAs and 32 TKAs in which a fungal organism Fourteen (14 of 18; 78%) patients underwent treatment for another
was cultured at the time of treatment. Based on the above criteria, PJI prior to diagnosis of fungal PJI (Table 2). The most common PJI
in 4 THAs (4 of 17; 24%) and 14 TKA cases (14 of 32; 44%) the treatment prior to diagnosis of fungal PJI was a 2-stage exchange
positive fungal cultures were considered contaminants. As such, protocol for prosthetic infection. Treatment for TKA fungal PJI
the cohort included 13 THAs and 18 TKAs. These 31 cases of fungal included 11 patients treated with a 2-stage exchange protocol, 3
PJI made up to 0.9% of the 3525 PJIs treated at our institution during patients treated with long-term antifungal suppression after a
the study period. fungal organism was cultured at the time of a second stage (reim-
plantation) of a 2-stage infection treatment protocol, 2 patients
Fungal PJI After THA treated with IDPE, 1 patient treated with a 1-stage exchange, and 1
patient treated with a resection arthroplasty. Amphotericin B was
In the THA cohort, the mean age at diagnosis of fungal PJI was 68 incorporated into the cement [28,29] in 10 patients who had a
years (range 37-89), 54% were female, and the mean body mass spacer inserted as part of a 2-stage exchange protocol, with a mean
index was 32 kg/m2 (range 24-51) (Table 1). There was 1 death and dose of 130 mg (range 100-150). Six of these patients had
6 revisions prior to 2 years of follow-up. The remaining patients had amphotericin B in the cement at the time of reimplantation, with a
a mean follow-up of 3.9 years (range 2.2-7) from the time of fungal
PJI diagnosis. Table 2
Patients underwent a mean of 3 procedures (range 0-13) from Clinical Data Prior to Fungal PJI.
the time of their primary THA to the time of diagnosis of fungal PJI.
THA TKA
Seven (7 of 13; 54%) patients underwent treatment for PJI before
Number 13 18
the fungal PJI was diagnosed and treated (Table 2). The most
Number of prior operations, no. (range) 3 (0-13) 3.6 (0-10)
common treatment for PJI prior to fungal PJI was a resection with Treatment for bacterial PJI, no. (%) 7 (54%) 14 (78%)
Revision arthroplasty, no. (%) 8 (62%) 9 (53%)
Prolonged antibiotics (>6 wk) prior to fungal 7 (54%) 11 (61%)
Table 1 PJI, no. (%)
Demographic Data. Immunosuppression, no. (%) 3 (23%) 2 (11%)
Draining sinus, no. (%) 2 (15%) 3 (19%)
THA (n ¼ 13) TKA (n ¼ 18)
CRP (mg/L), no. (range) 78 (3-433) 35 (3-67)
Age (y) 68 (range 37-89) 69 (range 50-92) ESR (mm/h), no. (range) 48 (2-101) 36 (6-81)
Follow-up (y) 3.9 (range 2.2-7) 4.2 (range 2.3-7.2) Acute inflammation on pathology, no. (%) 9 (69%) 11 (69%)
Female 7 (54%) 10 (56%) Gross purulence, no. (%) 8 (62%) 10 (63%)
BMI (kg/m2) 32 (range 24-51) 29 (range 23-35) MSIS major criteria satisfied, no. (%) 10 (77%) 14 (78%)
Age-adjusted CCI 6 (range 1-9) 6 (range 4-11) McPherson stage
ASA 1B2 3 patients 1 patient
2 5 patients 7 patients 3B2 6 patients 13 patients
3 7 patients 11 patients 3B3 3 patients 2 patients
4 1 patient None 3C2 None 1 patient
3C3 1 patient 1 patient
BMI, body mass index; CCI, Charlson Comorbidity Index; ASA, American Society of
Anesthesiologists score. CRP, C-reactive protein; ESR, erythrocyte sedimentation rate.
 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612 2607

mean dose of 83 mg (range 50-150). Five patients received chronic
antifungal suppression, with all 5 patients receiving fluconazole
200 mg daily.
Patient Follow-Up and Clinical Outcomes
After surgical management was completed, patients were
generally followed via clinical visits and radiographs at 6 weeks,
3 months, 1 year, 2 years, 5 years, and every 5 years thereafter. An
orthopedic infectious disease specialist tailored parenteral or
oral antifungal therapy based on cultured microorganisms. An
orthopedic infectious disease specialist also was present at every
clinic visit if there was concern for reinfection, or to manage
antifungal suppression therapy if utilized. The Harris hip score
[30] and Knee Society score [31] were completed at follow-up
visits.
Statistical Analysis
Continuous variables were summarized by means (standard
deviations) and medians (interquartile range), and categorical
variables as counts (%). Kaplan-Meier [32] methods were used to
calculate survivorship free of reinfections, revisions, and other
complications over the follow-up period. SAS 9.4 (SAS Institute Inc,
Cary, NC) and R version 3.1.1 (R Core Team; R Foundation for Sta-
tistical Computing, Vienna, Austria, 2014) were employed for these
analyses. Cox proportional hazards regression was used to evaluate
for differences in the risk of reinfection between those who had
amphotericin B used in the cement spacer and those who did not,
and between those with a Candida infection and all other fungal
organisms.
Results
Hip
There were 4 fungal organisms isolated in the major criteria.
Candida albicans was the most common infecting organism,
isolated in 8 hips (62%). Candida glabrata, Candida parapsilosis,
Coccidioides immitis, Aureobasidium/Hormonema spp., and Pith-
omyces spp. were each isolated in 1 hip. In 3 hips, a bacterial species
was isolated in conjunction with the fungal pathogen: Propioni-
bacterium acnes in 2 cases and methicillin-resistant Staphylococcus
aureus in 1 case (Table 3).
Survivorship Free of Revision and Reinfection
For the hips with periprosthetic fungal infections, survi-
vorship free from any implant revision or removal was 84% at 6
months, 67% at 1 year, and 45% at 2 years (Fig. 1A). Survivor-
ship free from aseptic revision was 91% at 6 months, 73% at 1
year, and 49% at 2 years (Fig. 1B). Survivorship free from
reinfection was 91% at 6 months, 64% at 1 year, and 38% at 2
years (Fig. 1C).
There were 6 hips with reinfections. Two of these hips initially
had been treated with IDPE alone, 2 with a 2-stage exchange
protocol, 1 with an articulating spacer that did not undergo
reimplantation, and 1 with a resection arthroplasty. Treatment of
the 6 reinfections included 2 IDPEs, 1 hip disarticulation, 1 addi-
tional resection with articulating spacer placement, 1 resection
arthroplasty, and 1 patient was placed on chronic antifungal
suppression.
In the 3 hip patients treated with a 2-stage protocol, 2 became
reinfected with the same fungal organism (C albicans) and had a
reoperation.
Regression analysis showed that type B hosts with type 2 ex-
tremities were at less risk for reinfection than B hosts with type 3
extremity or type C hosts (hazards ratio [HR] 0.06, 0.005-0.82, P ¼
.04). There was no difference in the reinfection risk for those pa-
tients who had amphotericin B in their cement spacer and those
who did not (HR 1.05, 0.19-5.82, P ¼ .95). Candida infection was not
found to be an independent risk for reinfection (HR 7.78, 0.34-179,
P ¼ .20).

MSIS Criteria and Microbiology

At the time of diagnosis of the fungal PJI, MSIS major criteria
commonly used for diagnosis of bacterial infections were satisfied
in 10 (77%) of the hip cases (Table 2). Two hips (15%) had draining
sinuses in communication with the joint. The same organism was
isolated on 2 separate intraoperative cultures in 10 (77%) hips. The
mean erythrocyte sedimentation rate was 48 mm/h (range 2-101)
and mean C-reactive protein was 78 mg/L (range 3-433) at the time
of diagnosis. Gross purulence was noted at the time of surgery in 8
hips (62%). Acute inflammation was seen on histopathology in 8
cases (62%).
Clinical Outcomes. Harris hip scores were poor prior to diagnosis of
fungal PJI (mean 53, range 23-71) and remained low after treatment
of the infection (mean 55, range 31-80).
Complications. There were 2 complications that were not re-
infections. There was 1 wound healing complication requiring a
return to the operating room for debridement and local flap
coverage. There was 1 death on postoperative day 8 in a patient
who had multiorgan system failure due to methicillin-sensitive
Staphylococcus aureus sepsis following IDPE.

Table 3
THA Fungal Infections.

Case Age, Gender McPherson Organism Treatment Antifungal Suppression Reinfection Reoperation Revision

1 77, Female 3B2 Pithomyces, P acnes Retention No No No No

2 84, Female 1B2 C albicans IDPE No Yes No No
3 75, Female 3B2 C albicans 2-stage No No No No
4 60, Male 3B2 Aureobasidium, Hormonema Suppression Yes No No No
5 68, Male 3B2 C albicans 2-stage Yes Yes Yes No
6 37, Male 1B2 C albicans IDPE Yes Yes No Yes
7 63, Female 3C3 C albicans, P acnes Retention Yes Yes No No
8 89, Male 3B2 Coccidioides immitis Suppression Yes No No No
9 56, Female 3B3 C albicans Resection No No No No
10 75, Female 3B3 C parapsilosis Resection No Yes Yes No
11 61, Female 3B3 Candida glabrata Resection No Yes Yes No
12 45, Male 3B2 C albicans 2-stage Yes Yes Yes No
13 76, Male 1B2 C albicans, MRSA IDPE Yes Yes Yes Yes

P acnes, Propionibacterium acnes; MRSA, methicillin-resistant Staphylococcus aureus; retention, retention of antibiotic spacer; 2-stage, 2-stage exchange arthroplasty.
2608 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612

Fig. 1. (A) Kaplan-Meier survivorship depicting survivorship free from any revision or implant removal for hips after fungal periprosthetic joint infection. (B) Kaplan-Meier curve
depicting survivorship free from any aseptic hip revision after treatment for fungal periprosthetic joint infection. (C) Kaplan-Meier curve depicting hip survivorship free from any
reinfection after treatment for fungal periprosthetic joint infection.
 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612 2609

Table 4
TKA Fungal Infections.

Case Age, Gender McPherson Organism Treatment Suppression Reinfection Reoperation Revision

1 81, Male 3B2 C albicans 2-stage No Yes Yes No

2 82, Male 3B2 C parapsilosis, E coli 2-stage Yes No No No
3 74, Female 3B3 CNS, C parapsilosis 2-stage Yes Yes Yes Yes
4 56, Female 3C2 C parapsilosis 2-stage No Yes No Yes
5 88, Female 3B2 Aspergillus versicolor, Staphylococcus lugdunensis 2-stage No No No No
6 71, Male 1B3 C parapsilosis IDPE No Yes Yes No
7 54, Male 3C3 Alternaria spp. 2-stage No No No No
8 70, Male 3B2 C albicans 2-stage No Yes Yes No
9 83, Female 3B3 C albicans Suppression Yes No No No
10 70, Male 3B2 Candida guilliermondii Resection No Yes Yes Yes
11 69, Female 3B3 C albicans 2-stage No No No No
12 75, Male 3B2 Candida tropicalis 1-stage No No No No
13 71, Female 3B2 C parapsilosis Resection No No No No
14 67, Male 3B2 C albicans 2-stage No No No No
15 51, Female 3B2 C albicans Suppression Yes No No No
16 60, Female 3B2 C parapsilosis Suppression Yes No No No
17 55, Female 3B2 Alternaria spp. 2-stage No No Yes Yes
18 69, Female 3B2 C albicans 2-stage No No No No

CNS, coagulase-negative Staphylococcus; E coli, Escherichia coli.

Knee
MSIS Criteria and Microbiology
At the time of diagnosis of the fungal infection, MSIS major
criteria were satisfied in 14 (78%) of the cases (Table 2). Three knees
(19%) had draining sinuses in communication with the joint. The
same organism was isolated on 2 separate intraoperative cultures
in 12 (66%) knees. The mean erythrocyte sedimentation rate was 36
mm/h (range 6-81) and mean C-reactive protein was 35 mg/L
(range 3-67.5) at the time of diagnosis. Gross purulence was noted
at the time of surgery in 10 knees (63%). Acute inflammation was
seen on histopathology in 11 cases (69%).
There were 4 fungal organisms isolated. C albicans was the most
common infecting organism, seen on multiple cultures in 7 knees
(39%). C parapsilosis was the next most common organism, and was
seen in 6 knees (33%). Alternaria species were isolated in 2 knees
(11%). Candida tropicalis, Candida guilliermondii, and Aspergillus
versicolor were each isolated once (6.7% each). Concomitant infec-
tion with a bacterial species occurred in 4 knees: 3 knees with
Staphylococcus species and 1 knee with Escherichia coli (Table 4).
Survivorship Free of Revision and Reinfection
Survivorship free from any implant revision or removal was 94%
at 6 months, 88% at 1 year, and 70% at 2 years (Fig. 2A). Survivorship
free from aseptic revision was 100% at 1 year and 93% at 2 years
(Fig. 2B). Survivorship free from reinfection was 94% at 6 months,
88% at 1 year, and 76% at 2 years (Fig. 2C).
There were 6 knees with reinfection. Four knees had undergone
2-stage exchange arthroplasty to treat the fungal PJI, 1 had under-
gone IDPE, and 1 had been treated with resection. Following the
reinfection, 2 knees underwent resection, 2 had IDPE, 1 underwent
above-knee amputation to control infection, and 1 was managed
with arthrodesis and chronic antifungal suppression.
In the 11 patients treated with an attempted 2-stage exchange
arthroplasty, 2 patients were left with an antibiotic spacer and
never had reimplantation of a prosthesis. In the 9 patients who
successfully completed a 2-stage exchange protocol, 3 had rein-
fection and required reoperation.
Host and extremity groups and outcomes were too small to
assess their effect on the risk of reinfection. Addition of ampho-
tericin B in the cement spacer did not change the risk of reinfection
in this cohort (HR 0.65, 0.09-4.6, P ¼ .20). Candida infection was not
found to be an independent risk for reinfection (HR 1.97, 0.08-52,
P ¼ .68).
Clinical Outcomes. Knee Society scores were poor prior to diagnosis
of fungal PJI (mean clinical score 56, range 43-69; mean functional
score 60, range 20-100) and worsened following treatment of the
fungal PJI (mean clinical score 36, range 2-79; mean functional
score 30, range 0-70).
Complications. There were 3 complications that did not require
revision surgery. There was 1 wound healing complication
requiring a return to the operating room for debridement and local
flap coverage. One patient underwent manipulation under anes-
thesia for stiffness. One patient had a periprosthetic fracture of the
tibia distal to the tibial stem that was managed nonoperatively with
cast immobilization.
Discussion
PJI remains a major cause of implant failure following THAs and
TKAs [33e36]. Although gram-positive bacterial infections are the
most common cause of PJI, fungal infections have been described in
the literature since a first case report in 1979 [37]. Although the
reported survivorship free from reinfection or revision after 2-stage
exchange arthroplasty for bacterial PJI is upwards of approximately
90% at 10 years in some large series [38,39], treatment of fungal PJI
has been less successful [7,21]. Treatment for any PJI is associated
with increased mortality compared with aseptic revision [40], and
the optimal treatment protocol for fungal PJI remains unknown.
Our data show that fungal PJIs are difficult to treat following
THA or TKA. Patients with multiple prior surgeries, prior treatment
for bacterial PJI, prolonged antibacterial treatment, systemic
immunocompromised status, and soft tissue compromise in the
extremity were common in this cohort of patients with fungal PJI.
Candida species were the most common infecting organism in our
series at 77% for THA PJI and 83% for TKA PJI, consistent with
published literature rates of 80%-84% [41,42]. This has important
implications for treatment given the ability of Candida to produce a
robust biofilm, making eradication difficult [43].
Our current clinical practice for most patients with fungal PJI
includes a 2-stage exchange arthroplasty, as long as the patient is
able to tolerate the procedure. After resection and thorough
debridement, a cement spacer with a high dose (>6 g antibiotic per
40 g cement) combination of vancomycin, gentamicin, and
amphotericin B is used [29,44,45], followed by frequent orthopedic
infectious disease follow-up with at least 6 weeks of systemic
antifungal therapy followed by a 6-week antifungal holiday. After a
2610 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612

Fig. 2. (A) Kaplan-Meier survivorship depicting survivorship free from any revision or implant removal for knees after fungal periprosthetic joint infection. (B) Kaplan-Meier curve
depicting survivorship free from any aseptic knee revision after treatment for fungal periprosthetic joint infection. (C) Kaplan-Meier curve depicting knee survivorship free from any
reinfection after treatment for fungal periprosthetic joint infection.
 T.S. Brown et al. / The Journal of Arthroplasty 33 (2018) 2605e2612
minimum of 3 months, and usually 6 or more months, the second
stage is carried out and an oral antifungal agent usually is given for
6 months postoperatively. The surgical and medical treatment of
fungal PJI in our current series was heterogeneous, in part because
the timing of diagnosis varied and in part due to the comorbidities
of the patients. This reflects a real-world practice. Notable is the
high complication rate, poor clinical outcomes, and low survivor-
ship from all-cause revision or implant removal (45% at 2 years for
THA, 70% at 2 years for TKA) in the treatment of fungal PJI.
Prior to a report in 1996 [16], every case of fungal PJI in the
literature was treated with resection arthroplasty, arthrodesis, or
amputation [6,17,37,46e56]. The case report by Hennessy [16] to
our knowledge represented the first successful eradication of
fungal PJI with salvage of the joint using 2-stage exchange protocol.
Subsequently, there have been a myriad of additional case reports
reporting early outcomes following different treatment regimens,
including antifungal suppression alone [25,57e59], irrigation and
debridement with implant retention [10,11,20,60], 1-stage ex-
change [61e63], and 2-stage exchange [5,9,15,22,24,64e68].
Although Anagnostakos et al [9] reported 100% infection erad-
ication with a 2-stage exchange protocol after fungal infection in 7
cases (4 THAs and 3 TKAs), the majority of series in the literature
have reported much lower success rates. Ueng et al [21] reported
infection eradication in 50% of fungal PJI treated with a 2-stage
exchange arthroplasty and prolonged postoperative fluconazole.
In a multi-institutional study of fungal PJIs [7], 31 cases (14 THAs
and 17 TKAs) were studied from 1999 to 2006. A salvage procedure
was used in 39% (12/31) to control infection: above-knee amputa-
tion in 5, arthrodesis in 3, permanent hip resection in 3, and hip
disarticulation in 1. Two-stage exchange arthroplasty was suc-
cessful in only 47% (9/19) of patients. In our series, survivorship free
from reinfection was 38% at 2 years for hips and 70% at 2 years for
knees. In our series, 2-stage exchange arthroplasty was successful
in only 50% (7/14).
There are limitations to this study. Foremost, the cohort is
limited by patient numbers. In addition, the patients were very
diverse and had varied treatments. However, this is the largest
single institution series reported. Moreover, given the complex
nature of these problems, it is difficult to standardize the diagnosis
and treatment of fungal PJI.
Fungal PJI is a devastating complication after THA or TKA.
Despite varied treatment methods, the rate of salvage treatment
with amputation or arthrodesis is high. Survivorship free from
revision or implant removal at 2 years was 45% in THA and 70% in
TKA. Survivorship free from reinfection at 2 years was 38% in THA
and 76% in TKA. The rate of salvage procedures was high (23% for
hips, 17% for knees). After THA, we found less risk of reinfection in
a type B host with grade 2 extremity compared with more
compromised hosts with compromised extremities. With the
numbers available these host and extremity grades did not
correlate statistically with reinfection rate for TKA patients.
Although our series is small, the reinfection rate for THA was
much higher than in TKA. The number of mean previous opera-
tions was similar between hip (3) and knee (4) patients, but the
knee patients were more likely treated with a 2-stage protocol
with all stages of the procedure performed at our institution. In
the THA cohort, a number of patients presented to our institution
with an infected spacer, having failed a prior attempt at infection
control. We speculate that this plays a main role in the decreased
chance of successful treatment in the hip patient. Patients should
be counseled that with current treatment methods the rate of
success is at best modest and salvage procedures may be consid-
ered as the definitive treatment in some patients. New and
improved methods of treatment of this fortunately uncommon
problem are needed. Potential areas of further research could be
2611
the effect of a prolonged antifungal holiday (>6 weeks) prior to
reimplantation, identification of host and pathogen characteristics
that affect treatment and prognosis, and the effect of suppressive
antifungal agents following reimplantation.
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 The Journal of Arthroplasty 33 (2018) 2556e2559

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Predictability of Pelvic Tilt During Total Hip Arthroplasty Using a

Traction Table
Paul S. Roettges, MD a, *, Jack R. Hannallah, MD b, Jordan L. Smith, MD a,
John T. Ruth, MD a
a
Department of Orthopaedic Surgery, University of Arizona College of Medicine, Tucson, AZ
b
Department of Medical Imaging, University of Arizona College of Medicine, Tucson, AZ

a r t i c l e i n f o a b s t r a c t

Article history: Background: Pelvic positioning during total hip arthroplasty (THA) affects functional position of the
Received 17 January 2018 acetabular component. We sought to evaluate whether preoperative pelvic tilt correlated with intra-
Received in revised form operative pelvic tilt while positioned on a traction table for direct anterior THA and furthermore to
23 February 2018
evaluate whether there was a consistent and predictable effect on pelvic tilt while positioned for surgery.
Accepted 5 March 2018
Methods: We evaluated the sagittal spinopelvic preoperative standing and supine pelvic tilt radiographic
Available online 16 March 2018
measurements as compared with intraoperative measurements of 25 patients. Changes in pelvic tilt were
analyzed for statistical significance and interobserver reliability.
Keywords:
pelvic tilt
Results: The mean standing pelvic tilt was 13.5
± 5.7
. The mean supine pelvic tilt was 13.3
± 6.1
. There
total hip arthroplasty was no statistically significant difference between standing and supine pelvic tilt (P ¼ .866). The mean
Hana table intraoperative pelvic tilt was 3.0
± 6.2
. There was a statistically significant decrease in pelvic tilt be-
traction table tween both standing to intraoperative comparison and supine to intraoperative comparison (P < .0001
anteversion for both). Difference in mean between these comparisons was 10.5
± 4.6
(95% confidence interval, 8.7
-
inclination 12.3
) and 10.3
± 6.3
(95% confidence interval, 7.8
-12.8
), respectively.
Conclusion: Patient positioning on a traction table for direct anterior THA has a reliable effect on pelvic
tilt in the magnitude of approximately 10
decreased pelvic tilt. This effect on pelvic tilt correlates to
approximately 7.4
and 3
altered anteversion and inclination, respectively. Taking into account this
change in pelvic tilt at the time of surgery will allow the hip arthroplasty surgeon to more accurately
place acetabular components in the desired functional position.
© 2018 Elsevier Inc. All rights reserved.

Pelvic positioning during total hip arthroplasty affects func-
tional position of the acetabular component. Studies have
demonstrated a linear relationship between pelvic tilt and func-
tional acetabular cup anteversion [1e3]. This relationship results in
approximately 0.74
change in anteversion for every 1
change in
pelvic tilt. Maratt et al [1] further demonstrated a nonlinear rela-
tionship between acetabular inclination and pelvic tilt with a mean
0.29
change in inclination per 1
change in pelvic tilt. This em-
phasizes the importance of the orthopedic total hip arthroplasty
surgeon's awareness of patient's pelvic position at the time of
Funding: This research did not receive any specific grant from funding agencies in
the public, commercial, or not-for-profit sectors.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.018.
* Reprint requests: Paul S. Roettges, MD, Department of Orthopaedic Surgery,
University of Arizona College of Medicine, Tucson, AZ 85724-5018.
surgery and how this will influence the functional cup position
throughout day-to-day activities. This is complicated by the
demonstrated difficulty and variability in attaining and maintain-
ing neutral pelvic position, while in a lateral decubitus, operative
position [4]. With the popularization of the direct anterior
approach, more total hip arthroplasty is performed in a supine
position. Often, this approach utilizes a specialty traction table
throughout the procedure. Although the supine procedure may
logically seem to allow for a more reproducible and functional
pelvic position at the time of implantation, there is sparse evidence
as to the effects on pelvic tilt with utilization of such tables.
We sought out to answer 2 questions:
1 Is the patient's pelvic tilt while positioned on the Hana (Mizuho
OSI) table during direct anterior approach total hip arthroplasty
predictable from preoperative standing or supine imaging?

https://doi.org/10.1016/j.arth.2018.03.018
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 P.S. Roettges et al. / The Journal of Arthroplasty 33 (2018) 2556e2559
Fig. 1. A line from the center of the S1 superior endplate to the center of the super-
imposed femoral heads and referenced against the coronal plane vertical line dem-
onstrates the measurement of pelvic tilt.
2 Does intraoperative positioning have a consistent effect on
pelvic tilt?
Methods
This is a radiographic study, in which images were obtained
preoperatively and intraoperatively in concordance with the insti-
tutional review board approval on patients who underwent direct
anterior total hip arthroplasty using a Hana table. The images of 25
patients were reviewed for radiographic measurement from a
period of January 2016 to August 2017. This represents a noncon-
secutive series in which all patients with the completed and saved
images were included. Surgeries were performed by 2 senior au-
thors (J.R. and J.S.). Lateral cassette preoperative sagittal spinopelvic
radiographs were obtained in both the supine and standing posi-
tion. These were compared to intraoperative fluoroscopic images
taken after placement of definitive implants. At that point, both
extremities, while still within the boots attached to the Hana table,
were brought to neutral in regards to rotation, flexion/extension,
and add/abduction. In this position, with gross traction to each
extremity unlocked, final fluoroscopic images were obtained,
including our lateral spinopelvic image, followed by surgical site
wound closure. Pelvic tilt was measured from the center of the
superior end plate of the S1 body to the center of the superimposed
femoral heads and referenced against the coronal plane as shown in
Figure 1. Differences in overlap of the femoral heads due to pelvic
rotation were accounted for by averaging the center position be-
tween the 2 femoral heads as shown in Figure 2 and documented
by Tyrakowski et al [5] to not have statistically significant difference
on the pelvic tilt measurement barring extreme pelvic rotation
>30
. Fluoroscopic images were referenced against images taken of
the table frame so as to confirm the images had not been rotated by
the technologist. The Student's t test was used to test the signifi-
cance of the difference in preoperative and intraoperative pelvic
tilt. Alpha level was set at 0.05 for all tests. Pelvic tilt measurements
were performed by junior authors (P.R. and J.H.). These were
analyzed for interobserver reliability.
2557
Fig. 2. Measurement of pelvic tilt uses the midpoint between the 2 femoral head
centers to account for pelvic radiograph obliquity.
Results
The mean standing pelvic tilt was 13.5
± 5.7
. The mean supine
pelvic tilt was 13.3
± 6.1
. There was no statistically significant
difference between standing and supine pelvic tilt (P ¼ .866). The
mean intraoperative pelvic tilt was 3.0
± 6.2
. There was a statis-
tically significant decrease in pelvic tilt between both standing to
intraoperative comparison and supine to intraoperative compari-
son (P < .0001 for both). Difference in mean between
these comparisons was 10.5
± 4.6
(95% confidence interval [CI],
8.7
-12.3
) and 10.3
± 6.3
(95% CI, 7.8
-12.8
), respectively. When
comparing this data set with that of the second observer, the mean
absolute difference was 1.4
, 1.2
, and 2
for standing, supine, and
intraoperative position, respectively. Standard deviations were no
more than ±1
for all and 95% CI each less than ±0.42
. All patients
demonstrated a flexion moment on the pelvis leading to decrease
in pelvic tilt intraoperatively as compared to preoperative mea-
surement. Figure 3 illustrates the breakdown of change in pelvic tilt
from standing to intraoperative position.
Discussion
We have demonstrated that intraoperative positioning on the
Hana table during direct anterior approach total hip arthroplasty
results in a consistent and predictable effect on pelvic orientation at
the time of surgery. This decrease in pelvic tilt seen at the time of
surgery is opposite the influence seen on pelvic orientation during
the functional activity of standing to sitting. Whereas intra-
operative positioning results in a deviation from standing to the
effect of lessening the pelvic tilt measurement as demonstrated in
Figure 4, the act of sitting has the effect of increasing pelvic tilt
measurement. Kanawade et al [6] have demonstrated this increase
in pelvic tilt and its interplay on acetabular cup position, seen when
transitioning from a standing to sitting position. This range of pelvic
tilt from standing to sitting is often viewed as the functional range
2558 P.S. Roettges et al. / The Journal of Arthroplasty 33 (2018) 2556e2559
Fig. 3. Graph demonstrating the change in pelvic tilt from standing to intraoperative
position. The majority of patients had a 7- to 13-degree decrease in pelvic tilt while
positioned on the Hana table.
of pelvic orientation in which the majority of daily activities, and
thus stress on the implants, will be performed. This functional
range of pelvic tilt would ideally be identified preoperatively and
targeted during intraoperative referencing of cup position. Not only
does the intraoperative pelvic position not replicate the patient's
preoperative standing or supine orientation but also it is altered in
a way that opposes the common daily changes in pelvic position
and lies outside the functional range of pelvic orientation. This
preoperative evaluation has proven to be sufficient as preoperative
pelvic tilt is highly correlated with postoperative pelvic tilt [1,7].
Although there was no statistical significance between standing
and supine pelvic tilt, the narrower 95% CI seen with comparing
standing to intraoperative tilt would indicate standing preoperative
evaluation likely to be preferable to supine.
The patients' intraoperative pelvic tilt demonstrates a consistent
relationship with preoperative tilt minus the predictable flexion
moment on the pelvis of approximately 10
with narrow confi-
dence intervals. Thus, if this is not accounted for during cup posi-
tioning, there is potential for malposition of the cup which will only
further be aggravated during the functional range of motion from a
standing to a seated position. The average 10
decrease in pelvic tilt
due to positioning during surgery will result in approximately 7.4

and 3
increased anteversion and inclination, respectively, while
Fig. 4. The left image demonstrates 15-degree standing pelvic tilt, and the right image demonstrates 1-degree pelvic tilt anterior to the coronal plane (defined as negative pelvic
tilt). This highlights the 16-degree decrease in pelvic tilt seen in this patient while on the Hana table during surgery.
standing. These increases in anteversion and inclination will
further increase from intraoperative position as the patient pro-
gresses from a standing to a seated position emphasizing the
counter desired effect on pelvic tilt encountered during intra-
operative positioning on a Hana table. Although not a purpose of
this study, one can infer that approximately 7
of increased ante-
version and 3
increase in inclination may affect the ultimate
long-term functionality and success of the implants. It would be
prudent to take this effect on pelvic orientation into mind during
cup placement and intraoperative radiographic evaluation. One
potential way to address these findings going forth would be to
obtain an intraoperative lateral spinopelvic image before acetabu-
lum reaming and/or implantation and compare the pelvic tilt with
preoperative measurements. If done at this time, the treating
surgeon wound know the exact change in pelvic tilt to account for
and amount of degrees to angle the C-arm so as to mirror the
preoperative anteroposterior (AP) image without having to guess
by other options commonly found to be highly inaccurate such as
appearance of the obturator foramen.
The impetus for this study was the observation that both senior
authors were consistently canting their C-arm fluoroscopy toward
the foot in an attempt to mirror the preoperative standing AP
radiograph. Without this adjustment, the patient's pelvis often
appeared to demonstrate more of an inlet view. This finding and the
recent increase in literature documenting pelvic tilt and functional
pelvic orientation's effect on cup positioning and function led to the
creation of our study. One weakness in our study was the com-
parison of preoperative radiographs to intraoperative fluoroscopy.
This has the potential to induce bias into the junior author during
pelvic tilt measurements. In an attempt to counteract this, we
recruited a radiologist unfamiliar with the concept and hypothesis
of the study to perform measurements as well. These measure-
ments proved to have high interobserver reliability. The noncon-
secutive nature of our series was not by design or subjectivity but
simply the random nature of incomplete imaging series. The pri-
mary barrier was obtaining the lateral preoperative images. Often
the patients would have prior pelvic and hip AP and frog-leg lateral
images, and upon decision for surgery, would simply get sent for a
1-view pelvis with markers. Other lapses were most common
earlier in the study period as the medical staff and radiograph
technicians became more accustomed to ordering and obtaining
our compete preoperative series for potential new direct anterior
 P.S. Roettges et al. / The Journal of Arthroplasty 33 (2018) 2556e2559
total hip arthroplasty patients. For the ease of maintaining sterility,
intraoperative images were obtained at the end of the case. Ideally,
image acquisition would have been completed at the time of
acetabular component implantation. For the purposes of our study,
we reviewed all patients who had the necessary series of images;
however, an interesting study going forth may be an attempt to
reproduce the study in patients with varying pelvic stiffness as well
as a subset patient population with degenerative or surgically
treated lumbosacral pathology. We had 1 patient with pre-existing
anterior interbody lumbosacral fusion. Interestingly, this patient
had the second lowest change in pelvic tilt from standing to
intraoperative evaluation.
Conclusion
Changes in pelvic tilt have a reliable effect on functional
acetabular cup position. Thus, it is important to have knowledge of
patients' pelvic tilt at the time of total hip arthroplasty as it com-
pares to common day-to-day activities ranging from a standing to a
seated position. Patient positioning on the traction table for direct
anterior approach total hip arthroplasty has a reliable effect on
pelvic tilt in the magnitude of approximately 10
decreased pelvic
tilt on average. This effect on pelvic tilt is opposite to that of the
2559
effect on pelvic tilt seen when transitioning from a standing to a
seated position. Taking into account this change in pelvic tilt at the
time of surgery will allow the hip arthroplasty surgeon to more
accurately place acetabular components in the desired functional
position.
References
[1] Maratt JD, Esposito CI, McLawhorn AS, Jerabek SA, Padgett DE, Mayman DJ.
Pelvic tilt in patients undergoing total hip arthroplasty: when does it matter?
J Arthroplasty 2015;30:387e91.
[2] Wan Z, Malik A, Jaramaz B, Chao L, Dorr LD. Imaging and navigation mea-
surement of acetabular component position in THA. Clin Orthop 2009;467:32.
[3] Lembeck B, Mueller O, Wuelker N. Peltic tilt makes acetabular cup navigation
inaccurate. Acta Orthop 2005;76:517.
[4] Grammatopoulos G, Pandit HG, da Assunça ~o R, Taylor A, McLardy-Smith P, De
Smet KA, et al. Pelvic position and movement during hip replacement. Bone
Joint J 2014;96-B:876e83.
[5] Tyrakowski M, Wojtera-Tyrakowska D, Siemionow K. Influence of pelvic rota-
tion on pelvic incidence, pelvic tilt, and sacral slope. Spine (Phila Pa 1976)
2014;39:E1276e83.
[6] Kanawade V, Dorr L, Wan Z. Predictability of acetabular component angular
change with postural shift from standing to sitting position. J Bone Joint Surg
Am 2014;96:978e86.
[7] Blondel B, Parratte S, Tropiano P, Pauly V, Aubaniac JM, Argenson JN. Pelvic tilt
measurement before and after total hip arthroplasty. Orthop Traumatol Surg
Res 2009;95:568.
 The Journal of Arthroplasty 33 (2018) 2582e2587

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

Predicting Failure in Early Acute Prosthetic Joint Infection Treated

With Debridement, Antibiotics, and Implant Retention: External
Validation of the KLIC Score
Claudia A.M. Lo € wik, MD a, *, Paul C. Jutte, MD, PhD a, 1, Eduard Tornero, MD b,
Joris J.W. Ploegmakers, MD a, 1, Bas A.S. Knobben, MD, PhD c, 1,
Astrid J. de Vries, PhD c, 1, Wierd P. Zijlstra, MD, PhD d, 1, Baukje Dijkstra, MSc d, 1,
Alex Soriano, MD, PhD e, Marjan Wouthuyzen-Bakker, MD, PhD f, on behalf of the
Northern Infection Network Joint Arthroplasty (NINJA)
a
Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
b
Department of Orthopaedic Surgery, Parc Sanitari Sant Joan de D eu, Sant Boi de Llobregat, Spain
c
Department of Orthopaedic Surgery, Martini Hospital, Groningen, The Netherlands
d
Department of Orthopaedic Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands
e
Department of Infectious Diseases, University of Barcelona, Hospital Clinic of Barcelona, Barcelona, Spain
f
Department of Medical Microbiology and Infection Prevention, University of Groningen, University Medical Center Groningen, Groningen,
The Netherlands

a r t i c l e i n f o a b s t r a c t

Article history: Background: Debridement, antibiotics, and implant retention (DAIR) is a widely used treatment modality
Received 9 January 2018 for early acute prosthetic joint infection (PJI). A preoperative risk score was previously designed for
Received in revised form predicting DAIR failure, consisting of chronic renal failure (K), liver cirrhosis (L), index surgery (I),
16 February 2018
cemented prosthesis (C), and C-reactive protein >115 mg/L (KLIC). The aim of this study was to validate
Accepted 17 March 2018
the KLIC score in an external cohort.
Available online 27 March 2018
Methods: We retrospectively evaluated patients with early acute PJI treated with DAIR between 2006 and
2016 in 3 Dutch hospitals. Early acute PJI was defined as <21 days of symptoms and DAIR performed within
Keywords:
joint arthroplasty
90 days after index surgery. Failure was defined as the need for (1) second DAIR, (2) implant removal, (3)
prosthetic joint infection suppressive antimicrobial treatment, or (4) infection-related death within 60 days after debridement.
DAIR Results: A total of 386 patients were included. Failure occurred in 148 patients (38.3%). Patients with KLIC
risk score scores of
2, 2.5-3.5, 4-5, 5.5-6.5, and 7 had failure rates of 27.9%, 37.1%, 49.3%, 54.5%, and 85.7%,
external validation respectively (P < .001). The receiver-operating characteristic curve showed an area under the curve of
0.64 (95% confidence interval 0.59-0.69). A KLIC score higher than 6 points showed a specificity of 97.9%.
Conclusion: The KLIC score is a relatively good preoperative risk score for DAIR failure in patients with
early acute PJI and appears to be most useful in clinical practice for patients with low or high KLIC scores.
© 2018 Elsevier Inc. All rights reserved.

This manuscript represents a multicenter study, in which authors are part of a

No author associated with this paper has disclosed any potential or pertinent
writing committee. All authors assume responsibility for the overall content and
conflicts which may be perceived to have impending conflict with this work. For
integrity of the article. C.L. and M.W. conducted the study, in collaboration with P.J.,
full disclosure statements refer to doi: https://doi.org/10.1016/j.arth.2018.03.041.
J.P., B.K., A.V., W.Z., and B.D., E.T. and AS aided in the legitimate process of validation
This research did not receive any specific grant from funding agencies in the
of the risk score.
public, commercial, or not-for-profit sectors.
* Reprint requests: Claudia A.M. Lo € wik, MD, University Medical Center Gronin-
The institutional review boards of the participating hospitals approved this study.
gen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.
The study is conducted in accordance to the principles of the Declaration of Hel- 1
This manuscript represents a multicenter study, in which authors are part of a
sinki, the Medical Research Involving Human Subjects Act (WMO), and the Good
writing committee. All authors assume responsibility for the overall content and
Clinical Practice standard (GCP). In consultation with the review boards, obtaining
integrity of the article.
informed consent from the participants was not required in this observational study.

https://doi.org/10.1016/j.arth.2018.03.041
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 €wik et al. / The Journal of Arthroplasty 33 (2018) 2582e2587
C.A.M. Lo
Total joint arthroplasty is a widely used treatment modality for
osteoarthritis of the hip and knee, with 310,800 total hip arthro-
plasties and 639,400 total knee arthroplasties performed in the
United States in 2010 [1,2]. In general, joint arthroplasty is a suc-
cessful procedure with large improvement in the patient’s quality
of life. However, prosthetic joint infection (PJI) is a major compli-
cation after joint arthroplasty with high impact on the patient’s
well-being, occurring in 1%-2% of primary joint arthroplasties and
up to 10% in revision arthroplasties [3,4]. Most of these infections
occur within the first 3 months after implantation and are defined
as early infections [5,6].
Surgical debridement, antibiotics, and implant retention (DAIR)
is the recommended treatment for patients with early PJI, being
most successful in early acute PJI, in which symptoms exist for less
than 3 weeks [7,8]. Nevertheless, rates of infection control after
DAIR vary widely from 37%-88% [9e16]. Therefore, it is important to
be able to predict DAIR failure to select eligible patients before
surgery, especially because performing a DAIR procedure could
negatively influence the outcome of subsequent revision arthro-
plasty. A couple of studies showed a higher failure rate of 2-stage
revisions after failed DAIR [17,18], although this has not been
confirmed by others [19,20].
Previous studies identified risk factors for DAIR failure including
high inflammatory parameters, infection with Staphylococcus
aureus, longer duration of symptoms, polyethylene retention, and
arthroscopic debridement [21e30]. In addition, Tornero et al [31]
designed a preoperative risk score with a high accuracy for pre-
dicting failure (area under the curve [AUC] 0.84). This score consists
of 5 preoperative factors, which were identified as independent
predictors of failure in 222 patients with early acute PJI: (1) chronic
renal failure (Kidney), (2) Liver cirrhosis, (3) Index surgery (revision
surgery or prosthesis indicated for a fracture), (4) Cemented pros-
thesis, and (5) C-reactive protein (CRP) > 115 mg/L.
To implement the chronic renal failure (K), liver cirrhosis (L),
index surgery (I), cemented prosthesis (C), and CRP >115 mg/L
(KLIC) score in other hospitals as a standard tool for predicting DAIR
failure in early acute PJI, it is important to validate the risk score in
an external cohort. Therefore, we assessed the predictive value of
the KLIC score in a large cohort of patients with early acute PJI
treated with DAIR in the Netherlands.
Materials and Methods
Study Design
We retrospectively analyzed patients with early acute PJI who
were treated with DAIR between January 2006 and December 2016
in 2 general hospitals (Martini Hospital and Medical Center Leeu-
warden) and 1 university hospital (University Medical Center
Groningen) in the Netherlands. Patients who developed a PJI within
3 months after joint arthroplasty and had a duration of symptoms
of <21 days were included. Diagnosis of PJI was determined ac-
cording to the diagnostic criteria defined by the Musculoskeletal
Infection Society [32]. Patients who did not meet the Musculo-
skeletal Infection Society criteria were excluded from the analysis,
as well as patients who underwent arthroscopic debridement
instead of open surgical debridement.
Variables that were collected included demographics, body
mass index, preoperative American Society of Anesthesiologists
(ASA) classification, comorbidities, medication, clinical signs,
serological markers, culture results and data of the index proced-
ure, and DAIR. The same definitions and cut-off values of these
variables were used as described by Tornero et al [31]. Sepsis was
defined as presence of 2 systemic inflammatory response syn-
drome criteria and a suspected source of infection. Consistent with
2583
Table 1
Preoperative Variables of the KLIC Score With Appointed Scores.
Variable Score
K Chronic renal failure (kidney) 2
L Liver cirrhosis 1.5
I Index procedure (revision surgery or prosthesis 1.5
indicated for a fracture)
C Cemented prosthesis 2
C C-reactive protein >115 mg/L 2.5
KLIC, chronic renal failure (K), liver cirrhosis (L), index surgery (I), cemented
prosthesis (C), and C-reactive protein >115 mg/L.
Tornero et al [31], we appointed scores to the preoperative vari-
ables of the KLIC score, adding up to a score ranging from 0-9.5
points (Table 1). The score was categorized into
2, 2.5-3.5, 4-5,
5.5-6.5, and 7 points.
Definition of Outcome
Primary outcome was early failure, defined as one of the
following events within 60 days after initial debridement: (1)
second DAIR, (2) revision surgery or implant removal, (3) infection-
related death, or (4) suppressive antimicrobial treatment. In case a
second DAIR procedure was solely performed for removal of
gentamicin-impregnated beads, without clinical and biochemical
signs of persistent infection, second debridement was not consid-
ered as failure.
Surgical and Antimicrobial Treatment
Surgical treatment consisted of DAIR, in which the wound was
opened via the preexisting incision and hematoma and avital tissue
were extensively excised. Subsequently, the wound was thoroughly
lavaged using 3-6 L of saline. According to local protocols and the
clinical judgment of the orthopedic surgeon, modular components
were optionally exchanged and gentamicin-impregnated beads or
sponges were inserted into the joint cavity. After obtaining multiple
deep tissue biopsies for culture, broad-spectrum intravenous
antimicrobial treatment was started, if necessary adjusted accord-
ing to the antibiogram, and maintained for 2 weeks. Subsequently,
oral antimicrobial treatment was administered for 10 weeks.
Rifampin was added to the antimicrobial treatment regimen in
infections caused by staphylococci.
Statistical Analysis
Categorical variables were expressed in absolute frequencies
and percentages. Continuous variables were presented as mean and
standard deviation or as median and interquartile range when not
normally distributed. Categorical variables were compared using
the chi-square test. Continuous variables were compared using the
Student t test or the Mann-Whitney U test according to the
Kolmogorov-Smirnov test of normality.
Failure rates were reported for each risk group of the KLIC score
and a receiver-operating characteristic curve was used to examine
its accuracy for predicting DAIR failure. In addition, a binary logistic
regression analysis was performed to evaluate whether additional
important variables were associated with failure. Multicollinearity
of variables was assessed. Multivariate logistic regression analysis
was performed to identify independent predictors for failure. All
preoperative variables with P < .20 in the univariate analyses were
assessed in the multivariate regression analysis. Statistical signifi-
cance was defined as a 2-tailed P < .05. Statistical analyses were
performed using IBM SPSS Statistics (version 24.0; Chicago).
2584 €wik et al. / The Journal of Arthroplasty 33 (2018) 2582e2587
C.A.M. Lo
Fig. 1. Percentage of failure after debridement per group of KLIC score.
Results
Patient Population
A total of 386 patients with early acute PJI treated with DAIR
were included. The mean age was 73.2 years (standard deviation ±
11.5) and 61.7% were female. Two hundred ninety-six patients
(76.7%) had an infected hip prosthesis and 86 patients (22.3%) an
infected knee prosthesis. 85.5% (n ¼ 330) of the infected prostheses
were primary implants. In 252 patients (65.3%), the indication for
the prosthetic joint was osteoarthritis, and in 89 patients (23.1%)
fracture. In 148 patients (38.3%), initial debridement failed within
60 days, of which 125 patients (84.5%) underwent a second DAIR, 5
patients (3.4%) needed suppressive antimicrobial treatment, 11
patients (7.5%) underwent revision surgery, and 7 patients (4.7%)
deceased because of PJI.
Validation KLIC Score
Patients with a score
2 points had a 27.9% failure rate (n ¼ 183),
compared with 37.1% for patients with 2.5-3.5 points (n ¼ 70),
49.3% with 4-5 points (n ¼ 71), 54.5% with 5.5-6.5 points (n ¼ 55),
and 85.7% with 7 points (n ¼ 7) (Fig. 1). Adjusting the stratification
of the KLIC score for optimal clinical applicability showed a failure
rate of 28.6% for patients with
3 points (n ¼ 192), 46.5% with
3.5-6.5 points (n ¼ 187), and 85.7% with 7 points (n ¼ 7).
Binary logistic regression analysis showed that the KLIC score
had good predictive value for DAIR failure (P < .001, odds ratio [OR]
1.32), in which one point increase in the KLIC score represents a
1.32 times higher risk of failure. The receiver-operating character-
istic curve showed an AUC of 0.64 (95% confidence interval 0.59-
0.69; Fig. 2). A score of 3.5 points showed the optimal cut-off point
value with a sensitivity and specificity of 52.2% and 70.9%, respec-
tively. A score higher than 6 points showed a specificity of 97.9%.
Differences Between Cohorts
Considering the lower accuracy of the KLIC score in our cohort
(AUC 0.64) compared with Tornero et al (AUC 0.84), we additionally
evaluated the differences between both cohorts. The incidence of
variables used in the KLIC score differed. The incidence of liver
cirrhosis in our cohort was significantly lower compared with
Tornero et al (1.0% vs 10.4%, P < .001), and the incidence of
cemented prostheses and CRP >115 mg/L was significantly higher
(83.9% vs 74.3%, P ¼ .004 and 32.4% vs 24.5%, P ¼ .046, respectively).
There were no differences in incidence of chronic renal failure and
index procedure.
Additional notable differences between cohorts were the
number of PJIs of the hip (76.7% vs 38.3%, P < .001) and the number
of infections caused by S. aureus (46.9% vs 36.5%, P ¼ .013). Poly-
ethylene exchange was performed to a lesser extent in our cohort
compared with that of Tornero et al (21.0% vs 72.9%, P < .001).
Furthermore, in our cohort, gentamicin-impregnated beads and
sponges were placed during a DAIR procedure in 184 patients
(47.7%) and 109 patients (28.2%), respectively, whereas Tornero et al
did not use any local antimicrobials. The accuracy of the KLIC score
did not change in the presence or absence of the above-mentioned
variables (data not shown).
Preoperative and Perioperative Variables According to Outcome
Table 2 shows the results of preoperative variables in relation to
the outcome of debridement in our cohort. Various preoperative
variables showed significant differences between patients with
remission and failure after debridement, including CRP (78.8 vs
132.4 mg/L, P < .001), age (72.0 vs 75.1 years, P ¼ .009), days from
arthroplasty to debridement (21.0 vs 18.2 days, P ¼ .018), ASA
classification (2.29 vs 2.44, P ¼ .021), and leukocyte count (11.0 vs
12.2 109/L, P ¼ .027).
Moreover, failure rates were significantly higher for the
following preoperative variables: CRP >115 mg/L (55.2% vs 30.3%,
P < .001), left-sided prosthesis (46.7% vs 31.1%, P ¼ .002), presence
of sepsis (52.1% vs 35.1%, P ¼ .007), ischemic heart disease (50.6% vs
35.3%, P ¼ .013), and prosthesis indicated for a fracture (52.8% vs
33.3%, P ¼ .047). Multicollinearity analyses revealed that a left-
sided prosthesis was associated with a higher percentage of posi-
tive cultures (93.6% vs 89.3%, P ¼ .028), sepsis (25.0% vs 13.6%, P ¼
.004), and S. aureus infection (57.8% vs 37.4%, P < .001). Presence of a
fistula was associated with a significant lower failure rate after
debridement (22.0% vs 40.3%, P ¼ .022) and was associated with
younger age (67.5 vs 73.9, P ¼ .001) and a lower percentage of
positive cultures (85.0% vs 92.1%, P ¼ .032). Multivariate regression
analysis showed that the following preoperative variables were
significant independent predictors for DAIR failure in our cohort:
gender (OR 2.03), ischemic heart disease (OR 1.84), laterality of the
arthroplasty (OR 1.80), age (OR 1.03), CRP (OR 1.01), and days from
arthroplasty to debridement (OR 0.97).
 €wik et al. / The Journal of Arthroplasty 33 (2018) 2582e2587
C.A.M. Lo 2585

Table 2
Preoperative Patient Characteristics According to Outcome.

Characteristics Remission Failure P Value

(n ¼ 238) (n ¼ 148)

Age, y
Mean (SD) 72.01 (11.47) 75.12 (11.23) .009
70 152 (63.9%) 105 (70.9%) .152
Gender
Male 79 (33.2%) 69 (46.6%) .080
BMI, kg/m2
Mean (SD) 30.17 (6.48) 29.10 (5.62) .117
35 50 (22.3%) 23 (17.4%) .269
Preoperative ASA
classification
Mean (SD) 2.29 (0.65) 2.44 (0.60) .021
3-4 90 (37.8%) 65 (43.9%) .234
Comorbidities
Hypertension 147 (61.8%) 92 (62.2%) .938
Fig. 2. Receiver-operating characteristic curve for the KLIC score. Ischemic heart disease 38 (16.0%) 39 (26.4%) .013
Heart failure 22 (9.2%) 19 (12.8%) .265
Diabetes mellitus 46 (19.3%) 36 (24.3%) .243
Table 3 shows the results of perioperative variables in relation to Malignancy 57 (23.9%) 30 (20.3%) .400
the outcome of debridement. Positive cultures in all the obtained COPD 43 (18.1%) 38 (25.7%) .074
intraoperative tissues and bacteremia were associated with a sig- Chronic renal failure 15 (6.3%) 11 (7.4%) .667
nificant higher failure rate (41.7% vs 26.2%, P ¼ .010 and 57.7% vs Liver cirrhosis 1 (0.4%) 3 (2.0%) .130
Dementia 8 (3.4%) 8 (5.4%) .327
34.4%, P ¼ .008, respectively), just as the use of gentamicin-
Rheumatoid arthritis 17 (7.1%) 11 (7.4%) .915
impregnated beads or sponges (43.0% vs 23.7%, P ¼ .001). Multi- Medication
collinearity analyses showed that use of local antimicrobials was Anticoagulants 51 (21.4%) 44 (29.7%) .066
associated with a higher CRP value (105.9 vs 78.6 mg/L, P ¼ .020) Steroid therapy 23 (9.7%) 21 (14.2%) .174
and a higher number of S. aureus infection (50.2% vs 36.6%, P ¼ Site of arthroplasty
Knee 54 (22.7%) 32 (21.6%) .697
.022). Hip 181 (76.1%) 115 (77.7%)
Infection with S. aureus showed a higher failure rate (47.5% vs Laterality
30.2%, P < .001), as well as infection with anaerobe microorganisms Left 96 (40.3%) 83 (56.8%) .002
(ie, Cutibacterium acnes [n ¼ 4], Bacteroides fragilis [n ¼ 4], and Indication for arthroplasty
Osteoarthritis 168 (70.6%) 84 (56.8%) .047
Finegoldia magna [n ¼ 4]; 66.7% vs 37.2%, P ¼ .021), although
Fracture 42 (17.6%) 47 (31.8%)
anaerobe microorganisms were isolated in only a limited amount of Type of surgery
cases (n ¼ 15). Although gram-negative microorganisms in general Primary 207 (87.0%) 123 (83.1%) .294
were not associated with DAIR failure (42.5% vs 37.3%, P ¼ .390), Revision 31 (13.0%) 25 (16.9%)
infection with Proteus species did show a significant higher failure Type of cementation
Not cemented 43 (18.1%) 19 (12.8%) .274
rate (61.1% vs 37.2%, P ¼ .042). However, Proteus species were also Cemented (without 8 (3.4%) 8 (5.4%)
isolated in only a limited amount of cases (n ¼ 18). Infection with antibiotics)
Corynebacterium species and other gram-positive microorganisms Cemented (with antibiotics) 187 (78.6%) 121 (81.8%)
showed a significant lower failure rate (23.5% vs 40.6%, P ¼ .020 and Days from prosthesis to
debridement
8.3% vs 39.3%, P ¼ .030, respectively).
Mean (SD) 21.03 (12.96) 18.24 (9.88) .018
>28 d 33 (13.9%) 13 (8.8%) .134
Discussion Days of symptoms
Mean (SD) 6.71 (5.95) 7.21 (6.01) .425
Clinical signs
We evaluated the preoperative predictive value of the KLIC score
Fever 42 (17.6%) 31 (20.9%) .421
for DAIR failure in a large external cohort of 386 patients. Our study Pain 77 (32.4%) 39 (26.4%) .211
showed that the KLIC score is a relatively good preoperative risk Redness 97 (40.8%) 64 (43.2%) .630
score for predicting failure, but its predictive value was lower than Wound drainage 207 (87.0%) 127 (85.8%) .745
previously described, with an AUC of 0.64 in our cohort compared Skin necrosis 6 (2.5%) 7 (4.7%) .242
Presence of fistula 32 (13.4%) 9 (6.1%) .022
with 0.84 in the study by Tornero et al [31]. This lower predictive
Sepsis 35 (14.7%) 38 (25.7%) .007
accuracy is probably due to the retrospective design of this study Antimicrobial treatment before 42 (17.6%) 24 (16.2%) .717
and differences in local epidemiology, clinical characteristics, and debridement
surgical techniques. Although performing an additional prospective Leukocyte count, 109/L
Mean (SD) 10.96 (4.44) 12.19 (5.79) .027
study could be useful, our results demonstrated that the KLIC score
>10 121 (50.8%) 85 (57.4%) .207
is applicable in clinical practice in patients with a low (<3.5 points) CRP, mg/L
or high (>6 points) KLIC score for predicting DAIR failure. Mean (SD) 78.80 (86.19) 132.37 (108.0) <.001
Differences between cohorts are the most important reason that >115 56 (23.5%) 69 (46.6%) <.001
a predictive model should be validated externally before it can be Creatinine, mg/L
Mean (SD) 79.94 (30.39) 79.23 (33.94) .831
implemented in clinical practice in other countries and hospitals.
>110 30 (12.6%) 15 (10.1%) .454
Therefore, validating the KLIC score in a large external cohort of Glycemia
patients in the Netherlands is one of the strengths of our study. In Mean (SD) 7.23 (1.85) 7.57 (2.65) .277
addition, by using the exact same variables, inclusion criteria, Bold indicates statistically significant differences.
definition of failure, and cut-off values as Tornero et al, the process ASA, American Society of Anesthesiologist; BMI, body mass index; COPD, chronic
of validation of the KLIC score was executed legitimately. obstructive pulmonary disease; CRP, C-reactive protein; SD, standard deviation.
2586 €wik et al. / The Journal of Arthroplasty 33 (2018) 2582e2587
C.A.M. Lo

Table 3 Preoperative risk factors for DAIR failure can be used in the
Perioperative Patient Characteristics According to Outcome. decision-making process to select eligible patients for debride-
Characteristics Remission Failure P Value ment. The KLIC score is an easy and clinical applicable risk score
(n ¼ 238) (n ¼ 148) which can help the clinician in discussing the risk of DAIR failure
Polyethylene exchange 47 (19.8%) 34 (23.0%) .462 with the patient. Although a DAIR procedure is in general a good
Local antimicrobials treatment modality for patients with early acute PJI, in patients
No antimicrobials 71 (29.8%) 22 (14.9%) .001 with a high estimated preoperative failure risk, the physician may
Gentamicin beads 12 (5.0%) 16 (10.8%)
consider a different treatment approach with a higher chance of
Gentamicin sponges 113 (47.5%) 71 (48.0%)
Gentamicin beads þ sponges 42 (17.6%) 39 (26.4%) infection control. For example, performing revision surgery instead
Need for muscle flap for skin 3 (1.3%) 5 (3.4%) .156 of debridement or starting suppressive antimicrobial treatment
coverage after debridement in patients who are not eligible for revision
Bacteremia 11 (4.6%) 15 (10.1%) .008
surgery due to severe comorbidity.
Percentage of positive cultures
Mean (SD) 89.38 (21.6) 94.45 (16.3) .009
In conclusion, we demonstrated in an external cohort that the
All cultures positive 176 (73.9%) 126 (85.1%) .010 KLIC score is a relatively good preoperative risk score for DAIR
Polymicrobial infection 109 (45.8%) 67 (45.3%) .919 failure in patients with early acute PJI. Its predictive value seems
Microorganism most prominent and therefore clinical applicable in patients with
Staphylococcus aureus 95 (39.9%) 86 (58.1%) <.001
low or high KLIC scores. Ideally, additional validation in a pro-
Methicillin-resistant 0 (0%) 0 (0%) 1.000
Staphylococcus aureus spective study should confirm these findings.
Staphylococcus epidermidis 85 (35.7%) 41 (27.7%) .103
Corynebacterium species 39 (16.4%) 12 (8.1%) .020
Enterococcus species 44 (18.5%) 26 (17.6%) .820
Streptococcus species 44 (18.5%) 22 (14.9%) .358 References
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 The Journal of Arthroplasty 33 (2018) 2417e2422

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Press Ganey Outpatient Medical Practice Survey Scores Do Not

Correlate With Patient-Reported Outcomes After Primary Joint
Arthroplasty
Jessica M. Kohring, MD *, Christopher E. Pelt, MD, Mike B. Anderson, MSc,
Christopher L. Peters, MD, Jeremy M. Gililland, MD
Department of Orthopaedics, University of Utah, Salt Lake City, Utah

a r t i c l e i n f o a b s t r a c t

Article history: Background: Patient delivery of care satisfaction surveys have emerged as instruments to assess the
Received 22 January 2018 quality of health care at both the hospital and provider levels. We evaluated the correlation between
Received in revised form these care satisfaction surveys and patient-reported outcomes (PROs).
19 March 2018
Methods: We reviewed secondary data on 540 patients with 540 random visits who underwent primary
Accepted 19 March 2018
total joint arthroplasty between January 2014 and February 2017. The Press Ganey Outpatient Medical
Available online 27 March 2018
Practice Survey was collected from outpatient clinical encounters to measure patient satisfaction with
their experience and matched to PRO measures from the same encounter. The PROs evaluated included
Keywords:
patient satisfaction
the Patient-Reported Outcomes Measurement Information System physical function computerized
Press Ganey adaptive test, v1.2, and the Patient-Reported Outcomes Measurement Information System Global 10
total joint arthroplasty health survey. In addition to the random selection, we reviewed separate cross-sections of the data
patient-reported outcomes including preoperative visits within 90 days of the index procedure, all postoperative visits at least 1 year
PROMIS from the index procedure, and the magnitude of change in PRO scores from preoperative to a minimum
1-year postoperative visit. Data were evaluated using the Spearman correlation coefficient (rs).
Results: There was little if any correlation between the Press Ganey scores and PROs at all time points
evaluated (all, rs:
0.13 to 0.14). When evaluating knee and hip arthroplasty cases separately, the data
demonstrated similar results (all, rs:
0.33 to 0.18).
Conclusion: We found little, if any, correlation between a patient’s satisfaction with their care experience
and their own perception of physical function and global health measures at all time points evaluated.
These data question the utility of these scores as surrogate measures of health care quality, especially
when reimbursements become tied to these metrics.
© 2018 Elsevier Inc. All rights reserved.

Patient delivery of care satisfaction surveys have emerged as
instruments to assess the quality of health care at both the hospital
and provider levels. One such instrument is the Press Ganey (PG)
Outpatient Medical Practice Survey. This instrument is becoming a
popular measurement of patient satisfaction for health care
delivery in outpatient clinics [1,2]. True measures of health care
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.044.
* Reprint requests: Jeremy M. Gililland, MD, Department of Orthopaedics, Uni-
versity of Utah, 590 Wakara Way, Salt Lake City, UT 84108.
quality such as validated questionnaires, morbidity and mortality of
different health conditions, and surgical procedures are cumber-
some and costly to collect. As these care satisfaction surveys are
convenient and easy to administer, they are being used to rank
providers and hospitals, as well as to help patients choose their
providers [3]. In addition, care satisfaction scores are increasingly
being used as a metric in performance-based compensation for
both hospitals and health care providers [4e6]. Our institution has
used these scores as a means of providing not only patients with
ratings on our providers, but also to allow for administration to
consider as a factor for reimbursement models and policy decisions
[2]. However, care satisfaction scores have yet to be validated as a
true measure of health care quality in relation to actual patient
outcomes.

https://doi.org/10.1016/j.arth.2018.03.044
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2418 J.M. Kohring et al. / The Journal of Arthroplasty 33 (2018) 2417e2422
It has become evident that there are other factors besides the
quality of care provided that influence satisfaction scores. For
example, previous studies have demonstrated that patients with
better self-reported function and health status have higher patient
satisfaction scores [7e15]. In addition, patient characteristics such
as age [15e17], sex [16,18], self-reported physical health [7,19],
mental health [11,20,21], socioeconomic status [22], personality
[23,24], employment status [9], and education [13,25] appear to
significantly influence satisfaction scores. Patients’ inherent rating
tendencies also appear to impact satisfaction scores and are
affected by both extrinsic and intrinsic factors [26,27]. In addition
to the important fact that patient care satisfaction scores are
significantly influenced by nonmodifiable patient characteristics,
there is limited data available on any correlation between care
satisfaction scores and patient-reported outcome (PRO) scores
associated with specific surgical interventions.
PRO scores have traditionally been used as an objective measure
of success for surgical interventions. In our population of total joint
arthroplasty (TJA) patients, we have recently incorporated the
Patient-Reported Outcomes Measurement Information System
(PROMIS) physical function computerized adaptive test (PF CAT),
v1.2. In addition, we have been collecting scores from the PROMIS
global health assessment [28]. Along with these recently incorpo-
rated PRO scores, our hospital routinely collects the PG Outpatient
Medical Practice Survey as a means of evaluating patient satisfac-
tion [29]. The purpose of this study was to determine if the overall
PG Outpatient Medical Practice score correlated with PRO scores in
patients undergoing primary knee or hip arthroplasty. Specifically,
we wanted to know (1) Is there a correlation between a random
selection of PG and PRO scores from the same visit? (2) Is there a
correlation between preoperative PG and PRO scores from the same
visit? (3) Is there a correlation between postoperative PG and PRO
scores at 1 year or greater after TJA from the same visit? And (4) is
there a correlation between PG scores and the magnitude of change
in PRO scores at a minimum 1-year follow-up?
Materials and Methods
After obtaining an exemption from the institutional review
board, we retrospectively reviewed secondary data from outpatient
clinical encounters at a single academic medical center for all pa-
tients who underwent a primary total knee or hip arthroplasty
from January 2014 to February 2017. During this period, 1899 pa-
tients underwent 2174 primary hip (n ¼ 902) or knee (n ¼ 1272)
arthroplasty procedures. Given the potential for subsequent joint
arthroplasty surgeries to impact both PRO and PG scores,
those with multiple joint arthroplasty procedures were excluded
(n ¼ 267). Furthermore, patients without PG scores were excluded
(n ¼ 1092), thus a total of 540 patients with 882 visits with PG
scores were evaluated (Fig. 1).
Outcome Questionnaires
PROs included the PROMIS PF CAT (physical function item bank,
v1.2) and the PROMIS global health assessment (Global 10). Both
the mental and physical health scores were derived from the Global
10 survey, as was a numeric pain score (NPS). PF CAT, Global 10, and
overall PG patient satisfaction survey results were linked to the
medical record by the encounter number.
The PROMIS PF CAT is a calibrated item bank of 124 questions
aimed at measuring one’s ability to perform tasks from routine
activities of daily living to more vigorous activities such as lifting
heavy objects or running [30]. This outcome measure is emerging
as a new tool in the assessment of physical function in patients with
knee osteoarthritis and benefits from the technology of
Fig. 1. A flow chart demonstrating the attrition of patients. TJA, total joint arthroplasty.
computerized adaptive testing [31]. The use of computerized
adaptive testing decreases patient burden by limiting the number
of questions that need to be answered. For our population, the
median number of questions answered was 4 (interquartile range
[IQR] 4 to 4). In addition, a subset of all lower extremity questions
from the PF CAT has demonstrated improved psychometric prop-
erties compared with legacy scales for measuring hip outcomes
[32]. The PROMIS team chose to use T-score units for scoring in
which a score of 50 T-score units is representative of the average
physical function of the US general population (with a standard
deviation of 10 T-score units). When interpreting the scores, a
higher score indicates more physical function.
The PROMIS global health assessment allows for the calcula-
tion of both a mental and physical health scores [28]. The in-
strument has recently been selected by the Center for Medicare
and Medicaid services (CMS) as an accepted PRO tool for quality
evaluations. T-scores are again standardized to the US general
population and higher values indicate more of the item being
evaluated. As part of the global health assessment, an 11-point
NPS is collected and was used to evaluate the patients average
pain over the last 7 days before when the outcome was completed.
On this scale, 0 represented no pain and 10 represented the “worst
pain imaginable.”
The PG Outpatient Medical Practice Survey (Press Ganey, South
Bend, IN) consists of 24 questions divided into 6 subdomains:
access, moving through your visit, nurse or assistant, care provider,
personal issues, and overall assessment of the practice [33].
Examples of these questions include:
1. “Ease of getting through to clinic on the phone”
2. “Courtesy of staff in the registration area”
3. “Wait time in clinic”
4. “Friendliness/courtesy of the nurse/assistant”
5. “Degree to which the care provider talked with you using words
you could understand”
6. “Your confidence in this care provider”.
Each question measures responses on a Likert scale ranging
from 1 (indicating very poor) to 5 (indicating very good). Responses
are converted to a 0 to 100-point scale, and the mean overall score
for all answered questions within an individual subdomain is used
to calculate the score for that subdomain. The unweighted mean of
the 6 individual subdomain scores is then used to calculate the
 J.M. Kohring et al. / The Journal of Arthroplasty 33 (2018) 2417e2422 2419

mean overall care satisfaction score, which was used for the anal-
ysis of this study [29,33].

Statistical Analysis

To comply with the assumption of independence, we randomly

selected one visit for each patient (n ¼ 540 patients, n ¼ 540 visits)
to determine if there was a correlation between the PROs and the
PG scores. We reviewed the correlation between the PRO and PG
scores from all the randomly selected visits using the Spearman
correlation coefficient (rs), as the data were found to be far from
normally distributed (Shapiro Wilk normality test, P < .01). Simi-
larly, we reviewed separate cross-sections of the data including all
preoperative visits within 90 days of the index procedure, all
postoperative visits at least 1 year from the index procedure, and
the magnitude of change in PRO scores from preoperative to a
minimum 1-year postoperative visit, using the PG score associated
with the last visit. Data are presented as median and IQRs. Inter-
pretation of rs was done using the method described by Hinkle et al
[34]. In this interpretation, Spearman correlation coefficients be-
tween 0.90-1.00 are considered very high correlations, 0.70-0.90
are high correlations, 0.50-0.70 are considered moderate, 0.30-0.50 Fig. 2. A scatter plot with best fit line demonstrating the correlation between the
randomly selected PF CAT T-score and the Overall Press Ganey Score. PF CAT, physical
are low, and 0.00-0.30 demonstrate little if any correlation.
function computerized adaptive test.
In addition, we evaluated the correlations between the PRO and
PG scores in total knee and hip arthroplasty patients separately.
Statistical analyses were performed using Stata v14.2 (College 12.2); Global Physical Health, 7.5 T-score units (IQR, 5.4 to 15.4);
Station, TX). and Global NPS,
3 points (IQR,
5 to
1).
Consistent with the previous findings, the correlations between
Results PRO and PG scores in total knee and hip arthroplasty patients,
separately, were low (rs >
0.18 to <0.33; Table 3).
The average patient age was 64 years (range 28-95 years), with a
mean BMI of 29 kg/m2 (range 16-50 kg/m2). Fifty-six percent (n ¼ Discussion
304) of patients were female and 56% (n ¼ 300) were total knee
arthroplasty patients, with the remaining 44% (n ¼ 240) being total There is a limited body of literature specific to orthopedic
hip arthroplasty patients. patients in regard to the correlation of PG care satisfaction surveys
In the random selection of patient visits (n ¼ 540), there was and actual postoperative outcomes in this population. The results of
little, if any, correlation between the PG score and all the PRO scores patient satisfaction surveys are increasingly being used as mea-
(Table 1), including the PF CAT (rs: 0.02; Fig. 2), the Global 10 mental sures of the quality of health care provided by both the provider
health (rs: 0.13; Fig. 3), Global 10 physical health (rs: 0.02; Fig. 4), and health care system [4e6]. CMS is currently using patient
and the Global 10 NPS (rs:
0.02; Fig. 5). satisfaction in their Medicare Inpatient Prospective Payment Sys-
For the preoperative visits (n ¼ 266), the correlation between tem, where 25% of the Total Performance Score comes directly from
the PG score and all the PRO scores was also negligible at best the PG Hospital Consumer Assessment of Healthcare Providers and
(rs:
0.04 to 0.14; Table 1). Similarly, there was no significant cor- Systems (HCAHPS) score. In addition to the HCAHPS, our institution
relation between the postoperative PG score and the PRO scores is using the PG Outpatient Medical Practice survey as a tool for
(rs:
0.13 to 0.004; Table 1). patient transparency and scores are being factored into institu-
The change in all the PRO scores at minimum 1-year follow-up tional reimbursement models. This may represent a trend to
demonstrated trivial correlation with the PG score (rs:
0.14 to further financial rewards and/or penalties for providers at an
0.03; Table 1). However, when looking at the magnitude of change institutional level. However, our findings suggest a lack of corre-
between the preoperative and postoperative PRO scores, we see an lation between patient delivery of care satisfaction scores and PRO
appropriate improvement in all the scores suggesting a positive scores in the domains of physical function, mental health, physical
response to the surgical intervention (Table 2). The median change health, and pain in the TJA population.
for the PROMIS measures was as follows: PF CAT, 8 T-score units This study contributes to the growing body of literature in both
(IQR, 1.7 to 12.6); Global Mental Health, 7.7 T-score units (IQR, 2.5 to the nonorthopedic and orthopedic patient populations that care

Table 1
Correlation Between PG and PRO Scores.

PRO Measure Random, n ¼ 540 Preoperative, n ¼ 266 Postoperative, n ¼ 85 Change in Scores, n ¼ 73

rs 95% CI rs 95% CI rs 95% CI rs 95% CI

PF CAT 0.02
0.07 to 0.10
0.04
0.16 to 0.08
0.13
0.33 to 0.09 0.02
0.21 to 0.25
Global 10 Mental Health 0.13 0.04-0.21 0.14 0.01-0.27
0.09
0.30 to 0.09
0.09
0.34 to 0.17
Global 10 Physical Health 0.02
0.07 to 0.11 0.05
0.08 to 0.018
0.05
0.27 to 0.16
0.14
0.38 to 0.13
Global 10 NPS
0.02
0.11 to 0.07 0.01
0.13 to 0.12 0.004
0.21 to 0.22 0.03
0.21 to 0.27

CI, confidence interval; NPS, numeric pain score; PF CAT, physical function computerized adaptive test; PG, Press Ganey; PRO, patient-reported outcome.
2420 J.M. Kohring et al. / The Journal of Arthroplasty 33 (2018) 2417e2422
Fig. 3. A scatter plot with best fit line demonstrating the correlation between the
randomly selected Mental Health T-score and the Overall Press Ganey Score.
satisfaction scores may not be a true measure of the quality of
health care provided. It appears that nonmodifiable patient char-
acteristics and variables outside the control of the health care
provider significantly impact patient satisfaction with care
[7,8,10,15e18,20,22,24]. Specific to the orthopedic population, Godil
et al [35] found that patient satisfaction scores were not a valid
measure for determining quality and effectiveness of spine surgery
in regard to postoperative morbidity, readmission rates, improve-
ment in quality of life, or improvement in general health. More
recently, Chughtai et al [36,37] showed no correlation between
commonly used PRO instruments in the total knee and hip
arthroplasty populations and the overall PG HCAHPS score. They
concluded that the use of PG HCAHPS surveys in assessing quality
for reimbursement purposes may be of little value. Their articles
reported on the correlation between inpatient patient satisfaction
scores (PG HCAHPS score) obtained within 1 month of hospital
Fig. 4. A scatter plot with best fit line demonstrating the correlation between the
randomly selected Physical Health T-score and the Overall Press Ganey Score.
Fig. 5. A scatter plot with best fit line demonstrating the correlation between the
randomly selected NPS and the Overall Press Ganey Score. NPS, numeric pain score.
discharge and PRO measures that were obtained at a mean follow-
up of 3.2 years after TKA. It is difficult to know if a lack of correlation
between these scores means much of anything as it has been
shown that PRO scores continue to improve until 1 year post-
operative after TKA [38]. In the present study, we have the benefit
of having had the PG Outpatient Medical Practice survey sent to all
our patients at every one of their preoperative and postoperative
visits. In addition, as part of our routine care, we collect PROMIS
scores on all these patients at each of their visits allowing us to have
PG scores associated with the same visit as PRO scores. This pro-
vides us with a greater ability to evaluate for any possible corre-
lation between patient satisfaction of health care delivery and
associated outcome measures as both these scores were obtained
around the same visit.
There are several limitations with this study, including the
inherent limitations of a retrospective chart review. Of the 1899
patients, only 540 (28%) completed at least one PG survey,
demonstrating a rather small response rate. However, the PG
response rate in the orthopedic patient population has been re-
ported at similar rates including 16.5%-26% [36,39]. There is a po-
tential for recall bias depending on when the PG survey was sent
out after a postoperative appointment. However, this practice of
survey administration is standard, and it may not be possible to
have the survey administered right after a clinic visit. A prospective
study may allow for better data acquisition to ensure the patient
satisfaction survey and outcome questionnaires are completed at
both the preoperative and postoperative clinic visits. Despite the
Table 2
The Magnitude of Change in PRO Scores From Preoperative and Postoperative Visits.
PRO Measure Preoperative Postoperative Change
Median (IQR) Median (IQR) Median (IQR)
PF CAT T-score 39.0 (34.1-41.4) 47.1 (41.3-51.3) 8.4 (1.7-12.6)
Global Mental Health 48.3 (42.3-54.7) 56 (49.6-62.5) 7.7 (2.5-12.2)
T-score
Global Physical Health 39.8 (37.4-44.9) 50.8 (44.9-57.7) 7.5 (5.4-15.4)
T-score
Global NPS 6 (4-8) 2 (1-5)
3 (
5 to
1)
IQR, interquartile range; NPS, numeric pain score; PF CAT, physical function
computerized adaptive test; PRO, patient-reported outcome.
 J.M. Kohring et al. / The Journal of Arthroplasty 33 (2018) 2417e2422 2421

Table 3
Correlation Between PG Scores and Outcome Measures in Both Hip and Knee Arthroplasty Patients.

Total Knee Arthroplasty

PRO Measure Random, n ¼ 300 Preoperative, n ¼ 136 Postoperative, n ¼ 49 Change in Scores, n ¼ 41

rs 95% CI rs 95% CI rs 95% CI rs 95% CI

PF CAT 0.04
0.08 to 0.15
0.10
0.26 to 0.07
0.18
0.44 to 0.11 0.20
0.12 to 0.48
Global 10 Mental Health 0.15 0.03-0.27 0.12
0.07 to 0.29 0.04
0.25 to 0.32
0.06
0.39 to 0.28
Global 10 Physical Health
0.03
0.15 to 0.09
0.01
0.19 to 0.16
0.03
0.31 to 0.25 0.03
0.31 to 0.36
Global 10 NPS 0.01
0.11 to 0.12 0.08
0.10 to 0.25 0.08
0.21 to 0.36
0.07
0.38 to 0.26

Total Hip Arthroplasty

PRO Measure Random, n ¼ 240 Preoperative, n ¼ 130 Postoperative, n ¼ 36 Change in Scores, n ¼ 32

rs 95% CI rs 95% CI rs 95% CI rs 95% CI

PF CAT
0.01
0.14 to 0.12 0.01
0.17 to 0.18
0.01
0.33 to 0.32
0.27
0.56 to 0.09
Global 10 Mental Health 0.11
0.03 to 0.24 0.18
0.01 to 0.35
0.18
0.49 to 0.16
0.19
0.55 to 0.24
Global 10 Physical Health 0.08
0.06 to 0.21 0.13
0.07 to 0.31
0.05
0.37 to 0.29
0.33
0.64 to 0.09
Global 10 NPS
0.05
0.18 to 0.09
0.07
0.25 to 0.11
0.13
0.44 to 0.20 0.10
0.28 to 0.46

CI, confidence interval; NPS, numeric pain score; PF CAT, physical function computerized adaptive test; PG, Press Ganey; PRO, patient-reported outcome.

potential benefits of a prospective study, we were able to link PG
scores to the PRO scores from the same visit using encounter
numbers and both the PRO and PG scores were completed per
routine practice making these results more generalizable. Finally,
this study was performed at a single institution within a specific
orthopedic subspecialty and these results may not be generalizable
to the general orthopedic population.
Conclusion
The PG Associates have provided the medical field with a useful
tool to better become aware of how satisfied our patients are with
the services that we provide. As providers, we should be aware of
these scores and strive to serve our patients better and improve
their satisfaction. However, in the current environment of
legislated improvement of quality of care, patient satisfaction with
their health care experience can be confused with health care
quality. CMS is currently using patient satisfaction in their Medicare
Inpatient Prospective Payment System, where 25% of the Total
Performance Score comes directly from the PG HCAHPS score. PG
HCAHPS scores are also being used as a quality metric in the CJR
demonstration bundle. In addition to the PG HCAHPS scores, our
institution is using the PG Outpatient Medical Practice survey as a
tool for patient transparency and scores are being factored into
internal reimbursement models. Despite the fact that these PG
Medical Practice Survey Scores are not currently being tied to
reimbursement by CMS or commercial payers, their use by our own
administration has given us concern that this could lead to adop-
tion more globally. This study demonstrates that there is little, if
any, correlation between a patient’s outpatient medical practice
satisfaction of health care delivery (PG scores) and their improve-
ments in physical function, mental health, physical health, or de-
creases in pain in a population of primary TJA patients. Although
patient satisfaction with health care delivery may be important to
providers or health care systems wishing to increase volume and
referrals, it is unlikely that efforts focused on improving these
scores are likely to lead to improved PROs of function, health, and
pain. These data question the utility of these scores as surrogate
measures of health care quality, especially when reimbursements
become tied to these metrics.
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 The Journal of Arthroplasty 33 (2018) 2412e2416

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Rapid Discharge in Total Hip Arthroplasty: Utility of the Outpatient

Arthroplasty Risk Assessment Tool in Predicting Same-Day and
Next-Day Discharge
Kelvin Y. Kim, MD, James E. Feng, MD, Afshin A. Anoushiravani, MD,
Edward Dranoff, BS, Roy I. Davidovitch, MD, Ran Schwarzkopf, MD, MSc *
Division of Adult Reconstructive Surgery, NYU Langone Orthopedics, NYU Langone Health, New York, New York

a r t i c l e i n f o a b s t r a c t

Article history: Background: Hospital length of stay is a major driver of cost in the total hip arthroplasty (THA) episode of
Received 16 January 2018 care, and as a result, significant efforts are being made to minimize it. This study aims to assess the utility
Received in revised form of the Outpatient Arthroplasty Risk Assessment (OARA) screening tool in accurately identifying patients
12 February 2018
for safe and early discharge after THA.
Accepted 12 March 2018
Methods: A retrospective review was conducted on 332 consecutive patients who underwent primary
Available online 17 March 2018
THA at a single tertiary academic center. Patients were evaluated using the OARA score, a tool that has
been proposed to identify patients who can safely undergo early discharge after THA. The validity of
Keywords:
total hip arthroplasty
these claims was assessed by analyzing the OARA score’s positive and negative predictive values for high
value-based care vs low OARA scores between patients enrolled in our (1) same-day discharge (SDD) and 2) next-day
outpatient arthroplasty risk assessment discharge (NDD) pathways.
next-day discharge Results: When comparing the utility of the OARA score in accurately predicting length of stay, the OARA
same-day discharge score demonstrated a (1) higher, but constant, positive predictive value for discharge on postoperative
length of stay day (POD) 0 for SDD (86.1%) than POD1 for NDD (35.5%) and (2) lower negative predictive value for
Level of evidence:
discharge on POD0 (23.1%) for SDD than POD1 for NDD (86.1%).
Level III Conclusion: The OARA score was developed to risk-stratify patients who can safely undergo SDD or NDD
retrospective cohort study after THA. In this study, the OARA score was a highly predictive tool in identifying NDD patients at risk
for failure of discharge by POD1.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) remains to be the gold standard of
management of end-stage degenerative hip disease. With the
continuing exponential growth of THAs performed annually, the
Centers for Medicaid and Medicare Services instituted the Bundled
Payment Care Initiative to mitigate the growing costs [1e3]. This
initiative led to a pivot in the hospital reimbursement model, which
placed a greater emphasis on value-based care programs and has
led to the widespread implementation of clinical care pathways for
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.025.
* Reprint requests: Ran Schwarzkopf, MD, MSc, Division of Adult Reconstructive
Surgery, NYU Langone Orthopedics, NYU Langone Health, 301 E 17th St., New York,
NY 10003.
orthopedic institutions throughout the United States. These path-
ways have been instrumental in reducing hospital lengths of stay
(LOSs) and episode of care costs, while maintaining and improving
patient safety, functional outcomes, and patient-reported outcome
metrics [4,5]. In light of their success, select hospitals and their
surgeons have developed short stay pathways such as outpatient or
same-day discharge THA, commonly referred to as same-day
discharge (SDD) or next-day discharge (NDD) [6,7].
When implemented in the appropriate patient population, SDD
and NDD pathways are safe and effective methods of delivering
high-quality value-based care [5,8e15]. However, the success of
SDD programs has been partially hindered by an inability to reliably
identify an appropriate patient cohort. Historically, orthopedic
surgeons have risk-stratified their patients by using the American
Society of Anesthesiologists (ASA) classification system and Charl-
son comorbidity index [16,17]. Although readily available and easy
to use, they are not specifically designed for the total joint

https://doi.org/10.1016/j.arth.2018.03.025
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 K.Y. Kim et al. / The Journal of Arthroplasty 33 (2018) 2412e2416
arthroplasty (TJA) population. As a result, clinicians and researchers
have investigated and developed new objective risk stratification
instruments to specifically screen for patients who will succeed
with accelerated discharge initiatives.
The Outpatient Arthroplasty Risk Assessment (OARA) score is a
risk stratification tool specifically designed to identify patients for
whom it is safe to undergo SDD and NDD TJA programs [13].
Although a previous study by Meneghini et al [13] has investigated
its validity in predicting successful early discharge in a single cohort
of patients, the aim of this study is to further refine the utility of the
OARA score by assessing its ability to predict successful discharge in
THA for patients enrolled in two, separate, institutionally-defined
cohortsdSDD vs NDD. The study will also assess whether earlier
discharge has any effect on quality outcomes including discharge
disposition, as well as 30- and 90-day readmission rates. We hy-
pothesize that the OARA score will prove to be a reliable instrument
in accurately predicting who can safely undergo both SDD and
NDD.
Materials and Methods
Study Design, Inclusion Criteria, and Demographics
A retrospective review of 332 consecutive patients receiving a
THA between January 2015 and December 2016 at a tertiary, aca-
demic institution was conducted. Inclusion criteria consisted of all
patients who underwent elective primary unilateral THA greater
than the age of 18 years. Exclusion criteria included all patients who
underwent bilateral, emergent or revision THA procedures. The
patients’ electronic medical records were reviewed for de-
mographics (eg, gender, age, body mass index [BMI], race, and ASA
scores), past medical, surgical, social histories, preoperative
discharge plan (SDD vs regular discharge protocols), and quality
metrics. Quality metrics included LOS, discharge disposition (home
vs postacute care facility), and 30- and 90-day readmission rates.
All patient comorbidities and inpatient complications were iden-
tified using International Classification of Diseases 10 codes.
After data collection, an OARA score was calculated for each
patient. The OARA score is a validated screening instrument to
predict SDD or NDD [13]. The scoring criteria includes 9 comor-
bidity areas which consist of various risk factors that have been
previously identified to be associated with prolonged discharge
after THA. Each risk factor is weighted and scored (Table 1). Based
on previous studies by Meneghini et al [13,18] scores of
59 are
predictive of discharge on the same day (cutoff 11:59 PM) or the
next day after surgery.
In the present study, patients were divided into 2 cohorts: (1)
patients enrolled in the SDD and (2) patients enrolled in our in-
stitution’s standard discharge pathway. Patients in the standard
discharge pathway were targeted for NDD, or hospital LOS <2 days.
Table 1
OARA Scoring Distribution.
Comorbidity Categories Points
General medical 180
Hematological 325
Cardiac 385
Endocrine 165
Gastrointestinal 185
Neurological/psychological 185
Renal/urology 220
Pulmonary 250
Infectious disease 65
Total 1960
OARA, Outpatient Arthroplasty Risk Assessment.
2413
Baseline demographics and outcomes were compared to assess the
differences between each cohort. Further analysis was then per-
formed to determine the accuracy of the OARA 59-point cutoff
score in predicting discharge for the 2 discharge protocols. A sub-
analysis was performed to determine the utility of the OARA score
in predicting successful SDD and NDD within each respective
cohort.
SDD Perioperative Management
The patients in the SDD cohort underwent a THA at our insti-
tution by 1 of 6 orthopedic surgeons. Under the institution’s SDD-
THA integrated pathway, each SDD-THA was preoperatively
risk-stratified and medically optimized before surgical interven-
tion. Qualifying measures for the SDD-THA program patients
included no history of coronary artery disease or arrhythmias, no
chronic anticoagulation, no history of moderate or severe sleep
apnea, hemoglobin 12 g/dL, an ASA <3, a BMI <40 kg/m2, and a
designated “coach” who would assist the patient immediately
postoperatively. In addition, all patients were scheduled for a 1-on-
1 encounter with a clinical care coordinator (CCC), and a physical
and occupational therapist for 2 hours before the surgical date to
educate the patient on the expected recovery course, pain man-
agement modalities, physical therapy exercises, and postoperative
expectations. At any point during the preoperative period, patients
could withdraw from the SDD-THA program.
Preemptive analgesia was used on both cohorts on the day of
surgery. This consisted of celecoxib, acetaminophen, and long-
acting oxycodone. A standardized anesthesia protocol was used
for all SDD patients in which all patients received spinal anesthesia.
Perioperatively, a uniform multimodal pain regimen was estab-
lished, which included periarticular injections.
Postoperatively, both cohorts were subject to similar pain
management strategies including the goal of strongly discouraging
oral or intravenous opioid administration. Non-narcotic medica-
tions including oral acetaminophen and celecoxib were routinely
used for pain control. All patients received perioperative antibiotics
for 24 hours and thromboprophylactic agents, consisting of either
325 mg per os bis in die or 81 mg per os bis in die of aspirin for a
period of 4 weeks and mechanical compression devices for a period
of 2 weeks. Active smokers were prescribed enoxaparin 40 mg daily
for 4 weeks instead of aspirin and compression devices as per our
institutional protocol.
Once the patient had been deemed medically and functionally
safe for discharge, all patients were discharged home with home-
healthcare services. After discharge, all other details of the pa-
tients’ medical management were identical between the 2 cohorts.
On postoperative day (POD) 1, the CCC nurse called each patient to
ensure they were doing well. In addition, physical therapists and
visiting nurses followed-up with the patient at the patient’s resi-
dence to assist with wound care and rehabilitation on an inter-
mittent basis for 2 weeks.
Statistical Analysis
All data were recorded using Microsoft Excel (Microsoft Cor-
poration, Richmond, WA). Standard descriptive values were used to
summarize baseline and demographic characteristics for both
continuous and categorical variables. Chi-squared analysis was
performed to compare categorical variables, whereas independent
sample Student t tests were used to compare continuous variables.
Positive predictive values (PPVs) were calculated to determine the
probability that subjects with a low OARA score (
59) were dis-
charged successfully, which was assessed by discharge on or before
the end of their target daydPOD0 in the SDD cohort and POD1 in
2414 K.Y. Kim et al. / The Journal of Arthroplasty 33 (2018) 2412e2416

Table 2 Table 4
Baseline and DemographicsdSDD vs NDD. OARA Predictive ValuedSDD vs NDD.

SDD, n ¼ 164 NDD, n ¼ 168 P Value SDD OARA
59 NDD OARA
59

Age, y 55.5 ± 8.3 63.2 ± 10.8 <.001 Positive predictive value, % 86.1 35.5
Gender .380 Negative predictive value, % 23.1 86.1
Female 78 (47.6%) 89 (53.0%)
NDD, next-day discharge; OARA, Outpatient Arthroplasty Risk Assessment; SDD,
Male 86 (52.4%) 79 (47.0%)
same-day discharge.
BMI, kg/m2 26.9 ± 4.6 29.6 ± 6.7 <.001
Race <.001
White 144 (87.8%) 117 (69.6%)
Black 5 (3.0%) 23 (13.7%) subanalysis investigating the intracohort differences in OARA score
Asian 2 (1.2%) 3 (1.8%) utility within the SDD cohort and the NDD separately demon-
Other 13 (7.9%) 25 (14.9%) strated no difference in predictability between patients with high
ASA score <.001
or low OARA scores.
1 32 (19.5%) 6 (3.6%)
2 125 (76.2%) 104 (61.9%)
3 7 (4.2%) 56 (33.3%) Quality Outcomes
4 0 2 (1.5%)
Median 2 2
Compared with standard discharge cohort with low OARA
ASA, American Society of Anesthesiologists; BMI, body mass index; SDD, same-day scores (
59), SDD patients with low OARA scores demonstrated a
discharge; NDD, next-day discharge.
trend toward lower 30-day readmission rates (P ¼ .069), a signifi-
cantly lower 90-day readmission rate (P < .001), and a significantly
the standard discharge cohort. Conversely, negative predictive greater proportion of patients discharged home (P < .001) (Table 5).
values (NPVs) were calculated to determine the probability that However, no significant difference in readmission rates or
subjects with a high OARA score (>59) were discharged on POD0 discharge disposition was observed when comparing standard
for SDD, and after POD1 for the standard discharge cohort. Odds discharge patients with high OARA scores (>59) against SDD pa-
ratios of successful discharges were calculated for both cohorts and tients with high OARA scores (P > .05). A subanalysis investigating
their contingency tables were compared using the Mantel- the intracohort differences in quality outcomes within the SDD
Haenszel test. A P value of <.05 was established as the cutoff for cohort and the NDD cohort separately demonstrated no difference
determining statistical significance for all statistical tests. All sta- in quality outcomes between patients with high and low OARA
tistical analyses were performed using MATLAB 2017a (MathWorks, scores (Tables 6 and 7).
Natick, MA).
Discussion
Results
With the growing body of literature reporting on the safety and
Baseline and Demographics economic feasibility of rapid discharge protocols for TJA, as well as
new healthcare policies from the Centers for Medicaid and Medi-
A total of 332 patients were included in this study. When care Services, physicians and hospitals are highly incentivized to
compared with patients in the standard cohort, patients in the SDD adopt such pathways [19e23]. Healthcare systems can further
cohort were younger (55.5 vs 63.2 years; P < .001), had lower BMIs improve on this success through the implementation of standard-
(26.9 vs 29.6 kg/m2; P < .001), were more often Caucasian (P < ized, robust risk-stratification instruments. Previously validated
.001), and had lower ASA scores (P < .001) (Table 2).

OARA Scoring Utility

When comparing the utility of the OARA score in accurately

predicting successful discharge based on discharge date, OARA
demonstrated (1) a significantly higher PPV for POD0 for SDD than
POD1 for the standard discharge cohort and (2) a significantly
lower NPV for POD0 for SDD than POD1 for standard discharge
cohort (Tables 3 and 4; P < .05). Despite a higher PPV for OARA in
the SDD cohort, the PPV remained constant throughout all OARA
score cutoffs (Fig. 1). The NPV demonstrated a peak value of 87.7% at
an OARA cutoff of 50 in the standard discharge cohort. A

Table 3
OARA Scoring UtilitydSDD vs NDD.

SDD NDD

Discharge Discharge

POD0 POD >0 POD1 POD >1

OARA
59 130 (79.3%) 21 (12.8%) OARA
59 49 (29.1%) 89 (53.0%)

Fig. 1. OARA cutoff score vs PPV and NPV graph demonstrates successful predictive
OARA >59 10 (6.1%) 3 (1.8%) OARA >59 4 (2.4%) 26 (15.5%)
value of the OARA tool by comparing the OARA score (x-axis) against the PPV (red) and
Mantel-Haenszel test: P < .05. NPV (blue) for successful discharge (y-axis). On the left is the OARA next day discharge
NDD, next-day discharge; OARA, Outpatient Arthroplasty Risk Assessment; POD, (NDD), on the right is OARA for SD. NPV, negative predictive value; OARA, Outpatient
postoperative day; SDD, same-day discharge. Arthroplasty Risk Assessment; PPV, positive predictive value.
 K.Y. Kim et al. / The Journal of Arthroplasty 33 (2018) 2412e2416 2415

Table 5
Quality OutcomesdSDD vs NDD.

SDD OARA
59, n ¼ 151 NDD OARA
59, n ¼ 138 P Value SDD OARA >59, n ¼ 13 NDD OARA >59, n ¼ 30 P Value

30-d readmissions 0 3 (2.2%) .069 0 1 (3.3%) .505

90-d readmissions 0 6 (4.4%) <.001 1 (7.7%) 1 (3.3%) .533
Discharge disposition <.001 .117
Home 151 (100%) 128 (92.8%) 13 (100%) 25 (83.3%)
SNF 0 10 (7.2%) 0 5 (16.7%)

NDD, next-day discharge; OARA, Outpatient Arthroplasty Risk Assessment; SDD, same-day discharge; SNF, skilled nursing facility.

instruments such as the Risk Assessment and Prediction Tool [24]
and Readmission Risk Assessment Tool [25] can accurately predict
patients who are at a higher risk for a discharge disposition to a
postacute care facility and hospital readmission, respectively.
Safely shortening the postoperative LOS is an essential compo-
nent to reducing the economic burden associated with TJA [26].
Prior studies have identified that patients with specific comorbid-
ities, such as chronic obstructive pulmonary disease, congestive
heart failure, coronary artery disease, and cirrhosis, should be
ineligible for short stay or outpatient THA because of their
increased postoperative complication rate [27,28]. In an attempt to
use more comprehensive guidelines, the OARA score was devel-
oped to predict LOS after a THA [9,13,14,18]. Thus, the goal of this
study was to assess the utility of the OARA risk stratification tool
when screening patients for accelerated discharge planning and
quality-related outcomes.
OARA Scoring Utility
In an original study by Meneghini et al [13] the OARA score was
assessed among a cohort of 1120 consecutive TJA patients under-
going SDD or NDD, and demonstrated a PPV of 81.6% (P < .001)d
comparable with the 86.1% found in the present study’s SDD cohort.
However, PPV remained constant throughout all OARA scores for
the SDD cohort in our study (Fig. 1). The discrepancy between
highly predictive, but constant PPV of the OARA scores likely stems
from the superior perioperative patient care protocols typically
found in most SDD protocols, specifically aggressive perioperative
patient education, and a multidisciplinary approach to post-
operative care involving surgeons, hospitalists, social work, and
physical and occupational therapies. Expectations for SDD was also
communicated to patients in all educational material and by all
physicians, nursing staff, physical therapists, and discharge plan-
ners involved in patient care. Furthermore, regular coordinated
care conferences were held among key members of the multidis-
ciplinary care team to discuss upcoming surgeries.
Conversely, the standard discharge cohort demonstrated higher
NPV, with a peak of 88% at a score of approximately 50, whereas the
PPV remained low at 35.5%. Our study of the OARA scoring tool was
therefore unable to reproduce the same PPVs as described in the
original study by Meneghini et al [13]. Instead, within our specific
patient population and established perioperative protocols, the
OARA score was a valuable screening instrument to identify pa-
tients at risk for failing rather than successfully undergoing early
discharge, particularly among NDD patients. Furthermore, the NPV
is more clinically meaningful when applied to preoperative evalu-
ation, as patients who screen out of the NDD protocol can be further
evaluated and treated for modifiable risk factors preoperatively,
reducing the risk of delayed discharge, readmission, and potential
postoperative complications. Lastly, among hospitals that may not
have the resources to pursue a rapid discharge program, OARA
scores can help alert the surgical team of patients who may benefit
from an extended LOS after THA.
Quality Outcomes
Previous studies have demonstrated that SDD and NDD THA is a
both safe and desirable discharge pathway for a select cohort of
patients [5e11,17,27]. These findings were supported by our study,
which demonstrated both noninferior and superior 30- and 90-day
readmissions for the SDD cohort despite being discharged sooner
than the standard discharge cohort. Furthermore, all patients were
safely discharged to home compared with 91% of patients from the
standard discharge cohort. When comparing patients within their
respective SDD and NDD cohorts, there were no differences in
quality outcomes found between patients with high and low OARA
scores. However, future prospective studies assessing similar pop-
ulations may better define long-term outcomes and complication
profiles associated with THA.
We hypothesize that the primary drivers for the success of the
SDD pathway are the additional educational components and ef-
forts at guiding perioperative patient expectations as well as proper
patient selection. Within our institution’s SDD protocol, patients
undergo thorough preoperative discussions with CCC, physical and
occupational therapists to alleviate doubts regarding the TJA,
manage expectations, and build the patient confidence necessary to
ensure positive outcomes.
Although patient selection and education are critical compo-
nents for successful SDD, these components alone do not ensure
successful discharges. The surgeon and their team must be fully
vested in the program. Prior studies have demonstrated that
approximately 10%-20% of SDD patients fail POD0 discharge
because of hospital operational logistics, particularly those

Table 7
Table 6 NDD Quality Outcomes.
SDD Quality Outcomes.
NDD OARA
59, NDD OARA >59, OR CI P Value
SDD OARA
59, SDD OARA >59, OR CI P Value n ¼ 138 n ¼ 30
n ¼ 151 n ¼ 13
30-d readmissions 3 (2.2%) 1 (3.3%) 0.64 0.06-6.42 .644
30-d readmissions 0 0 NA NA 1.000 90-d readmissions 6 (4.4%) 1 (3.3%) 1.32 0.15-0.37 1.000
90-d readmissions 0 1 (7.7%) NA NA .079 Discharge 2.56 0.81-8.13 .149
Discharge disposition NA NA 1.000 disposition
Home 151 (100%) 13 (100%) Home 128 (92.8%) 25 (83.3%)
SNF 0 0 SNF 10 (7.2%) 5 (16.7%)

CI, confidence interval; OARA, Outpatient Arthroplasty Risk Assessment; OR, odds CI, confidence interval; NDD, next-day discharge; OARA, Outpatient Arthroplasty
ratio; SDD, same-day discharge; SNF, skilled nursing facility. Risk Assessment; OR, odds ratio; SNF, skilled nursing facility.
2416 K.Y. Kim et al. / The Journal of Arthroplasty 33 (2018) 2412e2416
involving social work or physical therapy interventions. The
importance of interdisciplinary communication by healthcare in-
stitutions that hope to maximize the benefits of SDD initiatives
cannot be over emphasized.
Limitations
This study is not without its limitations. As a retrospective study,
patient selection biases and errors during data collection are
inherent to the study design. Furthermore, the standard discharge
cohort is not standardized to the extent of the SDD cohort. For
instance, patients opting into the SDD program have required
educational sessions with dedicated CCCs. However, perioperative
interventions including preoperative testing, anesthesia protocols,
and all surgical interventions were similar between cohorts. A
second limitation of this study was the assessment of quality out-
comes, particularly among the SDD cohort. Because of very low
incidence of readmissions, this study may be underpowered to
assess the predictive value of the OARA scoring tool in SDD patient.
Despite these limitations, our study demonstrates that the OARA
scoring tool is a safe and effective preoperative risk-stratification
tool, which can screen out poor THA candidates for rapid recov-
ery pathways.
Conclusion
To maximize the value of THA, it is necessary to avoid lengthy
hospital stays after surgery. Careful patient selection is necessary
when selecting candidates for SDD and NDD programs. Eligible
candidates may report reduced morbidity associated with THA
while experiencing superior outcomes, lower complication profiles,
and reduced readmission rate. Our findings suggest the OARA
scoring system is a reliable method that can be used to screen out
patients who are at risk for delayed recovery after a primary THA. In
addition, our study demonstrates that THA candidates enrolled in
an SDD program may benefit from perioperative interactions with a
dedicated CCC, which may promote enhanced patient education
and closer patient surveillance.
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 The Journal of Arthroplasty 33 (2018) 2381e2386

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Reducing Length of Stay Does Not Increase Emergency Room Visits

or Readmissions in Patients Undergoing Primary Hip and Knee
Arthroplasties
Andrea H. Stone, MSN, CRNP a, Leah Dunn a, James H. MacDonald, MD b,
Paul J. King, MD c, *
a
Department of Surgical Research, Anne Arundel Medical Center, Annapolis, Maryland
b
Anne Arundel Medical Center, Annapolis, Maryland
c
Center for Joint Replacement, Anne Arundel Medical Center, Annapolis, Maryland

a r t i c l e i n f o a b s t r a c t

Article history: Background: Total hip and total knee arthroplasty (total joint arthroplasty [TJA]) are 2 of the most
Received 2 January 2018 common elective surgeries. Identifying which patients are at highest risk for emergency room (ER) visits
Received in revised form or readmissions within 90 days of surgery and the reasons for return are crucial to formulate ways to
20 February 2018
decrease these visits and improve patient outcomes.
Accepted 17 March 2018
Available online 27 March 2018
Methods: This is a retrospective review of a consecutive series of 7466 unilateral primary TJA performed
from July 2013 to June 2017; any patients who had an ER visit or readmission in the first 90 days after
surgery were identified, and a detailed chart review was performed. Patients discharged home or to
Keywords:
emergency room visit
rehab were analyzed separately.
readmission Results: Three hundred thirty-six (4.5%) patients had 380 ER visits and 250 (3.3%) patients had 291
total hip arthroplasty readmissions in the first 90 days after TJA. Patients returning to the ER were equivalent to those who did
total knee arthroplasty not. Patients who went to a rehab facility on discharge were significantly more likely to be readmitted
length of stay (P ¼ .000). Patients who were readmitted had a higher American Society of Anesthesiologists score
(P ¼ .000). Length of stay decreased over the study period from 2.66 days to 1.63 days, while the number
of unplanned interventions remained steady. Pain and swelling was the most common reason for return
for ER visits (33.2%) and readmissions (14.1%).
Conclusion: The overall number of unplanned interventions after TJA in this population was low and
remained consistent over time despite decreasing length of stay. Patients who went to rehab were more
likely to experience readmission. The majority of unplanned interventions occurred in the first 4 weeks
after surgery.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA)
are 2 of the most common surgical procedures performed in the
United States, with the number of procedures performed increasing
each year. In 2015, TKA and hip arthroplasty, both total and partial,
were the 2 most common operations performed during inpatient
hospital stay with 236 TKA and 167 hip arthroplasties performed
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.043.
* Reprint requests: Paul J. King, MD, Center for Joint Replacement, Anne Arundel
Medical Center, 2000 Medical Parkway, Suite 101, Annapolis, MD 21401.
per 100,000 stays [1]. By the year 2030, the demand for primary
TKA is projected to be 3.48 million and for primary THA is 572,000
[2]. Any surgical procedure comes with an inherent risk of com-
plications and joint arthroplasty is no exception. Owing to the large
numbers of THA and TKA performed each year, even a modest
occurrence of complications requiring readmission or emergency
room (ER) visits will have a significant impact on the health-care
system. With the advent of the Affordable Care Act and the Cen-
ters for Medicare and Medicaid Services commitment to decrease
health-care costs, there is a move toward alternative payment
methods including bundled payment models. While this is not yet
mandatory, joint arthroplasty is one of the most common proced-
ures to utilize a bundled payment model, which will include all
costs associated with a procedure for the first 90 days, including

https://doi.org/10.1016/j.arth.2018.03.043
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2382 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2381e2386
readmission and ER visits [3]. Other payers are also linking quality
of care to insurance payments with readmissions being a common
measure of quality [4].
Unplanned interventions, ER visits, or readmissions in the first
90 days after surgery significantly add to the cost of patient care
and are associated with suboptimal patient outcomes [3]. Identi-
fying which patients are at highest risk for unplanned interventions
and the causes of return are crucial to formulate ways to decrease
unplanned interventions, thereby improving patient outcomes. A
number of factors have been hypothesized to increase the risk and
the rate of unplanned intervention in TKA and THA patients
including length of stay (LOS), discharge disposition, and patient
factors including comorbidities [4e8].
There have been many studies examining readmission after
total joint arthroplasty (TJA) with somewhat varied conclusions
[7,9e11] though few studies have examined ER visits either inde-
pendently or concurrently with readmissions [12e14]. We aim with
this study to add to the current body of literature by examining
both readmissions and ER visits experienced by patients after TJA
from one high-volume institution. We seek to identify the timing of
unplanned interventions and the reasons for the visits to identify
necessary areas of improvement to care pathways. We also seek to
evaluate whether decreased hospital length of stay increases the
rate of unplanned interventions.
Methods
The institutional review board approval was obtained. A retro-
spective chart review was performed for a consecutive series of all
primary unilateral TJA performed at this institution between July
2013 and June 2017. Surgeries were performed by one of 11 board-
certified orthopedic surgeons. Basic demographic data including
age, sex, and body mass index, discharge disposition, and LOS were
recorded for the entire population. American Society of Anesthe-
siologists (ASA) score was used to quantify preoperative health
status [15]. All patients who returned to this institution via ER or
readmission were identified, and a detailed chart review was
performed.
Perioperative Protocol
All patients were subject to the same perioperative protocols in
a coordinated Joint Replacement Center Program. Throughout the
study, all patients received preoperative education consisting of
written materials and a class, preoperative medical evaluation, and
preoperative strengthening via a home exercise program or formal
physical therapy. All patients underwent a standard decolonization
protocol with intranasal mupirocin ointment twice daily for 3 days
before surgery and chlorhexidine body wash for 3 days before
surgery. All patients also received parenteral antibiotics per the
Surgical Care Improvement Project guidelines. Before the imple-
mentation of an enhanced recovery after surgery (ERAS) protocol,
patients received either general anesthesia with a femoral nerve
block for TKA or spinal anesthesia and pain control via infiltrative
anesthetic and patient-controlled analgesia transitioning to oral
pain medication on postoperative day one. In this time period,
warfarin was the primary pharmacologic prophylaxis for deep vein
thrombosis (DVT) along with mechanical prophylaxis, and patients
were typically mobilized in the morning of postoperative day one.
Patients received group physical therapy twice daily while in the
hospital and were discharged either to a skilled nursing facility
(SNF) or to home health or outpatient physical therapy 3 times a
week. After the implementation of the ERAS protocol in April 2015,
patients received regional anesthesia wherever appropriate;
femoral nerve blocks and patient-controlled analgesia were
discontinued, and multimodal pain management regimens were
initiated with celecoxib, acetaminophen, pregabalin and short-
acting opioids. Patients also received aggressive intraoperative
fluid management, tranexamic acid utilization, and day of surgery
ambulation. Aspirin 325 mg bid became the primary pharmaco-
logic DVT prophylaxis, using warfarin in selected high-risk patients.
Postdischarge physical therapy protocols did not change.
Study Population
A total of 7466 patients were included in the study. All TKAs
(4720 patients) were performed via a standard medial patellar
arthrotomy, posterior approach THA (924 patients) in the lateral
decubitus position and anterior approach THA (1822 patients) us-
ing a modern fracture table. There were a total of 671 unplanned
interventions in the first 90 days postoperatively by 586 patients,
7.8% of the study group. There were 380 visits were made to the ER
by 336 (4.5%) patients and 250 (3.3%) patients experienced 291
readmission events.
Study Outcomes
We examined incidence and risk factors of patients who expe-
rienced an unplanned intervention, either ER visit or readmission
in the first 90 days after surgery. The entire group was analyzed,
and then patients discharged home or to an SNF were analyzed
separately. Unplanned ER visits or readmissions were defined as
any return to the hospital within 90 days of the index admission.
The primary diagnosis documented in the patient chart was
considered to be the reason for the return visit.
Statistical Analysis
Pearson's chi-squared tests were used to analyze the differences
in categorical variables between groups. A series of t tests and
analysis of variance were used to analyze continuous variables. A
P value less than or equal to .05 was treated as statistically signif-
icant. All analyses were performed using SPSS (SPSS 24.0, IBM Inc.,
Somers, NY).
Results
A total of 7466 patients were included in the study. Of the total
sample, 5835 (78.2%) patients were discharged home and 1631
(21.8%) patients discharge to an SNF. In the group of patients that
discharged home 264 (4.5%), patients experienced 303 ER visits and
169 (2.9%) patients experienced 194 readmissions. Of the patients
who discharged to an SNF, 72 (4.4%) patients experienced 77 ER
visits and 81 (5.0%) patients experienced 97 readmissions. The
percentage of patients experiencing an ER visit was not signifi-
cantly different between patients discharged to home vs an SNF
(P ¼ .827) though the readmission rate was (P < .000). There was a
47.4% decrease in patients discharged to an SNF instead of home,
from 29.3% in year 1 to 15.4% in year 4 (P < .000).
There was a significant decrease of 38.7% in overall LOS, from
2.66 days to 1.63 days over the course of the study (P < .000). Pa-
tients who discharged home also experienced a decrease in LOS,
from 2.38 days to 1.35 days (P < .000). The decrease in LOS expe-
rienced by patients discharged to an SNF was minimal (3.23 to 3.13
days, P ¼ .574). An ERAS protocol was implemented at this insti-
tution halfway through the study period. There was a 23.1%
increase in the overall number of patients having joint arthro-
plasties during the study, from 1674 the first year to 2061 by the last
year. The overall number of patients experiencing unplanned in-
terventions was unaffected by decreasing LOS or implementation of
 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2381e2386 2383

Table 2
Patient Factors That Increase Risk of Emergency Room Visit for Patients Discharged
Home.

No ER Visit ER Visit Sig.

Age, y (mean ± SD) 64.96 ± 9.24 64.38 ± 10.54 .377

Sex .043
Female (%) 55.6 49.2
Body mass index, kg/m2 31.28 ± 5.98 31.03 ± 5.85 .518
(mean ± SD)
ASA score 3 or 4 (%) 36.7 41.3 .151
Procedure time, min (mean ± SD) 82.92 ± 30.58 83.90 ± 20.71 .605
Total OR time, min (mean ± SD) 127.51 ± 24.23 127.95 ± 24.04 .773
Procedure type .332
THA (%) 37.4 34.5
TKA (%) 62.6 65.5
Length of stay, d (mean ± SD) 1.72 ± 0.97 1.78 ± 0.92 .287
Fig. 1. Patient volume by study year. Length of stay, h (mean ± SD) 47.72 ± 23.06 49.36 ± 22.13 .257

P  .05 are in bold.

ERAS protocols (Fig. 1) when examining the population as a whole,
and this remained true when looking only at patients who were
discharged home.
When examining the impact of patient variables on the risk of
an ER visit for the entire population, none showed significance
(Table 1). The only factor that approached significance was having a
TKA (63.0% vs 67.6%, P ¼ .091). Age (66.56 vs 65.92 years, P ¼ .288),
sex (59.2% vs 55.4% female, P ¼ .157), and LOS (2.08 vs 2.17 days,
P ¼ .262) were all equivalent between those that returned to the ER
and those that did not. Discharge to an SNF between the groups was
also equivalent (21.8% vs 21.4%, P ¼ .877). Table 2 compares only the
patients who discharged home. In this cohort, the sex of patients
became significant; 50.8% of patients returning to the ER were
males compared with 44.4% of patients who did not (P ¼ .043). The
groups were comparable on all other measures.
Table 3 shows the impact of patient factors on the risk of
readmission for the entire study population. Patients that were
readmitted were older (66.45 vs 68.92 years, P < .000), were more
likely to have an ASA score of 3 or 4 (41.3% vs 56.3%, P < .000), and
were more likely to be male (40.7% vs 48.0%, P ¼ .021). Of patients
who were readmitted, a higher percentage were initially dis-
charged to an SNF (21.4% vs 32.4%, P ¼ .000). Patients who were
readmitted had a longer length of stay compared with those who
did not get readmitted (2.06 vs 2.67 days, P ¼ .000). The percentage
of patients having a TKA was equivalent between groups (63.2% vs
64.4%, P ¼ .694). When looking only at the patients who discharged
Table 1
Patient Factors That Increase Risk of Emergency Room Visit for the Total Study
Population.
ASA, American Society of Anesthesiologists; ER, emergency room; SD, standard devi-
ation; THA, total hip arthroplasty; TKA, total knee arthroplasty; OR, operating room.
home, there were also significant differences (Table 4). Patients
who were readmitted were still older (64.88 vs 66.77 years,
P ¼ .020), more likely to have an ASA score of 3 or 4 (36.6% vs 45.9%,
P ¼ .022), and more likely to be male (44.5% vs 53.3%, P ¼ .023).
These patients also had a longer initial length of stay (1.72 vs 1.95
days, P ¼ .015).
The majority of unplanned interventions, both ER visits, and
readmissions occurred within the first 4 weeks after surgery
(Fig. 2). A total of 91% of ER visits and 83% of readmissions took
place in the first 4 weeks, with 169 ER visits and 90 readmissions
occurring in the first 5 days after discharge.
Table 5 compares the reasons for ER visits between patients who
were discharged home and patients who were discharged to an
SNF. The most common reason patients returned to the ER in both
cohorts was postoperative pain and swelling (35.0% vs 26.0%,
P ¼ .134), though this was not significant between the groups. Other
medical complications (12.2% vs 24.7%, P ¼ .006) occurred in a
significantly higher percentage of patients who were initially dis-
charged to an SNF; this category included diagnoses such as
pneumonia, anxiety, vertigo, and epistaxis. One other category
approached significance between groups; a greater percentage of
patients discharging to an SNF experienced an ER visit due to a fall
(3.0% vs 7.8%, P ¼ .052). The remainder of reasons for ER visits was
equivalent between groups. There were 4 thromboembolic events
(3 DVT and 1 pulmonary embolism) accounting for 1.1% of total
visits to the ER.
Table 3
Patient Factors That Increase Risk of Readmission for the Total Population.

No ER Visit ER Visit Sig. No Readmission Readmission Sig.

Age, y (mean ± SD) 66.56 ± 9.70 65.92 ± 10.73 .288 Age, y (mean ± SD) 66.45 ± 9.70 68.92 ± 10.65 .000
Sex .157 Sex .021
Female (%) 59.2 55.4 Female (%) 59.3 52.0
Body mass index, kg/m2 31.35 ± 6.23 31.52 ± 6.34 .633 Body mass index, kg/m2 31.33 ± 6.22 32.32 ± 6.54 .013
(mean ± SD) (mean ± SD)
ASA score 3 or 4 (%) 41.6 46.2 .116 ASA score 3 or 4 (%) 41.3 56.3 .000
Procedure time, min (mean ± SD) 82.99 ± 29.19 84.71 ± 21.38 .288 Procedure time, min (mean ± SD) 82.88 ± 29.00 88.72 ± 24.45 .002
Total OR time, min (mean ± SD) 127.71 ± 24.71 128.90 ± 24.65 .387 Total OR time, min (mean ± SD) 127.55 ± 24.57 133.90 ± 27.82 .000
Procedure type .091a Procedure Type .694
THA (%) 37.0 32.4 THA (%) 36.8 35.6
TKA (%) 63.0 67.6 TKA (%) 63.2 64.4
Discharge to SNF (%) 21.8 21.4 .877 Discharge to SNF (%) 21.4 32.4 .000
Length of stay, d (mean ± SD) 2.08 ± 1.41 2.17 ± 1.46 .262 Length of stay, d (mean ± SD) 2.06 ± 1.35 2.67 ± 2.60 .000
Length of stay, h (mean ± SD) 56.43 ± 33.66 58.79 ± 35.28 .209 Length of stay, h (mean ± SD) 56.04 ± 32.16 70.73 ± 62.76 .000

ASA, American Society of Anesthesiologists; ER, emergency room; SD, standard P  .05 are in bold.
deviation; SNF, skilled nursing facility; THA, total hip arthroplasty; TKA, total knee ASA, American Society of Anesthesiologists; SD, standard deviation; SNF, skilled
arthroplasty; OR, operating room. nursing facility; THA, total hip arthroplasty; TKA, total knee arthroplasty; OR,
a
P approaches significance. operating room.
2384 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2381e2386

Table 4 been linked to risk of readmission in other populations as well [18].

Patient Factors That Increase Risk of Readmission for Patients Discharged Home. In addition, while our rate of unplanned interventions stayed fairly
No Readmission Readmission Sig. consistent, our average LOS for the entire cohort fell by >1 day over
Age, y (mean ± SD) 64.88 ± 9.27 66.77 ± 10.37 .020
the study period. The LOS of patients discharged home also fell by
Sex .023 >1 day over the course of the study without an increase in ER visits
Female (%) 55.5 46.7 or readmission events.
Body mass index, kg/m2 31.24 ± 5.98 31.91 ± 5.89 .153 The rate of ER visits following TJA has been documented at
(mean ± SD)
anywhere from 5.8% to 12.0% in the first 30-90 days after surgery
ASA score 3 or 4 (%) 36.6 45.9 .022
Procedure time, min (mean ± SD) 82.83 ± 30.35 87.57 ± 24.33 .044 [3,12,14]. In our study population, the overall rate of ER visits was
Total OR time, min (mean ± SD) 127.39 ± 24.09 132.24 ± 27.80 .026 4.5% in the first 90 days, substantially lower than other published
Procedure Type .195 studies. When looking at patients who discharged to home and
THA (%) 37.4 32.5
patients who discharged to an SNF, they both had a similar rate of
TKA (%) 62.6 67.5
Length of stay, d (mean ± SD) 1.72 ± 0.96 1.95 ± 1.21 .015
ER visits. We also found that almost half of the visits, 45% occurred
Length of stay, h (mean ± SD) 47.63 ± 22.79 53.18 ± 29.45 .016 in the first 5 days after hospital discharge and 91% within 28 days.
About one-third of ER visits were due to pain and swelling which is
P  .05 are in bold.
ASA, American Society of Anesthesiologists; SD, standard deviation; THA, total hip likely a preventable cause of return [19]. Returning to the ER for
arthroplasty; TKA, total knee arthroplasty; OR, operating room. pain and swelling was not dependent on discharge disposition as it
was the most common reason for both patients discharged to home
and patients discharged to an SNF. All primary joint arthroplasty
Table 6 compares the reasons for readmissions between patients patients at our institution are included in a standardized pathway
who were discharged home and patients who were discharged to starting from the point at which surgery is scheduled and
an SNF. There were several reasons that differed significantly be- continuing into the postoperative period. One of the components of
tween the 2 groups, pain and swelling (19.1% vs 4.1%, P ¼ .001) and this is a preoperative education class that approximately 75% of
thromboembolic events (7.7% vs 1.0%, P ¼ .018) were more likely to patients take before surgery. In addition, all patients are given
occur in patients discharging to home. All but 2 of the thrombo- detailed written educational material both preoperatively and
embolic events in readmitted patients were for pulmonary embo- postoperatively in an attempt to reduce unnecessary unplanned
lism. Wound infection (10.3% vs 19.6%, P ¼ .029) and anemia (0.5% interventions. With the advent of newer technology, changing the
vs 6.2%) were more likely to occur in patients discharging to an SNF. way this information is disseminated and improving access to
A higher percentage of patients discharged to an SNF also experi- providers before resorting to emergency care may help decrease
enced other medical complications (9.8 vs 7.5%, P ¼ .059) and uri- this type of visit [20].
nary symptoms (2.1 vs 6.2%, P ¼ .069) and these both approached Readmission following TKA and THA has been more thoroughly
significance. Other medical complications included diagnoses such studied with recent publications documenting a readmission rate
as viral illnesses, renal complications, and diabetic complications. of 2.2%-7.8% in the first 30-90 days after surgery [3,4,6,7,9,11]. Our
readmission rate in this study was 3.3%. Readmissions were
Discussion somewhat delayed compared with ER visits, only 31% of read-
missions occurred in the first 5 days after surgery and 83% at 28
In this era of cost efficiency and bundled payment models, there days. We found that patients who were discharged to an SNF rather
has been concern that a decreasing length of stay after TKA and THA than home had an increased likelihood of readmission. This is
would increase ER visits and readmissions [5,16,17]. Similar to the consistent with other published studies, though those studies
study by Saucedo et al [11], we found that patients who were relied primarily on large national databases rather than a single
readmitted actually had a longer initial LOS. This held true for the institution's data [8,21e23]. The reasons for this are not entirely
entire study population and when we looked exclusively at the clear. Ponnusamy et al [23] suggests that SNFs may have a lower
patients who discharged to home. This could be explained by an threshold for transferring patients back to the hospital and that the
increased burden of medical comorbidities, though longer LOS has proximity of many SNFs to the acute care facility may be a factor as

ER visitt Readmisssion

200

175
Number of visits

150

125

100

75

50

25

0
1 2 3 4 5 6 7 8 9 10 11 12
Time frrom surgeery (weekss)
Fig. 2. ER visits and readmissions by time from discharge (by week).
 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2381e2386 2385

Table 5
Reasons for ER Visits.

Reason for Return Number of Visits (Discharge Number of Visits Sig. (Discharge All Visits Percent
Home) N ¼ 303 (%) (Discharge SNF) N ¼ 77 (%) Home vs SNF) (Total Population)

Pain/swelling 106 (35.0) 20 (26.0) .134 1.7

Other medical issues 37 (12.2) 19 (24.7) .006 0.75
Urinary symptoms 24 (7.9) 4 (5.2) .414 0.36
Shortness of breath 18 (5.9) 4 (5.2) .802 0.29
Wound infection 15 (5.0) 1 (1.3) .154 0.21
Other orthopedic issues 12 (4.0) 5 (6.5) .337 0.23
Nausea/vomiting/diarrhea 12 (4.0) 4 (5.2) .630 0.21
Constipation/Ileus 11 (3.6) 2 (2.6) .656 0.17
Syncope 10 (3.3) 2 (2.6) .753 0.16
Medication related 10 (3.3) 2 (2.6) .753 0.16
Fever 10 (3.3) 0 .106 0.13
Fall 9 (3.0) 6 (7.8) .052 0.20
Cardiac complication 9 (3.0) 4 (5.2) .338 0.17
Noncardiac chest pain 8 (2.6) 2 (2.6) .983 0.13
Mechanical complication 7 (2.3) 2 (2.6) .882 0.12
DVT/PE 4 (1.3) 0 .311 <0.01
Periprosthetic fracture 1 (0.3) 0 .614 <0.01

P  .05 are in bold.

DVT, deep vein thrombosis; ER, emergency room; SNF, skilled nursing facility; PE, pulmonary embolism.

well. Our institution does not have an on-site SNF, so that is not a
factor in this study. Overall preoperative health status is another
possible reason. Patients with a higher comorbidity burden pre-
operatively are more likely to discharge to an SNF and the same
patients are at higher risk of adverse events after surgery [21],
though in our study many of the patient characteristics associated
with readmission in the population as a whole also held true when
looking only at the patients discharged home.
While pain and swelling was also the most common reason for
readmission in patients who discharged to home, the reasons for
readmission were more evenly distributed across the categories.
When comparing groups by discharge disposition, patients who
were discharged home had a significantly higher rate of return for
pain and swelling and for thromboembolic events. It is probable
that patients discharged to an SNF who experienced similar
symptoms were able to be assessed and managed in that facility
rather than needing to return to an acute care facility. Patients who
were discharged to an SNF had a much higher rate of infectious
compared with those discharging home. While this may be related
to the patient's overall health status, it also raises concerns of
nosocomial infection in these patients and emphasizes the need to
continue to decrease SNF admissions in THA and TKA patients
[8,23]. Compared to ER visits, more readmissions were directly
related to surgical complications.
The study has multiple strengths. Our study sample is large and
extends over a 4- year period. We included all ER visits and read-
missions that occurred in the first 90 days after surgery, rather than
stopping at 30 days postoperatively. Because all the data are from
one institution, we can confidently state that all patients were
subjected to the same protocols preoperatively, during the hospi-
talization and postoperatively which decreases the risk of some
confounding variables. We also examined patients discharged
home and to an SNF separately.
We were unable to account for any readmissions or ER visits that
may have happened outside of our institution, though our insti-
tution is geographically isolated. When examining statewide

Table 6
Reasons for Readmission.

Reason for Return Number of Visits (Discharge Number of Visits Sig. (Discharge All Visits Percent
Home), N ¼ 194 (%) (Discharge SNF), N ¼ 97 (%) Home vs SNF) (Total Population)

Pain/swelling 37 (19.1) 4 (4.1) .001 0.55

Wound infection 20 (10.3) 19 (19.6) .029 0.52
Other medical issues 19 (9.8) 17 (17.5) .059 0.48
Cardiac complications 17 (8.8) 8 (8.2) .882 0.33
DVT/PE 15 (7.7) 1 (1.0) .018 0.21
Small bowel obstruction/GI bleed 12 (6.2) 6 (6.2) 1.0 0.24
Cellulitis 10 (5.2) 7 (7.2) .480 0.23
Neurologic complication 9 (4.6) 6 (6.2) .574 0.20
Other orthopedic issues 8 (4.1) 3 (3.1) .664 0.15
Periprosthetic infection 8 (4.1) 3 (3.1) .664 0.15
Mechanical complication 7 (3.6) 4 (4.1) .828 0.15
Periprosthetic fracture 7 (3.6) 3 (3.1) .820 0.13
Constipation/ileus 7 (3.6) 3 (3.1) .820 0.13
Syncope 6 (3.1) 0 .080 <0.01
Urinary symptoms 4 (2.1) 6 (6.2) .069 0.13
Shortness of breath 4 (2.1) 1 (1.0) .523 <0.01
Anemia 1 (0.5) 6 (6.2) .003 <0.01
Medication related 1 (0.5) 0 .479 <0.01
Fever 1 (0.5) 0 .479 <0.01
Nausea/vomiting/diarrhea 1 (0.5) 0 .479 <0.01

P  .05 are in bold.

DVT, deep vein thrombosis; SNF, skilled nursing facility; GI, gastrointestinal; PE, pulmonary embolism.
2386 A.H. Stone et al. / The Journal of Arthroplasty 33 (2018) 2381e2386
readmission data from the Chesapeake Regional Information Sys-
tem, 85.8% of TJA patients are readmitted back to our institution.
We hypothesize that the small number of unplanned interventions
that we cannot account for are similar in reason and occur in a
similar time frame that they did in this study so while the incidence
of these events may be underestimated in this study, the data still
have value in formulating strategies to improve care. In addition,
because this was a retrospective study, we are unable to account for
all possible confounding variables. We also limited this study to
elective, unilateral primary THA and TKA.
Conclusion
The overall number of unplanned interventions experienced by
this population was low. LOS decreased substantially in the total
population as well as in patients discharged to home over the study
period without an increase in either ER visits or readmissions. The
majority of unplanned interventions occurred within the first 4
weeks after surgery. Pain and swelling was the most common
reason for patients to return to the ER or be readmitted from home.
Acknowledgments
The authors would like to acknowledge T. Robert Turner, PhD,
for his support with statistical analysis.
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 The Journal of Arthroplasty 33 (2018) 2560e2565

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Resection Arthroplasty Compared With Total Hip Arthroplasty

in Treating Chronic Hip Pain of Patients With a History of
Substance Abuse
William Curtis, BS a, Meir Marmor, MD b, *
a
Keck School of Medicine, University of Southern California, Los Angeles, California
b
Department of Orthopaedic Surgery, University of California, San Francisco, Orthopaedic Trauma Institute, San Francisco, California

a r t i c l e i n f o a b s t r a c t

Article history: Background: Retrospective comparison of surgical management of severe hip pain in patients with a
Received 12 January 2018 history of substance abuse treated by modified Girdlestone resection arthroplasty (RA) vs delayed total
Received in revised form hip arthroplasty (THA) following yearlong sobriety pathway.
6 March 2018
Methods: Patients were identified using charts, current procedural terminology (CPT) code query, and THA
Accepted 8 March 2018
Available online 16 March 2018
sobriety pathway registry. The primary outcome was adequate pain control following surgery, defined as
visual analog scale
5 or verbal description of “moderate” or lower pain. RA patients with infectious
arthritis were analyzed separately. The secondary outcome was the level of mobility after surgery.
Keywords:
resection arthroplasty
Results: In the THA pathway, 15 of 28 (53.6%) proved sobriety, 11 (39.3%) underwent THA, and 9 (32.1%)
substance abuse achieved adequate pain control (median 77 days). After RA, 19 (76%) achieved adequate pain control
hip arthroplasty (median 119.5 days). Preoperative infection did not significantly affect time to pain control after RA (P ¼
pain management .94). Time to adequate pain control was not significantly different between RA and THA patients (P ¼ .19).
sobriety pathway Three patients (30%) experienced improved level of mobility after THA and 7 (70%) experienced no
hip arthritis change. After RA, 7 patients (29.1%) experienced improved level of mobility, 3 (13.6%) lost mobility, and
14 (63.6%) experienced no change. Three RA patients were later converted to THA without complication.
Conclusion: Yearlong sobriety pathway leading to THA leads to successful pain control in less than one-
third of enrolled patients. Compared to delayed THA, RA enables more patients with substance abuse to
be treated sooner and results in successful reduction of pain in a similar proportion of patients. RA may
be an effective pain-reducing procedure for these patients.
© 2018 Elsevier Inc. All rights reserved.

Substance use disorders are common and growing more
pervasive in our population, affecting approximately 8% of in-
dividuals aged 12 years or older according to a 2015 US survey [1].
According to the Centers for Disease Control and Prevention,
chronic joint pain is reported in 30.9% [2] of all patients, and those
with substance abuse have demonstrated lower tolerance to pain
[3,4]. Despite the frequency of these conditions, treating chronic
joint pain in patients with a history of substance abuse is an
understudied topic with little consensus on effective treatment.
Because of the fear of postoperative infection, difficult
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.016.
* Reprint requests: Meir Marmor, MD, Department of Orthopaedic Surgery,
University of California, San Francisco, Orthopaedic Trauma Institute, Zuckerberg
San Francisco General Hospital, 2550 23rd Street, San Francisco, CA 94110.
postoperative pain control, and other causes of poor outcomes,
these patients are often unable to undergo joint arthroplasty, and
alternatives are scarce [3e6]. Furthermore, patients with substance
abuse are more likely to develop tissue and bloodstream infections,
providing another risk factor when undergoing joint arthroplasty
[7,8]. To lower the operative risk of total hip arthroplasty (THA),
patients with a history of substance abuse and severe hip pain are
required by our institution to enter a sobriety pathway, in which
they must prove 1 year of clean urinary drug screenings urine
toxicology screen [UTOX] to be considered for THA. Unfortunately,
many of these patients are either unable to prove sobriety or are
lost to follow-up, leaving their severe pain untreated. However, in
some cases, Girdlestone resection arthroplasty (RA), a surgical
procedure first developed to achieve drainage of septic hip joints
following pyogenic bacterial infection in war [9], has been
described for treating pain [10,11]. A modified RA, that entails
resection of only the femoral head and neck, has been used by our

https://doi.org/10.1016/j.arth.2018.03.016
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 W. Curtis, M. Marmor / The Journal of Arthroplasty 33 (2018) 2560e2565
institution as a pain-reducing procedure for patients with severe
hip pain who fail or cannot undergo THA [10e12]. Despite being
used for this indication, the efficacy of RA in treating chronic pain in
the substance abuse patient population has been largely undocu-
mented. The specific aim of this retrospective case series is to
evaluate the outcomes of the THA sobriety pathway and RA in
treating severe hip pain in patients with a history of substance
abuse. We hypothesized that the sobriety pathway has a low suc-
cess rate and that RA provides adequate pain relief to a similar
proportion of patients compared to those who complete the so-
briety pathway and undergo THA.
Methods
We conducted a retrospective case series comparing outcomes of
RA vs yearlong sobriety pathway leading to THA in treating severe
hip pain of patients with documented substance abuse. All RA pa-
tients were identified using a 27,112 current procedural terminology
(CPT) code (Resection Arthroplasty) query of our institution's elec-
tronic medical record system. Patients in this population with a
history of substance abuse were then identified using their social
history records at the time of surgery (2005-2017, n ¼ 25). RA pa-
tients with chronic infection in addition to destructive joint disease
were stratified and analyzed separately (n ¼ 15). Eleven patients had
chronic infection/osteomyelitis of the hip joint (2 of them were after
ORIFs), two patients had an acute hip joint infection/hip abscess, and
one patient suffered from bacteremia/sepsis. The details of one pa-
tient's infection could not be discovered. All patients did have
destructive changes of the hip joint.
Patients in the THA sobriety pathway were identified using a
pathway registry (n ¼ 37), which documents all patients who have
enrolled in the pathway since beginning from 2014. This registry
also records the results of UTOX screenings as well as those who
have successfully completed the pathway. Patient factors including
age, body mass index, comorbidities at the time of surgery, and
preoperative pain level were recorded for members of both cohorts.
RA and THA sobriety pathways were considered as separate
treatments and analyzed using an intention-to-treat analysis.
Because the primary outcome was adequate management of hip
pain, patients who did not complete the pathway because of the
failure to prove sobriety or follow-up were assumed to have not
achieved this target. Historically, all patients with uncontrolled
arthritic hip pain, who were not immediate candidates for THA,
were offered RA as a temporizing pain management procedure
before beginning the yearlong sobriety pathway. All patients
included in the RA cohort were not enrolled in the THA sobriety
pathway at the time of their surgery. After RA, all patients who did
not have an active infection were offered enrollment in the sobriety
pathway for THA, realizing that although RA will control their pain,
THA will give them better function. Patients in the RA cohort were
not included in the THA/sobriety cohort if they chose to enter the
pathway after RA.
The RA procedures included in this study were performed by
multiple surgeons. To the best of our knowledge, and according to
the author's preferred technique, all procedures included a stan-
dard arthroplasty femoral neck cut, erring on being slightly long
rather than too short in anticipation of the future revision surgery.
Depending on the approach, the posterior or anterior capsule was
repaired in a standard fashion, as per the individual surgeon's
preferred technique.
Statistical Analysis
The primary outcome measurements were achievement of
adequate pain control and time to adequate pain control after
2561
surgery. “Adequate” was defined as visual analog scale pain of
5
or pain described as “moderate,” “mild,” or “no pain” using recor-
ded verbal description. These measurements were compared be-
tween groups using a chi-square test and Kaplan-Meier survival
analysis. Patients in the RA cohort with infectious arthritis were
stratified and analyzed separately. Time to adequate pain control
was also compared between the 3 cohorts using analysis of vari-
ance test for significant difference, and between RA and THA using
Student's t test. Change in level of mobility and reoperations were
recorded as secondary outcomes. Mobility was described as
ambulatory, ambulatory with assistive device, or nonambulatory.
Results
Figure 1 shows the outcomes of patients in the RA and sobriety
pathway/THA cohorts. Figure 2 shows the percent of each cohort
whose pain was controlled vs time after the initiation of treatment
(whether RA or pathway enrollment). Survival end point was
defined as the time at which adequate pain control was described
in the patient's medical chart, either postoperatively (for RA) or
postpathway enrollment (for pathway). Figure 3 compares cohorts
using the same end point, but only for patients who underwent
surgery, excluding all patients who were unable to complete the
pathway and undergo THA.
The RA cohort had a mean age of 57.6 years and was 72% (18)
male and 28% (7) female. The THA pathway cohort had a mean age
of 55.8 years and was 73% (27) male and 27% (10) female. Of 25
patients undergoing RA, 19 patients (76%) achieved adequate pain
control, at a mean of 225.35 and median of 119.5 days following
surgery (Table 1; min ¼ 12, max ¼ 800). Fifteen of these 25 patients
had documentation of hip joint infection in addition to severe joint
degeneration before RA, 3 of which had hardware removal as part
of their RA: 2 with a sliding hip screw and plate constructs and 1
patient with a hemiarthroplasty. Of patients without infection at
the time of surgery, 9 underwent RA as a pain-reducing procedure
for hip arthritis without infection, and 1 underwent RA for severe
hip contractures. Those with infectious arthritis reached target pain
levels at a mean of 201.1 days after RA, while those without pre-
operative infection reached adequate pain control at 192.6 days
postoperatively (P ¼ .47). In patients for whom postoperative pain
scores or descriptions were available, 10/11 (91%) of RA patients
with infectious arthritis and 9/10 (90%) without preoperative
infection reached adequate pain control (P ¼ .99). All 9 patients
who underwent RA for osteoarthritis without infection reached
target pain levels. Of the 6 total RA patients who did not reach
target pain levels, only 2 patients experienced unresolved severe
pain documented at their last follow-up. One of these patients was
quadriplegic due to unrelated medical conditions, complicating his
recovery and factoring into his pain level post-RA. The remaining 4
patients did not have specific pain scores or descriptions listed in
their charts, one of whom was in a vegetative state due to unrelated
medical conditions and therefore unable to provide pain informa-
tion. Of patients for whom pain scores were available, 19 of 21
(90.5%) patients with substance abuse experienced adequate con-
trol of hip pain through RA. Three patients who achieved target
pain levels after RA later converted to THA after proving sobriety at
238, 266, and 277 days post-RA, respectively, one of whom expe-
rienced infection before RA. These patients who underwent con-
version to THA in our series had no surgical complications and an
uneventful recovery.
In the sobriety pathway/THA cohort, of 37 patients enrolled in
the sobriety pathway, 28 patients had been enrolled for at least 1
year (the minimum required for THA consideration). Fifteen pa-
tients (53.6%) proved 1 year sobriety, but only 11 of these (39.3%)
then underwent THA. Nine patients (32.1%) had achieved target
2562 W. Curtis, M. Marmor / The Journal of Arthroplasty 33 (2018) 2560e2565
Fig. 1. Flowchart demonstrating the outcomes of each cohort.
pain levels at the time of data collection (Table 1). Eleven patients
(39.3%) had not completed the pathway due to at least one failed
UTOX test, 1 patient was waived from the pathway for unknown
reasons, and 1 patient transferred to and underwent THA at a
hospital that did not require a sobriety pathway. Nine patients
enrolled in the pathway had not yet been followed for 1 year and
therefore were ineligible for THA. However, 5 of these patients had
already been lost to follow-up before their second UTOX screening.
For those who completed the pathway and underwent THA (n ¼
11), the mean time from pathway enrollment to THA was 448 days,
median 386 (min ¼ 99, max ¼ 799), and the mean time from
enrollment to target pain level was 508 days. One patient under-
went THA only 99 days after enrollment by providing over a year of
documented sobriety before beginning the pathway. At the time of
data collection, 9 of the 11 patients (81.8%) who underwent THA on
completing the sobriety pathway had achieved adequate pain
control, at a mean of 107 days after surgery, median 77 (min ¼ 20,
max ¼ 273). Two patients had not yet reached target pain levels at
the time of data collection. These 2 patients were 198 and 307 days
post-THA, respectively.
A significantly greater proportion of RA patients (for whom pain
scores were recorded) achieved adequate pain control compared
with those enrolled in the THA sobriety pathway for at least 1 year
(P < .0001). There was no significant difference between RA and
THA patients in terms of proportion of patients who reached target
pain levels (P ¼ .85). The time at which RA and THA patients ach-
ieved target pain levels postoperatively was not significantly
different (P ¼ .19).
Of 25 patients in the RA cohort, 24 patients had preoperative
and postoperative ambulatory information available. Preopera-
tively, 16 (66.7%) were nonambulatory, 7 (29.2%) were ambulatory
with assistive device, and one (4%) was ambulatory (Table 2).
Postoperatively, 12 (50%) were nonambulatory, 9 (37.5%) were
ambulatory with assistive device, and 3 (12.5%) were ambulatory
(Table 3). Seven patients (29.1%) experienced a gain in level of
mobility, 3 patients (13.6%) lost mobility, and 14 patients (63.6%) no
change in ambulatory status following RA (Table 4). Two patients
were paralyzed before RA and 3 were nonambulatory post-
operatively due to unrelated conditions. In the THA cohort, in
which 10 patients had ambulatory information available, 2 (20%)
were nonambulatory preoperatively, 5 (50%) were ambulatory with
assistive device, and 3 (30%) were ambulatory (Table 2). Post-
operatively, 2 (20%) patients were nonambulatory, 3 (30%) were
ambulatory with assistive device, and 5 (50%) were ambulatory
(Table 3). Three patients (30%) experienced improved level of
mobility after THA and 7 (70%) experienced no change (Table 4).
However, one patient attributed inability to ambulate to pain in
their nonoperative hip.
Two patients (8%) experienced postoperative infections after RA,
both of which required reoperation. In the THA cohort, 2 patients
(18%) experienced recurrent dislocations after THA and one (9%)
requiring reoperation.
Discussion
Management of severe hip pain in patients with chronic sub-
stance abuse can be very challenging, with a paucity of medical
literature offering guidelines. In the present study, we report on our
experience with managing these patients with either RA or delayed
THA after completing a yearlong sobriety pathway. In this series, RA
has proven to be a very effective procedure for control of arthritic
pain, with 19 of 25 patients achieving the target pain levels,
regardless of whether preoperative infection was present. This
makes it a compelling option for treating severe degenerative hip
pathology in this patient demographic, in which pain management
poses a greater challenge than in the general population [3,4] and
in which infection is at higher risk [7,8]. Furthermore, we have
shown that a similar proportion of arthritic patients who wish to
 W. Curtis, M. Marmor / The Journal of Arthroplasty 33 (2018) 2560e2565 2563

Fig. 2. Percentage of cohort that experienced adequate pain relief vs the time from either surgery (for RA cohorts) or enrollment in the THA sobriety pathway.

% Cohort Reaching Pain Control vs. Days Post-Surgery

100

90

80

70
Percent of Cohort

60

50

40

30

20

10

0
130

310

490
10
30
50
70
90
110

150
170
190
210
230
250
270
290

330
350
370
390
410
430
450
470

510
530
550
570
590
610
630
650
670
690
710
730
750
770
790

Days AŌer Surgery

RA RA (InfecƟous ArthriƟs) THA

Fig. 3. Percentage of cohort that experienced adequate pain relief vs the time from surgery. This excludes all pathway patients who did not undergo THA.
2564 W. Curtis, M. Marmor / The Journal of Arthroplasty 33 (2018) 2560e2565

Table 1 Table 3
Path Completion and Pain Control. Postoperative Mobility.

THA Pathway RA (No RA (Infectious Arthroplasty Type Nonambulatory Ambulatory With Ambulatory
Infection) Arthritis) Assistive Device

Cohort size 28 10 15 THA (n ¼ 10) 2 (20%) 3 (30%) 5 (50%)

Pathway completion 15 (53.6%) N/A N/A
THA completion 11 (39.3%) N/A N/A
Postoperative pain scores 11 (100%) 10 (100%) 11 (73.3%)
available
Adequate pain control 9 (32.1%) 9 (90%) 10 (66.7%)
Mean time to pain 107 (from THA) 192.6 201.1
control (days) 508 (from
enrollment)
RA, resection arthroplasty; THA, total hip arthroplasty.
undergo RA experience pain relief compared to those who undergo
THA, with very few of them requiring future conversion to THA.
However, this study also demonstrates that those who wish to
convert to THA from RA can do so without complication. A recent
study showed that conversion of RA to THA had similar results to
revision THA for aseptic loosening in terms of pain, range of motion,
and clinical outcome [13]. Previous studies have reported increased
dislocation rate [14], leg-length discrepancy, and range of motion,
despite having good clinical outcomes [12e16]. We expect that the
3 RA patients who later converted to THA did so to gain function
rather than to alleviate pain. Although they were all ambulatory
after RA and reached target pain levels, it is expected that THA still
allows for an increased overall function relative to RA.
A safe approach to perform THA in patients with a history of
chronic substance abuse is to require the patients to demonstrate
sustained sobriety. The sobriety pathway that was required from
our patients entailed a full year of documented negative urinary
toxic substances tests. However, medical compliance in patients
with substance abuse has been shown to be lower than in the
general population [17], making this an obstacle to necessary care.
In the present study, we demonstrated a relatively low percentage
of success in this pathway (37.9%), the primary reason being
inability to follow-up and/or prove sobriety (Fig. 1).
The results of this study suggest that a yearlong sobriety
pathway leading to THA may be an unrealistic expectation for pa-
tients with substance abuse who experience severe hip pain,
resulting in successful pain reduction in fewer than 1 of 3 patients
who enrolled in the pathway. For patients willing to undergo RA,
particularly those with intractable uncontrolled pain, RA may offer
comparable if not better chances of effective early pain control,
even if these patients experience hip joint infection preoperatively
(Fig. 2). Our study further suggests that there is a very low likeli-
hood for these patients to undergo THA in the future but that this
option is available if necessary. In simply judging success of treat-
ment by the percent of patients whose pain is controlled, RA has a
far better success rate when compared to the current standard of
sobriety pathway leading to THA (79.6% compared to 32.1%,
respectively). Even compared to those patients who undergo THA
after proving sobriety, THA did not provide adequate pain control to
a greater proportion of patients than RA nor did it provide
pain relief significantly faster than RA for patients whose pain
RA (n ¼ 24) 12 (50%) 9 (37.5%) 3 (12.5%)
RA, resection arthroplasty; THA, total hip arthroplasty.
scores were available (Fig. 3). Owing to the lack of follow-up and
inability to prove sobriety, the THA sobriety pathway may leave
many patients untreated and continuing to experience debilitating
pain.
An interesting finding of this study is that RA has comparable
results to THA in terms of postoperative mobility in this patient
population. In previous studies, a primary documented drawback of
and counterargument to RA has been shortening of the operative
limb, thought to reduce mobility postoperatively and therefore
decrease the quality of life [18]. As shown in this study, only 3 of 24
(12.5%) patients reported loss of mobility after RA and 7 patients
(29.1%) experienced increased mobility after surgery (Table 4). For
patients who experienced improved mobility through RA, preop-
erative charts showed that they were nonambulatory because of
severe pain on ambulation before surgery and gained mobility
because of reduced pain after resection. A majority (63.6%) expe-
rienced no change in ambulation. We believe that these data show
that the frequency of post-RA mobility loss in this patient popula-
tion is low and is an acceptable risk given the reduction in pain that
RA offers. THA did not seem to offer better results than RA in
improving patient mobility. This result may be explained by the
severity of the patient arthritic disease, as well as their comorbid-
ities, making reduction of pain the primary goal of both procedures.
The primary limitations of this study relate to its retrospective
design, the small number of patients, and the subjective nature of
pain scores/descriptions. Owing to its retrospective design, all in-
formation was retrieved from existing chart notes, some more
complete than others in terms of documentation of pain and
medications. Although severe hip joint pain is a common problem
in this patient population, few patients seek and follow through
with treatment, leading to a small sample size. The subjective na-
ture of pain scores make them less comparable between cohorts,
and this is even more so for pain descriptions. Furthermore, pa-
tients in this population also frequently experienced other chronic
health issues, which could have affected their postoperative pain
levels. Finally, the inconsistency of follow-up in many of these pa-
tients made establishing strict end points for outcome measure-
ment difficult and led to the lack of accuracy in determining the
time at which outcomes were reached. For example, if a patient was
lost to follow-up for over a year after surgery and then returned
with adequate pain control, the outcome was recorded at that later
appointment, even though the patient may have reached adequate
pain control much earlier. However, we believe that the data pre-
sented here are sufficient to demonstrate that RA is a compelling
and overall beneficial treatment for patients in this difficult popu-
lation and one that should be investigated further.

Table 2
Preoperative Mobility. Table 4
Change in Mobility.
Arthroplasty Type Nonambulatory Ambulatory With Ambulatory
Assistive Device Arthroplasty Type Decrease No Change Increase

THA (n ¼ 10) 2 (20%) 5 (50%) 3 (30%) THA (n ¼ 10) 0 (0%) 7 (70%) 3 (30%)
RA (n ¼ 24) 16 (66.7%) 7 (29.2%) 1 (4%) RA (n ¼ 24) 3 (13.6%) 14 (63.6%) 7 (29.1%)

RA, resection arthroplasty; THA, total hip arthroplasty. RA, resection arthroplasty; THA, total hip arthroplasty.
 W. Curtis, M. Marmor / The Journal of Arthroplasty 33 (2018) 2560e2565
Conclusion
While THA is a proven treatment of chronic hip pain and should
continue to be a mainstay of treatment, our study shows that, owing
to poor follow-up and substance dependence, it may not be effective
when combined with a sobriety pathway in treating patients with
substance use disorders. As shown in our patient population, RA is a
compelling treatment option for patients with substance abuse who
experience severe hip pain. Compared with THA, which often re-
quires proof of sustained sobriety and is not usually performed in the
setting of preoperative infection, RA enables more patients to be
treated, patients to be treated sooner, and results in comparable
outcomes in terms of pain reduction. If nothing else, RA may be an
effective pain-reducing procedure for patients within a sobriety
pathway, to be later converted to THA, and should be offered to pa-
tients taking this route. For these reasons, we believe that more
research into the use of RA in treating this patient population is
warranted. The information gathered by this study will help in un-
derstanding the efficacy of RA used in this patient demographic,
giving these patients more choices in their medical care and
improving treatment of this underserved population.
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 The Journal of Arthroplasty 33 (2018) 2666e2670

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Residual Byproducts of Peroxide Crosslinked Vitamin E-Blended

Ultrahigh Molecular Weight Polyethylene
David A. Bichara, MD a, b, Caitlin C. O'Brien a, Brinda N. Doshi, MS a,
Gunnlaugur P. Nielsen, MD b, c, Ebru Oral, PhD a, b, *, Orhun K. Muratoglu, PhD a, b
a
Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts
b
Department of Orthopaedic Surgery, Harvard Medical School, Boston, Massachusetts
c
Bone and Soft Tissue Pathology, Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts

a r t i c l e i n f o a b s t r a c t

Article history: Background: Wear resistance of ultrahigh molecular weight polyethylene (UHMWPE) is improved via
Received 14 November 2017 ionizing radiation crosslinking and subsequent high temperature melting for improved toughness. Our
Received in revised form group has previously reported that crosslinking can also be achieved chemically using organic peroxides.
2 March 2018
However, volatile peroxide byproducts are generated during consolidation. The purpose of this study was
Accepted 5 March 2018
Available online 13 March 2018
to quantify elution of volatile peroxide byproducts from UHMWPE before and after in vivo implantation,
and to determine their effects on local tissues.
Methods: We prepared crosslinked UHMWPE samples with 5 times the nominal concentration of
Keywords:
UHMWPE
peroxide needed for improved wear resistance. Control samples (not crosslinked), crosslinked samples,
peroxide crosslinking and crosslinked high temperature melting samples were implanted subcutaneously in New Zealand
high temperature melting white rabbits for 28 days. Fourier-transform infrared spectroscopy (FTIR) was used to quantify elution of
biocompatibility residual peroxide byproducts, and biocompatibility was determined via histological analysis of peri-
medical device prosthetic tissues.
histology Results: Fourier-transform infrared spectroscopy demonstrated elution of residual peroxide byproducts
in vivo. No histological differences were observed between tissues in contact with any of the 3 groups of
implants; tissues were characterized by fibrosis and a synovial-like lining for all groups.
Conclusion: UHMWPE chemically crosslinked with very high concentration of organic peroxide did not
show any detrimental changes to surrounding subcutaneous tissues, further demonstrating feasibility of
crosslinking UHMWPE with a peroxide, rather than irradiation, for the potential use of the material as a
bearing surface for joint arthroplasty.
© 2018 Published by Elsevier Inc.

Long-term performance of load-bearing articular components
fabricated using ultrahigh molecular weight polyethylene
(UHMWPE) depend strongly on their wear and damage resistance.
Radiation crosslinking increases the wear resistance of UHMWPE,
but it also reduces its damage resistance by generating residual free
radicals. Melting [1] or annealing [2] (heating to below the melting
point) after irradiation, or incorporation of antioxidants [3] are
commonly used to improve the oxidative stability of UHMWPE.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.004.
* Reprint requests: Ebru Oral, PhD, Massachusetts General Hospital, Harris Or-
thopaedic Laboratory, 51 Morse Rd., Newton, MA 02460.
Highly crosslinked UHMWPE components with improved oxidative
stability have become the standard-of-care for the treatment of
total joint patients.
Although crosslinking is exclusively carried out by using ionizing
radiation, chemical crosslinking of UHMWPE with an organic
peroxide additive in combination with an antioxidant is also feasible
[4]. The organic peroxide (2,5-dimethyl-2,5-di(t-butylperoxy)-
hexyne-3 or P130) is commonly used to crosslink various grades of
polyethylene resins for industrial applications. A blend of
UHMWPE resin powder with P130 and vitamin E crosslinks during
consolidation, eliminating the need for subsequent irradiation. In
addition, postconsolidation exposure to temperatures above 280
C
in an inert gas (high temperature melting [HTM]) substantially
increases the impact toughness of the chemically crosslinked
UHMWPE without sacrificing its wear resistance [5].

https://doi.org/10.1016/j.arth.2018.03.004
0883-5403/© 2018 Published by Elsevier Inc.
 D.A. Bichara et al. / The Journal of Arthroplasty 33 (2018) 2666e2670 2667

Fig. 1. Gross appearance of the implants after 4 weeks in vivo. (A) Representative image of a polyethylene implant under subcutaneous tissue in a New Zealand white rabbit. (B)
Image of all polyethylene implants retrieved from the animals: the fibrous capsule surrounding the implants was easily removed and processed for histological examination. From
top: group 1: nonecrosslinked control, group 2: crosslinked, and group 3: crosslinked HTM. Note that during the implantation, the colors of the groups remained unchanged. HTM,
high temperature melting.

Chemical crosslinking of UHMWPE is initiated by the thermal
decomposition of the incorporated peroxide [6]. The free radicals
resulting from the decomposing peroxide initiate free radicals in
UHMWPE, which recombine to form crosslinks during consolida-
tion. The peroxide used in this study, P130, has a 1-min half-life,
decomposition temperature (>180
C) that is in the range of
consolidation temperatures for UHMWPE, allowing simultaneous
consolidation and crosslinking. During consolidation and cross-
linking, the peroxide is transformed into end products, the most
common of which are t-butyl alcohol, acetone, and carbon oxides
for P130, which are relatively volatile compounds [7]. Post-
crosslinking exposure of the UHMWPE to elevated temperatures
during HTM facilitates removal of the residual byproducts of
peroxide decomposition.
Although the byproducts are volatile and should be removed
during the HTM after consolidation, it is still crucial to understand
the potential adverse effects of these residuals on local tissue should
they elute out of the components in vivo. We optimized a chemically
crosslinked and high-temperatureemelted UHMWPE formulation
by maximizing the wear resistance, oxidation resistance, and impact
toughness. The residual byproducts were mostly not detectable with
the optimized formulation. However, in an effort to study the po-
tential adverse effects of residuals in vivo, we determined elution of
residual byproducts of a 5-fold higher peroxide formulation used to
crosslink UHMWPE, and investigated the biocompatibility of
peroxide crosslinked UHMWPE by determining its effects on local
tissues in a New Zealand white rabbit model.
prepared a master blend of UHMWPE with 2 wt% vitamin E by
manually mixing medical grade GUR 1050 UHMWPE powder
(Orthoplastics Inc, Bacup, Lancashire, UK) with the vitamin E/iso-
propanol solution and drying the blend in a convection oven under
vacuum at 60
C for 1 week. We diluted the master blend with
virgin GUR 1050 powder and 2,5-di (t-butylperoxy) 2,5-dimethyl-
3-hexyne (P130) (Sigma-Aldrich, St. Louis, MO) to prepare a 0.2 wt%
vitamin E/UHMWPE blend. We added 5 wt% P130 into the 0.2 wt%
vitamin E/UHMWPE by shaking for 1 hour in a Turbula Shaker (T2F;
Glen Mills Inc, Clinton, NJ). We used 2 blend formulations in this
study: (1) UHMWPE containing 0.2 wt% vitamin E and (2)
UHMWPE containing 0.2 wt% vitamin E and 5 wt% P130.
We compression molded the blends into cylindrical pucks
(diameter ~10 cm, thickness ~3 cm) using a laboratory press
(Carver, Wabash, IN). We melted a group of the compression
molded-UHMWPE/vitamin-E/P130 blend in an inert gas convection
oven (LCD1-16N-3, Despatch Industries, Minneapolis, MN) at 310
C
for 5 hours. We machined the pucks into cylindrical implants (2 cm
height, 2.5 cm diameter) with chamfered/smooth edges. Steriliza-
tion of the implants was with ethylene oxide gas. We used the
following implants in the animal experiments: (1) UHMWPE con-
taining 0.2 wt% vitamin E (not crosslinked control), (2) UHMWPE
containing 0.2 wt% vitamin E and 5 wt% P130 (crosslinked), and (3)
high-temperatureemelted UHMWPE containing 0.2 wt% vitamin E
and 5 wt% P130 (crosslinked and HTM).
Implantation and Histological Analysis

Materials and Methods
Preparation of Vitamin E/P130/UHMWPE Blends Followed by
Consolidation and HTM
We dissolved vitamin E (D,L-a-tocopherol; DSM, Parsippany, NJ)
in isopropanol with a concentration of 20 g/L in 1 kg batches. We
Institutional animal care and use committee's approval was ob-
tained before subcutaneous implantation. We operated on 9 male
New Zealand white rabbits aged 12 months weighing 3 ± 0.1 kg (Pine
Acres Rabbitry Farm/Research Facility, Norton, MA). Each rabbit
received 2 implants as described in the following (n ¼ 6 samples per
group). Rabbits were randomly allocated to their respective groups.
We anesthetized the animals using ketamine-xylazine (40 þ 5 mg/kg

Fig. 2. Representative images of histological slides of tissue that was in contact with polyethylene during implantation: (A) nonecrosslinked control, (B) crosslinked, and (C)
crosslinked HTM. All tissues exhibited signs of fibrosis and a synovial-like lining.
2668 D.A. Bichara et al. / The Journal of Arthroplasty 33 (2018) 2666e2670

Fig. 3. Representative Fourier-transform infrared spectroscopy (FTIR) absorbance spectra: (A) nonecrosslinked control, (B) crosslinked, and (C) crosslinked HTM.

intramuscularly) and isoflurane (3% inhalant), shaved the dorsum,
and prepped the animals in sterile fashion using chlorhexidine glu-
conate 4%. The incision using a 15 surgical scalpel blade was inter-
scapular and 4 cm in length. We created 2 dorsum pockets, located
on the right and left sides of the dorsum using curved Metzenbaum
scissors. We placed the implants inside the dorsum pockets, which
we sutured via interrupted stiches using 3-0 Nylon (Fig. 1A). Post-
operative analgesia was achieved using buprenorphine hydrochlo-
ride (0.1 mg/kg subcutaneously). After recovering from anesthesia,
rabbits were housed individually in cages (22ʺ  25ʺ  26ʺ) in a room
with 12-h light cycles. Food and water were provided ad libitum. We
monitored the implant sites daily for the entirety of the study. After
28 days, we euthanized the animals and dissected the implants from
their capsules. We wiped the retrieved implants with lint-free tissue
paper and deionized water (Fig. 1B). We fixed the tissue capsules
surrounding the implants in 10% buffered formalin and processed for
histological analysis using paraffin embedding and hematoxylin and
eosin staining of 5 mm tissue sections. In a blinded fashion, a
pathologist specialized in bone and soft tissue (G.P.N.) subjectively
analyzed 3 slides from the tissue collected around each implant, each
slide containing 2 tissue sections.
Analysis of Peroxide Decomposition Products by Fourier-Transform
Infrared Spectroscopy
We analyzed the implants with Fourier-transform infrared
spectroscopy (FTIR) before implantation and after retrieval from
the animals. The analysis consisted of cutting the implants in half
through the circular plane and microtoming sections (150 mm
thick). We collected FTIR spectra at 100 mm increments from the
edge of the thin section that corresponded to the free surface of the
implant at a collection frequency of 4 cm1 and an average of 32
scans (Varian FTS2000 FTIR spectrometer with a Bio-Rad UMA500
FTIR microscope attachment, Agilent Technologies Inc, Wilm-
ington, DE). We calculated peak indices as the ratio of the area
under the peak at 914, 1169, and 3450 cm1 to that of the peak at
1895 cm1. Subsequently, we soaked the samples in 200 mL of
refluxing hexane for 16 hours to extract any lipids absorbed in vivo
and any residual byproducts of peroxide chemistry, followed by
vacuum drying. We repeated the FTIR scans after the hexane
extraction step. We included at least n ¼ 3 specimens taken from
the same implant for each material before implantation and at least
n ¼ 6 specimens taken from 3 implants (n ¼ 2 from each) for each

Fig. 4. Comparison of significant peaks at implantation and after retrieval for noncrosslinked (A), crosslinked (B) and crosslinked and HTM (C) UHMWPE. Asterisk indicates sta-
tistical significance with P < .05.
 D.A. Bichara et al. / The Journal of Arthroplasty 33 (2018) 2666e2670 2669

Fig. 5. Absorbance value depth profiles for FTIR peaks at (A) 914 cm1, (B) 1169 cm1, and (C) 3400 cm1 of all 3 groups before implantation and after retrieval at day 28.

material after revision before and after hexane extraction. We used
Student t test and assigned significance to P < .05 where
appropriate.
Results
All rabbits (9 of 9) recovered uneventfully from surgery and
survived the 28-day implantation period. The skin contoured the
UHMWPE, encapsulating the implant (Fig. 1A). None of the sub-
cutaneous pockets containing the UHMWPE samples, throughout
the study and on retrieval, showed any signs of dorsum skin edema,
extrusion, seromas, or hematomas. Visually, the implants looked
unchanged on retrieval from the animals (Fig. 1B). Similarly, there
was minimal variance among all 3 groups in the histological
appearance of tissue surrounding the implants. Hematoxylin and
eosin staining exhibited signs of fibrosis and a synovial-like lining
around the implants for all groups (Fig. 2).
Multiple FTIR absorbances appeared with the addition of the
peroxide (Fig. 3). Three strongest absorbances were at 914, 1169,
and the OH peak at 3450 cm1. Nonecrosslinked control samples
did not have measurable absorbances at these wavenumbers
(Fig. 4A). Crosslinked samples had the highest absorbances among
all 3 groups and there was no significant change after the im-
plantation period (Fig. 4B). For the crosslinked HTM samples, the
average values for the analyzed absorbances were lower than those
of the crosslinked samples and there was a significant decrease
after the implantation period (P < .05; Fig. 4C). A comparison of the
absorbance profiles throughout the sample thickness showed a
decrease in intensity near the surface of the implants after the
implantation period (Fig. 5).
Discussion
Although the use of organic peroxides to crosslink polyolefins,
polyethylenes in particular, is common in the field of industrial
plastics, the use of this technology in the fabrication of orthopedic
implants requires increased scrutiny, specifically on potential
changes on the biocompatibility of UHMWPE with the peroxide
addition. The peroxide used in the current communication is typi-
cally supplied with a minimum of 90% purity; although the
remaining impurities are not commonly identified individually, most
are believed to be variant peroxides that are intermediate products in
the manufacturing of the desired peroxide compound. The expec-
tation is that all the variants of the peroxide will decompose similar

Fig. 6. Most common end products of the decomposition of the peroxide P130 used in this study.
2670 D.A. Bichara et al. / The Journal of Arthroplasty 33 (2018) 2666e2670
to the main compound with intermediate free radicals and similar
end products. The most common end products of the decomposition
of the peroxide P130 used in this study are t-butyl alcohol, acetone,
methane, carbon monoxide, carbon dioxide and 2,5-dimethyl-3-
hexyne-2,5-diol (Fig. 6), most of which are volatile and are ex-
pected to be removed from the polymer during the HTM step.
However, there might be some residual peroxide and its byproducts
that could compromise the biocompatibility of the peroxide cross-
linked polymer.
We previously tested the biocompatibility of peroxide crosslinked
and HTM UHMWPE optimized for wear resistance and mechanical
properties. That UHMWPE formulation contained 0.2 wt% vitamin E
and 0.875 wt% P130 and was ram extruded to 10 cm (4ʺ) diameter
bars, followed by HTM at 300
C. We found no histological signs of
inflammation or any other adverse effects when compared with
clinically used radiation crosslinked and melted UHMWPE [8]. In the
present study, we maximized the concentration of the potential re-
siduals by increasing the concentration of the peroxide in the starting
blend to more than 5-fold of that for the optimized formulation. Even
with this grossly increased peroxide concentration of 5 wt%, there was
no apparent adverse effects to the periprosthetic tissue in the sub-
cutaneous rabbit implantation model (Fig. 2). A limitation that we
were not able to assess in this in vivo model was the effect of physi-
ological load on peroxide byproduct elution; this could be assessed
using a hip or knee simulator study or finite element analysis to
determine byproduct elution rate per million cycle.
We adapted the biocompatibility model used here from ISO
10993-6. The ISO standard uses the rabbit paravertebral muscles as
implant sites to determine material biocompatibility. The recom-
mended implant size ranges from 1-3 mm in width and 10 mm in
length, or larger samples up to 10 mm diameter and 3 mm in
thickness. These dimensions were not feasible for our study, as
volatiles would have eluted after implants were machined from the
consolidated samples. Hence, we used larger size samples to
minimize dissipation of volatile byproducts. HTM decreased the
concentration of the byproducts, but did not eliminate them as was
measured by FTIR (Figs. 4 and 5). FTIR also detected release of the
byproducts during implantation; therefore, we were able to assess
the biocompatibility of these residual byproducts.
In summary, using an extremely high amount of peroxide to
crosslink UHMWPE followed by HTM resulted in compounds that
were eluted out in vivo; and, in the time frame of in vivo exposure
in the subcutaneous rabbit implantation model, the peri-implant
tissue response to this material was not any different than that
for the nonecrosslinked control. The results of the present study
should be combined with standard preclinical performance tests as
well as extractables and leachables testing to thoroughly evaluate
the potential of this material for use as a joint bearing surface.
Acknowledgments
David A. Bichara (D.A.B.), Caitlin C. O'Brien (C.C.O.), Brinda Doshi
(B.D.), G. Petur Nielsen (G.P.N.), Ebru Oral (E.O.), and Orhun K.
Muratoglu (O.K.M.) designed the experiments. D.A.B., C.C.O., and
B.D. performed the experiments. All authors were involved in the
analyses and interpretation of the data. D.A.B., E.O., and O.K.M.
wrote the manuscript, with help of the coauthors.
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[2] Wang A, Zeng H, Yau SS, Essner A, Manely M, Dumbleton J. Wear, oxidation and
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[3] Bracco P, Oral E. Vitamin E-stabilized UHMWPE for total joint implants: a re-
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[6] Peacock A. The chemistry of polyethylene. In: Handbook of polyethylene -
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paedic Research Society; 2016.
2702 Letters to the Editors
the operative procedures. Duration of operation, or referred to as
operative time, is a hotly debated and insufficiently explained
contributor [2,3] and is more of a predictor of adverse events [4].
Second, the associations between a 15-minute increase in
operative time and the occurrence of adverse events seem to
be largely influenced by the surgeon or hospital volume [5]. Evi-
dence suggests that complex surgical procedures such as joint
arthroplasty can result in improved outcomes when performed
by high-volume surgeons or in high-volume hospitals [6]. It has
been well established that both surgeon volume and hospital vol-
ume have impacts on postoperative complications, higher vol-
ume being associated with improved clinical outcomes [7e9].
Practice makes perfect, high-volume surgeons possess rich expe-
rience, clinical knowledge, and high-level surgical skills, who
tend to be more expertise than low-volume surgeons, and the
operative time would also be significantly reduced [5,10]. Simi-
larly, there is an apparent institutional volume effect within
high-volume hospitals, and the high efficacy teamwork and
availability of dedicated resources would contribute to short-
ening the operative time. Consequently, low-volume hospitals
or low-volume surgeons are associated with higher risk of
adverse events and prolonged operative time. Therefore, apart
from the mechanisms mentioned in the discussion section, the
hospital and surgeon volume would probably be fundamental
causes of increased risk of adverse events. Although the data
related to hospital or surgeon volume were missing, the potential
impact should be highlighted.
Last but not least, how slow is too slow? The study found there
was a consistent increase in relative risk across the spectrum of oper-
ative times, which seemed to indicate that the faster the operation,
the lower the risk of adverse event. However, we totally agree
with the authors that no compromise in surgical technique should
be made to obtain a shorter operative time. According to our experi-
ence, arthroplasty consists of many standardized surgical proced-
ures, which would take some time that could not accelerate
anymore. Thus, we believe there would be minimum operative times
for different types of joint arthroplasties. In addition, other clinical
outcomes (eg, mechanical axis, dislocation rate) were not collected,
and there might be a different association between operative time
and other outcomes. In the future, a possible recommended range
of operative time should be weighed against the clinical outcomes.
Xiang-Dong Wu, MDa
Ke-Jia Hu, MD, PhDb,c
Mian Tian, MDa
Wei Huang, MD, PhDa,*
a section.
Department of Orthopaedic Surgery
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
b work,” and “intraoperative management.” Relatedly, the authors
Department of Functional Neurosurgery, Ruijin Hospital
Shanghai Jiao Tong University School of Medicine
Shanghai, China
c
Department of Neurosurgery
Massachusetts General Hospital
Harvard Medical School
Boston, Massachusetts
*
Reprint requests: Wei Huang, MD, PhD, Department of
Orthopaedic Surgery, The First Affiliated Hospital of
Chongqing Medical University, No. 1, Youyi Road,
Yuanjiagang, Yuzhong District,
Chongqing, 400016, China.
References
[1] Bohl DD, Ondeck N, Darrith B, Hannon CP, Fillingham YA, Della Valle CJ. Impact
of operative time on adverse events following primary total joint arthroplasty. J
Arthroplasty 2018, https://doi.org/10.1016/j.arth.2018.02.037.
[2] Naranje S, Lendway L, Mehle S, Gioe TJ. Does operative time affect infection rate
in primary total knee arthroplasty? Clin Orthop Relat Res 2015;473:64e9.
[3] Duchman KR, Pugely AJ, Martin CT, Gao Y, Bedard NA, Callaghan JJ. Operative
time affects short-term complications in total joint arthroplasty. J Arthroplasty
2017;32:1285e91.
[4] Peersman G, Laskin R, Davis J, Peterson M, Richart T. Prolonged operative time
correlates with increased infection rate after total knee arthroplasty. HSS J
2006;2:70e2.
[5] Yasunaga H, Tsuchiya K, Matsuyama Y, Ohe K. High-volume surgeons in regard
to reductions in operating time, blood loss, and postoperative complications for
total hip arthroplasty. J Orthop Sci 2009;14:3e9.
[6] Halm EA, Lee C, Chassin MR. Is volume related to outcome in health care? A
systematic review and methodologic critique of the literature. Ann Intern
Med 2002;137:511e20.
[7] Ravi B, Jenkinson R, Austin PC, Croxford R, Wasserstein D, Escott B, et al. Rela-
tion between surgeon volume and risk of complications after total hip arthro-
plasty: propensity score matched cohort study. BMJ 2014;348:g3284.
[8] Katz JN, Losina E, Barrett J, Phillips CB, Mahomed NN, Lew RA, et al. Association
between hospital and surgeon procedure volume and outcomes of total hip
replacement in the United States Medicare population. J Bone Joint Surg Am
2001;83-A:1622e9.
[9] Tsai TC, Joynt KE, Orav EJ, Gawande AA, Jha AK. Variation in surgical-
readmission rates and quality of hospital care. N Engl J Med 2013;369:
1134e42.
[10] Lau RL, Perruccio AV, Gandhi R, Mahomed NN. The role of surgeon volume on
patient outcome in total knee arthroplasty: a systematic review of the litera-
ture. BMC Musculoskelet Disord 2012;13:250.
Response to Letter to the Editor on “Impact of
Operative Time on Adverse Events Following Primary
Total Joint Arthroplasty”
In Reply:
We would like to thank Wu et al [1] for writing a letter to the
editor regarding our manuscript entitled “Impact of Operative
Time on Adverse Events Following Primary Total Joint Arthro-
plasty.” That manuscript used the National Surgical Quality
Improvement Program (NSQIP) to test for independent associations
of operative time with adverse events following total hip and knee
arthroplasty. The major finding in our study was that operative
time was linearly associated with risks for anemia requiring trans-
fusion, wound dehiscence, renal insufficiency, sepsis, surgical site
infection, urinary tract infection, hospital readmission, and
extended hospital stay. This was true even with adjustment for
measured baseline patient characteristics. Wu et al made several
thoughtful observations, to which we respond in the following
First, the authors pointed out that there is the potential for con-
founding by unmeasured variables. Variables they highlighted
include “preoperative design,” “tourniquet use,” “efficacy of team-
pointed out that there is the potential for confounding of results
by hospital and surgeon volume. We fully agree with both of these
critiques. A hypothetical example of the potential confounding that
they highlight is that hospitals and surgeons who complete the op-
erations more quickly might also have better perioperative medical
management programs in place and hence a lower rate of medical
adverse events. As Wu et al point out, if this were the case, then
DOI of original article: https://doi.org/10.1016/j.arth.2018.04.030.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.029.
 Letters to the Editors 2703

operative time would be more a “predictor” of adverse events than additional research on the subject that better clarifies the causality
a “cause” of adverse events. The NSQIP does not collect information of our observed associations between operative time and adverse
on the variables that Wu et al highlight, and so such variables could events.
not be controlled for. Additional studies are needed with data sets
that enable adjustment for these potential unmeasured Daniel D. Bohl, MD, MPH
confounders. Craig J. Della Valle, MD*
Second, Wu et al asked whether there was a threshold cutoff at Department of Orthopaedic Surgery
which the adverse event rate began to increase: “How slow is too Rush University Medical Center
slow?” they wrote. We could not identify any threshold in the Chicago, Illinois
NSQIP data. Instead, similar risk increases tended to be associated
with 15-minute increases at both the lower and upper ends of *
Reprint requests: Craig J. Della Valle, MD, Department of
the operative time spectrum. As Wu et al pointed out, a major lim-
Orthopaedic Surgery, Rush University Medical Center,
itation of our study is the lack of information on orthopedic-specific
1611 W. Harrison Street, Suite 300, Chicago, IL 60612.
outcomes such as patient function, mechanical axis, dislocation
rate, and implant longevity. As a result, many technical aspects of
these procedures that could easily be compromised by rushing
through the case cannot be fairly assessed. Reference
In summary, we appreciate the interest and thoughtful com-
ments from Wu et al regarding our manuscript. Evaluating opera- [1] Bohl DD, Ondeck NT, Darrith B, Hannon CP, Fillingham YA, Della Valle CJ. Impact
of operative time on adverse events following primary total Joint arthroplasty. J
tive time as a cause of adverse events is difficult for each of the Arthroplasty 2018, https://doi.org/10.1016/j.arth.2018.02.037. [Epub ahead of
important reasons that the authors described. We look forward to print].
 The Journal of Arthroplasty 33 (2018) 2694e2703
Contents lists available at ScienceDirect
The Journal of Arthroplasty
journal homepage: www.arthroplastyjournal.org
Letters to the Editors
Letter to the Editor on “Local Infiltration
Analgesia With Liposomal Bupivacaine Improves
Pain Scores and Reduces Opioid Use After Total Knee
Arthroplasty: Results of a Randomized Controlled Trial”
To the Editor:
Mont et al [1] recently reported a statistically significant
decrease in postsurgical pain in patients receiving injections
of liposomal bupivacaine after total knee arthroplasty in the
Postsurgical Infiltration with exparel for Long Lasting Analgesia in
total knee aRthroplasty (PILLAR) study. The claim is incorrect. The
reduction in pain did not reach statistical significance.
Reference 20 describes the statistical analysis plan for the PILLAR
study [2]. According to the prespecified statistical plan: “the sample
size for the study was based on an assumption that 130 subjects per
group would be required to have a 90% power to detect a
0.3 unit
(mg intravenous morphine equivalent) between-group difference in
geometric means for total opioid dose, assuming a common standard
deviation of 0.670 using a 2-group t test with a 0.025 2-sided signifi-
cance level.” This is an entirely appropriate analysis plan. First, the pre-
specified statistical plan stipulates a 2-sided t test, the accepted
standard for randomized controlled trials. Second, the prespecified
plan stipulates a Bonferroni correction for 2 coprimary end points,
again an accepted standard.
In their report of the PILLAR study, the authors state “because
reduction in pain scores was being evaluated between treatment
groups, one-tailed tests were used… Mean (standard deviation)
AUC12-48 of visual analog scale pain intensity scores, the coprimary
efficacy end point, was 180.8 (94.80) with liposomal bupivacaine
and 209.3 (78.97) without liposomal bupivacaine, with a significant
least squares mean treatment difference (
26.88, P ¼ .0381).”
The reported 1-sided significance (P ¼ .0381) is half of the
2-sided significance (P ¼ .076). This is three-fold higher than the
prespecified threshold of 0.025. Thus, the reduction in pain score
was not statistically significant.
The prespecified statistical plan further states: “To control for
type 1 error, total opioid consumption will be tested only if the
comparison of pain intensity (area under the curve of visual analog
scale scores) between the liposomal bupivacaine and control
groups is significant.” However, the paper does exactly what the
prespecified plan prohibits. The authors report and statistically
test total opioid consumption. This propagates the type 1 error in
exactly the manner that the prespecified statistical plan was struc-
tured to avoid.
DOI of original article: https://doi.org/10.1016/j.arth.2017.07.024.
The author of this paper has disclosed potential or pertinent conflicts of inter-
est, which may include receipt of payment, either direct or indirect, institutional
support, or association with an entity in the biomedical field which may be
perceived to have potential conflict of interest with this work. For full disclosure
statement refer to https://doi.org/10.1016/j.arth.2018.03.032.
0883-5403/© 2018 Elsevier Inc. All rights reserved.
Thus, the author conclusions are compromised by 3 consequen-
tial deviations from the prespecific statistical plan:
(1). The authors substituted a 1-sided statistical analysis for the
customary and prespecified 2-sided statistical analysis,
(2). The authors ignored the prespecified Bonferroni penalty for
2 coprimary end points, interpreting their results against a
0.05 alpha level, and
(3). The authors propagated the type 1 error to the analysis of
total opioid consumption, ignoring the prespecified analysis
plan, and rending invalid their finding of a statistically sig-
nificant reduction in opioid consumption.
Steven L. Shafer, MD*
Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University
Stanford, California
*
Reprint requests: Steven L. Shafer, MD, Department of
Anesthesiology, Perioperative and Pain Medicine,
Stanford University School of Medicine, 300 Pasteur Drive,
MC-5640, Stanford, CA 94305-5640.
References
[1] Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local infiltration
analgesia with liposomal bupivacaine improves pain scores and reduces opioid
use after total knee arthroplasty: results of a randomized controlled trial. J
Arthroplasty 2018;33:90e6.
[2] Dysart S, Snyder MA, Mont MA. A randomized, multicenter, double-blind study
of local infiltration analgesia with liposomal bupivacaine for postsurgical pain
following total knee arthroplasty: rationale and design of the pillar trial. Surg
Technol Int 2016;30:261e7.
Response to Letter to the Editor on “Local Infiltration
Analgesia With Liposomal Bupivacaine Improves
Pain Scores and Reduces Opioid Use After Total Knee
Arthroplasty: Results of a Randomized Controlled Trial”
In Reply:
The active control treatment arm in this study is local infiltration
analgesia-bupivacaine HCl. The experimental treatment arm is lipo-
somal bupivacaine in addition to bupivacaine HCl. Both analgesics
have been approved by the Food and Drug Administration based on
demonstrated analgesic efficacy. Therefore, there is no scientific reason
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.032.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.033.
 Letters to the Editors
to believe that the addition of long-acting to immediate-release bupi-
vacaine would cause more pain. When the administrative decision was
made to reduce the sample size of the study, a one-sided test was
appropriately applied to test whether liposomal bupivacaine provided
better or comparable analgesia compared with bupivacaine HCl.
Hence, the hypothesis was one directional, and a one-sided statistical
test (P value) was fully justifiable [1,2]. In addition, the postsurgical
infiltration with EXPAREL for long-lasting analgesia in total knee
arthroplasty (PILLAR) study used a multilevel, hierarchical model
which inherently addressed the multiple comparison issues; therefore,
a Bonferroni correction would not be necessary or appropriate [3].
Michael A. Mont, MD*
Department of Orthopaedic Surgery
Lenox Hill Hospital
New York, New York
Walter B. Beaver, MD
Department of Orthopaedic Surgery
OrthoCarolina Hip & Knee Center
Charlotte, North Carolina
Stanley H. Dysart, MD
Department of Orthopaedic Surgery
Pinnacle Orthopedics
Marietta, Georgia
John W. Barrington, MD
Department of Orthopaedic Surgery
Joint Replacement Center of Texas
Baylor Medical Center Frisco
Plano, Texas
Daniel J. Del Gaizo, MD
Department of Orthopaedic Surgery
University of North Carolina Hospitals
Chapel Hill, North Carolina
* Department of Anesthesiology
Reprint requests: Michael A. Mont, MD, Department of
Orthopaedic Surgery, Lenox Hill Hospital, 100 E 77th Street, New
York, NY 10075.
References
[1] Knottnerus JA, Bouter LM. The ethics of sample size: two-sided testing and one-
sided thinking. J Clin Epidemiol 2001;54:109e10.
[2] Owen A. The ethics of two- and one-sided hypothesis tests for clinical trials.
Clin Ethics 2007;2:100e2.
[3] Gelman A, Hill J, Yajima M. Why we (usually) don't have to worry about multi-
ple comparisons. J Res Educ Effect 2012;5:189e211.
Letter to the Editor on “Continuous Adductor Canal
Blocks Provide Superior Ambulation and Pain Control
Compared to Epidural Analgesia for Primary Knee
Arthroplasty: A Randomized, Controlled Trial. J Arthroplasty”
To the Editor:
We read with great interest the article by Kayupov et al [1] in
a recent issue of the journal. The authors performed a
DOI of original article: https://doi.org/10.1016/j.arth.2017.11.013.
Financial Support: No funding was sought.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.036.
2695
randomized clinical trial on 145 patients who underwent pri-
mary total knee arthroplasty. Patients were randomized to 3
groups: combined spinal-epidural, spinal þ continuous
adductor canal block, or general þ continuous adductor canal
block. The authors concluded that continuous adductor anal-
gesia provides superior ambulation, lower pain scores, faster
discharge, and greater patient satisfaction when compared
with epidural analgesia for primary total knee arthroplasty.
The authors should be congratulated for performing a well-
designed study on an important topic (eg, acute pain) in
patients undergoing total knee arthroplasty [2,3]. The current
emphasis on the use of multimodal analgesics to enhance re-
covery across many orthopedic procedures makes the topic
timely in perioperative medicine [4,5].
Although the study by Kayupov et al was well conducted,
there are some questions regarding the study that need to be
clarified. First, the dropout imbalance between groups can
alter the study outcomes. It is not explained why the authors
did not perform an intention-to-treat analysis to demonstrate
that the results did not change. Second, Table 2 suggests an
imbalance between the groups for variables that may alter the
outcomes (eg, age and surgical duration). It would be important
to perform a multivariate analysis to demonstrate that the
imbalance on those variables does not affect the study results.
Finally, the authors reported on 5 outcomes in a 3-group study,
but they did not adjust P values (“significance set at <.05”) to
minimize the chance of type I errors due to multiple
comparisons.
We would welcome some comments from the authors as
this would help to further support the findings of this impor-
tant study.
Lucas J. Castro-Alves, MD
Mark C. Kendall, MD*
Rhode Island Hospital
Warren Alpert Medical School of Brown University
Providence, Rhode Island
*
Reprint requests: Mark C. Kendall, MD,
Department of Anesthesiology, Warren Alpert Medical
School of Brown University, 593 Eddy Street,
Providence, RI 02903.
References
[1] Kayupov E, Okroj K, Young AC, Moric M, Luchetti TJ, Zisman G, et al. Continuous
adductor canal blocks provide superior ambulation and pain control compared
to epidural analgesia for primary knee arthroplasty: a randomized, controlled
trial. J Arthroplasty 2017, https://doi.org/10.1016/j.arth.2017.11.013 [Epub ahead
of print].
[2] Khanna A, Saxena R, Dutta A, Ganguly N, Sood J. Comparison of ropivacaine
with and without fentanyl vs bupivacaine with fentanyl for postoperative
epidural analgesia in bilateral total knee replacement surgery. J Clin Anesth
2017;37:7e13.
[3] Sodhi N, Piuzzi NS, Dalton SE, George J, Ng M, Khlopas A, et al. What influence
does the time of year have on postoperative complications following total knee
arthroplasty? J Arthroplasty 2017, https://doi.org/10.1016/j.arth.2017.12.020
[Epub ahead of print].
[4] Bali C, Ozmete O, Eker HE, Hersekli MA, Aribogan A. Postoperative analgesic
efficacy of fascia iliaca block versus periarticular injection for total knee
arthroplasty. J Clin Anesth 2016;35:404e10.
[5] Cip J, Erb-Linzmeier H, Stadlbauer P, Bach C, Martin A, Germann R. Contin-
uous intra-articular local anesthetic drug instillation versus discontinuous
sciatic nerve block after total knee arthroplasty. J Clin Anesth 2016;35:
543e50.
2700 Letters to the Editors
Experience Increased Perception of Pain and Opioid Consumption
Following Total Joint Arthroplasty” on the Journal of Arthroplasty.
The authors have done an excellent job because there is a limited
number of reports investigating the influence of major depressive
disorder (MDD) on postoperative pain intensity and opioid con-
sumption for joint arthroplasty. They also provided arthroplasty
surgeons with some practical advice on dealing with MDD patients.
However, some questions confused us when we were reading the
article.
As we can see from the article, the diagnostic criteria of MDD
are of fundamental significance in the study because they influ-
ence the accuracy of the conclusion. However, neither did the
author provide a definition of MDD nor did they clarify what
kind of information was taken when evaluating MDD. The diag-
nosis of MDD can be established on the grounds of the clinical
records [2] or based on face-to-face surveys [3]. However, we
were not able to know anything about this from the study since
the Press Ganey survey the authors used is merely a quality
measure for patients' hospital experience [4], which is neither
suitable for evaluating MDD nor assessing the acute postoperative
pain. Furthermore, the diagnosis of MDD should be made by the
psychiatrists rather than orthopedic surgeons if more precise
results are to be achieved.
Another big concern of us about the study is the periopera-
tive treatment of MDD. According to the treatment protocol of
the study, no specific antidepression treatments (ADs) were
applied, thus may well leading to more consumption of opioid
drugs. We noticed that the authors did not subdivide the
MDD patients in terms of MDD severity, which we suppose is
a chink in the armor, because the ADs and opioid consumption
among varied severity levels of MDD must be different. Usually,
ADs are effective in severe MDD patients, while, for the mild-to-
moderate degree, the therapeutic effectiveness of placebos is
almost as effective as ADs [5,6]. Hence, it is reasonable for us
to assume that a lack of proper treatment to MDD plays a
confounding role here in this study. If placebos and/or
psychotherapies instead of more opioid are applied to those
mild-to-moderate MDD patients, the results may turn out to
be different.
Last but not least, the authors recorded postoperative pain
intensity for only 3 days, which is not sufficient to reflect the
whole picture of the opioid consumption and pain intensity dur-
ing the postoperative rehab period. In our medical center, MDD
patients with joint arthroplasty are followed up for at least 1
year, and they are also recommended to visit a psychiatrist on
a regular basis, because most of these patients suffer from
central sensitization pain and may consume more opioid after
discharge if MDD is not under well control, or their MDD symp-
toms can be exacerbated by postoperative pain, anxiety, or
nervousness.
We would like to further discuss these important issues
because it is helpful for surgeons to employ strategies for their
practice.
Appendix A. Supplementary Data
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.arth.2018.04.023.
Lingjia Yu, MD, PhDa,1
Ke Xiao, MD, PhDa,1
Danni Chib
Guixing Qiu, MD, PhDa
Xisheng Weng, MD, PhDa,*
a
Department of Orthopaedic Surgery
Peking Union Medical College Hospital
Peking Union Medical College and Chinese Academy of Medical
Sciences
Beijing, China
b
School of Psychology
Massey University
Auckland, New Zealand
*
Reprint requests: Xisheng Weng, MD, PhD, Department of
Orthopaedic Surgery, Peking Union Medical College Hospital,
Peking Union Medical College and Chinese Academy of Medical
Sciences, No. 1 Shuaifuyuan, Beijing 100730, China.
References
[1] Etcheson JI, Gwam CU, George NE, Virani S, Mont MA, Delanois RE. Patients
with major depressive disorder experience increased perception of pain and
opioid consumption following total joint arthroplasty. J Arthroplasty 2018;33:
997e1002.
[2] Rasouli MR, Menendez ME, Sayadipour A, Purtill JJ, Parvizi J. Direct
cost and complications associated with total joint arthroplasty in
patients with preoperative anxiety and depression. J Arthroplasty 2016;
31:533e6.
[3] Compton WM, Conway KP, Stinson FS, Grant BF. Changes in the prevalence
of major depression and comorbid substance use disorders in the United
States between 1991-1992 and 2001-2002. Am J Psychiatry 2006;163:
2141e7.
[4] Tyser AR, Abtahi AM, McFadden M, Presson AP. Evidence of non-response bias in
the Press-Ganey patient satisfaction survey. BMC Health Serv Res 2016;16:350.
[5] Paris J. The mistreatment of major depressive disorder. Can J Psychiatry
2014;59:148e51.
[6] Birnbaum HG, Kessler RC, Kelley D, Ben-Hamadi R, Joish VN, Greenberg PE.
Employer burden of mild, moderate, and severe major depressive disorder:
mental health services utilization and costs, and work performance. Depress
Anxiety 2010;27:78e89.
Response to Letter to the Editor on “Patients With
Major Depressive Disorder Experience Increased
Perception of Pain and Opioid Consumption
Following Total Joint Arthroplasty”
In Reply:
We thank Yu et al for the comments and appreciate the oppor-
tunity to reply. The goal of our study was to help arthroplasty
surgeons identify patients who may experience higher perceived
pain intensity and may be at risk for consuming more opioids in
the immediate postoperative period following lower extremity to-
tal joint arthroplasty (TJA). Furthermore, with patient satisfaction
serving as an important metric in determining reimbursement by
the Centers for Medicare and Medicaid Services under the Hospital
Value-Based Purchasing Program, identifying how specific patient
groups rate their experience of care is important for institutions
and orthopedic surgeons to understand [1, 2].
We recognize and agree that the diagnosis of major depressive
disorder (MDD) is most accurately made by psychiatrists, rather
than orthopedic surgeons. As such, a diagnosis of MDD was deter-
mined by a retrospective chart review to identify patients with a
diagnosis of MDD in their problem list. We rely on health profes-
sionals to maintain this problem list to accurately reflect active
DOI of original article: https://doi.org/10.1016/j.arth.2018.04.023.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.022.
 Letters to the Editors
health conditions; however, we acknowledge that electronic
medical records are prone to human input errors. With that
said, this is a limitation of all studies that perform a retrospective
chart review.
Furthermore, we would like to further clarify how we assessed
acute postoperative pain within the first 48 hours, as we did not
rely on the Press Ganey survey, as per your letter. We determined
first 48-hour post-operative pain intensity using area under the
P
curve (AUC) for visual analog scale (VAS) scores (AUC ¼ [Pain
score  Dtime]), which we included in our methods section [3].
We acknowledge that we did not subdivide patients with
MDD based on various degrees of MDD severity. We understand
your concerns regarding perioperative treatment with antide-
pressants; however, the purpose of this study was to determine
if a diagnosis of MDD influenced postoperative pain and opioid
consumption following TJA. Furthermore, a study conducted by
Kohring et al [4] investigated the role of antidepressant
treatment and outcomes following TJA. They evaluated the
clinical outcomes of depressed patients receiving perioperative
antidepressant treatment (as determined by their active medi-
cation list), depressed patients who were not receiving active
treatment (also determined by the active medication list), and
nondepressed patients. They found that patients who were
actively taking antidepressant medication experienced similar
clinical improvements as nondepressed patients at 1 year post-
operative, whereas depressed patients who were not receiving
treatment did not show a significant difference in functional
outcome scores.
We appreciate your comment regarding acute postoperative
pain intensity. As stated in your Letter to the Editor, the concern
was that pain intensity in the first 3 days following surgery was
not sufficient to completely reflect opioid consumption and pain in-
tensity during the postoperative rehabilitation period. While your
statement is correct, our stated purpose was to assess immediate
postoperative pain intensity and opioid consumption and specif-
ically in the first 48 hours (2 days) following surgery.
We value your comments as they in conjunction with our report
may stimulate further study on this important topic. We hope our
response has addressed your concerns.
Appendix A. Supplementary Data
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.arth.2018.04.022.
Jennifer I. Etcheson, MD, MSa
Chukwuweike U. Gwam, MDa
Nicole E. George, DOa
Sana Virani, MDa
Michael A. Mont, MDb
Ronald E. Delanois, MDa,*
a
Rubin Institute for Advanced Orthopedics
Center for Joint Preservation and Replacement
Sinai Hospital of Baltimore
Baltimore, Maryland
b
Department of Orthopaedics
Lenox Hill Hospital
New York, New York
* based on previous published studies; thus, no ethical approval or patient consent
Reprint requests: Ronald E Delanois, MD, Rubin Institute for
Advanced Orthopedics, Center for Joint Preservation and
Replacement, Sinai Hospital of Baltimore, 2401 West Belvedere
Avenue, Baltimore, MD 21215.
2701
References
[1] Etcheson JI, Gwam CU, George NE, Virani S, Mont MA, Delanois RE. Opioids
consumed in the immediate post-operative period does not influence how pa-
tients rate their experience of care after total hip arthroplasty. J Arthroplasty
2018;33:1008e11, https://doi.org/10.1016/j.arth.2017.10.033.
[2] Gwam C, Mistry JB, Piuzzi N, Chughtai M, Khlopas A, Thomas M, et al. What
influences how patients with depression rate hospital stay after total joint
arthroplasty? Surg Technol Int 2017;30:373e8.
[3] McGraw-Tatum MA, Groover MT, George NE, Urse JS, Heh V. A prospective, ran-
domized trial comparing liposomal bupivacaine vs fascia iliaca compartment
block for postoperative pain control in total hip arthroplasty. J Arthroplasty
2017;32:2181e5, https://doi.org/10.1016/j.arth.2017.02.019.
[4] Kohring JM, Erickson JA, Anderson MB, Gililland JM, Peters CL, Pelt CE. Treated
versus untreated depression in total joint arthroplasty impacts outcomes. J Arthro-
plasty 2018, https://doi.org/10.1016/j.arth.2018.01.065 [Epub ahead of print].
Letter to the Editor on “Impact of Operative Time
on Adverse Events Following Primary Total Joint
Arthroplasty”
To the Editor:
We read with great interest the recent study “Impact of Opera-
tive Time on Adverse Events Following Primary Total Joint Arthro-
plasty” by Bohl et al [1]. The authors evaluated the impact of a 15-
minute extension of operative time on the occurrence of adverse
events following primary total joint arthroplasty, and found pro-
portional and relatively consistent increases in complication risk
with increased operative time. They concluded that “prolonged
operative time increases the risk for multiple postoperative compli-
cations following total joint arthroplasty.” Their efforts are of great
clinical significance and should be applauded. However, we think
this article raised some interesting concerns that should be
clarified.
First, we agree that operative time could be interpreted as a
modifiable factor when evaluating the association between specific
adverse events and the operative times. However, we think the
operative time is more than an independent contributor, but also
a predictor of the risk of adverse events because the operative
time is a single parameter that is determined by multiple variables.
In this study, the authors have detected some patient demo-
graphics, comorbidity, and procedural characteristics that are asso-
ciated with prolonged operative time. In addition, surgeon-related
factors (eg, preoperative design, surgeon volume, tourniquet use)
and hospital-related factors (eg, efficacy of teamwork, hospital vol-
ume, intraoperative management) would also have significant in-
fluence on the operative time. Therefore, operative time
represents a series of heterogeneous parameters to be considered
and compared when focusing on the adverse events, and mini-
mizing operative time is a systematic exploration of optimizing
DOI of original article: https://doi.org/10.1016/j.arth.2018.02.037.
Funding: None.
Author contribution: Xiang-Dong Wu contributed substantially to conception
and design; drafted the article; gave final approval of the version to be published;
and agreed to act as a guarantor of the work. Ke-Jia Hu contributed substantially to
draft the article; gave final approval of the version to be published; and agreed to
act as a guarantor of the work. Mian Tian contributed substantially to draft the
article; gave final approval of the version to be published; and agreed to act as a
guarantor of the work. Wei Huang contributed substantially to conception and
design; revised it critically for important intellectual content; gave final approval
of the version to be published; and agreed to act as a guarantor of the work.
Ethical approval or institutional review board (IRB) approval: This letter was
is required.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.030.
2696
Response to the Letter to the Editor on “Continuous
Adductor Canal Blocks Provide Superior Ambulation
and Pain Control Compared to Epidural Analgesia for
Primary Knee Arthroplasty: A Randomized,
Controlled Trial”
In Reply:
We would like to thank Drs Castro-Alves and Kendall for their
thoughtful inquiry and comments on our article. We agree with
the intent of the suggestions and would like to describe our
motivation as well as include the results of your suggested modifi-
cations, which indicate that our results are robust.
As to the first point, we agree that dropout imbalance between
treatments can certainly affect outcomes, particularly if there is a causal
relationship between treatment and dropout rate. However, we found
no differences in demographics between groups irrespective of the
dropout rate. In addition, all analyses were originally performed as a
per-protocol (PP) and an intent-to-treat (ITT) analysis, but no differ-
ences were found in the resulting interpretations.
For example, here are the main and secondary outcomes as seen in
Table 2:
P values for both PP and ITT:
Ambulation distance PP: P ¼ .0206 ITT: P ¼
Pain scores PP: P ¼ .0094 ITT: P ¼
Procedure length PP: P ¼ .4105 ITT: P ¼
Discharge day PP: P ¼ .0037 ITT: P ¼
Patient satisfaction PP: P ¼ .0009 ITT: P ¼
Based on these results, we can see that the resulting outcomes were
not sensitive to the imbalance in the dropouts. We would like to clarify
that the P value of .0009 as originally reported in Table 2 under the “Pa-
tient satisfaction” outcome is intended only for the comparison of “very
satisfied” vs “not very satisfied” between groups. The percentages of
the other satisfaction ratings were included for completion, but inclu-
sion of the whole set would not change the significance.
As to the second point, we described in the article that neither
age nor surgical duration were statistically significant, so we did
not include them in our original multivariate model. However,
because they do trend toward significance, we factored them into
a new model per your suggestion to allay any concerns. We found
that our groups were still significantly different in our primary out-
comes of ambulation distance with a P value of .018 and for the
model covariates: age (P ¼ .5944), procedure length (P ¼ .0063).
For the pain score outcome, including the covariates once again
gave us similar result with a P value of .0056 for group differences
and covariates: age (P ¼ .5766), procedure length (P ¼ .2095).
Including the covariates improved the strength of our models.
As to the last suggestion; the use of a family-wise or study-wise
control of error inflation is based on our interpretation of the intent
of such adjustments. Taken to either extreme, these adjustments are
obviously overly conservative or overly liberal. We take the position
that accounting for error inflation of tests that are closely related is
reasonable, and as mentioned in the methods section, we use the
Tukey-Kramer method for within model control of error inflation.
We agree that for a set of tests/hypotheses that are related (a fam-
ily of hypotheses), the type I error should be properly controlled [1].
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.036.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.035.
Letters to the Editors
If, for instance, we were looking at ambulation distance, stair climb-
ing, getting up from a chair, or other closely related outcomes we
would apply adjustments such as a stepdown Bonferroni method
to this set of test to control the family-wise error.
In addition, we had 1 primary outcome, which was ambulation
distance. If this outcome was not significant after the first test, we
would not continue examining other outcomes to take its place in
the analysis. Therefore, we use this method as sort of a gatekeeper
to help control for overall type I error in the study. The primary
outcome was indeed significant, and so, we felt that it was appro-
priate to look at the secondary outcomes. Also, we believe it is
important that we do include several secondary outcomes, as these
provides the groundwork for other studies that can investigate
these outcomes in greater depth in further research.
We appreciate your inquiry into our study and hope that
we have been able to address all of your questions and concerns.
Erdan Kayupov, MD, MSE
Department of Orthopaedics
Rush University Medical Center
Chicago, Illinois
Mario Moric, MS
Department of Anesthesiology
Rush University Medical Center
.0220 Chicago, Illinois
.0067
.6272
.0005 Craig J. Della Valle, MD*
.0272 Department of Orthopaedics
Rush University Medical Center
Chicago, Illinois
*
Reprint requests: Craig J. Della Valle, MD, Division of Adult
Reconstructive Surgery, Rush University Medical Center,
Chicago, IL 60612.
Reference
[1] James Hung HM, Wang S-J. Challenges to multiple testing in clinical trials.
Biom J 2010;52:747e56, https://doi.org/10.1002/bimj.200900206.
Letter to the Editor on “Systematic Review of Three
Electrical Stimulation Techniques for Rehabilitation
After Total Knee Arthroplasty”
To the Editor:
Chen et al [1] recently conducted a systematic review that eval-
uated the effectiveness of neuromuscular electrical stimulation
(NMES), transcutaneous electrical nerve stimulation (TENS), and
electroacupuncture (EA) for improving patient rehabilitation after
total knee arthroplasty (TKA). It is encouraging to see how this non-
pharmacological interventions influence the patients after TKA. We
have several comments regarding this review.
The review is reported according to the Preferred Reporting
Items for Systematic Review and Meta-Analysis format, but the
inclusion criteria are ambiguous. The authors do not sufficiently
DOI of original article: https://doi.org/10.1016/j.arth.2018.01.070.
Funding: The authors received no financial support for the research, authorship,
and/or publication of this article.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.034.
2698 Letters to the Editors
Chest Physicians VTE prevention guidelines [7], for which the
selected statistics were inadequate.
As expected, authors acknowledge that 93% of the disagreement
in the CRS estimate was explained by the paucity of medical history.
It is important to emphasize that no copy of the form used was pro-
vided in the article nor were the CRS deficiencies in the 93% of pa-
tients documented. Therefore, the main variable of this study was
not and cannot be consider valid. Evidence of such deficiencies
and inaccurate calculation are seen in Figure 1 where “calculated
CRS” has a minimum of 5 points, which would represent an individ-
ual aged less than 40 years, not overweight, and with no comorbid-
ities, which is inconsistent with the typical joint arthroplasty patient
who is at least 50 years, generally with a body mass index of >25 kg/
m2 and other multiple comorbidities [8]. Correct assessment of such
population with CRS would result in scores around 9-12.
The CRS has been linearly correlated with incidence of VTE in
several surgical groups [5,9,10]. Although we agree with authors
that there is indeed a paucity of information regarding CRS and
VTE incidence in orthopedic surgical population, recent data sug-
gest that CRS could indeed predict VTE occurrence in patients un-
dergoing orthopedic surgical procedures [10]. We agree with
authors that orthopedic surgical population possesses a high risk
of VTE occurrence. It is well demonstrated that the use of risks
assessment tools empowers physicians to improve the VTE preven-
tion with measured mortality benefit.
Owing to multiple limitations, including retrospectively
collected data, incomplete documentation of comorbidities, only
inclusion of symptomatic deep vein thrombosis, limited knowledge
of deep vein thrombosis episodes seen in other institutions, and
lack of power, this study [1] cannot provide valid conclusions
regarding performance of CRS in detecting VTE occurrence in joint
arthroplasty patients.
Luis A. Diaz Quintero, MD*
Division of Internal Medicine
Department of Medicine
NorthShore University HealthSystem
Evanston, Illinois
Harry E. Fuentes, MD
Division of Internal Medicine
Department of Medicine
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois
Juan P. Salazar Adum, MD
Division of Internal Medicine
Department of Medicine
NorthShore University HealthSystem
Evanston, Illinois
Alfonso J. Tafur, MD
Division of Vascular Medicine
Department of Medicine
NorthShore University HealthSystem
Skokie, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois
James C. Kudrna, MD
Department of Orthopedic Surgery
University of Chicago Pritzker School of Medicine
NorthShore University HealthSystem
Glenview, Illinois
Joseph A. Caprini, MD
NorthShore University HealthSystem-Emeritus
Skokie, Illinois
University of Chicago Pritzker School of Medicine
Chicago, Illinois
*
Reprint requests: Luis Diaz Quintero, MD, Department of Internal
Medicine, Northshore University Healthsystem, 2650 Ridge
Avenue Room 5315, Evanston, IL 60201.
References
[1] Bateman DK, Dow RW, Brzezinski A, Bar-Eli HY, Kayiaros ST. Correlation of the
Caprini score and venous thromboembolism incidence following primary total
joint arthroplasty-results of a single-institution protocol. J Arthroplasty
2017;32:3735e41.
[2] Caprini JA, Arcelus JI, Hasty JH, Tamhane AC, Fabrega F. Clinical assessment of
venous thromboembolic risk in surgical patients. Semin Thromb Hemost
1991;17(Suppl 3):304e12.
[3] Fuentes HE, Paz LH, Al-Ogaili A, Andrade XA, Oramas DM, Salazar-Adum JP,
et al. Validation of a patient-completed Caprini risk score for venous thrombo-
embolism risk assessment. TH Open 2017;01:e106e12.
[4] Rios LHP, Fuentes HE, Oramas DM, Andrade XA, Al-Ogaili A, Iskander M, et al.
Validation of a patient-completed Caprini risk assessment tool for Spanish,
Arabic, and Polish Speakers. Clin Appl Thromb Hemost 2018;24:502e12.
[5] Hachey KJ, Sterbling H, Choi DS, Pinjic E, Hewes PD, Munoz J, et al. Prevention
of postoperative venous thromboembolism in thoracic surgical patients:
implementation and evaluation of a Caprini risk assessment protocol. J Am
Coll Surg 2016;222:1019e27.
[6] Gregory KE, Radovinsky L. Research strategies that result in optimal data
collection from the patient medical record. Appl Nurs Res 2012;25:108e16.
[7] Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, et al. Pre-
vention of VTE in nonorthopedic surgical patients: antithrombotic therapy
and prevention of thrombosis, 9th ed: American College of Chest physicians
evidence-based clinical practice guidelines. Chest 2012;141(2 Suppl):
e227Se77S.
[8] Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE,
Steiner CA, et al. Prevalence of total hip and knee replacement in the United
States. J Bone Joint Surg Am 2015;97:1386e97.
[9] Pannucci CJ, Swistun L, MacDonald JK, Henke PK, Brooke BS. Individualized
venous thromboembolism risk stratification using the 2005 Caprini score to
identify the benefits and harms of chemoprophylaxis in surgical patients: a
meta-analysis. Ann Surg 2017;265:1094e103.
[10] Luksameearunothai K, Sa-Ngasoongsong P, Kulachote N, Thamyongkit S,
Fuangfa P, Chanplakorn P, et al. Usefulness of clinical predictors for preoper-
ative screening of deep vein thrombosis in hip fractures. BMC Musculoskelet
Disord 2017;18:208.
Response to the Letter to the Editor on “Correlation
of the Caprini Score and Venous Thromboembolism
Incidence Following Primary Total Joint
ArthroplastydResults of a Single-Institution
Protocol”
In Reply:
We thank Quintero et al for their critical reading of our manu-
script regarding the relationship between the Caprini risk score
(CRS) and venous thromboembolism (VTE) following total joint
arthroplasty (TJA).
DOI of original article: https://doi.org/10.1016/j.arth.2018.03.065.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.064.
 Letters to the Editors
The authors are correct in describing the discrepancy between
“preoperative” and “calculated” scores in our article as poor
inter-rater reliability. However, Quintero et al do not characterize
how we obtained these scores correctly: “preoperative” scores
were collected retrospectively as recorded in the chart. However,
they were determined by preoperative nursing personnel before
surgery (not “retrospectively calculated preoperative CRS calcu-
lated done [sic] by nurses.”). While some suggest adequate staff
training may improve the accuracy of CRS calculation, other
reports, as we cited, have found the model has been poorly
implemented despite institutional training for nurses [1] and
physicians [2]. As stated in our article, according to our institu-
tion's protocol, this score is meant to be reviewed during the
surgical “time-out” and presumably acted upon at the surgeon's
discretion. We highlighted the poor accuracy of preoperative
scores to emphasize that, at our institution, these scores are
not obtained correctly in >90% of cases. Therefore, even if it
contained meaningful information to stratify VTE risk, the
surgeon would be presented with false values. Moreover, the
CRS utterly fails when considered as a categorical variable, as
every TJA patient is automatically considered “highest risk” by
virtue of undergoing “elective major lower extremity arthro-
plasty” (5 points) [3].
We agree that the poor inter-rater reliability reflects the
accuracy of data collection. Our suspicion was that preoperative
scores were not being calculated correctly, which is exactly
why we retrospectively determined them (calculated scores). Fig-
ures 1-3 demonstrate the distribution of preoperative
and calculated Caprini scores for 376 TJA patients. We clearly state,
“the correlation between preoperative and calculated scores was
poor (Fig. 3, r2 ¼ 0.079)” and do not attribute this value to the cor-
relation of the CRS to VTE occurrence. Data regarding the relation-
ship of CRS and VTE are presented in Table 3. We failed to
demonstrate a significant difference in calculated Caprini scores be-
tween patients with and without VTE.
As addressed in our limitations, it is plausible that not all
medical comorbidities were completely documented, poten-
tially leading to underestimation of Caprini scores for some
patients. However, 2 authors (D.K.B. and R.W.D.) independently
reviewed the senior author's history and physical, as well as the
documentation from each patient's primary care physician and/
or subspecialists providing medical clearance for arthroplasty
surgery. It is unlikely that a high number of relevant comorbid-
ities were not captured for the calculated Caprini scores. Both
the preoperative and calculated Caprini scores were determined
based on the table and methodology provided by Caprini [3].
We regret that this was not explicitly stated in our methods.
However, it would be impractical to list the CRS “deficiencies”
(missing items resulting in the discrepancy between preopera-
tive and our calculated scores) for all 376 patients, as Quintero
insists. We concede this to be another limitation. We found the
inaccuracy of nursing staffedetermined preoperative scores was
due to incomplete attribution of medical comorbidities and
technical error in using the model.
We maintain that our calculated scores are an accurate
representation of the CRS for our cohort. Quintero et al present
our minimum calculated score of 5 as evidence of “deficiencies
and inaccurate calculation.” Once again, a careful reading of our
inclusion criteria and our cohort's demographic characteristics
(Table 1) show an age range of 14e93 years. Indeed, we
included 3 patients who were aged less than 40 years and had
no medical comorbidities relevant to the CRS. Therefore, these
patients earned a calculated score of 5 (Figure 3b). The vast
majority of our patients had scores from 7 to 11, in keeping
with the typical TJA patient Quintero et al cite. The fact that
2699
these 3 young, healthy patients undergoing arthroplasty
surgery are still considered “highest risk” by the CRS demon-
strates that this model fails to provide clinically useful risk
stratification for TJA patients.
Several of the limitations Quintero et al present regarding our
study design have been adequately addressed in our manuscript.
We disagree regarding the end point of symptomatic VTE events,
as this is widely considered to be more clinically relevant in the
TJA population [4]. While we acknowledge the CRS has been vali-
dated in other medical and surgical groups, the immediate assign-
ment of “highest risk” to all TJA patients does not empower
physicians to improve VTE prevention. Furthermore, the CRS
scoring methodology attenuates the influence of other potentially
relevant comorbidities by assigning all patients 5 points for under-
going arthroplasty. We welcome the development of an accurate
and agile VTE risk assessment model tailored specifically to identify
higher risk TJA patients.
Dexter K. Bateman, MDa,*
Robert W. Dow, BSa
Andrzej Brzezinski, MDa
Howard Y. Bar-Eli, MDa
Stephen T. Kayiaros, MDb
a
Department of Orthopaedic Surgery
Rutgers Robert Wood Johnson Medical School
New Brunswick, NJ
b
University Orthopaedic Associates
New Brunswick, NJ
*
Reprint requests: Dexter K. Bateman, MD,
Department of Orthopaedic Surgery,
Rutgers Robert Wood Johnson Medical School,
1 RWJ Place, MEB 422A, New Brunswick, NJ 08901.
References
[1] Gharaibeh L, Albsoul-Younes A, Younes N. Evaluation of venous thromboembo-
lism prophylaxis after the introduction of an institutional guideline: extent of
application and implementation of its recommendations. J Vasc Nurs
2015;33:72e8.
[2] Pannucci CJ, Obi A, Alvarez R, Abdullah N, Nackashi A, Hu HM, et al. Inade-
quate venous thromboembolism risk stratification predicts venous throm-
boembolic events in surgical intensive care unit patients. J Am Coll Surg
2014;218:898e904.
[3] Caprini JA. Risk assessment as a guide for the prevention of the many faces of
venous thromboembolism. Am J Surg 2010;199(1 Suppl):S3e10.
[4] Friedman RJ. Optimal duration of prophylaxis for venous thromboembolism
following total hip arthroplasty and total knee arthroplasty. J Am Acad Orthop
Surg 2007;15:148e55.
Letter to the Editor on “Patients With Major
Depressive Disorder Experience Increased Perception
of Pain and Opioid Consumption Following Total
Joint Arthroplasty”
To the Editor:
We would like to congratulate Etcheson et al [1] on publication
of the article entitled “Patients With Major Depressive Disorder
DOI of original article: https://doi.org/10.1016/j.arth.2017.10.020.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.023.
 The Journal of Arthroplasty 33 (2018) 2368e2375

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Risk Adjustment Is Necessary in Medicare Bundled Payment

Models for Total Hip and Knee Arthroplasty
P. Maxwell Courtney, MD a, *, Daniel D. Bohl, MD, MPH b, Edmund C. Lau, MS c,
Kevin L. Ong, PhD c, Joshua J. Jacobs, MD b, Craig J. Della Valle, MD b
a
Department of Orthopaedic Surgery, Rothman Institute, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania
b
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois
c
Exponent, Inc, Philadelphia, Pennsylvania

a r t i c l e i n f o a b s t r a c t

Article history: Background: Concerns exist that high-risk patients in alternative payment models may face difficulties
Received 3 January 2018 with access to care without proper risk adjustment. The purpose of this study is to identify the effect of
Received in revised form medical and orthopedic specific risk factors on the cost of a 90-day episode of care following total hip
22 February 2018
(THA) and knee arthroplasty (TKA).
Accepted 26 February 2018
Available online 17 March 2018
Methods: We queried the Medicare 5% Limited Data Set for all patients undergoing primary THA and
TKA from 2010 to 2014. To evaluate the cost of an episode of care, we calculated all claims for 90
days following surgery. Multivariate analysis was performed to quantify the added episode-of-care
Keywords:
bundled payments
costs for demographic variables, geography, medical comorbidities, and orthopedic specific risk
risk adjustment factors.
total hip arthroplasty Results: Of the 58,809 TKA patients, the median 90-day Medicare costs was $23,800 (interquartile range,
total knee arthroplasty $18,900-$32,300), while the median of the 27,293 THA patients was $24,000 (interquartile range,
health policy $18,500-$33,900). Independent risk factors (all P < .05) resulting in at least a 10% increase in episode-of-
outcomes care costs following TKA included malnutrition, age over 85, male gender, pulmonary disorder, failed
internal fixation, Northeast region, lower socioeconomic status, neurologic disorder, and rheumatoid
arthritis. Independent risk factors (all P < .05) resulting in at least a 10% increase in episode-of-care costs
following THA included malnutrition, male gender, age over 85, failed internal fixation, hip dysplasia,
Northeast region, neurologic disorder, lower socioeconomic status, conversion THA, avascular necrosis,
and depression.
Conclusion: Certain comorbidities and orthopedic risk factors increase 90-day episode-of-care costs
in the Medicare population. The current lack of proper risk stratification could be a powerful driver of
decreased access to care for our most medically challenged members of society.
© 2018 Elsevier Inc. All rights reserved.

Debate continues to focus on efforts to reduce rising healthcare
costs in the United States, which are expected to exceed 20% of the
gross domestic product by 2025 [1]. Despite high patient satisfac-
tion and success rates, total hip (THA) and total knee arthroplasty
Institutional review board (IRB) statement: This study is exempt from approval
from our IRB.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to doi:10.1016/j.arth.2018.02.095.
* Reprint requests: P. Maxwell Courtney, MD, Department of Orthopaedic Sur-
gery, Sidney Kimmel Medical College, Rothman Institute, Thomas Jefferson Uni-
versity, 925 Chestnut St, 5th Floor, Philadelphia, PA 19107.
(TKA) are among Medicare’s largest expenditures, accounting for
$6.6 billion in reimbursements in 2013 [2]. Alternative payment
models (APMs), such as bundled payments, have been introduced
by the Centers for Medicare and Medicaid Services (CMS) and other
payors in order to reduce these costs and improve the quality of
care following THA and TKA. For physicians and hospitals not
participating in APMs, programs such as the Merit-based Incentive
Payment System and the Hospital Readmissions Reduction Pro-
gram also financially incentivize providers who focus on value [3,4].
Programs such as the CMS Bundled Payments for Care
Improvement (BPCI) initiative have shown early success in
reducing costs following THA and TKA without compromising
outcomes [5e9]. Concerns exist, however, regarding the lack of
risk adjustment in these value-based models. Without a

https://doi.org/10.1016/j.arth.2018.02.095
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375 2369

method to sufficiently account for medically complex patients, Specific orthopedic risk factors present on the 12 months before
bundled payment programs may unintentionally penalize the index THA or TKA were also identified. For TKA patients, these
providers who care for a high-risk patient population [10]. A factors included rheumatoid arthritis (ICD-9 code 714.0), post-
recent survey of adult reconstruction surgeons found that their traumatic arthritis (716.1), infection (711.0, 996.66), failed internal
greatest concern with APMs was access to care problems for fixation (996.47, 996.49, 996.78, 996.67), malnutrition (263.9), and
patients who may use more resources in an episode of care removal of deep implant (CPT code 20680). For THA patients, or-
[11]. While some studies have linked certain demographic and thopedic risk factors included avascular necrosis (733.4), hip
comorbid factors to poorer short-term outcomes following dysplasia (754.3), rheumatoid arthritis (ICD-9 code 714.0), post-
primary THA and TKA [12e14], the independent effect on traumatic arthritis (716.1), infection (711.0, 996.66), failed internal
episode-of-care costs has yet to be addressed in the literature, fixation (996.47, 996.49, 996.78, 996.67), malnutrition (263.9), and
particularly several orthopedic variables that are not captured conversion of prior surgery to THA (CPT 27132). Multivariate lo-
in many database studies. gistic regression analysis was also performed to quantify the rela-
The purpose of our study was to determine which demographic tive differences in episode-of-care costs, after adjusting for above
variables, medical comorbidities, and orthopedic-specific risk fac- patient variables, medical comorbidities, and orthopedic risk
tors CMS should adjust for in their bundled payment programs. factors.
Prior studies evaluating costs to CMS using administrative data-
bases have failed to account for orthopedic-specific risk factors.
Specifically, we asked which variables are associated with Results
increased costs to CMS in a 90-day episode of care following pri-
mary THA and TKA. We also sought to quantify the independent Total Hip Arthroplasty
effect of each risk factor in episode-of-care costs to determine how
much more CMS should compensate providers for caring for high- A total of 27,293 THA patients were identified for the study. The
risk patients. patients were primarily younger, females, from the South, and had
between 15 and 19 medical comorbidities derived from the Elix-
Materials and Methods hauser comorbidity index (Table 1). Solid tumor (85.6%), uncom-
plicated diabetes (72.4%), electrolyte disorder (68.7%), obesity
We queried the 5% sample of the Medicare Limited Data Set (68.4%), and hypothyroidism (67.4%) were the top 5 most
to identify all patients undergoing primary THA and TKA using commonly diagnosed Elixhauser comorbid conditions diagnosed in
Current Procedural Terminology (CPT) codes 27130, 27132 (for the 12 months before THA. Overall mean 90-day episode-of-care
THA), and 27447 for TKA between 2010 and 2014. This study was costs was $28,400 (standard deviation, $17,000), with a median of
exempt from institutional review board approval. No outside
funding was received for this study. Patients who had a diag-
Table 1
nosis of hip fracture (ICD-9 [International Classification of Dis- Demographic Variables With 90-Day Episode-of-Care Medicare Costs Using the
eases, Ninth Revision] code 820.xx) or knee fracture (ICD-9 code Medicare 5% Limited Data Set for Patients Undergoing Primary THA.
823.0, 821.2) on the same claim as the primary TJA were
Variable (N ¼ 27,293) N Mean 90-d Medicare Costs (SD) P Value
excluded from the study. To evaluate the cost of an episode of
care, we calculated all Part A or Part B reimbursement claims for Age (y)
65-69 8579 $24,700 ($15,000) *
the index inpatient stay, surgeon/carrier fees, readmission, 70-74 6927 $26,500 ($15,000) <.001
rehabilitation, and outpatient costs within 90 days following 75-79 5802 $29,200 ($17,000) <.001
surgery. Costs were considered from the payor perspective, in 80-84 4009 $33,300 ($17,000) <.001
terms of reimbursement payments (adjusted to January 2017 85 and older 1976 $38,800 ($19,000) <.001
Gender
dollars).
Male 10,165 $26,800 ($16,000) <.0001
A univariate analysis was conducted to evaluate whether the Female 17,128 $29,400 ($16,500)
costs differed by various patient variables, medical comorbidities, Ethnicity
and orthopedic risk factors. The patient variables included age, White 25,403 $26,200 ($15,500) *
socioeconomic status, race, census region, gender, and year of Black 1245 $31,500 ($18,800) <.001
Other 645 $28,900 ($16,800) .313
surgery. Socioeconomic status was based on the patient’s Medicare Geographic region
buy-in status. Low socioeconomic status patients were identified if Midwest 7434 $26,800 ($15,500) *
the patient received state subsidies for the insurance premium. The Northeast 5047 $32,900 ($17,900) <.001
medical comorbidities were based on the diagnosis of 31 conditions South 9541 $27,200 ($15,900) .0984
West 5271 $28,600 ($17,600) <.001
in the 12 months before the index THA or TKA. These comorbidities
Socioeconomic status
were identified from the Elixhauser comorbidity index, which Higher 25,434 $27,900 ($16,100) <.0001
comprised of congestive heart failure, cardiac arrhythmia, valvular Low 1859 $35,500 ($22,000)
disease, pulmonary circulation disorder, peripheral vascular disor- Charlson comorbidity index
der, uncomplicated hypertension, complicated hypertension, pa- 0 10,430 $24,800 ($13,700) *
1-2 10,868 $28,400 ($15,800) <.001
ralysis, other neurologic disorders, chronic pulmonary disease, 3-4 4245 $33,000 ($18,800) <.001
uncomplicated diabetes, complicated diabetes, hypothyroidism, 5 or greater 1750 $38,700 ($24,000) <.001
renal failure, liver disease, peptic ulcer, acquired immune defi- Elixhauser comorbidity index
ciency syndrome, lymphoma, metastatic cancer, solid tumor cancer, 0-4 7556 $25,300 ($15,800) *
5-9 2839 $29,800 ($18,800) <.001
rheumatoid arthritis, coagulopathy, obesity, weight loss, electrolyte
10-14 188 $27,600 ($14,500) .064
disorder, blood loss anemia, deficiency anemia, alcohol abuse, drug 15-19 16,550 $29,600 ($16,500) <.001
abuse, psychoses, and depression [15]. The ICD-9-CM and ICD-10- 20-24 160 $30,800 ($17,400) .002
CM diagnoses codes for these conditions are available through When groups had more than one variable, the asterisks (*) indicates the control
the Healthcare Cost and Utilization Project that is sponsored by the group to which other variables were compared.
Agency for Healthcare Research and Quality [16,17]. THA, total hip arthroplasty; SD, standard deviation.
2370 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375

Fig. 1. Comparison of mean 90-day episode-of-care Medicare costs by year among patients undergoing THA and TKA. THA, total hip arthroplasty; TKA, total knee arthroplasty.

Fig. 2. Comparison of mean 90-day episode-of-care Medicare costs by age among patients undergoing THA and TKA.
 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375
Fig. 3. Comparison of mean 90-day episode-of-care Medicare costs by Elixhauser index among patients undergoing THA and TKA.
$24,000 (interquartile range, $18,500-$33,900). From the univari-
ate analysis, mean 90-day episode-of-care costs were significantly
different by year (P < .001), from $30,300 (median $25,900) in 2010
to $26,300 (median $22,200) in 2014 (Fig. 1). Mean 90-day episode-
of-care costs also differed by patient age at the time of THA (P <
.001), from $24,700 (median $21,100) for those aged 65-69 years to
$38,800 (median $35,200) for those aged 85 years and older (Fig. 2).
Costs by Elixhauser comorbidities were also significantly different
(P < .001), ranging from $25,300 (median $21,200) for those with
scores less than 5 to $30,800 (median $25,000) for those with
scores between 20 and 24 (Fig. 3). Complete univariate cost com-
parisons for THA are shown in Tables 1 and 2.
Based on the multivariate analysis, independent risk factors
resulting in at least a 10% increase in adjusted episode-of-care costs
included history of infection (odds ratio [OR], 1.771, P < .001),
malnutrition (OR, 1.745; P < .001), male gender (OR, 1.443; P < .001),
failed internal fixation (OR, 1.312; P < .001), paralysis (OR, 1.261; P <
.001), hip dysplasia (OR, 1.218; P ¼ .014), Northeast geographic re-
gion (OR, 1.211; P < .001), electrolyte disorder (OR, 1.193; P < .001),
lower socioeconomic status (OR, 1.171; P < .001), neurologic dis-
order (OR, 1.156; P < .001), age 75 and older (OR  1.15; P < .001),
African Americans (OR, 1.131; P < .001), conversion THA (OR, 1.118;
P < .001), avascular necrosis (OR, 1.115; P < .001), and depression
(OR, 1.104; P < .001).
Total Knee Arthroplasty
A total of 58,809 TKA patients were identified for the study.
Similar to the THA patients, the TKA patients were primarily
2371
younger, females, from the South, and had between 15 and 19
medical comorbidities derived from the Elixhauser comorbidity
index (Table 3). Solid tumor (85.5%), uncomplicated diabetes
(75.2%), obesity (70.9%), electrolyte disorder (69.6%), and hypo-
thyroidism (68.6%) were the top 5 most commonly diagnosed
Elixhauser comorbid conditions diagnosed in the 12 months
before TKA (Table 4). Overall mean 90-day episode-of-care costs
was $27,200 (standard deviation, $14,000), with a median of
$23,800 (interquartile range, $18,900-$32,300). From the univar-
iate analysis, mean 90-day episode-of-care costs were signifi-
cantly different by year (P < .001), from $29,000 (median $25,500)
in 2010 to $25,200 (median $21,900) in 2014 (Fig. 1). Mean 90-day
episode-of-care costs also differed by patient age at the time of
TKA (P < .001), from $24,800 (median $21,900) for those aged 65-
69 years to $35,000 (median $31,900) for those aged 85 years and
older (Fig. 2). Costs by Elixhauser comorbidities were also signif-
icantly different (P < .001), ranging from $25,200 (median
$21,800) for those with scores less than 5 to $27,800 (median
$25,500) for those with scores between 20 and 24 (Fig. 3). Com-
plete univariate cost comparisons for TKA are shown in Tables 3
and 4 (Tables 5 and 6).
Based on the multivariate analysis, independent risk factors
resulting in at least a 10% increase in adjusted episode-of-care costs
included malnutrition (OR, 1.789; P < .001), history of infection (OR,
1.663; P < .001), male gender (OR, 1.319; P < .001), African Americans
(OR, 1.145; P < .001), lower socioeconomic status (OR, 1.131; P < .001),
pulmonary circulation disorder (OR, 1.316; P < .001), failed internal
fixation (OR, 1.266; P < .001), Northeast geographic region (OR, 1.213;
P < .001), electrolyte disorder (OR, 1.151; P < .001), neurologic
2372 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375

Table 2 Table 3
Orthopedic and Medical Comorbidities With 90-Day Episode-of-Care Medicare Demographic Variables With 90-Day Episode-of-Care Medicare Costs Using the
Costs Using the Medicare 5% Limited Data Set for Patients Undergoing Primary THA. Medicare 5% Limited Data Set for Patients Undergoing Primary TKA.

Variable N Mean 90-d Mean 90-d P Value Variable (N ¼ 58,809) N Mean 90-d P Value
(N ¼ 27,293) Medicare Costs Medicare Costs Medicare Costs (SD)
With Risk Without Risk
Age (y)
Factor (SD) Factor (SD)
65-69 20,604 $24,800 ($13,000) *
Orthopedic risk 70-74 16,099 $26,400 ($14,000) <.001
factors 75-79 12,644 $28,400 ($14,000) <.001
Rheumatoid 1088 $31,200 ($16,500) $28,300 ($16,700) <.001 80-84 7020 $31,300 ($16,000) <.001
arthritis 85 and older 2442 $35,000 ($16,000) <.001
Post-traumatic 296 $36,100 ($20,100) $28,300 ($16,600) <.001 Gender
arthritis Male 21,099 $26,300 ($15,100) <.0001
Avascular 1956 $33,500 ($19,600) $28,000 ($16,300) <.001 Female 37,710 $27,700 ($13,600)
necrosis Ethnicity
Infection 501 $61,000 ($38,200) $27,800 ($15,300) <.001 White 53,163 $26,900 ($13,700) *
Failed internal 994 $48,700 ($28,500) $27,600 ($15,500) <.001 Black 3131 $31,300 ($16,100) <.001
fixation Other 2515 $29,900 ($18,100) <.001
Conversion total 1085 $43,600 ($26,100) $27,800 ($15,800) <.001 Geographic region
hip Midwest 16,129 $25,400 ($13,000) *
arthroplasty Northeast 9133 $32,000 ($15,100) <.001
Malnutrition 301 $65,700 ($41,300) $28,000 ($15,700) <.001 South 23,110 $26,100 ($13,200) <.001
Removal of 275 $42,300 ($24,200) $28,200 ($16,500) <.001 West 10,437 $28,300 ($15,800) <.001
implant Socioeconomic status
Hip dysplasia 33 $37,500 ($21,400) $28,400 ($16,700) .002 Higher 53,725 $26,700 ($13,700) <.001
Elixhauser Low 5084 $32,300 ($17,000)
Comorbidity Charlson comorbidity index
index 0 22,149 $24,700 ($12,000) *
Congestive heart 872 $28,500 ($14,000) $28,400 ($17,000) .810 1-2 24,405 $27,300 ($13,500) <.001
failure 3-4 8959 $30,300 ($15,600) <.001
Cardiac 3321 $26,200 ($13,000) $28,700 ($17,000) <.001 5 or greater 3296 $35,200 ($21,400) <.001
arrhythmia Elixhauser comorbidity index
Valvular disease 2242 $28,100 ($15,000) $28,400 ($17,000) .402 0-4 15,549 $25,200 ($14,200) *
Pulmonary 450 $29,200 ($13,100) $28,400 ($17,000) .303 5-9 6016 $28,400 ($16,800) <.001
circulation 10-14 394 $26,200 ($12,000) .147
disorder 15-19 36,556 $27,900 ($13,600) <.001
Peripheral 1343 $26,500 ($13,000) $28,500 ($17,000) <.001 20-24 294 $27,800 ($10,700) <.001
vascular
When groups had more than one variable, the asterisks (*) indicates the control
disorder
group to which other variables were compared.
Uncomplicated 15,495 $26,100 ($13,000) $31,400 ($20,000) <.001
TKA, total knee arthroplasty; SD, standard deviation.
hypertension
Complicated 1811 $27,900 ($14,000) $28,400 ($17,000) .208
hypertension
Paralysis 157 $38,300 ($20,000) $28,300 ($17,000) <.001 disorder (OR, 1.138; P < .001), age 75 and older (OR  1.112; P < .001),
Other neurologic 902 $35,100 ($20,000) $28,200 ($14,000) <.001 and rheumatoid arthritis (OR, 1.102; P < .001).
disorders
Chronic 5508 $25,900 ($14,000) $29,000 ($17,000) <.001
pulmonary
disease Discussion
Uncomplicated 19,748 $29,500 ($17,000) $25,400 ($16,000) <.001
diabetes While the BPCI model for joint arthroplasty has widely been
Complicated 17,840 $29,700 ($17,000) $25,900 ($16,000) <.001
viewed as a success among surgeons, hospitals, and payors
diabetes
Hypothyroidism 18,387 $29,500 ($17,000) $26,100 ($17,000) <.001 [18e20], CMS implemented a parallel program known as
Renal failure 475 $24,800 ($12,000) $28,500 ($17,000) <.001 Comprehensive Care for Joint Replacement (CJR) [21]. CJR began
Liver disease 247 $25,500 ($15,000) $28,400 ($17,000) .007 in April 2016 as a mandatory bundled payment program for 800
Peptic ulcer 103 $23,600 ($11,000) $28,400 ($17,000) .003 hospitals across 67 geographic areas performing primary TKA and
disease
AIDS 1448 $25,800 ($14,000) $28,500 ($17,000) <.001
THA [22]. Unlike BPCI, which used historical institutional data to
Lymphoma 17,550 $29,500 ($17,000) $26,500 ($17,000) <.001 set a target episode-of-care price for reimbursement, CJR uses
Metastatic cancer 14,383 $27,400 ($17,000) $29,500 ($17,000) <.001 regional pricing, combining each hospital’s average spending
Solid tumor 23,356 $29,000 ($17,000) $24,900 ($15,000) <.001 with that of other facilities in the area. Under this model, hospi-
Coagulopathy 17,709 $29,600 ($17,000) $26,100 ($17,000) <.001
tals caring for patients who use more resources could be penal-
Obesity 18,661 $29,300 ($17,000) $26,300 ($17,000) <.001
Weight loss 17,064 $29,800 ($17,000) $26,000 ($15,000) <.001 ized financially. Even for surgeons and facilities not participating
Electrolyte 18,744 $30,100 ($17,000) $24,700 ($14,000) <.001 in bundled payment arrangements, CMS value-based programs
disorder such as Merit-based Incentive Payment System and the Hospital
Blood loss 17,341 $29,700 ($17,000) $26,200 ($16,000) <.001 Readmissions Reduction Program lack appropriate means to
anemia
Deficiency 17,804 $29,700 ($17,000) $25,900 ($16,000) <.001
adjust payments for complex patients. We present a large series
anemia of Medicare beneficiaries undergoing primary TKA and THA and
Alcohol abuse 17,155 $29,600 ($17,000) $26,400 ($16,000) <.001 have identified several demographic, medical, and orthopedic
Drug abuse 17,026 $29,500 ($16,000) $26,500 ($17,000) <.001 risk factors that are independently associated with an increase in
Psychosis 17,085 $29,600 ($17,000) $26,300 ($17,000) <.001
90-day episode-of-care costs to CMS. To our knowledge, we
Depression 17,938 $29,600 ($17,000) $26,100 ($17,000) <.001
present the first study incorporating orthopedic specific risk
THA, total hip arthroplasty; SD, standard deviation. factors with their corresponding episode-of-care costs following
primary joint arthroplasty.
 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375 2373

Table 4 Table 5
Orthopedic and Medical Comorbidities With 90-Day Episode-of-Care Medicare Multivariate Analysis of Risk Factors and Their Effect on 90-Day Episode-of-Care
Costs Using the Medicare 5% Limited Data Set for Patients Undergoing Primary TKA. Medicare Costs Following THA.

Variable (N ¼ N Mean 90-d Mean 90-d P Value Risk Factor Odds 95% Confidence P Value
58,809) Medicare Costs Medicare Costs Ratio Interval
With Risk Without Risk
Age (y)
Factor (SD) Factor (SD)
70-74 1.071 1.055-1.088 <.001
Orthopedic risk 75-79 1.150 1.133-1.169 <.001
factors 80-84 1.284 1.262-1.308 <.001
Rheumatoid 2637 $30,000 ($14,400) $27,100 ($14,100) <.001 85 and older 1.422 1.389-1.455 <.001
arthritis Ethnicity
Post-traumatic 412 $27,900 ($13,900) $27,200 ($14,100) .311 Black 1.131 1.102-1.162 <.001
arthritis Other 1.014 0.978-1.052 .458
Infection 856 $51,100 ($32,000) $26,900 ($13,400) <.001 Geographic region
Failed internal 743 $40,900 ($25,200) $27,000 ($13,900) <.001 Midwest 1.006 0.992-1.020 .434
fixation Northeast 1.211 1.192-1.230 <.001
Malnutrition 399 $56,500 ($41,400) $27,000 ($13,600) <.001 West 1.085 1.068-1.102 <.001
Removal of 199 $31,800 ($24,600) $27,200 ($14,100) <.001 Female gender 0.693 0.652-0.736 <.001
implant Low socioeconomic status 1.171 1.145-1.197 <.001
Elixhauser Year of surgery 0.956 0.951-0.960 <.001
comorbidity Orthopedic risk factors
index Rheumatoid arthritis 1.083 1.051-1.115 <.001
Congestive heart 1675 $27,900 ($13,000) $27,200 ($14,000) .036 Post-traumatic arthritis 1.061 0.005-1.120 .032
failure Avascular necrosis 1.115 1.092-1.140 <.001
Cardiac 6764 $25,600 ($12,000) $27,400 ($14,000) <.001 Infection 1.771 1.698-1.847 <.001
arrhythmia Failed internal fixation 1.312 1.267-1.358 <.001
Valvular disease 4281 $26,900 ($13,000) $27,200 ($14,000) .089 Conversion total hip 1.118 1.082-1.155 <.001
Pulmonary 1023 $30,000 ($15,000) $27,200 ($14,000) <.001 arthroplasty
circulation Malnutrition 1.745 1.653-1.841 <.001
disorder Removal of implant 1.001 0.946-1.061 .963
Peripheral 2438 $26,100 ($12,000) $27,300 ($16,000) <.001 Hip dysplasia 1.218 1.041-1.426 .014
vascular Elixhauser comorbidity index
disorder Congestive heart failure 1.096 1.029-1.096 <.001
Uncomplicated 34,557 $25,400 ($12,000) $29,800 ($20,000) <.001 Cardiac arrhythmia 0.976 0.959-0.993 .006
hypertension Valvular disease 1.001 0.981-1.022 .919
Complicated 3792 $27,400 ($14,000) $27,200 ($14,000) .383 Pulmonary circulation disorder 1.052 1.007-1.099 .024
hypertension Peripheral vascular disorder 0.978 0.953-1.004 .091
Paralysis 251 $37,400 ($22,000) $27,200 ($14,000) <.001 Uncomplicated hypertension 0.888 0.878-0.899 <.001
Other neurologic 1937 $32,500 ($19,000) $27,000 ($14,000) <.001 Complicated hypertension 1.037 1.013-1.062 .002
disorders Paralysis 1.261 1.173-1.356 <.001
Chronic 12,062 $25,600 ($12,000) $27,600 ($15,000) <.001 Other neurologic disorders 1.156 1.121-1.192 <.001
pulmonary Chronic pulmonary disease 0.965 0.951-0.980 <.001
disease Uncomplicated diabetes 1.059 1.035-1.084 <.001
Uncomplicated 44,204 $27,900 ($14,000) $25,100 ($14,000) <.001 Complicated diabetes 1.043 1.008-1.079 .017
diabetes Hypothyroidism 1.013 0.988-1.038 .329
Complicated 39,517 $28,100 ($14,000) $25,400 ($14,000) <.001 Renal failure 0.910 0.871-0.950 <.001
diabetes Liver disease 0.930 0.878-0.985 .014
Hypothyroidism 40,372 $27,900 ($14,000) $25,700 ($15,000) <.001 Peptic ulcer disease 0.965 0.882-1.055 .433
Renal failure 935 $24,300 ($12,000) $27,300 ($14,000) <.001 AIDS 0.996 0.971-1.023 .786
Liver disease 488 $27,400 ($15,000) $27,200 ($14,000) .769 Lymphoma 1.025 0.989-1.062 .177
Peptic ulcer 199 $24,900 ($10,000) $27,200 ($14,000) .019 Metastatic cancer 1.046 1.025-1.067 <.001
disease Solid tumor 1.032 1.010-1.055 .004
AIDS 3219 $26,000 ($13,000) $27,300 ($14,000) <.001 Coagulopathy 1.030 0.998-1.064 .065
Lymphoma 38,559 $27,800 ($14,000) $26,200 ($15,000) <.001 Obesity 1.053 1.028-1.078 <.001
Metastatic cancer 29,604 $26,600 ($15,000) $27,900 ($14,000) <.001 Weight loss 1.069 1.006-1.136 .032
Solid tumor 50,273 $27,800 ($14,000) $24,000 ($12,000) <.001 Electrolyte disorder 1.193 1.165-1.221 <.001
Coagulopathy 38,920 $28,000 ($14,000) $25,700 ($15,000) <.001 Blood loss anemia 1.076 1.032-1.121 <.001
Obesity 41,704 $27,800 ($14,000) $25,800 ($15,000) <.001 Deficiency anemia 1.052 1.020-1.085 .001
Weight loss 37,480 $28,000 ($17,000) $25,900 ($15,000) <.001 Alcohol abuse 0.986 0.937-1.037 .583
Electrolyte 40,928 $28,300 ($14,000) $24,800 ($14,000) <.001 Drug abuse 0.870 0.816-0.927 <.001
disorder Psychosis 1.030 0.973-1.090 .313
Blood loss 38,083 $28,000 ($14,000) $25,800 ($15,000) <.001 Depression 1.104 1.072-1.137 <.001
anemia
THA, total hip arthroplasty.
Deficiency 38,972 $28,000 ($14,000) $25,700 ($15,000) <.001
anemia
Alcohol abuse 37,633 $27,900 ($14,000) $26,000 ($15,000) <.001
Drug abuse 37,497 $27,900 ($14,000) $26,000 ($15,000) <.001
pulmonary hypertension, neurologic disorders, and malnutrition
Psychosis 37,564 $27,900 ($14,000) $25,900 ($15,000) <.001 increase costs following primary joint arthroplasty. Although the
Depression 39,456 $27,900 ($14,000) $25,800 ($15,000) <.001 number of patients with a diagnosis code for malnutrition was
TKA, total knee arthroplasty; SD, standard deviation. small, their 90-day costs to CMS were more than twice that of those
without malnutrition for both THA and TKA. Our findings agree
with several other studies linking malnutrition to poorer outcomes
While others have identified at-risk patients with medical and increased resource utilization [23e25]. As a modifiable risk
comorbidities that should be excluded from bundled payment factor, consideration should be given to screening at-risk patients
models [12], few studies have examined their independent effect of for malnutrition and intervening before elective total joint arthro-
episode-of-care costs. Not surprisingly, our data showed that plasty in order to reduce episode-of-care costs.
2374 P.M. Courtney et al. / The Journal of Arthroplasty 33 (2018) 2368e2375

Table 6 opportunity for intervention in this population to decrease costs.

Multivariate Analysis of Risk Factors and Their Effect on 90-Day Episode-of-Care Without risk adjustment, however, patients of lower socioeco-
Medicare Costs Following TKA.
nomic class may face future problems with access to care for THA
Risk Factor Odds Ratio 95% Confidence P Value and TKA. Surgeons and facilities should not be penalized for caring
Interval for these patients with nonmodifiable risk factors for increase costs.
Age (y) Although it may be intuitive that payors should adjust reim-
70-74 1.057 1.046-1.068 <.001 bursement for patients with certain medical comorbidities, sur-
75-79 1.112 1.100-1.123 <.001
geons have been advocating for risk adjustment for orthopedic
80-84 1.204 1.189-1.219 <.001
85 and older 1.342 1.316-1.368 <.001 specific risk factors as well. We found large increases in 90-day CMS
Ethnicity costs for avascular necrosis, failed internal fixation, hip dysplasia,
Black 1.145 1.125-1.164 <.001 and conversion THA. Other studies have evaluated these risk factors
Other 1.047 1.027-1.068 <.001
individually and found poorer outcomes and increased costs
Geographic region
Midwest 0.991 0.982-1.000 .047
[31,32]. Our multivariate analysis can give payors a reference for
Northeast 1.213 1.199-1.226 <.001 risk adjustment for these orthopedic comorbidities. We hope that
West 1.101 1.089-1.113 <.001 our data can influence all stakeholders in the episode-of-care
Female gender 0.758 0.725-0.792 <.001 continuum to make decisions to incentivize quality care with the
Low socioeconomic status 1.131 1.115-1.147 <.001
resources available. While our data identify which complex pa-
Year of surgery 0.959 0.956-0.962 <.001
Orthopedic risk factors tients have higher episode-of-care costs, our study does not eval-
Rheumatoid arthritis 1.102 1.081-1.123 <.001 uate outcomes for surgeons or hospitals who take care of patients
Post-traumatic arthritis 0.997 0.954-1.043 .905 with more medical comorbidities. Further study is needed to
Infection 1.663 1.612-1.716 <.001 determine how to best optimize these patients to improve out-
Failed internal fixation 1.266 1.223-1.310 <.001
Malnutrition 1.789 1.709-1.887 <.001
comes and decrease overall spending.
Removal of implant 1.051 0.985-1.122 .133 Our study does have several limitations. Using a CMS adminis-
Elixhauser comorbidity index trative database as a primary source, the quality of our data relies
Congestive heart failure 1.056 1.032-1.080 <.001 on the accuracy of coding for medical comorbidities and orthopedic
Cardiac arrhythmia 0.988 0.976-1.000 .047
risk factors. Several of the Elixhauser comorbidity variables such as
Valvular disease 0.995 0.981-1.010 .498
Pulmonary circulation disorder 1.136 1.104-1.169 <.001 alcohol and drug abuse, solid tumor, electrolyte abnormalities, and
Peripheral vascular disorder 0.988 0.970-1.007 .211 psychosis were coded to be present preoperatively in a majority of
Uncomplicated hypertension 0.887 0.879-0.894 <.001 patients in this series. Hospitals may be incentivized to overcode
Complicated hypertension 1.041 1.024-1.057 <.001 certain risk factors in order to be classified in a more complex
Paralysis 1.293 1.222-1.369 <.001
Other neurologic disorders 1.138 1.114-1.162 <.001
diagnosis-related group that could increase their facility reim-
Chronic pulmonary disease 0.965 0.955-0.974 <.001 bursement. Caution should be used when interpreting these find-
Uncomplicated diabetes 1.029 1.014-1.045 <.001 ings. Several of the orthopedic specific risk factors are also likely
Complicated diabetes 1.085 1.061-1.109 <.001 undercoded as the coders may not recognize when these are pre-
Hypothyroidism 1.030 1.013-1.048 <.001
sent. In order to advocate for risk adjustment for our patients in
Renal failure 0.924 0.896-0.953 <.001
Liver disease 1.005 0.965-1.047 .795 value-based CMS payment models, it is paramount that surgeons
Peptic ulcer disease 0.972 0.912-1.036 .379 and hospitals accurately code medical and orthopedic comorbid-
AIDS 0.999 0.982-1.016 .900 ities. Further studies using arthroplasty-specific databases, such as
Lymphoma 0.966 0.942-0.990 .007 the American Joint Replacement Registry, are needed to confirm
Metastatic cancer 1.067 1.052-1.082 <.001
Solid tumor 1.077 1.010-1.055 <.001
our findings.
Coagulopathy 1.061 1.038-1.085 <.001
Obesity 1.049 1.034-1.065 <.001 Conclusion
Weight loss 0.993 0.946-1.042 .774
Electrolyte disorder 1.151 1.132-1.170 <.001
Blood loss anemia 1.083 1.051-1.116 <.001 Certain medical comorbidities increase 90-day episode-of-care
Deficiency anemia 1.048 1.025-1.072 <.001 costs following THA and TKA in the Medicare population. Socio-
Alcohol abuse 0.942 0.905-0.981 .004 economic status, age, and other orthopedic-specific risk factors
Drug abuse 0.951 0.907-0.997 .037 including conversion THA, failed internal fixation in TKA, hip
Psychosis 1.048 1.003-1.095 .038
Depression 1.057 1.036-1.078 <.001
dysplasia, and avascular necrosis are also associated with large
increases in costs. The current lack of proper risk stratification
TKA, total knee arthroplasty.
could be a powerful driver of decreased access to care for our most
medically challenged members of society.
Our results show that advanced age is also linked to increased
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 The Journal of Arthroplasty 33 (2018) 2355e2357

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

AAHKS Symposium

Robotics in Orthopedics: A Brave New World

Brian S. Parsley, MD *
Department of Orthopedic Surgery, University of Texas Health Science Center at Houston, Bellaire, TX

a r t i c l e i n f o a b s t r a c t

Article history: Future health-care projection projects a significant growth in population by 2020. Health care has seen
Received 6 February 2018 an exponential growth in technology to address the growing population with the decreasing number of
Accepted 8 February 2018 physicians and health-care workers. Robotics in health care has been introduced to address this growing
Available online 16 February 2018
need. Early adoption of robotics was limited because of the limited application of the technology, the
cumbersome nature of the equipment, and technical complications. A continued improvement in effi-
Keywords:
cacy, adaptability, and cost reduction has stimulated increased interest in robotic-assisted surgery. The
arthroplasty
evolution in orthopedic surgery has allowed for advanced surgical planning, precision robotic machining
instrumentation
robotics
of bone, improved implant-bone contact, optimization of implant placement, and optimization of the
healthcare innovations mechanical alignment. The potential benefits of robotic surgery include improved surgical work flow,
robotic assisted surgery improvements in efficacy and reduction in surgical time. Robotic-assisted surgery will continue to evolve
in the orthopedic field.
© 2018 Elsevier Inc. All rights reserved.

Robotics is here to staydat least in healthcare.
Future healthcare projections consider that the global popula-
tion has doubled over the past 45 years. By 2020, 95% of the world's
8 billion people will live in developing nations [1]. Concomitant
with this growth, we have experienced an exponential growth in
technology. During this period, we have witnessed the most rapid
increase in technological advance in our history and the growth
curve continues to be steep. Compared with the technological
improvements in the automotive industry that began back in the
late 1940s, we have witnessed an exponential growth just in the
past several years with the development of electric cars, guidance
systems, and a commitment to driverless vehicles for commercial
and private use.
Healthcare has experienced a similar type of evolution as it
seeks to address the growing population with the decreasing
number of physicians and health care workers. Significant effort has
been focused on eliminating the monotonous and repetitive work
that health care workers perform. Providers could then focus more
on direct patient care and decrease their overall workload. In
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.032.
* Reprint requests: Brian S. Parsley, MD, Department of Orthopedic Surgery,
University of Texas Health Science Center at Houston, 5420 West Loop South Suite
2400, Bellaire, TX 77401.
addition, there has been an increased interest in using technology
to refine the surgical procedures that we perform repetitively.
Over 13.6 billion is estimated to be spent by 2019 on surgical
robotics to address many of these health care issues. In
November 2016, Tractica [2] reported that healthcare robotic
shipments would surpass 10,000 units annually by 2021. The
demand for surgical, rehabilitation, and hospital robots will
continue to rise driven by the declining cost of robotic produc-
tion, the increasing labor shortages, and the successful pilot
projects that demonstrated the efficacy of this evolving tech-
nology. Robotics will see the greatest growth in the surgical area
while noninvasive radiosurgical systems will also demonstrate
significant growth. Other areas of robotic development include
emergency response robotic systems, prosthetics and endoskel-
eton development, assistive rehabilitation systems, and
nonmedical hospital systems.
As the world population continues to grow and the baby
boomers enter into the over age 65 population, a decline in the
number of physicians and health care professionals is predicted. As
a result, Tractica forecast that robots will have a growing presence
in the health care system not only in North America, but also an
exponential growth increase in Europe and Asia.
Robotic-assisted surgery had limited adoption when initially
introduced in the late 1980s. The initial introduction of an auton-
omous robot into orthopedic surgery was in 1992 with the intro-
duction of Robodoc for the performance of hip arthroplasty on the
femoral side only [3,4]. Early adoption was limited because of the
limited application of the technology, the cumbersome nature of

https://doi.org/10.1016/j.arth.2018.02.032
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2356 B.S. Parsley / The Journal of Arthroplasty 33 (2018) 2355e2357
the equipment, and technical complications at the time of surgery
[5]. Intuitive surgical introduced the da Vinci which was first
approved by the Food and Drug Administration in 2000 for lapa-
roscopic surgery. At the time of its initial roll out in 2002,
approximately 1% of the prostatectomies in the United States were
robotically performed. In 2014, more than 89% of the prostatec-
tomies were performed robotically. The growth worldwide
continues to increase. Additional competition is evolving, stimu-
lating further improvements in efficiency, adaptability, and cost
reduction.
In the orthopedic arena, robotics was first introduced more than
30 years ago [3,6]. However, adoption was very limited until
recently. Ongoing surgical challenges faced by orthopedic surgeons
result from the use of manual instruments causing inconsistency in
implant placement and bone removal, the introduction of human
error, and less predictable outcomes because of the lack of repro-
ducible accuracy. The surgeon's desire to achieve the best outcome
for the patient fueled interest in alternative techniques to achieve
this goal.
The evolution of robotics allows for advanced surgical plan-
ning, precision robotic machining of bone with reduced error
resulting in improved implant-bone contact, optimization of
component placement, and optimization of the mechanical
alignment [3,7,8]. All these factors have stimulated an increased
interest in robotics.
The growing body of clinical research studies and presentations
has also improved the perceptions of robotic surgery. These studies
have confirmed the reliability of implant position resulting in a
decrease in early failures. Restoration of mechanical alignment,
improved implant positioning, and the reduction in the percentage
of outliers has increased the interest in robotics. The longer term
clinical outcomes are still needed to validate the benefits of these
changes.
The earliest adoption was limited because efficiencies were not
improved, a significant capital expenditure was required and initial
changes in outcomes were not evident [9,10]. The initial robotic
machines were cumbersome and unreliable, therefore were often
relegated to the back storage area and were underutilized. Since
2007, interest has grown steadily in the arthroplasty community as
well as in the public for new technology. Patient demands for new
technology has been driven by an increase in access to information
via social media and direct to consumer marketing.
Traditional Delivery Model
The traditional operating room delivery model requires
extensive implant inventory, storage, and management. All in-
struments systems require extensive set up time, break down and
cleaning time, and resterilization of multiple trays. Up to 8-12
trays of specialized instruments may be required for one joint
replacement procedure. This model is inefficient, labor intensive,
and not cost-effective. With a focus on cost-effectiveness, alter-
native methods to the traditional delivery model have been
sought. Reduced need for instrumentation can result in a sub-
stantial savings for the device manufacturers, the hospitals, and
cost of delivery of care. When new instruments or implant designs
are introduced or modified after initial product release, the capital
costs for change in instrumentation can be expensive. When ro-
botics is used, a change in the workflow or programing is usually
all that is required.
Instrument loss, replacement, repair, and maintenance are a
substantial cost to the medical industry. It has been estimated to
exceed $15 million per year. Robotics reduces this capital
expense.
What Are the Potential Benefits?
The evolution of the surgical workflow has improved, resulting
in an improvement in efficiency and reduction in surgical time.
Surgical maps are computer generated preoperatively to achieve
optimal mechanical alignment, implant sizing, and placement. The
surgeon can review and modify the surgical plan before initiating
the procedure and perform a mental walk-through of the proced-
ure. The use of the robotic system has resulted in a decrease in
blood loss and improvement in accuracy [6,11e13].
What Does the Future Hold?
Today, robotic tools and more anatomically designed joint
implants are available. In addition, knee implants may now be
custom designed. The future operating room could easily incor-
porate multiple technologies to allow the surgeon to preoperatively
plan the surgical procedure, use a robotically guided cutting system
to achieve high accuracy on the bone cuts and achieve optimal
mechanical alignment while using very few instruments on the
back table. By using either a custom implant specifically designed
for the patient or a preselected implant from an off-the-shelf
design, the need for additional pans of instrumentation on the
back table would be eliminated. The cost of sterilization and pro-
cessing, storage, and instrument loss or breakage would be signif-
icantly reduced. In addition, the inefficiencies of room turnover and
preparation for the start of the next case would be significantly
decreased. The time saved would facilitate the performance of
more cases in a normal working day. This results in improved cost
utilization of the operating room, the staff, and the equipment.
Three-dimensional printing is another evolving technology that
could also benefit from the use of robotics. Three-dimensional
printing generates custom implants that address a multitude of
bony abnormalities. The information can be loaded into the robotic
surgical instrument to perform the surgery with a higher degree of
accuracy and restore the optimal mechanical environment for the
success of the implant and the patient.
Finally, robotic tools may assist in repetitive learning and
training of the next generation of surgeons. The robot provides
excellent feedback at the time of use and can follow outcomes and
changes in technique over time. The ability to accurately record the
data points at the time of surgery is an excellent research tool for
review of the outcomes both early and late after surgical
intervention.
To quote William Pollard: Without change there is no innovation,
creativity, or incentive for improvement. Those who initiate change
will have a better opportunity to manage the change that is inevitable.
References
[1] United Nations, Department of Economic and Social Affairs, Population Divi-
sion. World Population Prospects: The 2017 Revision, Key Findings and
Advance Tables. 2017. Working Paper No. ESA/P/WP/248.
[2] Chun W, Wheelock C. Healthcare Robotics. Surgical Robotics, Hospital Logis-
tics Robots, Rehabilitation Robots, Robot Nurses, Telepresence Robots, and
Diagnostic Robots: Global Market Analysis and Forecasts. Tractica 2016.
[3] Lang JE, Mannava S, Flloyd AJ, Goddard MS, Smith BP, Mofidi F, et al. Robotic
systems in orthopedic surgery. Bone Joint J 2011;93eB:292e9.
[4] Bargar WL. Robots in orthopedic surgery. Clin Orthop Relat Res 2007;463:
31e6.
[5] Schulz AP, Seide K, Queitsch C, von Haugwitz A, Meiners J, Kienast B, et al.
Results of total hip replacement using the Robodoc surgical assistant system:
clinical outcome and evaluation of complications for 97 procedures. Int J Med
Robot 2007;3:301e6.
[6] Gourin G, Terris J. History of robotic surgery. In: Faust RA, editor. Robotics in
surgery: history, current and future applications. New York, NY: Nova Science
Publishers, Inc; 2007. 3e12.
[7] Pearle AD, O'Loughlin PF, Kendoff DO. Robot-assisted unicompartmental knee
arthroplasty. J Arthroplasty 2010;25:230e7.
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[8] Domb BG, El Bitar YF, Sadik BS, Stake CE, Botser IB. Comparison of robotic-
assisted and conventional acetabular cup placement in THA: a matched-pair
controlled study. Clin Orthop Relat Res 2014;472:329e36.
[9] Hansen DC, Kusuma SK, Palmer RM, Harris KB. Robotic guidance does not
improve component position or short-term outcome in medial uni-
compartmental knee arthroplasty. J Arthroplasty 2014;29:1784e9. https://
doi.org/10.1016/j.arth.2014.04.012.
[10] Jacofsky DJ, Allen M. Robotics in arthroplasty: a comprehensive review.
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[11] DiGioia III AM, Jaramaz B, Picard F, Nolte LP. Computer and robotic assisted
hip and knee surgery. New York, NY: Oxford Univeristy Press; 2004.
[12] Song EK, Seon JK, Yim JH, Netravali NA, Bargar WL. Robotic-assisted
TKA reduces postoperative alignment outliers and improves gap
balance compared to conventional TKA. Clin Orthop Relat Res 2013;471:
118e26.
[13] Conditt MA, Coon T, Hernandez A, Branch S. Short term survivorship and
outcomes of robotically assisted bicompartmental arthroplasty. Bone Joint J
2016;98eB(Supp 1):49.
VOL 33, NO 8 August 2018

CONTENTS
EDITORIAL
2341 Opioids in Total Joint Arthroplasty: Moving Forward
Mohamad J. Halawi and Jay R. Lieberman

AAHKS SYMPOSIUM: THROUGH THE LOOKING GLASS: WHAT DOES THE FUTURE
HOLD FOR ARTHROPLASTY?
2344 Digital Health and Advanced Technology in Arthroplasty
Mark I. Froimson

2345 The Emergence of Distance Health Technologies

Jonathan L. Schaffer, Peter A. Rasmussen, and Matthew R. Faiman

2352 The Emerging Role of 3D Printing in Arthroplasty and Orthopedics

Kenneth B. Trauner

2355 Robotics in Orthopedics: A Brave New World

Brian S. Parsley

2358 Artificial Intelligence, Machine Learning, Deep Learning, and Cognitive Computing: What Do These
Terms Mean and How Will They Impact Health Care?
Stefano A. Bini

HEALTH POLICY & ECONOMICS

2362 Bundled Payments for Care Improvement in the Private Sector: A Win for Everyone
Jared S. Preston, Darleen Caccavale, Amy Smith,Lauren E. Stull, David A.Harwood, and Stephen Kayiaros

2368 Risk Adjustment Is Necessary in Medicare Bundled Payment Models for Total Hip and Knee Arthroplasty
P. Maxwell Courtney, Daniel D. Bohl, Edmund C. Lau, Kevin L. Ong, Joshua J. Jacobs, and
Craig J. Della Valle

2376 Time Trends in Characteristics of Patients Undergoing Primary Total Hip and Knee Arthroplasty in
California, 2007-2010
Cheongeun Oh, James D. Slover, Joseph A. Bosco, Richard Iorio, and Heather T. Gold

2381 Reducing Length of Stay Does Not Increase Emergency Room Visits or Readmissions in Patients
Undergoing Primary Hip and Knee Arthroplasties
Andrea H. Stone, Leah Dunn, James H. MacDonald, and Paul J. King

2387 Improved Perioperative Care of Elective Joint Replacement Patients: The Impact of an Orthopedic
Perioperative Hospitalist
Steven J. Fitzgerald, Terrence C. Palmer, and Matthew J. Kraay

(continued)
2392 Treatment Success Following Joint Arthroplasty: Defining Thresholds for the Oxford Hip and Knee Scores
David F. Hamilton, Fanny L. Loth, Deborah J. MacDonald, Karlmeinrad Giesinger, James T. Patton,
A. Hamish Simpson, Colin R. Howie, and Johannes M. Giesinger

2398 Evidence-Based Thresholds for the Volume and Cost Relationship in Total Hip Arthroplasty: Outcomes
and Economies of Scale
Heather S. Haeberle, Sergio M. Navarro, William C. Frankel, Michael A. Mont, and Prem N. Ramkumar

2405 Conversion vs Primary Total Hip Arthroplasty: Increased Cost of Care and Perioperative Complications
Sean P. Ryan, Marcus DiLallo, David E. Attarian, William A. Jiranek, and Thorsten M. Seyler

2412 Rapid Discharge in Total Hip Arthroplasty: Utility of the Outpatient Arthroplasty Risk Assessment Tool in
Predicting Same-Day and Next-Day Discharge
Kelvin Y. Kim, James E. Feng, Afshin A. Anoushiravani, Edward Dranoff, Roy I. Davidovitch, and
Ran Schwarzkopf

PRIMARY ARTHROPLASTY
2417 Press Ganey Outpatient Medical Practice Survey Scores Do Not Correlate With Patient-Reported Outcomes
After Primary Joint Arthroplasty
Jessica M. Kohring, Christopher E. Pelt, Mike B. Anderson, Christopher L. Peters, and Jeremy M. Gililland

2423 Improvement in Depression and Physical Health Following Total Joint Arthroplasty
Belal A. Tarakji, Aaron T. Wynkoop, Ajay K. Srivastava, Erin G. O'Connor, and Theresa S. Atkinson

2428 Patients With Poor Baseline Mental Health Undergoing Unicompartmental Knee Arthroplasty Have Poorer
Outcomes
Graham Seow-Hng Goh, Ming Han Lincoln Liow, Hee-Nee Pang, Darren Keng-Jin Tay, Ngai-Nung Lo, and
Seng-Jin Yeo

2435 Medial Mobile-Bearing Unicompartmental Knee Arthroplasty in Young Patients Aged Less Than or Equal to
50 Years
Nicholas J. Greco, Adolph V. Lombardi Jr, Andrew J. Price, Michael E. Berend, and Keith R. Berend

2440 Multimodal Clinical Pathway With Adductor Canal Block Decreases Hospital Length of Stay, Improves Pain
Control, and Reduces Opioid Consumption in Total Knee Arthroplasty Patients: A Retrospective Review
Terry A. Ellis II, Hassan Hammoud, Philip Dela Merced, Nishankkumar P. Nooli, Farhad Ghoddoussi,
Joshua Kong, and Sandeep H. Krishnan

2449 Patient Factors Associated With Prolonged Postoperative Opioid Use After Total Knee Arthroplasty
Robert S. Namba, Anshuman Singh, Elizabeth W. Paxton, and Maria C.S. Inacio

2455 Periarticular Ropivacaine Cocktail Is Equivalent to Liposomal Bupivacaine Cocktail in Bilateral Total Knee
Arthroplasty
Jonathan R. Danoff, Rahul Goel, R. Andrew Henderson, James Fraser, and Peter F. Sharkey

2460 Liposomal Bupivacaine vs Plain Bupivacaine in Periarticular Injection for Control of Pain and Early Motion
in Total Knee Arthroplasty: A Randomized, Prospective Study
Jason P. Zlotnicki, Brian R. Hamlin, Anton Y. Plakseychuk, Timothy J. Levison, Scott D. Rothenberger,
and Kenneth L. Urish

2465 Autologous Impaction Bone Grafting for Bone Defects of the Medial Tibia Plateau During Primary Total Knee
Arthroplasty: Propensity Score Matched Analysis With a Minimum of 7-Year Follow-Up
Jong M. Sohn, Yong In, Sang H. Jeon, Jin Y. Nho, and Man S. Kim

(continued)
2471 The Recovery Curve for the Patient-Reported Outcomes Measurement Information System Patient-Reported
Physical Function and Pain Interference Computerized Adaptive Tests After Primary Total Knee Arthroplasty
Ryland Kagan, Mike B. Anderson, Jesse C. Christensen, Christopher L. Peters, Jeremy M. Gililland, and
Christopher E. Pelt

2475 The Influence of Postoperative Knee Stability on Patient Satisfaction in Cruciate-Retaining Total Knee
Arthroplasty
Tomoyuki Kamenaga, Hirotsugu Muratsu, Yutaro Kanda, Hidetoshi Miya, Ryosuke Kuroda, and
Tomoyuki Matsumoto

2480 Correlation Between Intraoperative Anterior Stability and Flexion Gap in Total Knee Arthroplasty
Shinichiro Nakamura, Shinichi Kuriyama, Kohei Nishitani, Hiromu Ito, Koichi Murata, and
Shuichi Matsuda

2485 Modern Day Bicruciate-Retaining Total Knee Arthroplasty: A Short-Term Review of 146 Knees
Omar K. Alnachoukati, Roger H. Emerson, Elizabeth Diaz, Emily Ruchaud, and Kwame A. Ennin

2491 Cruciate-Retaining vs Posterior-Stabilized Primary Total Arthroplasty. Clinical Outcome Comparison With
a Minimum Follow-Up of 10 Years
Ricardo Serna-Berna, Alejandro Lizaur-Utrilla, Maria F. Vizcaya-Moreno, Francisco A. Miralles Mu~ noz,
Blanca Gonzalez-Navarro, and Fernando A. Lopez-Prats

2496 Iatrogenic Bone and Soft Tissue Trauma in Robotic-Arm Assisted Total Knee Arthroplasty Compared With
Conventional Jig-Based Total Knee Arthroplasty: A Prospective Cohort Study and Validation of a New
Classification System
Babar Kayani, Sujith Konan, Jurek R.T. Pietrzak, and Fares S. Haddad

2502 The Reliability of Sensor-Assisted Soft Tissue Measurements in Primary Total Knee Arthroplasty
Just A. van der Linde, Ken J. Beath, and Anthony K.L. Leong

2506 Morphological Patterns of Anterior Femoral Condylar Resection in Kinematically and Mechanically Aligned
Total Knee Arthroplasty
Jung-Taek Kim, Jun Han, Quan Hu Shen, Sung Won Moon, and Ye-Yeon Won

2512 Using a Tibial Short Extension Stem Reduces Tibial Component Loosening After Primary Total Knee
Arthroplasty in Severely Varus Knees: Long-term Survival Analysis With Propensity Score Matching
Min-ho Park, Seong-Il Bin, Jong-Min Kim, Bum-Sik Lee, Chang-Rack Lee, and Young-Hee Kwon

2518 Ten-Year Mortality and Revision After Total Knee Arthroplasty in Morbidly Obese Patients
Mina Tohidi, Susan B. Brogly, Katherine Lajkosz, Heather J. Grant, Elizabeth G. VanDenKerkhof, and
Aaron R. Campbell

2524 Excellent Survival and Good Outcomes at 15 Years Using the Press-Fit Condylar Sigma Total Knee Arthroplasty
William M. Oliver, Calum H.C. Arthur, Alexander M. Wood, Robert A.E. Clayton, Ivan J. Brenkel, and
Philip Walmsley

2530 Evaluation of the Learning Curve When Transitioning From Posterolateral to Direct Anterior Hip
Arthroplasty: A Consecutive Series of 1000 Cases
Andrea H. Stone, Udai S. Sibia, Ryan Atkinson, Timothy R. Turner, and Paul J. King

2535 Is Direct Anterior Approach a Credible Option for Severely Obese Patients Undergoing Total Hip
Arthroplasty? A Matched-Control, Retrospective, Clinical Study
Alexander Antoniadis, Dimitris Dimitriou, Andreas Flury, Gregor Wiedmer, Julian Hasler, and
Naeder Helmy

2541 No Difference in Major Complication and Readmission Rates Following Simultaneous Bilateral vs Unilateral
Total Hip Arthroplasty
Mina W. Morcos, Adam Hart, John Antoniou, Olga L. Huk, David J. Zukor, and Stephane G. Bergeron

(continued)
2546 Total Hip Arthroplasty for Periacetabular Metastatic Disease. An Original Technique of Reconstruction
According to the Harrington Classification
Julien Wegrzyn, Matthieu Malatray, Turki Al-Qahtani, Vincent Pibarot, Cyrille Confavreux, and
Gilles Freyer

2556 Predictability of Pelvic Tilt During Total Hip Arthroplasty Using a Traction Table
Paul S. Roettges, Jack R. Hannallah, Jordan L. Smith, and John T. Ruth

2560 Resection Arthroplasty Compared With Total Hip Arthroplasty in Treating Chronic Hip Pain of Patients With
a History of Substance Abuse
William Curtis and Meir Marmor

REVISION ARTHROPLASTY
2566 Tritanium Acetabular Cup in Revision Hip Replacement: A Six to Ten Years of Follow-Up Study
Hazem A.H. Hosny, Ahmed El-Bakoury, Sreebala C.M. Srinivasan, Rathan Yarlagadda, and
Jonathan Keenan

COMPLICATIONS - INFECTION
2571 The Leukocyte Esterase Test Strip Is a Poor Rule-Out Test for Periprosthetic Joint Infection
Carl A. Deirmengian, Lihua Liang, John P. Rosenberger, Tony R. Joaquim, Martin R. Gould,
Patrick A. Citrano, and Keith W. Kardos

2575 What Is the Role of Diagnostic and Therapeutic Sonication in Periprosthetic Joint Infections?
Rita Hameister, Chin T. Lim, Christoph H. Lohmann, Wilson Wang, and Gurpal Singh

2582 Predicting Failure in Early Acute Prosthetic Joint Infection Treated With Debridement, Antibiotics, and
Implant Retention: External Validation of the KLIC Score
Claudia A.M. L€ owik, Paul C. Jutte, Eduard Tornero, Joris J.W. Ploegmakers, Bas A.S. Knobben,
Astrid J. de Vries, Wierd P. Zijlstra, Baukje Dijkstra, Alex Soriano, and Marjan Wouthuyzen-Bakker, on
behalf of the Northern Infection Network Joint Arthroplasty (NINJA)

2588 Does Prior Failed Debridement Compromise the Outcome of Subsequent Two-Stage Revision Done for
Periprosthetic Joint Infection Following Total Knee Arthroplasty?
Ashok Rajgopal, Inayat Panda, Arun Rao, Vivek Dahiya, and Himanshu Gupta

2595 Outcomes of Articulating Spacers With Autoclaved Femoral Components in Total Knee Arthroplasty Infection
Daniel E. Goltz, E. Grant Sutter, Michael P. Bolognesi, and Samuel S. Wellman

2605 Periprosthetic Joint Infection With Fungal Pathogens

Timothy S. Brown, Stephen M. Petis, Douglas R. Osmon, Tad M. Mabry, Daniel J. Berry, Arlen D. Hanssen,
and Matthew P. Abdel

COMPLICATIONS - OTHER
2613 The Impact of an Acute, Traumatic Wound Dehiscence on Clinical Outcomes Following Primary Knee
Arthroplasty
Robert A. Sershon, Nahom Tecle, Craig J. Della Valle, Brett R. Levine, Richard A. Berger, and Denis Nam

2616 How Fast Should a Total Knee Arthroplasty Be Performed? An Analysis of 140,199 Surgeries
Jaiben George, Bilal Mahmood, Assem A. Sultan, Nipun Sodhi, Michael A. Mont, Carlos A. Higuera, and
Kim L. Stearns

2623 Chronic Obstructive Pulmonary Disease Is Associated With Short-Term Complications Following Total
Knee Arthroplasty
George A. Yakubek, Gannon L. Curtis, Anton Khlopas, Mhamad Faour, Alison K. Klika, Michael A. Mont,
Wael K. Barsoum, and Carlos A. Higuera

(continued)
2627 A Higher Altitude Is an Independent Risk Factor for Venous Thromboembolisms After Total Hip Arthroplasty
Dhanur Damodar, Chester J. Donnally III, Jonathan I. Sheu, Tsun Y. Law, Martin W. Roche, and
Victor H. Hernandez

2631 The Fate of Elevated Metal Ion Levels After Revision Surgery for Head-Neck Taper Corrosion in Patients With
Metal-on-Polyethylene Total Hip Arthroplasty
Young-Min Kwon, John MacAuliffe, Yun Peng, and Paul Arauz

BASIC SCIENCE
2636 Variability in Elongation and Failure of the Medial Collateral Ligament After Pie-Crusting With 16- and
18-Gauge Needles
Spencer H. Amundsen, Kathleen N. Meyers, Timothy M. Wright, and Geoffrey H. Westrich

2640 Anthropometric Measurements of Knee Joints in the Hispanic Population

Colin A. McNamara, Amer A. Hanano, Jesus M. Villa, Gustavo M. Huaman, Preetesh D. Patel, and
Juan C. Suarez

2647 Anatomical Features of the Descending Genicular Artery to Facilitate Surgical Exposure for the Subvastus
ApproachdA Cadaveric Study
Yuya Kawarai, Junichi Nakamura, Takane Suzuki, Shigeo Hagiwara, Michiaki Miura, and Seiji Ohtori

2652 Correct Assessment of Acetabular Component Orientation in Total Hip Arthroplasty From Plane Radiographs
Diana Widmer, Kilian Reising, Elmar Kotter, and Peter Helwig

2660 A Retrieval Analysis of Impingement in Dual-Mobility Liners

Trevor P. Scott, Lydia Weitzler, Anthony Salvatore, Timothy M. Wright, and Geoffrey H. Westrich

2666 Residual Byproducts of Peroxide Crosslinked Vitamin E-Blended Ultrahigh Molecular Weight Polyethylene
David A. Bichara, Caitlin C. O'Brien, Brinda N. Doshi, Gunnlaugur P. Nielsen, Ebru Oral, and
Orhun K. Muratoglu

2671 Wear Kinetics of Highly Cross-Linked and Conventional Polyethylene Are Similar at Medium-term Follow-Up
After Primary Total Hip Arthroplasty
Constantin Mayer, Moritz Rommelmann, Michael Behringer, Marcus J€ ager, Rüdiger Krauspe, and
Christoph Zilkens

2677 Are Radiographic and Direct Measures of Acetabular Polyethylene Wear Comparable?
Krista K. Parran, Christopher P. Bechtel, Rebecca D. Moore, Jeremy J. Gebhart, Michael S. Reich,
Matthew J. Kraay, and Clare M. Rimnac

REVIEW
2684 Clinical Outcomes of Gap Balancing vs Measured Resection in Total Knee Arthroplasty: A Systematic Review
and Meta-Analysis Involving 2259 Subjects
Shuxiang Li, Xiaomin Luo, Peng Wang, Han Sun, Kun Wang, and Xiaoliang Sun

LETTERS TO THE EDITORS

2694 Letter to the Editor on “Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and
Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial”
Steven L. Shafer

2694 Response to Letter to the Editor on “Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain
Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial”
Michael A. Mont, Walter B. Beaver, Stanley H. Dysart, John W. Barrington, and Daniel J. Del Gaizo

(continued)
2695 Letter to the Editor on “Continuous Adductor Canal Blocks Provide Superior Ambulation and Pain
Control Compared to Epidural Analgesia for Primary Knee Arthroplasty: A Randomized, Controlled Trial.
J Arthroplasty”
Lucas J. Castro-Alves and Mark C. Kendall

2696 Response to the Letter to the Editor on “Continuous Adductor Canal Blocks Provide Superior Ambulation and
Pain Control Compared to Epidural Analgesia for Primary Knee Arthroplasty: A Randomized, Controlled Trial”
Erdan Kayupov, Mario Moric, and Craig J. Della Valle

2696 Letter to the Editor on “Systematic Review of Three Electrical Stimulation Techniques for Rehabilitation After
Total Knee Arthroplasty”
Mohammad Alwardat, Mohammad Etoom, and Paola Sinibaldi Salimei

2697 Letter to the Editor on “Correlation of the Caprini Score and Venous Thromboembolism Incidence Following
Primary Total Joint ArthroplastydResults of a Single-Institution Protocol”
Luis A. Diaz Quintero, Harry E. Fuentes, Juan P. Salazar Adum, Alfonso J. Tafur, James C. Kudrna, and
Joseph A. Caprini

2698 Response to the Letter to the Editor on “Correlation of the Caprini Score and Venous Thromboembolism
Incidence Following Primary Total Joint ArthroplastydResults of a Single-Institution Protocol”
Dexter K. Bateman, Robert W. Dow, Andrzej Brzezinski, Howard Y. Bar-Eli, and Stephen T. Kayiaros

2699 Letter to the Editor on “Patients With Major Depressive Disorder Experience Increased Perception of Pain and
Opioid Consumption Following Total Joint Arthroplasty”
Lingjia Yu, Ke Xiao, Danni Chi, Guixing Qiu, and Xisheng Weng

2700 Response to Letter to the Editor on “Patients With Major Depressive Disorder Experience Increased
Perception of Pain and Opioid Consumption Following Total Joint Arthroplasty”
Jennifer I. Etcheson, Chukwuweike U. Gwam, Nicole E. George, Sana Virani, Michael A. Mont, and
Ronald E. Delanois

2701 Letter to the Editor on “Impact of Operative Time on Adverse Events Following Primary Total Joint
Arthroplasty”
Xiang-Dong Wu, Ke-Jia Hu, Mian Tian, and Wei Huang

2702 Response to Letter to the Editor on “Impact of Operative Time on Adverse Events Following Primary Total
Joint Arthroplasty”
Daniel D. Bohl and Craig J. Della Valle
 The Journal of Arthroplasty 33 (2018) 2518e2523

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Ten-Year Mortality and Revision After Total Knee Arthroplasty in

Morbidly Obese Patients
Mina Tohidi, MD a, b, Susan B. Brogly, PhD c, d, Katherine Lajkosz, MSc d,
Heather J. Grant, MSc a, e, Elizabeth G. VanDenKerkhof, PhD d, f, g,
Aaron R. Campbell, MD a, *
a
Division of Orthopaedic Surgery, Department of Surgery, Kingston Health Sciences Centre, Queen's University, Kingston, Canada
b
Department of Public Health Sciences, Queen's University, Kingston, Canada
c
Department of Surgery, Queen's University, Kingston, Canada
d
Institute for Clinical Evaluative Sciences, Queen's University, Kingston, Canada
e
Human Mobility Research Centre, Queen's University, Kingston, Canada
f
School of Nursing, Queen's University, Kingston, Canada
g
Department of Anesthesiology and Perioperative Medicine, Kingston Health Sciences Centre, Kingston, Canada

a r t i c l e i n f o a b s t r a c t

Article history: Background: Although morbid obesity has been associated with early surgical complications after total
Received 4 February 2018 knee arthroplasty (TKA), evidence of long-term outcomes is limited. We conducted a population-based
Received in revised form study to determine the association between morbid obesity and 10-year survival and revision surgery in
1 March 2018
patients undergoing primary TKA.
Accepted 17 March 2018
Methods: A cohort study of 9817 patients aged 18-60 years treated with primary TKA from April 1, 2002
Available online 4 April 2018
to March 31, 2007 was conducted using Ontario administrative health-care databases of universal health-
care coverage. Patients were followed up for 10 years after TKA. Risk ratios (RRs) of mortality and TKA
Keywords:
mortality
revision surgery in patients with body mass index > 45 kg/m2 (morbidly obese patients) compared with
revision surgery body mass index
45 kg/m2 (nonmorbidly obese) were estimated adjusting for age, sex, socioeconomic
knee arthroplasty status, and comorbidities.
obesity Results: About 10.2% (1001) of the cohort was morbidly obese. Morbidly obese patients were more likely
arthroplasty to be female than nonmorbidly obese patients (82.5% vs 63.7%, P < .001) but otherwise similar in
characteristics. Morbidly obese patients had higher 10-year risk of death than nonmorbidly obese pa-
tients (adjusted RR 1.50, 95% confidence interval 1.22-1.85). About 8.5% (832) of the patients had at least
1 revision procedure in the 10 years after TKA; revision rates did not differ by obesity (adjusted RR 1.09,
95% confidence interval 0.88-1.34).
Conclusion: Morbidly obese patients
60 years had a 50% higher 10-year risk of death but no difference
in the risk of revision surgery. Results of this population-based study inform evidence-based perioper-
ative counseling of morbidly obese patients considering TKA.
© 2018 Elsevier Inc. All rights reserved.

Funding for this project was provided by the Department of Surgery, Queen's
One or more of the authors of this paper have disclosed potential or pertinent
University.
conflicts of interest, which may include receipt of payment, either direct or
indirect, institutional support, or association with an entity in the biomedical
No endorsement by the ICES or the Ontario Ministry of Health and Long-Term
field which may be perceived to have potential conflict of interest with this
Care is intended or should be inferred. Parts of this material are based on data
work. For full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.
and information compiled and provided by CIHI. However, the analyses, con-
03.049.
clusions, opinions and statements expressed herein are those of the author,
and not necessarily those of CIHI.
This study was supported by the Institute for Clinical Evaluative Sciences
* Reprint requests: Aaron R. Campbell, MD, Department of Surgery, Queen's
(ICES), which is funded by an annual grant from the Ontario Ministry of Health
University, Kingston Health Sciences Centre, Victory 3, 76 Stuart Street, Kingston,
and Long-Term Care. The opinions, results, and conclusions reported in this
Ontario, Canada K7L 2V7.
paper are those of the authors and are independent from the funding sources.

https://doi.org/10.1016/j.arth.2018.03.049
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 M. Tohidi et al. / The Journal of Arthroplasty 33 (2018) 2518e2523
Obesity, defined as abnormal or excessive fat accumulation that
may impair health, has become a worldwide epidemic [1].
Approximately 34% of adults in the Unites States and 25% of adults
in Canada are obese [2,3]. Obesity is a recognized risk factor for the
development of knee osteoarthritis [4]. Yet, there is no established
threshold body mass index (BMI) value to separate individuals at
high and low risk of developing osteoarthritis. Approximately 50%
of patients undergoing total knee arthroplasty (TKA) are obese, and
this proportion is expected to continue to increase [5].
The World Health Organization describes 3 classes of obesity:
class I, 30.0-34.9 kg/m2; class II, 35.0-39.9 kg/m2; and class III,
 40.0 kg/m2 [6]. Morbid obesity, which encompasses individuals
with class III obesity, has been linked to several early postoperative
complications after TKA, including wound dehiscence, superficial
infection, and thromboembolic events [7e10]. George et al [10]
estimated the association between BMI and 30-day complications
after TKA. They found that morbid obesity was associated with
increased risk of hospital readmission, reoperation, superficial
infection, periprosthetic joint infection, wound dehiscence, pul-
monary embolism, reintubation, and renal insufficiency.
While no study has examined the association between morbid
obesity and long-term survival after primary TKA, studies have
examined other long-term patient outcomes. Results have been
conflicting among the few available studies [5,11e15]. Differences
in BMI categories, length of follow-up, and failure to adjust for
important confounders in some studies may explain the varying
study results. To our knowledge, there are no data on the most
comorbid and growing group of TKA patients: young, morbidly
obese patients. Given the increasing prevalence of this patient
group seeking surgical management for knee osteoarthritis, better
understanding of the long-term outcomes of TKA in morbidly obese
patients is warranted [5]. The purpose of this study, therefore, was
to determine the association between morbid obesity and 10-year
survival and revision surgery in patients undergoing primary TKA.
Materials and Methods
Data Source
This population-based retrospective cohort study utilized pro-
vincial, routinely collected administrative health-care data. Ontario
is the most populated province in Canada with approximately 13.6
million residents. Permanent residents are entitled to universal
health-care coverage under the Ontario Health Insurance Plan
(OHIP) free of charge. The Institute for Clinical Evaluative Sciences
(ICES) holds linked databases of administrative data for health-care
encounters. This repository of linked providence-wide databases
includes individual-level data. The databases used in this study
included: OHIP physician billing claims database, Canadian Insti-
tute for Health Information Discharge Abstract Database and Same
Day Surgery, National Ambulatory Care Reporting System, and
Ontario Registered Persons Database (RPDB). The data sets were
linked using unique encoded identifiers and analyzed at ICES. The
full data set creation plan is available from the authors on request.
The study was approved by the institutional review board and the
University Health Sciences and Affiliated Teaching Hospitals
Research Ethics Board.
Study Population
Ontario patients aged between 18 and 60 years who underwent
primary TKA (OHIP physician billing code R441) for osteoarthritis
(OHIP diagnostic code 715) between April 1, 2002 and March 31,
2007 were included in the study cohort. We restricted the date of
TKA to March 2007 to allow for 10 years of follow-up after TKA.
2519
Patients with a diagnosis of rheumatoid arthritis (OHIP diagnostic
code 714) or osteomyelitis (OHIP diagnostic code 730) in the year
preceding joint arthroplasty were excluded because the disease
process and risk of complications differ for these patients compared
to patients with osteoarthritis. Patients who underwent bilateral
TKA on the same day were also excluded because simultaneous
bilateral TKA is independently associated with high 30-day mor-
tality after surgery [16]. Finally, patients who lost OHIP eligibility
during the follow-up period were excluded from risk models. For
patients who underwent more than 1 primary TKA during the
study period, the date of the first arthroplasty was recorded as the
index date.
Baseline Characteristics
We identified patient's age, sex, and income quintile at the index
date from the RPDB database. The neighborhood income quintile, a
marker of socioeconomic status (SES), compared the average in-
come of a postal code against all other postal codes in the census
area or census metropolitan area. The higher the percentile, the
higher the average income relative to other postal codes in the area.
Baseline comorbidity was measured using Johns Hopkins Aggre-
gated Diagnosis Group (ADG) Index including health-care
encounter data for the year before the index TKA from the
following databases: Discharge Abstract Database, Same Day Sur-
gery, National Ambulatory Care Reporting System, and OHIP [17].
This index system measures health status by grouping International
Classification of Disease codes into one of 32 clinically relevant
diagnosis clusters based on 5 dimensions: duration of condition,
severity of condition, diagnostic certainty, etiology of condition,
and specialty care involvement. Three or more ADGs over a speci-
fied period are considered a significant morbidity burden. The
mean number of ADGs was calculated and classified as total and
major ADGs.
Morbid obesity was identified using an anesthesia premium
(OHIP physician billing code E010C) that is billed by the anesthe-
siologist for patients with a BMI > 45 kg/m2. Patients without such
a code were classified as BMI
45 kg/m2 (nonmorbidly obese).
Outcome Measures
The primary outcome measures were (1) 10-year all-cause
death and (2) 10-year revision TKA, defined as revision arthro-
plasty occurring any time after the index TKA. Death was identified
through the RPDB database. Revision arthroplasty was identified
through the OHIP physician billing code specific to revision TKA
(R244).
Statistical Analysis
Differences in patient characteristics by morbid obesity status
were assessed using the chi-square test for categorical variables
and the Student t test for continuous variables.
Kaplan-Meier survival curves were used to estimate time to
death and time to revision for morbidly obese and nonmorbidly
obese patients. The log-rank test was used to test statistical
significance.
The 10-year risk of death and revision TKA in morbidly obese
patients compared with nonmorbidly obese patients was estimated
using generalized linear models. A priori confounders of morbid
obesity and TKA outcomes available in the ICES data included age,
sex, SES, and comorbidities as measured by the Johns Hopkins
ADGs [18]. The small number of patients who lost OHIP eligibility
was excluded from the regression models. Modification of the risk
2520 M. Tohidi et al. / The Journal of Arthroplasty 33 (2018) 2518e2523

Table 1
Characteristics of Patients in Ontario 2002 to 2007 Undergoing Total Knee Arthroplasty at the Time of Surgery by BMI Category.

Baseline Characteristic BMI > 45 kg/m2 BMI
45 kg/m2 Total P Value

N ¼ 1001 N ¼ 8816 N ¼ 9817

Sex
Female 826 (82.5%) 5615 (63.7%) 6441 (65.6%)
Male 175 (17.5%) 3201 (36.3%) 3376 (34.4%) <.001
Age, mean (±SD) 54.57 ± 4.33 54.90 ± 4.77 54.87 ± 4.73 .033
SES (percentile) <.001
0-20 232 (23.2%) 1581 (17.9%) 1813 (18.5%)
21-40 209 (20.9%) 1756 (19.9%) 1965 (20.0%)
41-60 195 (19.5%) 1751 (19.9%) 1946 (19.8%)
61-80 198 (19.8%) 1879 (21.3%) 2077 (21.2%)
81-100 164 (16.4%) 1823 (20.7%) 1987 (20.2%)
Missing <6 26 (0.3%) 29 (0.3%)
Sum of all ADGs, mean (±SD) 6.8 ± 2.9 6.6 ± 2.9 6.6 ± 2.9 .164
Sum of major ADGs, mean (±SD) 1.2 ± 1.0 1.2 ± 1.0 1.2 ± 1.0 .505
Multiple TKAs
During study period 284 (28.0%) 1560 (17.7%) 1841 (18.8%) <.001
Before study period 95 (9.4%) 436 (4.9%) 530 (5.4%) <.001

BMI, body mass index; TKA, total knee arthroplasty; SD, standard deviation; SES, socioeconomic status.

ratio (RR) by sex was examined. Statistical analyses were performed
using SAS (9.3).
Results
Among the 9934 patients in the study cohort who underwent
primary TKA for osteoarthritis, 1015 (10.2%) had BMI > 45 kg/m2
and were therefore classified as morbidly obese, while 8919 (89.8%)
were classified as nonmorbidly obese. Following index TKA, 117
(1.2%) patients in the cohort (14 morbidly obese, 103 nonmorbidly
obese) lost OHIP eligibility and were therefore excluded from the
models of risk of death and risk of revision TKA. Of the remaining
9817, 10.2% (n ¼ 1001) were morbidity obese (Table 1). No clinically
meaningful differences in patient characteristics were identified in
those who were included in the analysis cohort and those who lost
OHIP eligibility and were excluded.
Compared with nonmorbidly obese patients, morbidly obese
patients were more likely to be female (82.5% vs 63.7%, P value
<.001) and more likely to have primary TKA on the opposite
leg during the study period (28.0% vs 17.7%, P value <.001) and
prior to the study period (9.4% vs 4.9%, P value <.001). The
study cohort had a mean (±standard deviation) of 6.6 (±2.9)
ADGs and 1.2 (±1.0) major ADGs. There was no statistically
significant difference in baseline comorbidity level by obesity
status.
Ten-Year Mortality Status
Kaplan-Meier curves demonstrate that nonmorbidly obese pa-
tients had a crude lower risk of death than morbidly obese patients
(Fig. 1, P value ¼ .001). In the regression models, the 10-year risk of
death after TKA was 42% higher in patients classified as morbidly
obese compared with those classified as nonmorbidly obese (RR
1.42, 95% confidence interval [CI] 1.15-1.74); Table 2. There was little
change after controlling for age, sex, SES, and ADG (RR 1.50, 95% CI
1.22-1.85); Table 2. There was no modification of RR by sex:
adjusted RR 1.67 (95% CI 1.13-2.47) for men and adjusted RR 1.43
(95% CI 1.12-1.82) for women.

Fig. 1. Kaplan-Meier curves for the length of time from index procedure to death by BMI category.
 M. Tohidi et al. / The Journal of Arthroplasty 33 (2018) 2518e2523
Table 2
Crude and Adjusted 10-Year Risk Ratio of Death in Morbidly Obese Compared With Nonmorbidly Obese Patients in Ontario Undergoing Primary TKA.
Exposure Alive Dead
N ¼ 9124 N ¼ 693
2
BMI >45 kg/m 905 (9.9%) 96 (13.9%)
BMI
45 kg/m2 8219 (90.1%) 597 (86.1%)
ADG, Aggregated Diagnosis Group; BMI, body mass index; CI, confidence interval; TKA, total knee arthroplasty; RR, risk ratio; SES, socioeconomic status.
a
Adjusted for age, sex, SES, and Johns Hopkins ADG.
Ten-Year Revision Rate
Kaplan-Meier curves showed a similar risk in revision by obesity
(Fig. 2, P- value ¼ .311). In regression models, the 10-year RR of
revision surgery was 1.11 (95% CI 0.90-1.36) in morbidly obese
patients compared with nonmorbidly obese patients (Table 3). The
association was unchanged after adjustment for potential con-
founders (RR 1.09, 95% CI 0.88-1.34); Table 3. There was no modi-
fication of RR by sex: adjusted RR 1.33 (95% CI 0.86-2.06) for men
and adjusted RR 1.04 (95% CI 0.83-1.32) for women.
Discussion
Ten-Year Mortality Status
This large population-based cohort study is the first to examine
the effect of morbid obesity on long-term survival following pri-
mary TKA survival. Although the overall 10-year risk of death was
relatively low (7.06%), there was a 50% increased risk of death in
morbidly obese patients compared with nonmorbidly obese
patients.
The study by Hamoui et al reported similar rates of long-term
(median 11.3 years) survival in 31 obese (BMI > 30 kg/m2) and 31
nonobese (BMI
30 kg/m2) patients undergoing TKA. Their study
may have been unpowered to show a survival difference between
groups, and furthermore, the patients in their obese group were
generally mildly obese (BMI 30-35 kg/m2), with only 3 patients
Fig. 2. Kaplan-Meier curves for the length of time from index procedure to revision TKA by BMI category.
2521
Total Unadjusted RR (CI) Adjusteda RR (CI)
N ¼ 9817
1001 (10.2%) 1.42 (1.15, 1.74) 1.50 (1.22, 1.85)
8816 (89.8%) (ref) (ref)
having BMI > 35 kg/m2. Therefore, the cohort and exposure groups
in the study by Hamoui et al are not directly comparable to ours.
Several studies have examined the effect of morbid obesity on
short-term survival, and results have been mixed [7e9,13,19e21]. A
recent meta-analysis found no difference in perioperative mortality
between patients with BMI  30 kg/m2 and BMI < 30 kg/m2 [13].
The authors were unable to evaluate this outcome using higher BMI
cutoffs due to the lack of published studies. In a large, population-
based study, Zusmanovich et al [21] reported no difference in
30-day death rate between patients with BMI  40 kg/m2 and BMI
< 25 kg/m2. Alternatively, D'Apuzzo et al [7] found that morbid
obesity, which they also defined as BMI > 45 kg/m2, was associated
with 3.2-fold increased odds of in-hospital mortality (odds ratio
[OR] 3.2, 95% CI 2.0-5.2). Ward et al [8] conducted a large study on
over 22,000 veterans classified into 6 BMI categories and
found increasing 1-year mortality rates with increasing BMI; BMI >
45 kg/m2 was an independent predictor of death at 1 year (OR 2.46,
95% CI 1.34-4.52).
Wallace et al [9] found no statistically significant difference in
6-month mortality rates for patients with BMI 35 kg/m2
compared with BMI 18.5-25 kg/m2 after adjusting for baseline
covariates. The authors controlled for comorbidities including
diabetes mellitus, chronic pulmonary obstructive disease, ischemic
heart disease, atrial fibrillation, and previous use of several classes
of medications. These comorbidities, which are often preceded by
obesity, likely lie on the causal pathway and controlling for them
would attenuate the relationship between obesity and death; this
may explain the lack of mortality difference found in the study by
2522 M. Tohidi et al. / The Journal of Arthroplasty 33 (2018) 2518e2523
Table 3
Crude and Adjusted 10-Year Risk Ratio of Knee Arthroplasty Revision in Morbidly Obese Compared With Nonmorbidly Obese Patients in Ontario.
Exposure No Revision Revision
N ¼ 8985 N ¼ 832
2
BMI > 45 kg/m 908 (10.1%) 93 (11.2%)
BMI
45 kg/m2 8077 (89.9%) 739 (88.8%)
ADG, Aggregated Diagnosis Group; BMI, body mass index; CI, confidence interval; RR, risk ratio; SES, socioeconomic status.
a
Adjusted for age, sex, SES, and Johns Hopkins ADG.
Wallace et al. In addition, there may be a threshold effect with
respect to BMI and increased mortality that may explain, at least in
part, the difference between existing study results.
The increased risk of death observed in our study may be
partially due to the increased risk of mortality from obesity, irre-
spective of TKA. A large meta-analysis of over 2.88 million in-
dividuals estimated an all-cause mortality hazard ratio of 1.29 (95%
CI 1.18-1.41) for BMI  35.0 kg/m2, relative to normal weight [22]. It
would be valuable to compare long-term mortality rates for
morbidly obese patients undergoing primary TKA to morbidly
obese people who do not undergo arthroplasty.
Ten-Year Revision Rate
We found no difference in 10-year risk of revision surgery by
morbid obesity. This finding is consistent with a number of pub-
lished studies, which found similar long-term revision rates for
obese and nonobese patients [11,12,19,20]. In the long-term study
by Griffin et al [11], 3 of 120 study patients underwent revision
surgery in the 10 years following surgery; revision rates in patients
who were obese were not higher than those in nonobese patients.
Similarly, in another small study, there was no difference in long-
term revision rates in morbidly obese patients (BMI > 40 kg/m2)
compared with nonmorbidly obese patients [12]. Bordini et al [19]
also found that risk of implant failure was not influenced by BMI,
though they caution interpretation of results related to morbid
obesity owing to small sample size. Thus, despite evidence of
increased wound complications and postoperative infection, the
long-term risk for revision surgery in morbidly obese patients may
be comparable to nonmorbidly obese patients.
The existing literature, however, contains several published
studies with contradictory results. For example, a 2015 meta-
analysis that combined results of studies with at least 5 years
of follow-up showed increased odds of revision surgery for obese
patients (BMI  30 kg/m2) compared to nonobese patients (OR
1.6, 95% CI 1.07-2.40) but no significant difference in revision
rates between morbidity obese (BMI  40 kg/m2) and nonobese
patients (OR 1.98, 95% CI 0.88-4.45). Again, low power from small
sample sizes and outcomes, even within this meta-analysis, limits
the available evidence. Conversely, in a large prospective cohort
study, Zingg et al [5] found a threshold effect at BMI  35 kg/m2,
where the hazard ratio for all-cause revision was twice as high
compared with BMI < 35 kg/m2. In this cohort, revision rate
was 6.4/1000 patient-years with BMI  35 kg/m2, compared to
3.2/1000 patient-years with BMI < 35 kg/m2 (hazard ratio 2.0,
95% CI 1.2-3.3). Similar findings are reported in the large registry-
based study by Wagner et al [15], which used smoothing spline
parameterization to show that risk of revision surgery increased
with increasing BMI after TKA. Interestingly, in their study,
the risk of revision for mechanical failure is higher among pa-
tients with BMI between 35.0 and 39.9 kg/m2, compared to BMI
 40 kg/m2.
The relationship between BMI and revision risk may be
nonlinear, where mildly obese patients are at higher risk than both
nonobese and morbidly obese patients. Wagner et al [15] attribute
Total Unadjusted RR (CI) Adjusteda RR (CI)
N ¼ 9817
1001 (10.2%) 1.11 (0.90, 1.36) 1.09 (0.88, 1.34)
8816 (89.8%) (ref) (ref)
the decline in revision surgery in morbidly obese patients,
compared with nonobese and mildly obese patients, to decreased
implant wear because of lower activity levels in this group of pa-
tients. Unfortunately, these intricacies are lost with dichotomized
exposure groups. Finally, owing to increased perioperative risks,
physicians may be more hesitant to offer morbidly obese patients,
compared with nonobese patients, revision surgery without a
strong indication. This is an example of confounding by indication.
Along the same line, a morbidly obese patient may decline revision
TKA, despite an indication for surgery, given their increased risk for
perioperative complications.
One of the biggest challenges when comparing existing litera-
ture is the varying definitions of obesity and morbid obesity; some
studies used BMI cutoffs or a threshold excess weight above ideal
body weight, while others define morbid obesity as an elevated BMI
in addition to obesity-related health conditions such as high blood
pressure or diabetes [23]. BMI as an exposure status is categorized
into 2 or more groups in some studies, while others use BMI as a
continuous variable.
Furthermore, some studies control for comorbidities associated
with obesity, while others do not. We did not include the American
Society of Anesthesiologists score as a potential confounder
because it includes obesity and thus removed some of the inde-
pendent effect of obesity on our outcome.
Strengths and Limitations
Our study has several strengths. A population-based sample
from Ontario's diverse population of over 13.5 million was used.
Universal, province-wide health coverage and ICES-enabled data
linkage between multiple databases enable us to follow this cohort
over many years with minimal loss to follow-up. Abstraction
studies have demonstrated high coding consistency and agreement
for diagnostic and intervention codes using administrative data
[24,25]. To our knowledge, this is the only published study exam-
ining the long-term risk of death, and this is one of the largest
cohorts used to evaluate death and revision surgery following TKA.
This study also has some limitations. Laterality (right- or left-
sided TKA) cannot be established with current diagnostic and
procedure codes. Because only a small portion of patients had
primary TKA before the study period, and even a smaller propor-
tion underwent subsequent revision TKA, we do not expect this
coding limitation to have a significant effect on our results. To avoid
overestimating risk of revision for patients with multiple TKAs
during our study period, we followed up patients for up to 10 years
from the date of their first TKA.
Using a BMI cutoff >45 kg/m2 to categorize patients in our study
likely attenuated study results due to misclassification. Patients
with BMI
45 kg/m2 include those who are not obese and obese
(BMI >30 to <40 kg/m2) and some morbidly obese (BMI 40 kg/m2 to
45 kg/m2) patients; these latter groups would likely increase the
risk of adverse outcomes in our reference groups and attenuate
associations between obesity and death and revision TKA.
Thus, the risk of these outcomes compared to healthy weight in-
dividuals is likely higher than that estimated in our study. Further
 M. Tohidi et al. / The Journal of Arthroplasty 33 (2018) 2518e2523
refinement of exposure categories is not possible with existing data
sources.
Given the low incidence of revision surgery at 10 years and a
relatively small proportion of the total cohort (10.2%) being clas-
sified as morbidly obese, despite our large cohort of 9817 in-
dividuals, it is possible that our study was underpowered to
identify any increased risk in revision from obesity.
Finally, comprehensive patient counseling implications also
require data on the outcomes of patients who are morbidly obese
and are not offered or chose not to undergo TKA. Whether such
patients have better or worse survival and/or quality of life than
morbidly obese patients who undergo TKA are additional
important data to guide treatment choices in this population.
Because we defined our morbidly obese group using an anes-
thesia premium code, which is only applicable to patients un-
dergoing surgery, we were unable to examine survival in this
group of patients.
Conclusions
Morbid obesity, defined in our study as BMI > 45 kg/m2, was
associated with increased 10-year mortality in patients aged
younger than 60 years undergoing primary TKA. There was no ef-
fect of morbid obesity on the 10-year risk of revision. Though their
risk of death is higher over 10 years, morbidly obese patients are
not at increased risk of revision surgery over this period of time,
compared with nonmorbidly obese patients. These new findings
have important implications for this growing patient population.
Results of this population-based study can be used to counsel obese
patients about risks following TKA.
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 The Journal of Arthroplasty 33 (2018) 2345e2351

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

AAHKS Symposium

The Emergence of Distance Health Technologies

Jonathan L. Schaffer, MD, MBA a, *, Peter A. Rasmussen, MD b,
Matthew R. Faiman, MD, MBA, FACP c
a
Digital Health, Information Technology Division, Department of Orthopaedic Surgery, Center for Joint Replacement and Adult Reconstruction,
Orthopaedic and Rheumatologic Institute, Cleveland Clinic, Cleveland, OH
b
Digital Health, Information Technology Division, Cerebrovascular Center, Neurological Institute, Cleveland Clinic, Cleveland, OH
c
Digital Health, Information Technology Division, Community Internal Medicine, Cleveland Clinic Community Health, Cleveland Clinic, Cleveland,
OH

a r t i c l e i n f o a b s t r a c t

Article history: Removing the geographic barriers to health care and extending care to the home has been the goal of the
Received 9 April 2018 health-care system for decades as the introduction of new information technology capabilities has driven
Accepted 10 April 2018 operational efficiencies in our daily lives. Patient demand for convenience and access continues to surge
Available online 30 May 2018
as these technologies are used for their personal lives. Coupled with the need to lower our health-care
cost structure, distance health technologies are emerging as a care facilitator for our arthroplasty pa-
Keywords:
tients. A critical aspect of introducing distance health technologies is the requirement to define the entire
distance health
episode of care. Once defined, metrics to assess success can be measured, and clinical and technical
digital health
ehealth
outcomes can be determined. Distance health technologies are emerging in the management of the
arthroplasty arthroplasty episode of care through the preponderance of connectivity coupled with the adoption of
information technology mobile technologies, ushering in a new era of improved efficiency, efficacy, satisfaction, and outcomes
episode of care while providing greater value for our patients.
© 2018 Elsevier Inc. All rights reserved.

The emergence of distance health technologies as a care mo-
dality for our arthroplasty patients has become a reality in 2018 [1].
Extending the healthcare environment to the patient’s home has
been a goal for decades. Over the years, the barriers for making this
possible on a grand scale have impeded progress. Whether it was
reimbursement and payment strategies, technology platforms,
devices, security, or clinician workflow and incentives, distance
health has resided just out of health care’s tight grasp and standard
of care for many years. In the interim, we have witnessed many
years of trials, experiments, and modest growth in distance health
while the barriers are being addressed. Doctors, employers, in-
surers, government leaders, and innovators have been gradually
removing demographic, logistical, financial, regulatory, and
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.04.017.
* Reprint requests: Jonathan L. Schaffer, MD, MBA, Department of Orthopaedic
Surgery, Center for Joint Reconstruction, Orthopaedic and Rheumatologic Institute,
Cleveland Clinic, 9500 Euclid Avenue, Desk A41, Cleveland, OH 44195.
technological barriers. Meanwhile patient demand continues to
surge as the technologies are used for their personal lives.
The most important contributors to progress are the mobile
technologies and the preponderance of connectivity. More people
are connected now than ever before with over 80% of Americans
owning smartphones [2] and nearly 75% have broadband service
[3]. The demand for distance health now has the global infra-
structure to support and accelerate it. Hospitals are also getting
ready for the new technologies. Ninety percent of healthcare ex-
ecutives reported to have or are currently building a telehealth
program [4]. Over 7 million patient users are predicted in 2018, a
19-fold increase from 2013 [5]. New technologies are being applied
to existing care processes. Greater than 19 million patients are
projected to use remote monitoring devices that record and report
monitoring information to their doctors in 2018 [6]. Platforms are
also being developed that enable interaction between clinicians
around the world. After years of experiments and modest growth,
momentum is building to establish distance health as a widely
accepted standard of care.
Remote, digital, and distance health technologies (or “tele-
health”) encompass a group of technologies and services that
enable care for those patients who are not physically colocated in
time or space with the services and the professionals providing care

https://doi.org/10.1016/j.arth.2018.04.017
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2346 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351
for them or other clinicians providing care for them. In 2018, these
forces have converged to change the way patients expect and de-
mand their care and the way in which clinicians provide care for
their patients. For those patients who are challenged to travel any
distance for their health care, including postoperative arthroplasty
patients, these distance health technologies are enabling the
physically infirm as they can remove the impediments to their care.
Removing the geographic barriers to care can provide more effi-
cient, timelier, and more optimal outcomes while also leading to
significant cost savings. The role of this communication is to
describe the emergence of distance health technologies in the care
of our arthroplasty patients.
Distance health technologies have been evolving for many years
as advances in information and communication services have been
introduced and applied to various healthcare scenarios. The critical
stage for adoption has been reached as the technologies, regulatory,
and financial considerations are becoming more permissive for
main stream implementation. A revolution is underway in our
patient care models as we usher in a new era of improved effi-
ciency, improved efficacy, and hopefully improved outcomes at a
lower cost and increased value [7]. Distance health technologies
have the capability to help us achieve these goals, and the trends in
the adoption and utilization of these technologies will increasingly
impact our arthroplasty practices over the coming years [8].
However, distance health technologies can only be effectively
applied when the underlying processes are well designed and
appropriately controlled [9]. Our arthroplasty care processes must
be rationally designed and applied before distance health tech-
nologies can provide the desired benefits [9,10].
We are actually in the midst of 2 revolutions simultaneously:
clinical care and distance health technologies. Over the past 6 de-
cades, we have witnessed a digital revolution that started with the
introduction of the transistor and led to computers, the Internet,
the World Wide Web to mobile communications and computing
Fig. 1. Consumer and patient portals for mobile phones.
[11]. The migration from analog to digital devices has forever
changed the way we perform our daily activities. The emergence of
distance health technologies is here today because we have seen an
evolution with small adaptations developing which increase the
ability of the organism or the person or an organization to compete
to survive and to thrive amidst the competitive forces and threats to
its survival [12]. Adoption of these changes permits the survival of
the one most organized around the response to the challenges
being experienced. In order to survive as arthroplasty surgeons, we
must develop an episode of care and have active management of
this episode of care for our patients. This episode of care manage-
ment includes descriptions of the care continuum and all of the
metrics that would help us understand whether we have been
successful in our endeavor. Only then can we examine what is in
our distance health technology inventory. So we begin first with an
examination of what the future may hold in the midst of this tel-
ehealth evolution or revolution. Removing the geographic barriers
to care is quickly becoming the norm during this digital and care
revolution.
Technologies have evolved to provide even more function and
more features for the user and a better return on investment for
those who produce them. The telephone originated with a simple
point-to-point communication service over a couple of wires [13].
Through the advent of early analog and then digital technologies,
we have gone from the rotary dial to the touch tone system, then to
briefcase-size mobile phones, and we now have technologies being
held in our hand that have computing power that exceeds a
building full of the older technologies. Current mobile devices,
thanks in large part to the genius of Steve Jobs, are handheld, have
the ability to communicate, access data, and analyze and control
devices remotely irrespective of physical location. This anywhere,
anytime culture has become the norm (Fig. 1).
The iPhone (Apple) was introduced less than a decade ago and
its touch screen has revolutionized the way in which we
 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351
communicate to the point that a flip phone, once the darling of the
industry, seems incredibly antiquated. Many of us remember
traveler’s checks and bank tellers, both now essentially obsolete.
Banking systems and processes have evolved to become more
effective and more efficient. On those rare occasions when we need
cash for purchases, we no longer wait in line at a bank to make a
transaction with a teller. Thanks to the adoption of worldwide
standards in the banking industry, financial transactions are now so
seamless you can take money out of an ATM (Automated Teller
Machine) anywhere in the world and expect that your accounts
reflect an accurate balance seconds later. For both communications
and the banking industry, technology has relatively quickly turned
retail, manufacturing, travel, entertainment, and every other in-
dustry upside down. In fact, developments in seemingly disparate
areas such as banking and communications can facilitate the
permissive evolution that occurs when causal factors in 2 separate
domains can lead to digital transformation [12].
Many of these developments are driven by the need for improved
operational effectiveness which in turn is driven by lowering the
cost structure. Continuous improvement and constant evolution has
become the norm. The car factory of yesteryear had many people,
many manual processes with precision that was considered accurate
at that specific time point. Once a level of precision is achieved, our
expectations change and that level becomes significant imprecision.
The car factory of today has manufacturing processes that are under
the control by robotic devices. In today’s language, this is digitiza-
tion, the standardization of processes are now an absolute necessity.
In fact, most factory floors have people stationed only at monitors
checking on what is going on in each of the different machines.
While the machine analytics can provide warnings of impending
failure or faults, the humans currently have some oversight until that
function can be handled by a machine. We know that man has
evolved from early Cro-Magnon times when everything was manual
labor to our current state where manual labor in many instances
consists solely of our fingers running across a keyboard. This has led
to its own set of challenges.
While health care requires significant human interaction, we
have a long way to go to improve our operational processes. While
the world around us is changing quickly, health care is one of the
last bastions of analog transactions. Patients are demanding the
same ease of access, precision, and automation value as they get in
every other part of their modern lives, and they want it on their
phone. The transition from fee-for-service to a value-based care
process requires significant effort to transition to lower cost with
greater efficiency and efficacy [7]. Those technologies already
developed and in use in other industries will be needed to support
that transition to help us move the practice of medicine from a
paper model to a digital model. Undertaking the transition to
operational improvement does not guarantee success. John
Chambers, former CEO of Cisco System, noted that while 70% of
businesses will attempt to digitally transform, perhaps only 30%
will succeed while 40% will probably fail over the long term [14].
For this transition to the digital model of care, many different
technologies have been discussed and proposed. To improve the
convenience of care and the access to care, the distance health
technologies encompass a wide range of specific applications and
services. Telehealth, telemedicine, and distance health could best
be viewed as alphabet-health as there are many eHealth, tHealth,
mHealth, rHealth, aHealth, oHealth, and iHealth discussions. The
most commonly accepted definition is medical information that is
electronically exchanged between sites that will help improve a
patient’s clinical health status. This development can be traced back
to the 1964 New York World’s Fair when Bell Labs introduced the
picture phone [15]. Development of this device was stimulated by
NASA to assist monitoring the health of astronauts during space
2347
flight. Further funding was provided by the US Department of De-
fense to provide care in remote locations. More than 50 years after
the introduction of the video phone, the technologies are here and
being applied to health care. Providing medical advice and assis-
tance to our patients anytime, anywhere using distance health
technologies has finally reached critical momentum.
We would be remiss if we did not give credit to the first described
use of technology to save a life. It was Mark Twain in his short story
“From the London Times in 1904” who described the telectroscope,
essentially a futuristic video phone [15,16]. US Army Lieutenant
Clayton and Mr. Sczcepnik were wrapped in an intrigue that pro-
vided an early demonstration of a prototype video phone and its use
to save a life. In fact, Twain could also be credited with accurately
describing the Internet and World Wide Web as we know it today.
Patient and consumer demand are also influencing the emer-
gence of distance health technologies. The consumer use of digital
technologies has been increasing significantly as noted in the
Deloitte 2016 survey of US Healthcare Consumers [17]. Consumers
are using these technologies for shopping (86%), banking (72%),
filling prescriptions (58%), filing taxes (51%), paying medical bills
(31%), monitoring health (24%), and checking the cost of care (18%).
Unfortunately, the healthcare issues are far lower in part because
the applications to seek and manage health care from the health-
care providers do not exist. Providing content on the provider’s
online presence started with physician directories in the 1990s [18].
The transition from content to care is being driven in large part by
consumer demand. However, the providers need their own digital
processes, including all aspects of the episode of care in order to
make this happen. Electronic medical records (EMRs), Internet
access to medical information and professional services, Internet-
based patient monitoring, and Internet-based patient in-
terventions are all used to direct the episode of care.
Organizing the areas of distance health technologies that will
help impact physicians in the near future, especially arthroplasty
physicians, will help us explain and justify the impact of these
technologies for our patients and the payors as we deliver care. The
framework for organizing distance health technologies can be
divided into 4 distinct application domains [19]. While distinct,
these domains are a reference point and guide with applications
often overlapping domains. Synchronous technologies are real-
time interactions that could include virtual visits (primary and
specialist care), virtual rounding, and virtual consults such as tel-
estroke [20], ehospital monitoring programs, central monitoring
units, critical and chronic care monitoring programs, and real-time
assistance for international travelers. The central monitoring unit
(Fig. 2) provides greater oversight and more effective monitoring in
conjunction with the onsite staff [21].
Fig. 2. Central monitoring unit.
2348 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351
Fig. 3. Cleveland Clinic’s mobile stroke treatment unit. (A) Extended rescue vehicle
with reinforced structure to accommodate the computed tomography (CT) scanner and
advanced communication technologies. (B) Internal view of patient gurney and CT
scan. (C) Treatment simulation depicting control station at the foot of the patient with
the stroke neurologist contributing to the evaluation.
Asynchronous applications are interactions outside of a real-
time interaction that may involve other time constraints, such as
remote, online second opinions [22], internal EMR-based profes-
sional messaging requests such as evaluating a dermatologic rash,
when a dermatologist is not co-located with the primary care team,
or an imaging study, and professional and patient care
adviceebased consultation services.
Remote patient monitoring technologies can be either syn-
chronous or asynchronous while evaluating data that are trans-
mitted for evaluation by a medical provider to determine optimal
diagnostic or treatment recommendations. Measuring various pa-
rameters from afar and then transmitting that data for evaluation
and decision making fits with the anytime, anywhere model of care
ensuring that the use of remote patient monitoring will expand.
Mobile health domains may be used in any of these 3 other do-
mains but are a distinct domain as well given the importance from a
Fig. 4. eHospital monitoring station.
public health standpoint for informing populations about healthy
behaviors or health alerts. The applications in each of these domains
can either be scheduled or on demand depending on clinical need.
Crossing over many domains are portals focused on engagement
with consumers, patients, referring physicians and suppliers, and
specific care process technologies such as Cleveland Clinic’s Mobile
Stroke Treatment Unit (Fig. 3), ehospital monitoring of critical care
units (Fig. 4), and remote emergent consultation services for global
travelers. Many of these platforms are also being built that enable
more interaction between clinicians. Cleveland Clinic’s Mobile
Stroke Treatment Unit is equipped with the tools needed to treat a
patient having a stroke at the patient’s home through telehealth
connections to a stroke neurologist and a neuroradiologist who
deliver expert guidance remotely. Initial results have been impres-
sive with the time to treatment decreasing by 40% for acute stroke, a
factor that leads to more patients that can regain the ability to walk
independently [20]. As noted by the authors, the distance health-
enabled ambulance model as compared to the traditional ambu-
lance model resulted in significantly decreased time to imaging and
more importantly to treatment. In developing this framework, the
focus is on function and the episode of care first before considering
the application of technologies to improve the processes.
Another issue for consideration is cybersecurity. Patients do not
necessarily trust the online community for their own health care
given the daily conversation revolving on the extensive number of
breeches that have been witnessed over the past few years. In the
2015 Trends and Virtual Healthcare Services Survey from Technol-
ogy Advice Research [23], 65% of patients said they would be
Fig. 5. Episode of care continuum
 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351
Fig. 6. Arthroplasty continuum of care.
somewhat or much more likely to conduct a virtual follow-up with
their provider while 16% said they would be somewhat less likely or
less likely with 19% not being impacted either way. This is still a
significant population to get the digital health revolution underway
and a very good start to demonstrate the value of a virtual follow-up.
There are also challenges in the implementation of distance
health services. The 2017 KPMG Digital Health Pulse [24] notes that
maintaining a sustainable business and financial model is the top
challenge for healthcare organizations by a factor of 2. Adoption
issues with clinicians and defining a plan or strategy on how to
implement and incorporate virtual care come in a distant second
and third concern. The most significant challenge to technology
adoption is the need to make obvious business sense to the users
and to be readily incorporated into existing clinical processes.
Defining the episode of care as a continuum is critical to develop
schemas to overcome these challenges to design, implementation,
Fig. 7. Communication workflows for arthroplasty episode of care continuum.
2349
and utilization of these distance health technologies. Our health
today influences our health tomorrow. In that aspect, health care
can be viewed as we do Nonaka’s Spiral Theory of Knowledge [25].
The knowledge of today becomes the knowledge of tomorrow with
the addition of the knowledge gained during the intervening period
to constitute the knowledge of tomorrow. In a similar manner, the
Spiral Theory of Healthcare [25] can be used to describe the tran-
sition from our health today to our health tomorrow. It is a cu-
mulative series of events that lead to the new steady state.
Often a global continuum can describe and be applicable to
many clinical situations (Fig. 5). The management process for the
specific clinical episode of care also requires definition to ensure
that the clinician and foremost the patient can have a successful
outcome in a specific care continuum. Each and every day, we are in
steady state care in the community. This means we are at home, at
work, we might use a wellness or fitness center, a retail pharmacy;
we may even go for a routine outpatient visit or need an imaging
study. We remain in this steady state because we are the same
health status and we need to maintain it and provide treatments
and evaluations that help us maintain that steady state.
At some point, we face a challenge and we enter the acute or
episodic care state. This may require urgent care or care at a family
health or surgery center or even at a hospital facility. After that care
has occurred, we then start on the back side of that acute episodic
care as we seek a new equilibrium and we try to go through
inpatient or outpatient rehabilitation or care at a nursing facility or
homecare to recover. That recovery and rehabilitation state then
leads us to return back to a steady state in the community. How-
ever, that steady state care may not be at the exact same level as it
was before this episode of care took place. It is a cumulative series
of events that lead to the new steady state.
For arthroplasty care, a specific arthroplasty episode of care is
helpful for achieving clinical and administrative success and su-
perior patient-reported outcomes. The arthroplasty care contin-
uum can be divided into 6 major states ([26], Fig. 6): awareness
2350 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351
Fig. 8. Distance health toolbox for arthroplasty care.
programs, outpatient clinic, preoperative evaluation, day of surgery,
postop inpatient, and postop rehab. All of these states lead to
returning the patient to their steady state so that they can then
enjoy their health. Throughout the arthroplasty continuum, sur-
geons need technologies that will help us take care of the patient
and provide the appropriate materials.
To further evaluate the use of distance health technologies in the
management of the episode of arthroplasty care, the first step starts
with a side-by-side comparison of the care process steps with
available and future technologies. For awareness programs, pa-
tients will seek care, they will see content online, they may have
questions, they may get a first opinion, they may need a second
opinion, and they may need to remotely upload their images or
their clinical data so that their data can be evaluated. Each of these
actions could be accomplished during a face-to-face visit, a syn-
chronous online visit, or an asynchronous online visit through
portals for engagement for consumers, for patients, referring phy-
sicians, and appointment scheduling. Educational and preoperative
materials can be read online after the patient has completed that
initial outpatient clinic evaluation from a musculoskeletal provider.
At some point, the patient may in fact become a candidate for an
arthroplasty. The day of surgery at this time is the state that re-
quires a face-to-face interaction although future developments
may change that requirement.
During the postoperative course, remote monitoring can be
used to ensure compliance with the postoperative protocol and to
identify progress variances [26e29]. The patients may have virtual
visit follow-ups during the global period as there is no additional
cost to the patient, they do not have to travel to a physician’s office,
and in many cases those evaluations are more helpful to ensuring
protocol compliance and are cost-effective [26,27]. There are also
online self-management tools that may help in this postoperative
course as well [28,29]. For the day of surgery, there are also many
different technologies that are available in the management of the
episode of care. When we see a patient we are documenting all of
our thoughts about what we are going to do at the time of surgery
at that specific visit and placing them in the EMR which can then be
transferred to the various groups that need to better understand
those requirements to execute the events on the day of surgery that
will lead to a successful outcome. For surgeons, these modes of
communication cross over to many areas (Fig. 7). Each of these
distance health technologies can be applied at many different
points of the episode of care continuum.
The inventory of distance health technologies can be segmented
by intended communication target. Focusing on clinician to
Fig. 9. Distance health metrics and scorecard.
clinician, clinician to patient, and chronic disease management
classification facilitates discussion about the management of the
episode of care (Fig. 8). Many of these technologies contribute to
each of these 3 different segments and apply to the arthroplasty
surgeon. As was observed with browser and social media apps,
convergence and consolidation are anticipated in this fragmented
space. Consolidation will occur when tools become platforms that
address the entire care continuum. The future state of these tools
should provide access anytime, anywhere with descriptive and
prescriptive analytics with an assessment and recommendations
[30]. Of course establishing metrics to evaluate these processes is
key to the evaluation of our care. Technical and clinical outcome
and provider and patient satisfaction should be assessed (Fig. 9) as
one would for the evaluation of the business value of information
technology [31].
The emergence of distance health technologies will increase
efficiency and lower costs while staying current with patient ex-
pectations in large part due to the permissive environment for our
arthroplasty episode of care through the preponderance of con-
nectivity coupled with the adoption of mobile technologies. These
technologies will expand access and remove time and geographic
barriers with reach far beyond that of a new building. However,
these technologies can only be effectively applied to an episode of
care when you have control of the underlying processes. Granted,
simple communication technologies can be used for its intended
use and provide significant benefit with decreased friction while
obtaining health care. The tools that are used for the care of the
arthroplasty patients will continue to expand and evolve depend-
ing on the availability of the technologies and their utilization by
the care stakeholders (Fig. 8).
We will continue to adapt and develop the episode of care
management through the use of our distance health technologies.
These trends in distance health will continue to increase for
arthroplasty care in future years, bringing care to a new era of
improved efficiency, improved efficacy, and improved outcomes
with greater value as our goal. Simultaneously, patient demand for
convenience, value, access, quality, safety, and satisfaction will be
addressed. The awareness, engagement, and utilization of these
technologies for one’s health care will increasingly provide a
permissive environment for patients and clinicians to engage
remotely for routine and episodic health care. We will then be pre-
pared to fully support the transition to value-based care. After years
of building sufficient momentum, the emergence and acceleration of
distance health technologies and services are assured in 2018 for
access anywhere, anytime.
 J.L. Schaffer et al. / The Journal of Arthroplasty 33 (2018) 2345e2351 2351

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 The Journal of Arthroplasty 33 (2018) 2352e2354

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

AAHKS Symposium

The Emerging Role of 3D Printing in Arthroplasty and Orthopedics

Kenneth B. Trauner, MD *
Department of Orthopedic Surgery, Kaiser Permanente Medical Center, Oakland, CA

a r t i c l e i n f o a b s t r a c t

Article history: This article reviews the emerging role of 3D printing in arthroplasty and orthopedics, a topic of growing
Received 7 February 2018 relevancy. It discusses the evolution of the technology, the value offered by the technology, current
Accepted 8 February 2018 trends and factors impacting adoption in orthopedics, and areas of current and potential future use in
Available online 16 February 2018
arthroplasty and orthopedics.
© 2018 Elsevier Inc. All rights reserved.
Keywords:
3D printing
additive fabrication
digital manufacturing
arthroplasty
orthopedics

This article reviews the emerging role of 3D printing (3DP) in
arthroplasty and orthopedics, a topic of growing relevancy. It aims
to cover the evolution, impact, and use in orthopedics and
emerging technologies.
3DP, also known as “additive manufacturing” (AM), “rapid
prototyping”, or “solid free-form technology” [1], is a process in
which objects are made by fusing or depositing materials in layers.
A digital design is formulated, sliced in layers, typically in an "STL"
format, and sent to a printer for production. There are over 20
different 3DP processes. Extensive efforts are underway to address
production standards [2], and increasing numbers of devices are
recognized by the Food and Drug Administration. A large array of
materials are now available for production including plastics,
metals, and ceramics using both solid and liquid elements.
Most orthopedic products are produced by powder bed fusion of
either metal or plastic [3]. For powder bed printing, the printer
devices contain a chamber of powder that is heated to a tempera-
ture slightly below the melting temperature of the printing mate-
rial. The digital design of the production part is divided into slices,
with each slice correlating to an individually printed layer. To
produce each layer, a high intensity laser beam or other energy
sources scan the surface of the powder bed at locations determined
The author of this paper has disclosed potential or pertinent conflicts of interest,
which may include receipt of payment, either direct or indirect, institutional sup-
port, or association with an entity in the biomedical field which may be perceived
to have potential conflict of interest with this work. For full disclosure statement
refer to https://doi.org/10.1016/j.arth.2018.02.033.
* Reprint requests: Kenneth B. Trauner, MD, Department of Orthopedic Surgery,
Kaiser Oakland Medical Center, 275 W MacArthur Blvd, Oakland, CA 94611.
by the digital design of each slice. At the sights that receive laser
irradiation, the powder is melted, sintered, or annealed such that it
transforms into a solid. After the layer is treated, the powder bed is
lowered and new layer of powder is spread evenly over the surface,
and the process is repeated. The material that is melted or sintered
mechanically binds the underlying treated areas in sequential
fashion until the final product is generated.
3DP has generated a great deal of excitement for its potential
to transform manufacturing. It is the enabling platform as we
transition from an era of mass production to an era of mass
personalization. AM allows products to be produced without
traditional design constraints. Complexity is free. There is no
added cost to produce highly complex parts. There are no tooling
requirements to produce limited production runs of the finished
product. AM allows for parts that could not be previously pro-
duced or improvement of the existing parts. It allows for internal
geometries, part assemblies, and part consolidation [4]. AM can
reduce the development cost to market and provide supply chain
efficiencies [5].
Given the potential of the technology, 3DP has generated sub-
stantial hype in the lay press in the recent years. In the Gartner
Research hype cycle, published in 2012 [6], 3DP was listed at the
peak of inflated expectations. However, in reality, enormous
progress was underway at the time in the field. Only 3 years later, in
2015, 3DP had advanced to such a degree that Gartner published a
full hype cycle for 3DP technologies alone [7]. By that time, 3DP had
disrupted multiple medical sectors, including dentistry and ENT/
maxillofacial surgery [8,9], and most hearing aid custom shell
production had converted to 3DP [10]. Invisalign had extensively
impacted the field of orthodontics [11]. In lay sectors, 3DP had

https://doi.org/10.1016/j.arth.2018.02.033
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 K.B. Trauner / The Journal of Arthroplasty 33 (2018) 2352e2354
gained broad adoption in areas as disparate as jewelry and aero-
space manufacturing [4].
Currently, 3DP is having significant impact in many health-care
disciplines. In dentistry, nearly all elements of production are
moving to digital workflows including crowns, bridges, drill guides,
and so forth [12]. Digital workflows now significantly contribute to
reconstructive maxillofacial surgery [8,9]. Virtual Surgical Planning
(VSP) with 3DP has become the standard tool in orthognathic
surgery, custom osteotomies, and maxillofacial oncology using
digital planning with 3DP cutting guides and custom plates [13].
With regards to orthopedics and 3DP, cost barriers have
contributed to the field lagging in adoption behind fields such as to
ENT and dentistry. Orthopedics faces the challenge of using larger
devices with greater structural requirements. For 3DP, part costs
are tied to multiple variables including the size of the device, the
amount of metallic powder used, the quality of the materials used
and the speed and cost of the machines. Orthopedic implants
require the use of the most expensive 3DP machines and large
amounts of more expensive materials and as such have awaited
progress in the field to become cost-effective and economically
viable [3].
For 3DP, we are currently at an inflection point. In the recent
years, key 3DP patents have expired. This has produced an explo-
sion of innovation and brought many new players into the field,
both large and small including General Electric and Hewlett Pack-
ard. New machines are now being introduced that aim to optimize
all elements of production. Machine speed, new materials, software
tools, and postprocessing automation all are advancing to provide
more rapid production with a broader array of materials and lower
costs [3]. The Food and Drug Administration has also issued recent
guidance for 3DP of medical devices removing some regulatory
uncertainty [14].
In orthopedics, a combination of 3D original equipment manu-
facturers and traditional orthopedic manufacturers are producing
an array of products and services at an accelerating pace. 3DP of
anatomic models for complex surgical planning is available with
numerous vendors [15,16]. VSP allows for streamlined workflows in
which digital imaging and communications in medicine data are
converted into functional models. Surgical planning then generates
sterile custom resection guides, allograft cutting guides to dovetail
with the resections, and custom plates and implants for complex
reconstructions. Numerous guides and instruments are now made
available of rigid Selective Laser Sintering-generated plastic for
patient specific instrumentation, surgical cutting guides, and
standard instrument sets. 3DP technology has been the core tech-
nology enabling the cost-efficient production of patient specific
instrumentation throughout arthroplasty and trauma surgery.
Most recently, reduced costs of the 3DP parts are also pushing 3D-
printed single-use instrument sets into the field as a cost-reducing
alternative to traditional reusable metal sets.
In the realm of complex total joint arthroplasty, the increasingly
sophisticated VSP tools now allow for full surgical planning,
aligning screw placement to the best host bone with drill guides,
cutting guides for complex osteotomies, and custom implants.
[17e19] Implants are generated as a single build of ingrowth and
cage/plate assemblies from the same material. Ingrowth surface
locations, construct design, and fixation elements are determined
by the physician designer. Complex implants are beginning to take
advantage of the potential of the technology, and combined with
generative design tools, we will see newer implants with less ma-
terial and better modulus matching properties in the future.
With regards to conventional total joint arthroplasty, 3DP has
streamlined production of several implant types now in the field.
The single build of ingrowth implants eliminates the need to bind
ingrowth material to a supportive substrate. For knees, 3D-printed
2353
cones and baseplates are now available. For hips, acetabular cup
production is broadly adopting 3DP. Thinner, printed constructs are
less expensive to manufacture than traditional constructs and also
offer the advantage of allowing for the use of larger diameter
femoral heads with smaller shells. Combined manufacturing mo-
dalities also now start to appear, combining robotics with 3DP/6
axis milling for fully automated production. There is now an early
mandate among some manufacturers to transition to digital
workflows over the upcoming years.
Both direct and indirect production methods are in use for the
production of arthroplasty implants. Direct printing of metal with
laser or electron beam sintering of metal powders has been out-
lined in previous examples and utilizes high power energy sources
to build parts. Implants are also being produced by indirect
methods in which the personalized implant is printed in wax
variant by liquid stereolithography methods (in which light is
shined on a photopolymer) and used as a positive for conventional
casting of the part [20]. Newer less expensive metal printing has
also been introduced just recently in which metals are printed with
binder jet technology at low energy and temperature, and the
printed part is later sintered as a whole. This technology has
opened the door for low-cost desktop printing of metal parts and
offers the potential long-term promise of lower cost production of
3DP metal parts.
For prosthetics and orthotics, 3DP opens the door for modern
industrial design and true mass personalization. Since the intro-
duction of 3DP fairings for amputees in the recent years, there has
been an explosion of innovation in prosthetic and orthotic design.
Workflows for production of personalized exoskeletal products are
being expedited by incorporating rapid advances in digital scan-
ning, computer aided design, and additive manufacturing [21]. By
removing traditional manufacturing constraints and allowing for
personalized structural design, 3DP offers opportunity for replacing
the stigma of traditional designs with prosthetics as fashionable
accessories.
In areas where clinical outcomes are tied to patient compliance,
3DP offer the ability to improve clinical results. For scoliosis, the
success of bracing treatments is tied to patient compliance with
brace wear. By improving the comfort, breathability, and aesthetics,
3DP offers potential for an improved patient experience in a patient
demographic of typically young female patients during formative
years of development. 3DP also allows for development of novel
approaches to bracing. For example, custom spring designs bracing
have been developed that provide an adaptive fit while still cor-
recting deformity, a design approach not possible with traditional
manufacturing technology.
For casting bracing and splinting, 3DP devices offer the
potential for improved patient experience and work flow. 3DP
devices offer breathability, adaptive fitting for swelling, windows
for wound care, modularity, so a single device such as a
sequential modular long-arm cast can be used for the full course
of fracture care. This technology is moving quickly. When low
temperature thermoplastics are available with more rapid pro-
duction times, casting and bracing be one of the first applications
where we see true distributed manufacturing of 3DP medical
devices in physician offices.
3DP bioprinting is an early evolving field which is generating
excitement and capturing much attention [1,22,23]. Bioprinting
refers to techniques for growing or building biological tissues and is
currently classified academically under the field of regenerative
medicine [24]. Bioprinters are typically bioplotters containing
syringe-like devices that extrude specialized “inks” that contain
cells, substrates, and growth factors in various combinations to
produce 3D matrices. Output matrices are typically placed into
bioreactors where they are differentiated into the targeted tissues.
2354 K.B. Trauner / The Journal of Arthroplasty 33 (2018) 2352e2354
Orthopedic applications in development include most types of
musculoskeletal tissue [1], including artificial tendons, ligaments,
cartilage muscles, and bones [25]. The field of regenerative medi-
cine is evolving quickly but is currently at an early stage of clinical
development. The realm of 3DP of biologics offers much promise
and will be the subject of great attention in upcoming years.
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 The Journal of Arthroplasty 33 (2018) 2631e2635

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Other

The Fate of Elevated Metal Ion Levels After Revision Surgery

for Head-Neck Taper Corrosion in Patients With
Metal-on-Polyethylene Total Hip Arthroplasty
Young-Min Kwon, MD, PhD *, John MacAuliffe, MEng, Yun Peng, PhD, Paul Arauz, PhD
Department of Orthopaedic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA

a r t i c l e i n f o a b s t r a c t

Article history: Background: Elevated metal ion levels have been associated with the presence of adverse local tissue
Received 8 February 2018 reactions in patients with metal-on-polyethylene (MoP) total hip arthroplasty (THA) secondary to
Received in revised form corrosion at head-neck taper junction. Patients are frequently concerned with their elevated systemic
6 March 2018
metal ion levels. This study investigated the rate of decline of serum cobalt and chromium ion levels after
Accepted 21 March 2018
Available online 30 March 2018
revision surgery.
Methods: A total of 39 patients with MoP THA were revised because of the presence of symptomatic
adverse local tissue reactions on magnetic resonance imaging with elevated serum metal ion levels. The
Keywords:
adverse local tissue reaction
time between initial implantation of MoP THA (index surgery) and revision surgery was considered the
head-neck taper corrosion duration of metal exposure. The prerevision measure of ion level was considered the intensity of
cobalt and chromium metal ion level exposure. Prerevision median serum Co and Cr levels, as well as revision serum Co/Cr ratio, were
metal-on-polyethylene total hip reported.
arthroplasty Results: The median serum levels of cobalt and cobalt-to-chromium ratio significantly decreased from
metal ion levels decline prerevision levels of 8.2 mg/L (0.2-56.1 mg/L) and 5.6 mg/L (0.1-53.3 mg/L) to 3.1 mg/L (0.2-14 mg/L) and 1.7
mg/L (0.4-3.8 mg/L) at postrevision (P < .01), respectively. The rate of decline of Co was 0.45% per day
during the first month. For chromium, the rate of decline was slower with 0.08% per day during the first
month.
Conclusion: At 3 months after revision surgery, cobalt and chromium ion levels declined by 34% and 8%
of prerevision level, respectively. This study provides evidence-based practical information for surgeons
to provide MoP THA patients when considering revision surgery for head-neck taper corrosion.
© 2018 Elsevier Inc. All rights reserved.

Metal ions are released from the bearing surfaces and corrosion
and fretting from modular taper connections. Mechanically assisted
crevice corrosion (MACC) in metal-on-polyethylene (MoP) total hip
arthroplasty (THA) has been identified as a cause of symptomatic
implant failure for contemporary femoral components [1e4], spe-
cifically when a cobalt-chromium (CoCr) alloy femoral head is used
[2,5,6]. MACC produces cobalt (Co) and chromium (Cr) ions and
corrosive debris that may cause adverse local tissue reaction (ALTR)
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.061.
* Reprint requests: Young-Min Kwon, MD, PhD, Department of Orthopaedic
Surgery, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St,
Yawkey Suite 3B, Boston, MA 02114.
[2,5,6]. More recently, however, MACC causing an ALTR (pseudo-
tumors) has been recognized as a mode of THA failure in patients
with a MoP bearing surface [1,7e11]. Despite the wide adoption of
modular femoral heads, reports of MACC at the head-neck junction
causing THA failure had primarily been isolated to case reports
until recently [12e14].
The true prevalence of corrosion at the head-neck junction has
not been well studied; however, the present literature suggests that
the prevalence of MACC-associated ALTR causing clinical THA fail-
ure may be as high as 1%-2% [3,5,15]. Because the majority of the
THAs performed in the United States in the past decade are MoP
bearings with a modular femoral head, corrosion at the head-neck
junction is emerging as an important mode of failure [7]. Current
guidelines recommend revision surgery for symptomatic patients
with high metal ion levels and ALTRs [16,17]. In fact, patients are
frequently concerned with their elevated systemic cobalt and
chromium ion levels. However, the fates of these elevated ion levels

https://doi.org/10.1016/j.arth.2018.03.061
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2632 Y.-M. Kwon et al. / The Journal of Arthroplasty 33 (2018) 2631e2635
Fig. 1. Intraoperative photographs of corrosion at femoral stem trunnion (A), head taper (B), and debrided local tissue necrosis (C) at the time of revision surgery.
after the revision surgery remain largely unknown. Therefore, the
aim of this study was to investigate the rate of decline of serum
cobalt and chromium ion levels after revision surgery for adverse
tissue reactions in MoP THA patients due to head-neck taper
corrosion.
Materials and Methods
Patients
Patients with metal-on-polyethylene (MoP) total hip arthro-
plasty (THA) secondary to corrosion at head-neck taper junction
who underwent revision surgery with both prerevision and post-
revision serum metal ion levels were identified from the database
of a multidisciplinary referral center at the authors' hospital. The
study was approved by the institutional review board. Implant
information was recorded and used for analysis. At the time of
revision surgery, patient demographics were recorded including
age and sex. In addition, all patients underwent serum cobalt and
chromium levels. The indication for revision surgery was the
presence of symptomatic pseudotumors on magnetic resonance
imaging (MRI) with elevated metal ion levels (Fig. 1). All hips had
metal-on-polyethylene THA with highly cross-linked polyethylene
liners with cobalt-chromium (CoCr) femoral heads on titanium (Ti)
alloy femoral stems with only a single site of modularity at the
head-neck taper junction. Implants included 19 Versys/ML Taper
(Zimmer, Warsaw, IN), 11 LFIT Anatomic/Accolade (Stryker, Kala-
mazoo, MI), 4 Howmedica/Accolade (Stryker, Kalamazoo, MI), 1
Howmedica/Osteonics (Stryker, Kalamazoo, MI), 2 Pinnacle/Sum-
mit (DePuy, West Chester, PA), and 2 Ringloc/Taper Lock (Biomet,
Warsaw, IN). The index CoCr femoral head diameter was 28 mm in
2 hips (5%), 32 mm in 15 hips (38%), 36 mm in 17 hips (43%), and 40
mm in 6 hips (15%). The time between initial implantation of MoP
THA (index surgery) and revision surgery was 59 months (range 4-
182), and this duration was considered the duration of metal
exposure. The prerevision measure of ion level was considered the
intensity of exposure. Prerevision median serum Co and Cr levels,
as well as serum Co/Cr ratio, were used for analysis. Pearson cor-
relation coefficient was used to determine whether duration of
exposure or intensity of exposure affect the rate of decline of Co, Cr,
and Co/Cr ratio.
Data Analysis
Serum cobalt and chromium levels were measured preopera-
tively and at the routine clinical patient follow-up at 1, 3, and 12
months. To characterize the postrevision surgery decline of metal
ion levels, the postoperative cobalt and chromium levels were
normalized to a percent of the preoperative value. A best fitted
exponential decay curve was applied to describe the rate of metal
ion decline and metal ion half-life after removal of the implants.
The percentage rate of decline of cobalt and chromium serum ion
level was calculated as a function of time (months) after revision
surgery.
Statistics
Paired t test was applied to determine if there is a significant
difference in prerevision and postrevision metal ion levels. The
level of significance was set at a ¼ 0.05. All the statistical analyses
were performed using SPSS, version 22, software (SPSS Inc, Chi-
cago, IL).
 Y.-M. Kwon et al. / The Journal of Arthroplasty 33 (2018) 2631e2635 2633

Results

A total of 39 patients were identified for inclusion in this study:

16 males and 23 females with an average age of 68 years (range:
46-87 years). All patients were symptomatic and had metal-on-
polyethylene THA with highly cross-linked polyethylene liners
with cobalt-chromium femoral heads on Ti alloy femoral stems.
Positive diagnosis of ALTR was confirmed by radiographic inter-
pretation of metal artifact reduction sequence-MRI (MARS-MRI).
In this study, ALTR was defined as any mass, solid or cystic, with
the definite presence of a cyst wall in continuity with the hip joint
[18], excluding isolated distension or thickening of a noncom-
municating trochanteric burse. The time between initial implan-
tation of MoP THA and revision surgery was 59 months (range 4-
182 months), and this duration was considered the duration of
metal exposure.
Prerevision median serum Co and Cr levels were 8.2 mg/L (range
0.2-56.1 mg/L) and 2.1 mg/L (range: 0.3-16.4 mg/L), respectively.
Prerevision serum Co/Cr ratio averaged 5.6 (range: 0.1-53.3). On
average, the prerevision Co level was significantly higher than the
Cr level (P < .01). The median serum levels of cobalt and cobalt-to-
chromium ratio significantly decreased from prerevision levels of
8.2 mg/L (range: 0.2-56.1 mg/L) and 5.6 (range: 0.1-53.3) to 3.1 mg/L
(range: 0.2-14 mg/L) and 1.7 (range: 0.4-3.8) at postrevision (P <
.01), respectively. The median serum levels of chromium did not
decline significantly from prerevision levels 2.1 mg/L (range: 0.3-
16.4 mg/L) to 2 mg/L (range: 0.1-8.3 mg/L) at postrevision (P ¼ .28).
At approximately 12-week follow-up, the serum cobalt and
chromium levels dropped on average by 34% and 8%, whereas co-
balt and chromium half-life (time required for metal ion levels to
reach 50% of their preoperative values, after revision surgery) were
5 and 27 months, respectively (Fig. 2). In addition, the cobalt serum
levels declined for the vast majority of patients (95%) following
revision surgery with approximately half of those patients (51%),
showing a reduction in the serum chromium levels after revision
surgery (Fig. 3). For most patients with serum cobalt levels below 5
mg/L, this translates to a return to low (less than 2 mg/L) levels
within 10 months of the revision surgery (Fig. 3).
The rate of decline for both cobalt and chromium was fastest
shortly after revision surgery and gradually slowed over time. The
Fig. 2. The percentage decline per month of cobalt and chromium serum ion levels as a
rate of decline of Co was 0.45% per day during the first month, 0.2% function of time (months) after revision surgery.
per day at 6 months, and slowed to less than 0.1% per day at 12
months. For chromium, the rate of decline was slower with 0.08%
per day during the first month, 0.07% per day at 6 months, and clinically useful practical information for surgeons to provide
slowed to 0.06% per day at 12 months (Fig. 4). MoP THA patients when considering revision surgery for head-
The intensity of Co, Cr, and Co/Cr ratio ion exposure (as neck taper corrosion.
measured by extent of elevation of ions before revision) did not Patients with MoP THA are often concerned about the systemic
significantly affect the rate of decline postrevision (R ¼ 0.12, P ¼ elevation of metal ion levels and inquire about the time required to
.65 for Co, R ¼ 0.19, P ¼ .46 for Cr, and R ¼ 0.38, P ¼ .12 for Co/Cr return to normal. One of the sequelae of the revision surgery is to
ratio). There was no significant correlation between exposure reduce this unwanted systemic exposure. In this study, the vast
duration (time between index surgery and revision surgery) and majority of patients with elevated serum cobalt and chromium ion
rate of decline of ion levels (R ¼ 0.33, P ¼ .18 for Co; R ¼ 0.05, P ¼ .85 levels declined to very low levels after revision surgery. However,
for Cr, and R ¼ 0.41, P ¼ .09 for Co/Cr ratio). the rates of decline of cobalt and chromium were lower than those
reported for patients with metal-on-metal (MoM) THA by Ball el al
Discussion [19]. This difference may be attributed to the fact that the preop-
erative serum cobalt and chromium ion levels in 25 MoM THA
Taper junction corrosion and fretting, also known as MACC, patients reported by Ball et al [19] were higher (cobalt: 56.3 mg/L,
produces cobalt and chromium ions and corrosion debris, which chromium 20.5 mg/L) than in the current cohort of head-neck taper
may cause ALTRs. Recently, MACC-associated ALTR in patients with corrosion patients (cobalt: 8.2 mg/L, chromium: 2.1 mg/L). In this
a metal-on-polyethylene bearing has been recognized as a poten- study, the decline rate of cobalt and chromium was similar to those
tial cause of pain and failure [3,5,15]. Although the fate of metal ion reported by Dimitriou et al [21] and Liow et al [22]. Whereas
levels has been reported in patients with MoM THA [19e22], there Dimitriou et al [21] reported a decline rate of cobalt and chromium
is a paucity of specific literature that has determined the fate of levels of 0.2%, after revision for dual taper modular neck femoral
cobalt and chromium levels in patient with MoP THA due to head- stem in 187 patients at 6-week follow-up, Liow et al [22] reported a
neck taper corrosion. The present study provides evidence-based decline rate of cobalt and chromium levels of 0.2% and 1.8% after
2634 Y.-M. Kwon et al. / The Journal of Arthroplasty 33 (2018) 2631e2635
Fig. 3. Cobalt and chromium serum levels decline for each patient (n ¼ 39) after
revision surgery.
revision for MoM THA in 95 patients at 6-week follow-up. Matsen
Ko et al [23] recently reported postrevision serum levels of cobalt
0.7 mg/L and chromium 0.6 mg/L in 100 patients after THA with
cobalt-chromium modular dual-mobility components.
This study presented a reproducible decline in cobalt ion levels
over the first 12 weeks and then slows over the ensuing 12 weeks.
For the patient, this implies that by 12 weeks after revision, their
cobalt and chromium levels should drop by approximately 34% and
8%, respectively. For most patients with elevated Co levels, this
translates to a return to low levels within just a few months of the
revision surgery. Nevertheless, our findings suggest that for those
patients with ultra-high Co levels (Co > 50 mg/L), it may take longer
than one year for Co to return to very low levels (Fig. 3), and in
patients with ultra-high Cr levels (Cr > 20 mg/L), the rate of decline
becomes less predictable and typically more protracted (Fig. 3). In
these cases, Cr levels may remain persistently detectable above 10
mg/L for more than 1 year. This may, in part, be due to the pre-
dominant ion release at modular taper junction being a chemical
corrosion process that involves chromium precipitating as chro-
mium orthophosphate in tissues and more soluble cobalt dissi-
pating as free ions.
This study should be interpreted in light of its potential limi-
tations. First, the specific time interval of repeat laboratory draws
was not standardized owing to variability among follow-up in-
tervals. Even though an attempt was made to normalize the data,
Fig. 4. The rate percentage decline per day of cobalt and chromium serum ion levels as
a function of time (months) after revision surgery.
likely the data would have created more reliable clearance curves
if all patient laboratories were obtained at the exact same post-
revision intervals. Second, we do not have specific data regarding
the first exposure to elevated metal levels. We used the date of
initial implantation to mark the beginning of the exposure time.
However, it is possible that many of these patients did not develop
elevated metal wear until sometime after their initial surgery. In
addition, this study included a relative short-term follow-up
period. However, despite the short follow-up time, this study
demonstrated a decline of serum cobalt and chromium ion levels
in the vast majority of patients after revision surgery within the
first 3 months.
In conclusion, in the vast majority of patients with elevated ion
levels, metal ion levels declined to very low levels following revi-
sion surgery for adverse tissue reactions in MoP THA patients due
to head-neck taper corrosion. At 3 months after revision surgery,
cobalt and chromium ion levels declined by approximately 34% and
8% of prerevision level, respectively. This study provides evidence-
based clinically useful practical information for surgeons to provide
MoP THA patients when considering revision surgery for head-
neck taper corrosion.
 Y.-M. Kwon et al. / The Journal of Arthroplasty 33 (2018) 2631e2635 2635

References [12] Atwood SA, Patten EW, Bozic KJ, Pruitt LA, Ries MD. Corrosion-induced frac-
ture of a double-modular hip prosthesis: a case report. J Bone Joint Surg Am
2010;92:1522e5.
[1] Cooper HJ, Della Valle CJ, Berger RA, Tetreault M, Paprosky WG,
[13] Dangles CJ, Altstetter CJ. Failure of the modular neck in a total hip arthro-
Sporer SM, et al. Corrosion at the head-neck taper as a cause for adverse
plasty. J Arthroplasty 2010;25:1169.e5e77.e5.
local tissue reactions after total hip arthroplasty. J Bone Joint Surg Am
[14] Gilbert JL, Buckley CA, Jacobs JJ, Bertin KC, Zernich MR. Intergranular
2012;94:1655e61.
corrosion-fatigue failure of cobalt-alloy femoral stems. A failure analysis of
[2] Hussey DK, McGrory BJ. Ten-year cross-sectional study of mechanically
two implants. J Bone Joint Surg Am 1994;76:110e5.
assisted crevice corrosion in 1352 consecutive patients with metal-on-
[15] Cooper HJ. Diagnosis and treatment of adverse local tissue reactions at the
polyethylene total hip arthroplasty. J Arthroplasty 2017;32:2546e51.
head-neck junction. J Arthroplasty 2016;31:1381e4.
[3] McGrory BJ, MacKenzie J, Babikian G. A high prevalence of corrosion at the
[16] Kwon Y-M, Fehring TK, Lombardi AV, Barnes CL, Cabanela ME, Jacobs JJ. Risk
head-neck taper with contemporary zimmer non-cemented femoral hip
stratification algorithm for management of patients with dual modular taper
components. J Arthroplasty 2015;30:1265e8.
total hip arthroplasty: consensus statement of the American Association of
[4] Plummer DR, Berger RA, Paprosky WG, Sporer SM, Jacobs JJ, Della Valle CJ.
Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons and
Diagnosis and management of adverse local tissue reactions secondary to
the Hip Society. J Arthroplasty 2014;29:2060e4.
corrosion at the head-neck junction in patients with metal on polyethylene
[17] Molloy DO, Munir S, Jack CM, Cross MB, Walter WL, Walter Sr WK, et al.
bearings. J Arthroplasty 2016;31:264e8.
Fretting and corrosion in modular-neck total hip arthroplasty femoral stems.
[5] Jacobs JJ. Corrosion at the head-neck junction: why is this happening now?
J Bone Joint Surg Am 2014;96:488e93.
J Arthroplasty 2016;31:1378e80.
[18] Hauptfleisch J, Pandit H, Grammatopoulos G, Gill HS, Murray DW, Ostlere S. A MRI
[6] Jacobs JJ, Cooper HJ, Urban RM, Wixson RL, Della Valle CJ. What do we know
classification of periprosthetic soft tissue masses (pseudotumours) associated with
about taper corrosion in total hip arthroplasty? J Arthroplasty 2014;29:668e9.
metal-on-metal resurfacing hip arthroplasty. Skeletal Radiol 2012;41:149e55.
[7] Fillingham YA, Della Valle CJ, Bohl DD, Kelly MP, Hall DJ, Pourzal R, et al. Serum
[19] Ball ST, Severns D, Linn M, Meyer RS, Swenson FC. What happens to serum
metal levels for diagnosis of adverse local tissue reactions secondary to
metal ion levels after a metal-on-metal bearing is removed? J Arthroplasty
corrosion in metal-on-polyethylene total hip arthroplasty. J Arthroplasty
2013;28(8 Suppl):53e5.
2017;32:S272e7.
[20] Barlow BT, Assini J, Boles J, Lee YY, Westrich GH. Short-term metal ion trends
[8] Lindgren JU, Brismar BH, Wikstrom AC. Adverse reaction to metal release from
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[21] Dimitriou D, Liow MHL, Tsai T-Y, Leone WA, Li G, Kwon Y-M. Early outcomes
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187 patients. J Arthroplasty 2016;31:1549e54.
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[22] Liow MHL, Dimitriou D, Tsai T-Y, Kwon Y-M. Preoperative risk factors asso-
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[23] Matsen Ko LJ, Pollag KE, Yoo JY, Sharkey PF. Serum metal ion levels following
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 The Journal of Arthroplasty 33 (2018) 2613e2615

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Other

The Impact of an Acute, Traumatic Wound Dehiscence on Clinical

Outcomes Following Primary Knee Arthroplasty
Robert A. Sershon, MD *, Nahom Tecle, BA, Craig J. Della Valle, MD, Brett R. Levine, MD,
Richard A. Berger, MD, Denis Nam, MD
Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, Illinois

a r t i c l e i n f o a b s t r a c t

Article history: Background: Early wound healing complications and persistent drainage are associated with an
Received 11 December 2017 increased risk of infection following knee arthroplasty. However, the scenario in which a patient sustains
Received in revised form an acute, traumatic wound dehiscence has not been investigated. The purpose of this study is to
21 February 2018
determine the outcomes of an acute traumatic wound dehiscence following arthroplasty treated with an
Accepted 28 February 2018
urgent irrigation and debridement and primary wound closure.
Available online 13 March 2018
Methods: Using a single institution's arthroplasty registry, patients sustaining an acute, traumatic wound
dehiscence within 30 days of undergoing a primary knee arthroplasty were identified. Patients experi-
Keywords:
wound dehiscence
encing chronic wound drainage without injury or a history of prior infection were excluded. Patients
knee arthroplasty were followed for the occurrence of complications and clinical outcomes using the Knee Society Score.
wound complication Results: From 2006 to 2016, 14 of 25,819 eligible patients (0.05%) were identified as having a traumatic
periprosthetic joint infection wound dehiscence. The mean time from arthroplasty to wound dehiscence was 9.3 days. All but one
revision knee arthroplasty patient was treated operatively within 24 hours of dehiscence. Postoperative antibiotics were admin-
istered for a mean of 21 days. At a mean of 6.5 years, 6 patients were considered failures (43%) including
2 deep infections, 3 revisions for instability, and 1 patient with a Knee Society Score <60 points.
Conclusion: Despite emergent incision and drainage and wound closure, patients experiencing an acute
traumatic wound dehiscence following knee arthroplasty subsequently exhibit high rates of reoperation
for instability, periprosthetic infection, and clinical failure. Further work is required to better understand
the optimal modes of treatment for this complication.
© 2018 Elsevier Inc. All rights reserved.

Wound complications and surgical site infections requiring a
return to the operating room remain common and concerning
problems following total knee arthroplasty (TKA) [1,2]. Wound
complications may increase the risk of a deep periprosthetic
infection, which predictably results in a revision operation, joint
fusion, or amputation [1,3,4]. It is known that early wound healing
complications and persistent drainage are associated with an
increased risk of infection and subsequent interventions following
TKA [1e4].
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.090.
* Reprint requests: Robert A. Sershon, MD, Department of Orthopaedic Surgery,
Rush University Medical Center, 1611 W Harrison St, Suite 300, Chicago, IL 60612.
However, to our knowledge, the scenario in which a patient
sustains an acute, traumatic wound dehiscence (ie, after a fall
directly onto the knee) has not been investigated. There is the po-
tential that this scenario, rather than one in which the patient
sustains wound necrosis or persistent wound drainage, may have a
different clinical outcome. Therefore, the purpose of this investi-
gation is to determine the incidence, recommended treatment, and
outcomes of patients who sustain an acute, traumatic wound
dehiscence following a primary knee arthroplasty. We hypothesize
that patients sustaining an acute traumatic wound dehiscence
treated with an emergent irrigation and debridement will have a
low incidence of subsequent complications.
Materials and Methods
Institutional review board approval for this study was obtained.
This is a retrospective review of a single institution's arthroplasty
registry. Patients sustaining an acute, traumatic wound dehiscence

https://doi.org/10.1016/j.arth.2018.02.090
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2614 R.A. Sershon et al. / The Journal of Arthroplasty 33 (2018) 2613e2615
following primary knee arthroplasty between the years 2006 and
2016 were identified. During this period, a total of 27,797 primary
and revision TKAs were available for analysis. Revision TKA, pa-
tients experiencing chronic wound drainage without injury or a
history of prior knee infection, those undergoing explantation of a
prosthesis, placement of an antibiotic spacer, or reimplantation of a
TKA were excluded. Following application of exclusion criteria,
25,819 met inclusion criteria. Patients initially falling within the
hospital or those presenting to our emergency department were
treated with a gentle saline rinse (to remove gross contamination if
present), placement of sterile gauze dressings, and administration
of intravenous antibiotics with an update of the patient's tetanus
vaccination if necessary. To define the incidence and long-term
sequelae of an acute, traumatic wound dehiscence, patients were
followed for the occurrence of subsequent complications including
periprosthetic joint infection (superficial or deep extending below
the fascia), subsequent surgical interventions, and clinical outcome
scores including the Knee Society Score (KSS). Patients were
followed for a minimum of 1 year.
Results
Fourteen of 25,819 patients (0.05%) were identified as having a
traumatic wound dehiscence following a primary knee arthroplasty.
Eleven patients underwent primary TKA with a cruciate-retaining
implant and 3 patients underwent a partial knee arthroplasty. The
cause of traumatic wound dehiscence was a fall directly onto the
knee in 12 cases, while 2 instances occurred abruptly during passive,
forced maximum flexion with physical therapy. The mean time from
knee arthroplasty to wound dehiscence was 9.3 days (range 0-23). Of
the 14 cases, 4 falls occurred in the hospital.
All but one patient was treated operatively within 24 hours of
dehiscence. The individual not treated operatively within 24 hours
was initially treated with a superficial, bedside irrigation and 3 days
of oral antibiotics by an outside orthopedic surgeon. This occurred
17 days postop, following a deep squat. The patient followed up in
our office 3 days following the event and was subsequently treated
with irrigation and debridement, modular polyethylene change,
and 2 weeks of oral antibiotics. This patient eventually underwent
an additional irrigation and debridement, modular polyethylene
exchange, and a course of antibiotics per infectious disease
recommendations.
Three patients (21%) were reported to have an intact deep fascial
closure during the time of surgery, and were treated with a su-
perficial incision and drainage (I&D) alone. The remaining 11 pa-
tients (79%) were treated with a deep I&D and modular
polyethylene liner exchange. Two patients were found to have an
increased flexion-extension gap, which was addressed by
increasing the modular polyethylene size. One of these patients
underwent a subsequent revision for continued flexion instability.
No instances of varus-valgus laxity were reported. Postoperative
antibiotics were administered for a mean of 21 days (±39 days;
range 1-150) based on the surgeon's discretion or an infectious
disease consultant's recommendations.
At a mean of 6.5 years (range 0-12), KSS improved to 88 (range
57-100) compared to 50 preoperatively (range 26-69). Six patients
were considered failures (43%). Two patients were revised for
periprosthetic joint infections and 3 patients were revised for
instability. One patient reported a KSS of 57 points (KSS ¼ 50
preoperatively) at final follow-up and was considered a clinical
failure, never having recorded a KSS above 60. Of the 3 patients
undergoing isolated superficial I&D, 2 patients (67%) were revised
within 1 year: 1 for deep infection and 1 for instability. Of the 11
patients undergoing I&D with polyethylene liner exchange, 4 (36%)
patients failed their initial treatment, with 2 patients revised for
instability, 1 for infection, and 1 patient with a KSS <60. The
mean KSS for the 8 remaining clinical successes was 89 points
(range 77-99).
Discussion
Clinical outcomes following an acute, traumatic wound dehis-
cence following primary knee arthroplasty have not been investi-
gated. Current literature suggests that 0.33% of patients following a
primary TKA experience early wound complications including
dehiscence, necrosis, persistent drainage, and superficial infections
that warrant a return trip to the operating suite [1,2]. This represents
a relatively small percentage of patients undergoing primary TKA;
however, the potential sequela are ominous, with increased rates of
deep infection and/or other major surgery [1,2,4e6]. To our knowl-
edge, no prior study has investigated the impact of an acute traumatic
wound dehiscence on clinical outcomes and complications following
TKA. We hypothesized that patients sustaining an acute traumatic
wound dehiscence treated with an emergent irrigation and
debridement would have a low incidence of subsequent complica-
tions. However, in our series, we found that these patients experience
high rates of reoperation, periprosthetic infection, and failure
(particularly for instability) even when expeditiously treated with an
operative intervention. Only 57% of our patients were considered a
clinical success at a mean follow-up of 6.5 years postoperatively.
There are several limitations to this investigation that must be
recognized prior to interpretation of our results. First, the cohort of
patients who sustained an acute, traumatic wound dehiscence after
primary knee arthroplasty was small, with only 14 cases identified
over a 10-year period. This is likely due to the rare nature of this
complication, which thus limits the conclusions that can be drawn
from this study. Although there is the potential that some cases
were not identified, we attempted a thorough review of our insti-
tutional registry of nearly 30,000 cases. Second, the manner in
which these patients were managed after sustaining their acute,
traumatic wound dehiscence was heterogenous. This is likely due
to a lack of recommendations in the literature as to the optimal
method of managing these patients. For example, questions remain
regarding the optimal length, regimen, and route of antibiotic
treatment that should be administered. Unfortunately, given the
small cohort of patients reviewed and the low incidence of this
complication, it still remains difficult to make firm recommenda-
tions as to the optimal mode of management.
Galat et al [1] reported on 59 of nearly 18,000 knees from the
Mayo Clinic Registry that experienced early wound complications,
including persistent drainage, delayed healing, superficial infection,
and atraumatic wound dehiscence, necessitating surgical inter-
vention within 30 days of surgery. The authors found 5.3% and 6.0%
probabilities of undergoing major subsequent surgery (ie, resec-
tion, flap, amputation) or developing deep infection, respectively.
The group reported the presence of diabetes mellitus as the single
greatest risk factor for superficial wound complications, although
numerous other patient-specific, intraoperative, and postoperative
risk factors have been implicated [2,7]. In contrast to this study,
Galat et al did not specifically focus on the repercussions of sus-
taining an acute traumatic wound dehiscence. Our results
demonstrate an even bleaker outcome, with 43% of patients
considered failures at an average follow-up of 6.5 years.
In our series, 3 of 6 failures resulted from persistent instability.
We find this failure mechanism particularly interesting, as only one
operative report in the failure group specifically described an
obvious increase in the flexion-extension laxity at the time of I&D.
The cause of this instability is unknown, however, and the onset of
symptom presentation varied in patients who went on to be revised
to instability. Given the high incidence of failure secondary to
 R.A. Sershon et al. / The Journal of Arthroplasty 33 (2018) 2613e2615
instability, we recommend that joint stability be carefully reas-
sessed at the time of I&D with polyethylene exchange, with
particular attention turned toward flexion-extension and varus-
valgus balancing. The use of a thicker insert should be considered
if global instability is identified at the time of irrigation and
debridement with serious consideration given to a more
constrained insert if compatible with the implanted components.
To our knowledge, this is the first report in the literature that
specifically investigates patient outcomes following traumatic
wound dehiscence in the setting of primary knee arthroplasty.
Although the event is an uncommon phenomenon (0.05%), most
arthroplasty surgeons will encounter this complication during their
careers. In our series, 2 of 3 patients undergoing superficial I&D
failed within 1 year. One patient was revised for an infection, with
the other revised for persistent flexion-extension instability. In
light of the potential for bacterial contamination after a traumatic
wound dehiscence, we recommend emergency room management
to consist of a gentle saline rinse to remove gross contamination if
present, placement of sterile gauze dressings, and administration of
intravenous antibiotics with an update of the patient's tetanus
vaccination if necessary. We also recommend that all patients
experiencing a traumatic wound dehiscence following partial or
total knee undergo an urgent, surgical exploration with a low
threshold for performing a deep irrigation and debridement and
polyethylene liner exchange. Particular attention should be paid
toward joint stability, which accounted for 50% of failures.
Regardless of the treatment pursued, it is imperative that patients
are counseled appropriately regarding the high incidence of com-
plications that occur following acute, traumatic wound dehiscence.
2615
Conclusion
Despite emergent I&D and wound closure, patients experi-
encing an acute traumatic wound dehiscence following knee
arthroplasty subsequently exhibit high rates of reoperation, peri-
prosthetic infection, and clinical failure. Further work is required to
better understand the optimal modes of treatment for this
complication and to mitigate the risk of falls in the early post-
operative period that can lead to wound dehiscence.
References
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Surgical treatment of early wound complications following primary total knee
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 The Journal of Arthroplasty 33 (2018) 2475e2479

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

The Influence of Postoperative Knee Stability on Patient

Satisfaction in Cruciate-Retaining Total Knee Arthroplasty
Tomoyuki Kamenaga, MD a, Hirotsugu Muratsu, MD, PhD a, *, Yutaro Kanda, MD b,
Hidetoshi Miya, MD a, Ryosuke Kuroda, MD, PhD b, Tomoyuki Matsumoto, MD, PhD b
a
Department of Orthopaedic Surgery, Steel Memorial Hirohata Hospital, Himeji, Japan
b
Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Kobe, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Background: Although knee stability is well known as an important element for the success of total knee
Received 15 December 2017 arthroplasty (TKA), the direct relationship between clinical outcomes and knee stability is still unknown.
Received in revised form The purpose of this study was to determine if postoperative knee stability and soft-tissue balance affect
28 February 2018
the functional outcomes and patient satisfaction after cruciate-retaining (CR) TKA.
Accepted 1 March 2018
Methods: Fifty-five patients with varus osteoarthritis of the knee who underwent CR TKA were included
Available online 16 March 2018
in this study, and their postoperative knee stability was assessed by stress radiography at extension and
flexion 1 month postoperatively. Timed Up and Go test, patient-derived clinical scores using the 2011
Keywords:
total knee arthroplasty
Knee Society Score, and Forgotten Joint Score-12 were also assessed at 1 year postoperatively. The effects
patient satisfaction of stability parameters on clinical outcomes were analyzed using Spearman's rank correlation.
knee stability Results: Medial stability at both knee extension and flexion had significant correlations with the shorter
cruciate retaining Timed Up and Go test and the higher patient satisfaction. Moreover, lateral laxity at extension was
functional outcome significantly correlated with the better patient satisfaction and Forgotten Joint Score-12. However, these
Forgotten Joint Score-12 correlation coefficients in this study were low in the range of 0.32-0.51.
Conclusion: Medial stability and lateral laxity play an important role in influencing 1-year postoperative
clinical outcomes after CR TKA. However, we should keep in mind that these correlations are weak with
coefficients at 0.50 or less and the clinical results are also affected by various other factors.
© 2018 Elsevier Inc. All rights reserved.

One of the primary principles of a successful total knee arthro-
plasty (TKA) is balancing the ligaments in both flexion and exten-
sion positions. Failure to properly balance the ligaments results in
unequal contact stresses in the medial and lateral compartments,
thus increasing the risk of wear and/or premature failure of poly-
ethylene insert [1,2]. Therefore, a rectangular and equal gap balance
has been recommended. However, in varus-type osteoarthritic
knee, excessive release of medial structures for achieving a rect-
angular gap balance is more likely to result in medial instability,
which could deteriorate postoperative clinical results along with
induction of persistent pain [3]. Previous authors have also re-
ported that lateral laxity of the knee is physiological [4], necessary
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.017.
* Reprint requests: Hirotsugu Muratsu, MD, Department of Orthopaedic Surgery,
Steel Memorial Hirohata Hospital, 3-1, Yumesaki-chou, Hirohata-ku, Himeji, Hyogo
671-1122, Japan.
for medial pivot knee kinematics [5], and important for post-
operative knee flexion angle [6] after cruciate-retaining (CR) TKA.
However, it is not completely understood as to how medial stability
and lateral laxity could influence clinical outcomes.
For clinical assessment of TKA, an objective scoring system is
often used to assess patient function and residual pain, along with
more objective factors. However, patient dissatisfaction has been
reported to be as high as 19% among patients who have undergone
TKA including CR and posterior-stabilized (PS) TKA [7], and several
authors have highlighted that it is important to include patient-
reported outcomes when evaluating the success of TKA, as there
is a discordance between the outcomes assessed by clinicians and
those reported by patients [8]. Therefore, surgeons should design
their surgical procedures to improve patient outcomes, reduce
postoperative complications, and, ultimately, improve the patient's
quality of life and satisfaction [9].
Despite many investigations on knee stability using radiographs
postoperatively [10e12], the effects of postoperative knee stability
on functional outcomes and patient satisfaction are not clearly

https://doi.org/10.1016/j.arth.2018.03.017
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2476 T. Kamenaga et al. / The Journal of Arthroplasty 33 (2018) 2475e2479
described in the literature. Therefore, the present study aimed to
investigate postoperative medial stability and lateral laxity and
identify whether these could influence postoperative functional
outcomes and patient satisfaction in patients who underwent CR
TKAs.
Material and Methods
The hospital ethics committee approved the study protocol, and
the patients provided informed consent for participation in this
study. The inclusion criteria were substantial pain and loss of
function due to varus-type osteoarthritis (OA) of the knee. In
addition to the knee condition, patients whose outcome scores
could be measured in the outpatient clinic 1 year after their sur-
geries were included in the study. The exclusion criteria were knees
with valgus deformity, severe fixed flexion contractures more than
15
, severe extra-articular deformities, severe bony defect requiring
bone graft or augmentation, revision TKA, prior high tibial osteot-
omies, active knee joint infection, and bilateral TKA. In addition to
this, we were often forced to release posterior cruciate ligament for
control of severe fixed varus deformity and had to convert CR to PS
TKA. We also excluded these patients. We retrospectively selected
consecutive 55 cases who met the previously mentioned criteria
and underwent primary CR TKA with asymmetric design (Persona
CR, Zimmer Inc., Warsaw, IN) between 2014 and 2015. The patient
population was composed of 41 women and 14 men (age, 73.1 ± 5.9
years; body mass index, 25.4 ± 3.3 kg/m2). Among these patients,
the average preoperative coronal plane alignment on standard
weight-bearing anteroposterior radiographs was 12.1
± 4.8
in
varus. Preoperative range of motion was 3.7
± 5.5
in extension
and 119.2
± 13.0
in flexion. All CR TKA procedures were per-
formed by the same senior author.
Operative Procedures
TKAs were performed using the measured resection technique
with a conventional resection block. After inflating the tourniquet
with 280 mmHg of air at the beginning of procedure, a medial
parapatellar arthrotomy was performed. The anterior cruciate lig-
ament was resected. A distal femoral osteotomy was performed
perpendicular to the mechanical axis of the femur using an intra-
medullary resection guide, based on preoperative long-leg radio-
graphs. Thereafter, a proximal tibial osteotomy was performed
perpendicular to the mechanical axis in the coronal plane and with
7
of posterior inclination along the sagittal plane using an extra-
medullary resection guide. No bony defects were observed along
the eroded medial tibial plateau. After neutral alignment was
confirmed with each cut of the distal femur and proximal tibia, a
posterior femoral cut was made using the anterior referencing
technique. Femoral external rotation was set at 3
or 5
relative to
the posterior condylar axis, while referring to Whiteside's line and
the transepicondylar axis, measured using preoperative computed
tomography images. After each osteotomy, we removed the
osteophytes and released MCL mainly using pie cluster technique
[13] until spacer block corresponding the resected bone thickness
from lateral tibial condyle could be inserted.
Postoperative Laxity Measurements
Knee stabilities at extension and flexion were assessed by stress
radiographies at 1 month after TKA. Stability at extension was
assessed by varus and valgus stress X-ray using a Telos arthrometer
(10 kgf). We evaluated extension stability at 15
of flexion to perform
fair measurement under the same condition even in patients who
cannot extend the knee completely. We measured joint separation
distance (mm) between the lower point of femoral prosthesis and
the line in contact with the lower surface of tibial prosthesis at
medial and lateral compartments and adjusted it using magnifica-
tion based on the keel width of tibial prosthesis. We also calculated
the distance between the lower point of femoral prosthesis and
upper surface of the polyethylene insert as medial joint opening
(MJO) and lateral joint opening (LJO) as follows: joint opening ¼ joint
separation distance (magnification adjusted) e insert thickness. The
insert thickness means what was actually selected intraoperatively.
On the varus and valgus stress radiographs, the angles between the
line in contact with the bottom of femoral prosthesis and the line in
contact with the lower surface of tibial prosthesis were measured.
The valgus and varus angles indicated the values of medial laxity or
lateral laxity, respectively. We calculated “varus angle  valgus
angle” as “varus ligament balance at extension” (lateral laxity; pos-
itive value in varus) following a previously reported method [14] and
used this value for the analysis (Fig. 1A, B).
Stability at flexion was assessed by the stress epicondylar view
with 1.5 kg weight at the ankle [15,16], which enabled us to visu-
alize the posterior condylar axis and the tibia articular line. We also
calculated the MJO and LJO in the same way at extension. The angle
between the line in contact with the bottom of femoral prosthesis
and the line in contact with the lower surface of tibial prosthesis
was measured, which defined varus angle as “varus ligament bal-
ance at flexion” (lateral laxity; positive value in varus). This value
was for analysis (Fig. 1C).
In our hospital, source to image receptor distance was set to 120
cm at both knee extension and flexion uniformly.
Patient-Reported Outcome Scores
The 2011 Knee Society Score (KSS) was developed as a new
patient-derived outcome measure to better characterize satisfac-
tion, expectations, and physical activities after TKA [17]. The
Forgotten Joint Score-12 (FJS-12) was intended for patients who
forgot about the presence of their artificial joint and is reportedly a
useful patient-reported outcome tool for artificial joints [18]. Its
reliability and validity were demonstrated by a recent study [19].
We evaluated patient-reported measurements using the 2011 KSS
and FJS-12 at 1 year after TKA. We evaluated 4 patient-reported
sections (patient satisfaction, walking and standing, standard ac-
tivities, advanced activities) of the 2011 KSS.
Performance Test
The Timed up and go test (TUG) measures the time it takes for a
patient to rise from an arm-chair (seat height of 46 cm), walk 3
meters, turn, and return to the sitting position in the same chair.
Patients were instructed to walk as quickly as they felt safe and
comfortable. The use of arms of the chair was permitted to stand up
and sit down. A stopwatch was used to measure the time to complete
the TUG within the nearest one hundredth of a second. The TUG is
widely used to measure mobility in older adults with excellent test-
retest reliability (intraclass correlation coefficients ¼ 0.97) [20]. The
TUG was performed preoperatively and 1 year postoperatively to
assess basic ambulatory function. A practice trial was completed, and
the best time from 3 subsequent trials was used for analysis.
Statistical Analysis
All values are presented as mean ± standard deviation. The re-
sults were analyzed using a statistical software package (StatView
5.0, Abacus Concepts Inc, Berkeley, CA). We compared preoperative
and postoperative TUG using paired t test and performed Spear-
man's rank correlation analysis to assess the correlations between
 T. Kamenaga et al. / The Journal of Arthroplasty 33 (2018) 2475e2479 2477

Fig. 1. (A and B) Extension knee stability at the lateral and medial sides assessed by varus and valgus stress radiographies. Extension: lateral joint opening (a) ¼ lateral joint
separation distance (magnification adjusted) (e) e insert thickness (i); Extension: medial joint opening (b) ¼ medial joint separation distance (magnification adjusted) (f) e insert
thickness (i); Varus ligament balance at extension ¼ varus angle (j)  valgus angle (k). (C) Flexion knee stability assessed by stress epicondylar view. Flexion: medial joint opening
(c) ¼ medial joint separation distance (magnification adjusted) (g) e insert thickness (i); Flexion: lateral joint opening (d) ¼ lateral joint separation distance (magnification
adjusted) (h) e insert thickness (i); Varus ligament balance at flexion ¼ varus angle (l).

stability parameters (MJO, LJO, and varus angle at both extension
and flexion) and postoperative outcomes (TUG, 2011 KSS, FJS-12).
A statistical power analysis was performed before the study,
which was expected to require a power of 0.8 based on a pre-
specified significance level of a < 0.05 and assuming a medium
effect size (effect size f2 ¼ 0.20) using G power 3 [21]. The estimated
sample size was 54 patients. A P value <.05 was considered sta-
tistically significant.
Results
Knee Stability
satisfaction” of 2011 KSS were 23.7 ± 7.0/30 (range, 2-30), 24.8 ±
3.3/30 (range, 16-30), 14.3 ± 5.3/25 (range, 3-21), and 28.8 ± 6.1/40
points (range, 12-40), respectively.
The average 1-year postoperative FJS-12 was 52.4 ± 18.6/100
points (range, 8.3-89.6).
Functional Performance
The average preoperative and 1-year postoperative TUG was
11.4 ± 3.1 and 9.5 ± 2.6 sec, respectively. Functional recoveries were
observed at 1 year after surgery with a significant decrease in TUG
(P < .05).

The mean postoperative MJOs at extension and flexion were
2.25 ± 1.16 mm (range, 0.52-4.75) and 0.98 ± 1.28 mm (range,
0-5.78), and the mean postoperative LJOs at extension and flexion
were 3.12 ± 1.30 mm (range, 0-5.42) and 1.41 ± 1.55 mm (range,
0-6.37), respectively.
The mean postoperative values of varus ligament balance at
extension and flexion were 1.12 ± 2.26
(range, 4.24 to 6.15) and
0.57 ± 1.85
(range, 2.88 to 8.47).
Patient-Reported Outcomes
The average 1-year postoperative “walking and standing,”
“standard activities,” “advanced activities,” and “patient
Correlations of Knee Stability With Patient-Reported Outcomes and
Functional Performance
Correlations between knee stability and clinical outcomes are
shown in Table 1. MJO at extension showed a negative correlation
with patient satisfaction (r ¼ 0.44, P < .05) and FJS-12 (r ¼ 0.37,
P < .05). MJO at extension also exhibited positive correlations with
TUG (r ¼ 0.44, P < .05).
MJO at flexion showed negative correlations with “walking and
standing” (r ¼ 0.39, P < .05), “standard activities” (r ¼ 0.34, P <
.05), patient satisfaction (r ¼ 0.39, P < .05), and FJS-12 (r ¼ 0.32,
P < .05). Moreover, MJO at flexion exhibited positive correlations
with TUG (r ¼ 0.51, P < .05).
2478 T. Kamenaga et al. / The Journal of Arthroplasty 33 (2018) 2475e2479
Table 1
Correlation Coefficients Between 1-Month Postoperative Stability Parameters and 1-Year Postoperative Outcome Measures.
TUG 2011 KSS Walking
and Standing
Ext. MJO 0.44a 0.24
Ext. LJO 0.08 0.24
Flex. MJO 0.51a 0.39a
Flex. LJO 0.10 0.21
Ext. ligament balance 0.34a 0.34a
Flex. ligament balance 0.27 0.09
Ext. MJO, extension medial joint opening; Ext. LJO, extension lateral joint opening; FJS-12, Forgotten Joint Score-12; Flex. MJO, flexion medial joint opening; Flex. LJO, flexion
lateral joint opening; TUG, Timed Up and Go test.
a
Correlations are statistically significant (P < .05).
Varus ligament balance at extension also showed correlations
with “walking and standing” (r ¼ 0.34, P < .05), patient satisfaction
(r ¼ 0.42, P < .05), FJS-12 (r ¼ 0.32, P < .05), and TUG (r ¼ 0.34, P <
.05). However, varus ligament balance at flexion showed no cor-
relations with any parameters.
Discussion
The main finding in this study is that patient satisfaction and
functional outcomes at 1 year after CR TKA are affected by main-
taining medial stability in extension and flexion for varus-type OA
knees. In addition, the study showed that postoperative varus lig-
ament balance at extension has significant correlations with pa-
tient satisfaction and joint awareness. This implies that preserving
medial stability while permitting lateral laxity is extremely
important for favorable postoperative clinical outcomes. To the best
of our knowledge, this is the first study to describe the effects of
ligament laxity and balance on functional outcomes and patient
satisfaction after CR TKA.
In the present study, we found significant correlations of early
postoperative MJOs at both extension and flexion with 1-year
postoperative TUG, patient satisfaction, and FJS-12. In addition,
MJOs at flexion showed a significant correlation with functional
scores of 2011 KSS, although LJOs at both extension and flexion
showed no correlation with these outcomes. These results suggest
that early postoperative medial knee stabilities at both extension
and flexion are important for postoperative function and patient
satisfaction after CR TKA. Medial instability, after TKA is reported to
deteriorate early postoperative pain relief [3], has negative effects
on functional outcomes [22], and finally leads to a decrease in pa-
tient satisfaction at 1 year after CR TKA. Therefore, surgeons should
prioritize medial stability for achieving better clinical outcomes
after CR TKA.
Other interesting findings of this study are that postoperative
patient satisfaction and FJS-12 were correlated with extension
varus ligament balance. However, varus ligament balance at flexion
had no significant correlation with these parameters. These results
suggest that varus ligament balance at extension and relative
lateral laxity to medial stability are beneficial for postoperative
patient satisfaction and joint awareness after CR TKA. This study
was not the first to suggest that subtle mediolateral (ML) imbal-
ances may be beneficial. Edwards et al [10] were the first to report
improved subjective outcomes in TKAs with some degree of ML
laxity than those without ML laxity. Similarly, Liebs et al [3] re-
ported that patients with a larger lateral gap in extension demon-
strated significantly greater Western Ontario and McMaster
Universities Osteoarthritis pain scores than those that had an
increased medial gap. In the native knee, lateral laxity is greater
than medial laxity that creates a medial pivot allowing for lateral
femoral rollback during knee flexion [23]. A more normal kine-
matics with a medial pivot and lateral femoral rollback may be
2011 KSS Standard 2011 KSS Advanced 2011 KSS Patient FJS-12
Activities Activities Satisfaction
0.28 0.18 0.44a 0.37a
0.01 0.06 0.12 0.10
0.34a 0.20 0.39a 0.32a
0.20 0.21 0.12 0.20
0.02 0.19 0.42a 0.32a
0.08 0.03 0.19 0.02
created by preserving medial stability while permitting lateral
laxity. Intraoperative soft-tissue balance is reported previously to
significantly affect postoperative knee stabilities [14]. Therefore,
based on our findings, surgeons may be encouraged to manage
intraoperative soft-tissue balance for preserving medial stability at
both extension and flexion while permitting lateral laxity, which
would enhance function and patient satisfaction after CR TKA for
varus-type OA knees. However, we should not ignore that many of
correlation coefficients between knee stability and clinical out-
comes in this study were low in the range of 0.32-0.51. This fact
suggests that various other factors uncontrollable by the surgeon
affect the postoperative function and satisfaction.
Our study has several limitations. First, it was a retrospective
analysis, and the authors did not evaluate preoperative 2011 KSS,
and this limited their ability to analyze the degree of improvement
of these scores and relation with stability parameters. Second, we
only investigated 1 CR-type of prosthesis. Different designs such as
PS-type prostheses may offer varying outcomes. In addition, using
other CR-type prostheses with different levels of conformities be-
tween the femoral component and tibial insert may lead to
different results. Additional studies using different implant designs
are necessary to further examine the relationship between knee
stability and clinical outcomes. Third, the study population was
almost composed of women and limited to patients with varus-
type OA and excluded severe osteoarthritic knees with large bony
defects. So, in the future, it will be necessary to conduct a research
in a group with equal proportion of gender including valgus and
severe osteoarthritic knees and compare with the populations in
this series. Finally, although the current results suggest that
modifying surgical techniques for preserving medial stability while
permitting lateral laxity may improve patient outcomes and satis-
faction, future long-term studies are needed to verify these results
and to ensure that improved function at 1 year is not a tradeoff for
inferior long-term survival.
Conclusions
Early postoperative medial stability at both extension and
flexion plays an important role in beneficial 1-year postoperative
functional outcomes and patient satisfaction. Lateral laxity at
extension is also important for postoperative joint awareness and
patient satisfaction after CR TKA. However, we should recognize
that these correlations are weak with coefficients at 0.50 or less,
and the clinical results are affected not only by stability parameters
but also by various other factors.
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 The Journal of Arthroplasty 33 (2018) 2571e2574

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

The Leukocyte Esterase Test Strip Is a Poor Rule-Out Test for

Periprosthetic Joint Infection
Carl A. Deirmengian, MD a, *, Lihua Liang, PhD b, John P. Rosenberger, BS b,
Tony R. Joaquim, PhD b, Martin R. Gould, PhD, MS b, Patrick A. Citrano, BS b,
Keith W. Kardos, PhD b
a
Department of Orthopaedic Surgery, The Rothman Institute, Thomas Jefferson University, Philadelphia, Pennsylvania
b
CD Diagnostics, Zimmer Biomet, Claymont, Delaware

a r t i c l e i n f o a b s t r a c t

Article history: Background: The urinary leukocyte esterase (LE) test strip has been suggested as a good screening test for
Received 8 December 2017 periprosthetic joint infection (PJI). The purpose of this study is to compare the diagnostic profile of LE
Received in revised form assays from different manufacturers and determine whether the LE test strip is a good rule-out test.
12 February 2018
Methods: Synovial fluid samples (N ¼ 344), sent to 1 laboratory for PJI testing, were used in this pro-
Accepted 1 March 2018
Available online 13 March 2018
spective study. Four different tests for synovial fluid LE were simultaneously evaluated for their per-
formance in detecting white blood cell (WBC) positive samples (>3000 cells/mL).
Results: Both neutrophil elastase immunoassays demonstrated greater sensitivity than urinary LE test
Keywords:
leukocyte esterase test strip
strips (92.0% and 90.8% vs 72.4% and 80.3%; all P < 0.011). Fifty-three percent of false-negative urinary LE
PJI test strip results clearly missed the presence of elevated levels of synovial fluid LE. Invalid urinary LE test
arthroplasty strip results were 4-fold more likely among WBC (þ) compared with WBC () samples (27.0% vs 6.8%; P <
synovial fluid 0.0001). The combined failure to detect an elevated WBC count, because of either false-negative or
neutrophil elastase invalid results, was 47.1% and 41.4% for the Roche and Siemens test strips, respectively.
diagnostic tests Conclusions: This study agrees with the existing literature demonstrating that the LE test strips are
among the lowest sensitivity tests for PJI. The urinary LE tests strips should not be used to rule-out PJI, as
they often fail to detect abundant levels of LE in synovial fluid. Instead, it is more appropriate to use the
(þþ) LE test strip result as a secondary confirmatory rule-in test for PJI because of its high specificity.
© 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

The urinary leukocyte esterase (LE) test strip was first developed
to provide for a rapid estimate of urinary white blood cells (WBCs)
as a screening test for pyuria. One of the major proteases that is
detected by the LE test strip is neutrophil elastase (NE), which
catalyzes the esterase reaction on the LE test strip pad. The test
optimization and regulatory approvals related to the urinary LE test
strip were achieved with the assumption that the test strip would
be used for urinary screening.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.005.
* Reprint requests: Carl A. Deirmengian, MD, Department of Orthopaedic Surgery,
The Rothman Institute, Thomas Jefferson University, 925 Chestnut Street, 5th Floor,
Philadelphia, PA 19107.
The arthroplasty literature has recently suggested considering
the use of the urinary LE test strip for the purposes of screening
synovial fluid for periprosthetic joint infection (PJI) [1]. However,
the performance of the LE test strip in synovial fluid has demon-
strated suboptimal diagnostic characteristics for PJI. In fact,
research on the use of the urinary LE test strip to screen synovial
fluid has revealed 3 serious concerns: (1) several institutions have
demonstrated a low LE test strip sensitivity for PJI [1e6], (2) several
institutions have reported on a high rate of uninterpretable results
because of the presence of blood [1,5e7], and (3) the optimal cutoff
for LE test strip positivity in synovial fluid has varied between in-
stitutions [6,7]. These are the type of issues that need to be
accounted for when validating an off-label use of a diagnostic test.
The Synovasure brand of diagnostic tests (Zimmer Biomet, CD
Diagnostics) offers several different tests for the differential diag-
nosis of a painful joint. These include the Synovasure Alpha-
Defensin Test for PJI, the Synovasure Alpha-Defensin Test for

https://doi.org/10.1016/j.arth.2018.03.005
0883-5403/© 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
2572 C.A. Deirmengian et al. / The Journal of Arthroplasty 33 (2018) 2571e2574
native septic arthritis, the Synovasure Microbial Identification Test,
and the Synovasure NE Test. The Synovasure NE Test is an immu-
noassay for the major protein in synovial fluid contributing to LE
activity. Therefore, while the LE test strip is a test of a protein's
enzyme activity, the Synovasure NE test is a test of the actual
protein's concentration.
Although the Musculoskeletal Infection Society (MSIS) has
included the LE test strip as a proxy to the WBC count [8], very few
large studies have tested the agreement between LE assays of
different technologies, or their accuracy as a proxy for the WBC
count. The purpose of this study is to compare the diagnostic profile
of LE assays of differing technologies, and determine whether the
LE test strip is a good rule-out test.
Methods
A prospective diagnostic study using remnant synovial fluid
samples was conducted to evaluate the results of LE testing in sy-
novial fluid. Institutional review board's approval was attained for
this remnant sample study.
Patient and Sample Population
All studies were completed at the laboratories of CD Diagnostics
(Zimmer Biomet, Towson, MD). The laboratory receives clinical
synovial fluid samples from 49 states in the United States, for the
purposes of diagnosing PJI. In February and March of 2017, our
group selected 13 days when all remnant synovial fluid samples
received at CD Diagnostics for clinical testing were considered for
inclusion in this study. During these 13 days, a total of 1574 synovial
fluid samples were evaluated for testing at our laboratory. Several
inclusion criteria were necessary to allow for this study to be
conducted. Availability of a WBC count for the samples was
required, as this test was used in data analysis. This inclusion
resulted in 671 samples from the total of 1574 samples received.
Furthermore, the samples qualifying for inclusion must have at
least 1 cc of remaining remnant fluid for the purposes of this study,
resulting in a 344 synovial fluid sample cohort for this study.
Of the 344 samples included, there were 329 samples from an
arthroplasty and 15 samples from a native knee. Of the 329 samples
from an arthroplasty, there were 256 from a knee arthroplasty, 27
from a hip arthroplasty, 1 from a shoulder arthroplasty, and 45 from
unspecified arthroplasties.
Study Design
Each of the 344 synovial fluid samples had a WBC count. With
the remaining fresh remnant synovial fluid, several tests were
performed in duplicate by 2 trained laboratory staff members: (1)
the urinary LE test strip (Roche), (2) the urinary LE test strip
(Siemens), and (3) the NE lateral flow immunoassay (Synovasure
NE lateral flow test; Zimmer Biomet). In addition, the NE
laboratory-based immunoassay (Synovasure NE Laboratory-Based
Table 1
Diagnostic Profile of Various LE Tests in Detecting WBC >3000 cells/mL.
Roche LE test strip
Siemens LE test strip
Synovasure Neutrophil Elastase Lateral Flow immunoassay
Synovasure Neutrophil Elastase Laboratory-Based immunoassay
CI, confidence interval; LE, leukocyte esterase; WBC, white blood cell.
*
Equals significantly higher sensitivity (P < .011).
^
Equals significantly higher specificity (P < .0001).
test; Zimmer Biomet) was completed. Therefore, all included sy-
novial fluid samples had a WBC count from the laboratory, in
addition to 4 different LE tests simultaneously run in duplicate in
our laboratory.
Given the utilization of the urinary LE test strip as a rapid test
estimate of the synovial fluid WBC count, and also given the fact
that the MSIS chose to include the urinary LE test strip result as an
equivalent minor criteria to the synovial fluid WBC count [8], we
chose to use the synovial fluid WBC count as the gold standard in
this study. Therefore, all synovial fluid samples with a WBC count
>3000 cells/mL were considered positive in this study.
The synovial fluid WBC counts in this study were first completed
on a clinical laboratory Sysmex 2000 automated cell counter, as
standard in the clinical laboratory. In addition, as a quality control
measure, whenever a WBC count was found to be >3000 cells/mL on
the automated cell counter, a reflex manual cell count was
completed to confirm the automated cell counter results. Of the
344 samples in this study, 87 (25%) were positive and 257 were
negative.
For the 2 urinary LE test strips, fresh synovial fluid was placed on
the reagent pad and the test was performed and interpreted based
on the manufacturer's directions. In cases where blood interfered
with the interpretation of the colorimetric reagent pad, the result
was considered invalid. For the urinary LE test strips, a reading of
(þþ) was considered positive, as recommended by several previous
studies [6,9] and the MSIS consensus [8].
For the lateral-flow LE test (Synovasure NE lateral flow test;
Zimmer Biomet), synovial fluid was added to the testing well and
the fluid was allowed to traverse the lateral flow cartridge. The
appearance of a test line was considered a positive result. For the
laboratory-based LE test (Synovasure NE Laboratory-Based Test;
Zimmer Biomet), a signal to cutoff value 1 was considered
positive.
Data Analysis
The urinary LE test strips and the lateral-flow LE immunoassay
were read by 2 trained technicians. The totals of both technicians'
results were used to calculate diagnostic data and percentages. The
results of each LE test were compared with the WBC count. Each
test's invalid result percentage was calculated, as was each test’s
sensitivity, specificity, and relevant confidence intervals. The Fisher
exact test was used to compare the tests in a 2  2 fashion, eval-
uating the statistical significance of differences of proportion.
Results
Both Synovasure NE immunoassays demonstrated significantly
greater sensitivity that the urinary LE test strips (92.0% and 90.8% vs
72.4% and 80.3%; all P < .011; Table 1). The lower sensitivities
exhibited by the Roche and Siemens urinary LE test strips trans-
lated to synovial fluid false-negative rates of 19.7% and 27.6%,
respectively. Of 60 total false-negative LE test strip reads (including
Sensitivity Specificity
72.44% (95% CI: 63.81%-79.99%) 97.29% ^ (95% CI: 95.40%-98.55%)
80.31% (95% CI: 72.33%-86.84%) 97.08% ^ (95% CI: 95.14%-98.39%)
91.95% * (95% CI: 86.87%-95.53%) 90.47% (95% CI: 87.59%-92.86%)
90.80% * (95% CI: 85.50%-94.65%) 94.94% (95% CI: 92.68%-96.67%)
 C.A. Deirmengian et al. / The Journal of Arthroplasty 33 (2018) 2571e2574
the strips from both companies), there were 32 instances (53.3%)
where the urinary LE test strip clearly missed the presence of
elevated levels of synovial fluid LE, as evidenced by an elevated
neutrophil count (range 3074-170,637 cells/mL) and markedly
positive LE immunoassay results. Although all tests demonstrated
specificities >90%, the urinary LE test strips demonstrated greater
specificity than the NE lateral flow immunoassay.
The Roche and Siemens urinary LE test strips both yielded invalid
results among 11.9% of all samples in this study. However, invalid
urinary LE test strip reads were most often observed in the setting of
a high WBC count (Table 2). When the WBC count is >3000 cells/mL,
both urinary LE test strips yielded an invalid rate of 27.0%, which is 4-
fold higher than the invalid rate of 6.8% in the setting of a WBC count
<3000 cells/mL (P < .0001). The 2 Synovasure LE immunoassays did
not yield any invalid results because of blood.
The combined failure to detect an elevated WBC count, because of
either false-negative or invalid results, was 47.1% and 41.4% for the
Roche and Siemens test strips, respectively. The combined failure to
detect an elevated WBC count because of false-negative or invalid
results for the Synovasure NE immunoassays was 8.0% and 9.2%,
respectively. The higher failure rates observed for the urinary LE test
strips were statistically significant with P < .0001 for all comparisons.
Discussion
Among the many biomarkers in synovial fluid with the potential
to diagnose PJI, the urinary LE test strip is unique and intriguing in
that it is inexpensive, rapid, and commercially available. However,
considering that the urinary LE test strip was optimized and
developed for urinary testing, it is expected that the test would
have altered characteristics in synovial fluid. In fact, the previous
arthroplasty literature reporting on the urinary test strip for diag-
nosing PJI has found that the test has a generally low sensitivity
[1,3e5] and yields a high rate of invalid results because of blood
[5,7]. Nevertheless, the use of the urinary LE test strip in arthro-
plasty has been suggested to diagnose PJI.
Previous studies have demonstrated the relatively low sensitivity
of the urinary LE test strip result in diagnosing PJI. The original report
on the utility of LE by Parvizi et al [6] found that a (þþ) LE cutoff
provided 80.6% sensitivity in diagnosing PJI. Although there are a few
centers reporting a higher sensitivity for the urinary LE test strip
[10,11], most centers have reported lower values, including sensi-
tivities of 69% [5], 66% [9], 81% [1], 84.21% [2], 75% [3], and 84% [4]. A
recent large retrospective study of tests for PJI including the eryth-
rocyte sedimentation rate, C-reactive protein, WBC count, poly-
morphonuclear neutrophil percentage, and LE found that LE had the
lowest sensitivity of all tests [3].
Previous studies have also demonstrated the high invalid rate of
the urinary LE test strip because of colorimetric interference from
blood in the synovial fluid. This observation was first made by
Parvizi et al [6], finding that 11.6% (17 of 147) of samples were
unreadable because of blood. Subsequent studies verified this rate
of invalid results, finding invalid test strip rates of 29.2% [7], 17% [5],
and 9.5% [1]. Because of the high rate of blood interference, it has
Table 2
Invalid Rates of LE Tests Because of Bloody Interference.
Roche LE test strip
Siemens LE test strip
Synovasure Neutrophil Elastase Lateral Flow immunoassay
Synovasure Neutrophil Elastase Laboratory-Based immunoassay
LE, leukocyte esterase; WBC, white blood cell.
*
Equals significantly higher invalid rate (P < .0001).
2573
been suggested that the sample is centrifuged to remove blood cells
before the fluid is placed on the test strip [12]. Our study confirms
the previous studies on the urinary LE test strip, demonstrating a
high invalid rate and relatively low sensitivity of the test strips. In
addition, our study has demonstrated 2 new findings. First, the
invalid test strip results are predominantly those with a high WBC
count, which are often cases with PJI. Therefore, although the
overall LE test strip invalid rate is 11.9%, the invalid test result rate is
actually 27% among samples with a WBC count above 3000 cells/mL.
Previous studies have excluded these invalid samples from the
analysis, preventing this effect from being apparent [6,7]. We have
concerns from a diagnostic point of view that a test suggested to
screen for PJI may yield invalid results in up to 25% of the very
samples most likely to have PJI.
Secondly, our study is the first to demonstrate that the urinary
LE tests strip sometime fails to detect LE enzymatic activity, even
when there is abundant LE in the synovial fluid as demonstrated by
an elevated WBC count and greatly elevated LE immunoassay
result. We suggest that LE inhibitors in inflamed synovial fluid may
be responsible for inhibiting the LE test strip reaction. This hy-
pothesis also explains the large observed discrepancy [3] between
the very low concentration of WBCs that the urinary LE test strip is
calibrated to detect in urine, and the greatly elevated concentration
of WBCs required to yield a positive test from synovial fluid.
This study also is the first to consider the combined effect of invalid
results and false-negative results. Because invalid results predomi-
nantly occur among high WBC count samples, the LE test strip invalid
rate is disproportionately high, at 27%, among these samples.
Combining this with an LE test strip sensitivity near 80% results in the
finding that the urinary LE test strip would be either invalid or
negative for 41% of samples with a WBC >3000 cells/mL. This means
that the LE test strip would only detect 58% of samples with a high
WBC count, although the overwhelming majority of these are infec-
ted. In contrast, with a sensitivity at 91%, the Synovasure NE immu-
noassays detect 91% of all samples with a WBC count >3000 cells/mL.
Despite demonstrating urinary LE test strip sensitivities ranging
from 69%-84%, previous studies [1,2,6,9] have suggested enthu-
siasm regarding the utility of the test strip for diagnosing PJI. In fact,
one study demonstrating a test strip sensitivity of 81% suggested
that a negative urinary LE test strip result may rule-out PJI with no
need for further testing [1]. Although the results of this study agree
with these previous studies, we disagree with their conclusions. At
an estimated sensitivity of 80%, the urinary LE test strip will miss 1
in 5 patients with a PJI. Consideration of the invalid rate decreases
the detection of PJI even further. This level of sensitivity does not
constitute a good rule-out test and does not obviate the need for
further testing. In fact, this low level of urinary LE test strip sensi-
tivity observed in most studies is inferior to almost all other
generally used tests for PJI [3], such as the serum C-reactive protein,
the synovial fluid WBC count, the synovial fluid neutrophil per-
centage, and the alpha-defensin test [5]. We recommend that
whenever the urinary LE test strip is used for the diagnosis of PJI,
that it is strictly used as a secondary rule-in test, given the high test
specificity.
Overall Invalid Rate, % Invalid When Invalid When
WBC >3000 cells/mL, % WBC <3000 cells/mL, %
11.9 27* 6.8
11.9 27* 6.8
0 0 0
0 0 0
2574 C.A. Deirmengian et al. / The Journal of Arthroplasty 33 (2018) 2571e2574
Given the low cost of LE test strips, it appears most appropriate
that in emergent situations, such as unexpected intraoperative
findings, that a “þþ” reading on a nonbloody LE test strip can be
used to rule-in PJI. However, the surgeon must understand that a
negative or invalid result is not very informative for decision-
making. The LE test strip could also be used as recommended as a
minor criterion in the MSIS definition for PJI. However, further
research is required to define the potential differences between
brands of LE test strips, and also to define how to consistently
differentiate between valid and invalid LE test strip results.
In summary, our study has confirmed the results of previous
studies demonstrating a high invalid test result rate and a low
sensitivity of the urinary LE test strip in the setting of arthroplasty.
We further demonstrate that invalid test results are predominantly
associated with high WBC count samples, and that the urinary LE
test strip fails to test positive in many samples with a high WBC
count, even when there is abundant LE in the synovial fluid. The
urinary LE test strip is a poor rule-out test for PJI.
References
[1] Shafafy R, McClatchie W, Chettiar K, Gill K, Hargrove R, Sturridge S, et al. Use
of leucocyte esterase reagent strips in the diagnosis or exclusion of prosthetic
joint infection. Bone Joint J 2015;97-B:1232e6.
[2] Wang C, Li R, Wang Q, Duan J, Wang C. Leukocyte esterase as a biomarker in
the diagnosis of periprosthetic joint infection. Med Sci Monit 2017;23:353e8.
[3] Shahi A, Tan TL, Kheir MM, Tan DD, Parvizi J. Diagnosing periprosthetic joint
infection: and the winner is? J Arthroplasty 2017;32:S232e5.
[4] Koh IJ, Han SB, In Y, Oh KJ, Lee DH, Kim TK, Knee Multicenter Collaboration
Team. The leukocyte esterase strip test has practical value for diagnosing
periprosthetic joint infection after total knee arthroplasty: a multicenter
study. J Arthroplasty 2017;32:3519e23.
[5] Deirmengian C, Kardos K, Kilmartin P, Cameron A, Schiller K, Booth Jr RE, et al.
The alpha-defensin test for periprosthetic joint infection outperforms the
leukocyte esterase test strip. Clin Orthop Relat Res 2015;473:198e203.
[6] Parvizi J, Jacovides C, Antoci V, Ghanem E. Diagnosis of periprosthetic joint
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[7] Wetters NG, Berend KR, Lombardi AV, Morris MJ, Tucker TL, Della Valle CJ.
Leukocyte esterase reagent strips for the rapid diagnosis of periprosthetic
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[8] Zmistowski B, Della Valle C, Bauer TW, Malizos KN, Alavi A, Bedair H, et al.
Diagnosis of periprosthetic joint infection. J Arthroplasty 2014;29(2 Suppl):
77e83.
[9] Tischler EH, Cavanaugh PK, Parvizi J. Leukocyte esterase strip test: matched
for musculoskeletal infection society criteria. J Bone Joint Surg Am 2014;96:
1917e20.
[10] Li R, Li X, Yu B, Li X, Song X, Li H, et al. Comparison of leukocyte esterase
testing of synovial fluid with synovial histology for the diagnosis of peri-
prosthetic joint infection. Med Sci Monit 2017;23:4440e6.
[11] Guenther D, Kokenge T, Jacobs O, Omar M, Krettek C, Gehrke T, et al.
Excluding infections in arthroplasty using leucocyte esterase test. Int Orthop
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[12] Aggarwal VK, Tischler E, Ghanem E, Parvizi J. Leukocyte esterase from synovial
fluid aspirate: a technical note. J Arthroplasty 2013;28:193e5.
 The Journal of Arthroplasty 33 (2018) 2471e2474

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

The Recovery Curve for the Patient-Reported Outcomes

Measurement Information System Patient-Reported Physical
Function and Pain Interference Computerized Adaptive Tests
After Primary Total Knee Arthroplasty
Ryland Kagan, MD, Mike B. Anderson, MSc, Jesse C. Christensen, DPT, PhD,
Christopher L. Peters, MD, Jeremy M. Gililland, MD, Christopher E. Pelt, MD *
Department of Orthopaedics, University of Utah School of Medicine, Salt Lake City, Utah

a r t i c l e i n f o a b s t r a c t

Article history: Background: We sought to characterize the typical recovery in physical function (PF) and pain inter-
Received 24 January 2018 ference (PI) after TKA using Patient-Reported Outcomes Measurement Information System (PROMIS)
Received in revised form patient-reported outcome (PRO) measures.
21 February 2018
Methods: Ninety-one patients were enrolled into an institutional review board -approved prospective
Accepted 2 March 2018
observational study. PROs were obtained preoperatively and postoperatively at 6 weeks, 3 months, 6
Available online 17 March 2018
months, and 1 year. PROs included the PROMIS PF computerized adaptive test (CAT) and the PROMIS PI
CAT. Generalized estimating equations were used to evaluate outcomes over time.
Keywords:
total knee arthroplasty
Results: There was no difference in the preoperative and 6-week postoperative T-scores for the PF CAT
patient-reported outcomes (P ¼ .410). However, all subsequent postoperative T-scores were greater than the preoperative T-score
PROMIS (all, P < 0.05). There was a significant reduction in PI CAT T-scores between the preoperative and all
pain interference subsequent postoperative T-scores (all, P < .05). A clinically important difference in PF CAT T-scores
physical function (b ¼ 5.44, 95% confidence interval 4.10-6.80; P < .001) and PI CAT T-scores (b ¼ 7.46, 95% confidence
interval 9.52 to 5.40; P < 0.001) was seen between the preoperative and 3-month postoperative visits.
Sixty-three percent of the improvement in PF occurred by 3 months, and 89% had occurred by 6 months.
The majority of reduction in PI (68%) occurred by 3 months and 90% had occurred by 6 months.
Conclusion: The greatest magnitude of improvement in both PF and PI occurred within the first
3 months. After 6 months, patients might expect modest improvements in PF and mild reductions of PI.
Patients and surgeons should use this information for setting expectations, planning for recovery, and
improving care.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is a reliable surgical procedure to
improve function and alleviate pain associated with end-stage
osteoarthritis [1]. Thus, it is not uncommon for patients preparing
This research was funded in part by the LS Peery Discovery Program in Muscu-
loskeletal Restoration.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to doi:10.1016/j.arth.2018.03.020.
* Reprint requests: Christopher E. Pelt, MD, Department of Orthopaedics, Uni-
versity of Utah School of Medicine, 590 Wakara Way, Salt Lake City, UT 84108.
for TKA to question their surgeon on the expected postoperative
recovery of these items. Although many providers have a general
sense of what their patients can typically expect after TKA surgery,
there may be a role for an improved chronologic description of an
average expected postoperative recovery. With this information,
both the patient and surgical team alike may have a better under-
standing of the level of recovery to be expected at various post-
operative time intervals, which in turn may improve their own
expectations and preparedness.
A patient’s recovery of physical function (PF) and pain after TKA
has been measured in a variety of ways including physical exami-
nation findings such as scar healing, range of motion, and lower
limb strength. In addition, performance-based metrics based on
timed walking, stair climbing, and chair-rising tasks have also been

https://doi.org/10.1016/j.arth.2018.03.020
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2472 R. Kagan et al. / The Journal of Arthroplasty 33 (2018) 2471e2474
studied [2]. More recently, the focus has been on patient-reported
outcomes (PROs). PROs offer the advantages of direct input from
the patient’s perspective on how influential the degree of pain and
functional ability have been affected after surgery. Unfortunately,
historical PROs (legacy scales) suffer from disadvantages of floor
and ceiling effects, low collection rates, high patient and provider
burden, clinical naivety in applying results, and the lack of patient
involvement in the creation of such instruments [3e6]. Given the
weaknesses associated with legacy scales, the National Institutes of
Health developed the Patient-Reported Outcomes Measurement
Information System (PROMIS) initiative to improve health status
measurements [6e10]. Instead of disease-specific measures, the
PROMIS developed measures to test domains of health, such as
physical, mental, and social health.
The PROMIS was rigorously developed with item banks that
yielded conceptually clear and well-calibrated measurement in-
struments and can use Item Response Theory (IRT) and computer-
ized adaptive testing (CAT) [5,7]. The IRT and CAT techniques can
increase reliability and statistical power [8]. The CAT-based PF (PF
CAT) has demonstrated superior performance over static forms of
equal length with high levels of accuracy and decreased patient and
administrative burden [10e12]. Although one of the driving factors
for the PROMIS initiative was to establish standardized metrics for
clinical research across National Institutes of Healthefunded
research, some studies suggest that these instruments could assist
in clinical decision making and the modification of treatment plans
based on patient response [3,7]. Given the functionally restorative
benefits of TKA, the PROMIS PF CAT is particularly relevant to
accurately assess the severity of functional limitation in this popu-
lation. Although the PROMIS PF CAT may be gaining traction in the
TKA arena, there appears to be little, if any, research on the use of the
PROMIS pain interference (PI) CAT in this population [3,13]. Pain is
often measured as a level of intensity; however, this may not
demonstrate the impact (interference) pain has on the individual’s
level of function. As such PI is gaining in popularity when measuring
the patients experience with care [14,15]. In a recent publication by
Kendall et al [16], the relationship of the PROMIS PF CAT with the
PROMIS PI CAT is evaluated in a spine population. They demon-
strated a strong association between the two suggesting that PI, as
measured by the PI CAT, may be a good indicator of how a patient’s
subjective experience of pain interferes with their level of function.
The current published literature with legacy PROs offer con-
flicting results for the expected trajectory of recovery after TKA.
Lenguerrand et al [17] evaluated the trajectory of pain and function
after primary TKA using the Western Ontario and McMaster Uni-
versities Osteoarthritis Index and showed that most improvement
occurred within the first 3 months postoperatively without sig-
nificant change thereafter. However, others report slow, but
continued improvement from 3 up to 18 months after TJA [18e20].
This leaves clinicians and patients with conflicting information for
their expected recoveries. To our knowledge, no study has
described the trajectory of recovery after TKA for the PROMIS PF
CAT or the PROMIS PI CAT in the TKA population. As such, we
sought to characterize the typical recovery in PF and PI using a
novel computerized adaptive PRO tool in a prospectively enrolled
cohort of TKA patients.
Materials and Methods
As part of a prospective observational study on functional out-
comes after TKA, the study team approached 111 patients who were
scheduled to undergo primary unilateral TKA at a single academic
medical center, of which written informed consent was obtained
from 91 patients. Of those not consented, 11 were outside the local
geographic region and did not want to participate, 3 were planning
to have the contralateral knee surgery performed within the next
year, 5 were not interested, and 1 patient was approached who did
not meet criteria. All procedures were performed between January
2015 and November 2016. The inclusion criteria included patients
who were 40 years of age, scheduled for primary unilateral TKA,
and willing to complete the follow-up visits. Patients were
excluded during the screening process if they had undergone TKA
on the contralateral knee within 6 months and if they had any
additional orthopedic, neurological, visual, or surgical conditions
that could have affected their outcomes. This study was approved
by the institutional review board (IRB# 000075446) and registered
with clinicaltrials.gov (NCT02364011).
PROMIS PROs were obtained preoperatively and at the following
postoperative time points: 6 weeks, 3 months, 6 months, and 1
year. The 1-year period was chosen as the last follow-up point
based on recommendations within the literature for measuring
outcomes after hip and knee arthroplasties [19]. The PROMIS
measures collected included the PF CAT, v1.2, and the PI CAT, v1.1.
The PROMIS PF CAT contains a bank of 121 individually validated
items that have been calibrated using IRT. Similarly, the PI CAT
contains an item bank of 40 questions. For both measures, T-scores
were recorded and used for this analysis. A PROMIS T-score of 50 is
the average score related to the US general population, which has a
standard deviation (SD) of 10. It is important to note that a higher T-
score indicates more of the item being measured. Thus, for the PF
CAT, higher scores mean greater PF and for the PI CAT, higher scores
indicate greater PI. For interpreting PF, an average patient in our
population with a preoperative T-score between 38 and 42 often
report some limitations with performing physical labor, house or
yard work, and walking more than a mile. In addition, they report
being greatly limited or unable to hike a couple of miles because of
their health. However, a patient in our population with a PF CAT T-
score of 43-47 is more likely to report little if any limitations with
performing 2 hours of physical labor, house or yard work, walking a
mile, or hiking a couple of miles.
Patient demographics are reported using descriptive statistics.
Generalized estimating equations, with an unstructured correlation
matrix, were used to evaluate PROMIS measures over time and the
appropriate postestimation commands were used to compare
scores between time intervals. As approximately 3% of the T-scores
were missing at random for both the PF CAT and PI CAT, imputation
was performed using the median T-score of the nonmissing values
[21]. To determine clinical significance, the distributive method was
used to evaluate the minimal clinically important difference (MCID)
for both PROMIS measures, with ½ a SD being considered a clini-
cally detectable difference [22]. As such, the MCID for the PF CAT
was 3.34 T-score units and the MCID for the PI CAT was 4.43 in this
patient population. Based on previous reports where the majority
of change occurs within the first 3 months, we used the preoper-
ative and 3-month postoperative visits for a power analysis
[17,18,23e25]. Our sample size of n ¼ 91 provided 80% power to
detect a standardized mean difference in the repeated measures of
0.30 SD, where the 2 repeated measures (preoperative to 3 months)
had a correlation of r ¼ 0.46. Significance was assessed at the 0.05
level and the analyses were performed using commercially avail-
able statistical software (Stata v14.2, College Station, TX).
Results
The mean age of the cohort (n ¼ 91) was 63 years (range 44-83
years). Forty-nine of the participants were male (54%) and 42 were
female (46%). The mean body mass index was 29.38 kg/m2 (range
18.4-41.5 kg/m2).
There was no difference in the preoperative and 6-week post-
operative T-scores for the PF CAT (P ¼ .410). However, all
 R. Kagan et al. / The Journal of Arthroplasty 33 (2018) 2471e2474 2473

Table 1 Table 2
PF CAT Scores and Beta Coefficients for Repeated Measures Analysis. PI CAT Scores and Beta Coefficients for Repeated Measures Analysis.

Visit Adjusted Mean b (95% CI) P Value Visit Adjusted Mean b (95% CI) P Value
T-Score (95% CI) T-Score (95% CI)

Preoperative 38.7 (37.5-39.8) Reference Reference Preoperative 61.7 (60.1-63.2) Reference Reference
6 wk 39.2 (38.0-40.5) 0.59 (0.81 to 2.00) .410 6 wk 58.1 (56.4-59.9) 3.52 (5.55 to 1.50) .001
3 mo 44.1 (42.3-45.3) 5.44 (4.10-6.80) <.001 3 mo 54.2 (52.5-55.9) 7.46 (9.52 to 5.40) <.001
6 mo 46.4 (45.1-47.6) 7.71 (6.29-9.12) <.001 6 mo 52.2 (50.5-53.9) 9.46 (11.51 to 7.40) <.001
1y 47.3 (46.1-48.5) 8.64 (7.31-9.97) <.001 1y 50.7 (49.0-52.4) 10.96 (12.90 to 9.02) <.001

CAT, computerized adaptive test; CI, confidence interval; PF, physical function. CAT, computerized adaptive test; CI, confidence interval; PI, pain interference.

subsequent postoperative T-scores (3 months, 6 months, and 1
year) were greater than the preoperative T-score (Table 1). A clin-
ically important difference in PF was first seen between the pre-
operative and 3-month postoperative visits (b ¼ 5.44, 95%
confidence interval [CI] 4.10-6.80; P < .001; Fig. 1) and the change
from the 3-month to 1-year postoperative visits approached an
additional MCID (b ¼ 3.20, 95% CI 1.84-4.56; P < .001). Sixty-three
percent of the improvement in PF occurred by 3 months and 89% by
6 months (Fig. 1).
There was a significant reduction in PI (PI CAT) between the
preoperative and all subsequent postoperative T-scores (Table 2). A
clinically important difference was first observed between the
preoperative and 3-month postoperative visits (b ¼ 7.46, 95%
CI 9.52 to 5.40; P < .001; Fig. 2). No clinically relevant reductions
in PI were observed beyond this time point. Most reduction in PI
(68%) occurred by the 3-month postoperative visit. By 6 months,
90% of the reduction in PI had occurred (Fig. 2).
Discussion
The ability to demonstrate the typical recovery of PF and PI after
TKA is important to patients and surgeons who may use this data
for both planning and prognostics. This study supports the over-
whelming body of evidence from legacy scales that has shown
improvement in PF and PI after TKA. To our knowledge, this is the
first report on the recovery of PF and PI after TKA using the PROMIS
PF CAT and PI CAT instruments. As such, we provide new insight
regarding the trajectory of recovery from the immediate preoper-
ative visit to 1-year postoperatively. Our findings indicate that by 6
weeks postoperatively, patients with TKA have returned to their
perceived preoperative PF state. By 3 months, approximately 63% of
the improvement in the patient’s perceived PF and 68% of the
decrease in PI was obtained. Although there appears to be
continued improvement in PF after 3 months, with additional gains
that approach another full MCID in the PF CAT, the improvements in
PI seem to plateau. Thus, after 3 months of recovery, patients with
TKA should expect the majority of improvement in PF and reduc-
tion in PI to be obtained, although modest continual improvements
in function are seen within the first year after surgery.
Our findings add meaningful data to the existing literature by
providing information on the typical postoperative recovery tra-
jectory of patients after TKA using a novel self-reported metric of PF
and PI over the first year after surgery. Consistent with the prior
literature, our data show that most improvement occurs within the
first 3 months postoperatively [18,23,25,26]. Although the greatest
amount of improvement was seen in the first 3 months for both the
PF CAT and PI CAT, our population approached another clinically
meaningful improvement in PF from 3-12 months postoperatively.
This is consistent with our own clinical finding, anecdotally, and is
supported by other studies which show continued improvement up
to 12 months after TJA [19,20,24,27]. As the responsiveness of PROs
has been shown to differ considerably [28], it seems feasible that
recovery trajectories for PF and pain would vary between in-
struments as well.
The variance in the recovery trajectories is likely due to the
inherent weaknesses of the instruments, including limited
responsiveness or the floor and/or ceiling effects in legacy scales
such as the Oxford Knee Score, Western Ontario and McMaster
Universities Osteoarthritis Index, Knee Society Score, and Knee
Injury and Osteoarthritis Outcome Score (KOOS) [5,28e31].
Although these scores are valid and reproducible, the responsive-
ness to change is particularly important for studies monitoring
trajectory of recovery as scoring change is reflected over different
postoperative time points. As such, a recent study demonstrates
good psychometric properties for the PF CAT in an adult recon-
struction population and reports improved responsiveness over the
newly developed HOOSejoint reconstruction and KOOSejoin

Fig. 1. A cross-sectional time series graph demonstrating the adjusted mean outcomes
of PF over time. Error bars show 95% confidence intervals. PF, physical function; CAT, Fig. 2. A cross-sectional time series graph demonstrating the adjusted mean outcomes
computerized adaptive test. of PI over time. Error bars show 95% confidence intervals. PI, pain interference.
2474 R. Kagan et al. / The Journal of Arthroplasty 33 (2018) 2471e2474
reconstruction [13]. Capturing functional improvement or pain
relief after TKA over midterm points where patients pain and
limited function is not typically as pronounced as in the early re-
covery can be difficult to measure as the change may be more
subtle [32].
The PROMIS PF scale, using IRT and CAT, has shown improved
responsiveness, reduced sample size requirements for PF scales and
minimal floor and/or ceiling effects, [13,33,34]. In addition, the
PROMIS PF CAT underwent rigorous development of the item bank
by a skilled team of psychometricians that yielded a conceptually
clear and well-calibrated measurement instrument [5,10].
A limitation of this study is that all patients were taken from a
single center, a regional tertiary referral hospital and our patients
comorbidities and demographics may not represent other practices
limiting our external validity. Another potential limitation is that
we did not evaluate patients starting at very low scores separately
from patients with higher starting PROs. It has been shown that
patients with severe preoperative symptoms may show the great-
est gains, but have worse final outcomes [35]. However, our patient
population was part of a diverse prospectively enrolled cohort
which may have minimized the effect of a selection bias. That being
said, we limited our population to primary TKA cases without
recent or planned contralateral surgery or other conditions that
could affect their outcomes. Thus, it is reasonable that patients who
were excluded could experience a different rate of recovery.
Conclusions
This study contributes new information on the trajectory of
recovery of PF and PI after TKA. By 6 weeks after TKA, patients have
returned to their preoperative PF state, and already had significant
decrease in PI from preoperative levels. The greatest magnitude of
improvement in both the PF and PI measures occurred within the
first 3 months and began to plateau near maximum potential in
their recovery after 6 months. After 6 months, patients might
expect modest improvements in PF and only mild reductions of PI
out to the full year after surgery. Patients and surgeons should use
this information for setting expectations, planning for recovery, and
improving care.
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 The Journal of Arthroplasty 33 (2018) 2502e2505

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

The Reliability of Sensor-Assisted Soft Tissue Measurements in

Primary Total Knee Arthroplasty
Just A. van der Linde, MD, PhD a, b, *, Ken J. Beath, PhD c,
Anthony K.L. Leong, MBBS, FRACS (Ortho), MS, FAOrthA a
a
Department of Orthopedic Surgery, Wollongong Hospital, South Coast Mail Centre, Wollongong, New South Wales, Australia
b
Department of Orthopaedic Surgery and Traumatology, St. Antonius Ziekenhuis Nieuwegein, Utrecht, the Netherlands
c
Department of Statistics, Macquarie University, Sydney, New South Wales, Australia

a r t i c l e i n f o a b s t r a c t

Article history: Background: In pursuit to improve soft tissue balancing in total knee arthroplasties (TKAs), a wireless
Received 4 January 2018 device was introduced to assess femorotibial pressures. The aim of this study was to evaluate the reli-
Received in revised form ability of this device.
14 March 2018
Methods: After 33 TKAs were balanced by conventional techniques, contact pressures were measured
Accepted 27 March 2018
Available online 9 April 2018
using a wireless sensor 3 times in a row; twice while the examiner was blinded for the result (n ¼ 29);
and once while the examiner was able to see the result as visual feedback (n ¼ 32). Femorotibial
pressures were measured in the medial and lateral compartments with the knee in 10 , 45 , and 90 of
Keywords:
knee
flexion (6 measurements per TKA). Furthermore, both the combined pressure and the difference in
arthroplasty pressure between the compartments was calculated throughout the 3 positions (together another 6
replacement measurements per TKA).
sensor Results: The intraclass correlation coefficient between the blind measurements was poor in 2 of the 12
reliability (17%), moderate in 4 of 12 (33%), and good in 6 of 12 (50%) measurements. The intraclass correlation
balancing coefficient between the blind and observing measurement was poor in 2 of the 12 (17%), moderate in 6 of
12 (50%), and good in 4 of 12 (33%) measurements. Especially measurements in 10 of flexion are
associated with poorer reliability.
Conclusion: The wireless sensor has a moderate to good reliability in 83% of the measurements.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasties (TKAs) are used to treat patients with
end-stage osteoarthritis. It has been estimated that 4.7 million in-
dividuals had a TKA in 2010 in the USA, with approximately
600.000 new patients each year [1e3]. About 20% of these patients
report to be dissatisfied [4], which can ultimately lead to revision
surgery. In the USA, 35% of the early TKA revisions are attributed to
soft tissue imbalance, manifesting as instability or stiffness, and
femorotibial incongruency that could lead to component loosening
[5,6]. Soft tissue balancing refers to ligamentous tension
throughout the range of motion that is intraoperatively determined
by the surgeon [7].
All authors have participated in the research.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.067.
* Reprint requests: Just A. van der Linde, MD, PhD, St. Antonius Ziekenhuis
Nieuwegein, Soestwetering 1, 3543 AZ, Utrecht, the Netherlands.
In pursuit of improving the soft tissue balance, a wireless sensor
has been developed to measure femorotibial pressures during TKA
implantation [8e10]. Clinical studies report that early functional
outcome improves when contact pressures are evaluated with the
wireless sensor [8,10]. However, studies that assess the reliability of
the sensor are lacking.
The objective of this study was to evaluate the reliability of this
sensor.
Methods
We prospectively evaluated the femorotibial compartment
pressures in 31 patients receiving 33 TKAs (2 patients received a
bilateral TKA). Eligible patients were diagnosed with osteoarthritis,
rheumatoid, or other inflammatory arthritis and were aged 40-80
years.
The mean (standard deviation) age was 63.8 (9.4) years, and the
mean body mass index was 32.1 (5.8). Twenty-two TKAs were

https://doi.org/10.1016/j.arth.2018.03.067
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J.A. van der Linde et al. / The Journal of Arthroplasty 33 (2018) 2502e2505
implanted in right knees and 11 in left knees. There were 13 TKAs
implanted in female patients, 20 in male patients. Twenty-seven
knees had a preoperative varus alignment and 6 knees had a
valgus alignment.
Patients who required a constrained or revision TKA and pa-
tients who received a hemicompartmental or unicompartmental
TKA were excluded.
Ethical approval was obtained from our local institutional re-
view board.
Patients were operated in supine position, with a side support
on the thigh and bolster under the heel to allow flexion. Access to
the knee joint was obtained through a standard medial para-
patellar approach. The femur and tibia were prepared for a
posterior-stabilized TKA with patella resurfacing using intra-
medullary guidance (Legion Oxinium, Smith & Nephew, Memphis,
TN). Rotation of the femur was applied by assessing the epi-
condylar axis and the Whiteside's line. Rotation of the tibia was
applied by placing the tibial tray on the midmedial third of the
tuberosity as anatomical landmark, by evaluating the patella
tracking and if necessary with extramedullary guidance.
After removal of osteophytes, the soft tissue balance was
traditionally trialed by applying varus and valgus stress with an
uncemented trial implant and a trial liner. Once the soft tissue
balance was deemed adequate by the surgeon, the femorotibial
pressures were measured with the wireless tibial liner (VERASENSE
Knee System; OrthoSensor, Inc., Dania Beach, FL) whose
morphology is identical to a normal liner. Femorotibial pressures
were measured with the patella relocated in the trochlear groove,
with arthrotomy provisionally closed using 2 towel clips or tem-
porary sutures; 1 proximal and 1 distal to the patella. The pressures
were measured 3 consecutive times; twice while the examiner was
blinded to the measurement results and once while the examiner
was able to see the results as visual feedback.
No interventions were performed in between these meas-
urements to improve the balance. The knee was held in each po-
sition for approximately 2 seconds, while the observer documented
the pressures from the screen. Adequate femorotibial pressures
required 2 criteria. First, pressures in the medial and lateral com-
partments must not exceed 40 pounds, and second, the difference
between both compartments (the intercompartmental difference)
was not allowed to exceed 15 pounds [8,10,11].
After the third and final measurement, the surgeon could decide
to make final adjustments to balance the knee before the TKA was
implanted. Although the sensor was used as a guide, conventional
balancing with manual feedback was still leading in this process.
After balancing was deemed adequate, the final TKA was
implanted with bone cement, local intra-articular anesthesia was
applied, and the wound was washed and closed. All procedures
were performed, and all measurements obtained were completed
by a single dedicated hip and knee surgeon with over 20 years of
surgical experience.
Femorotibial pressures were measured in 2 compartments
(medial compartment and lateral compartment) through 3 posi-
tions (10 , 45 , and 90 of flexion), resulting in 6 pressures that
were observed and recorded per patient.
Furthermore, we calculated the difference in pressure between
the medial and lateral compartments (intercompartmental differ-
ence) throughout all 3 positions.
Finally, the total femorotibial pressure was calculated for each
patient by adding the medial to the lateral compartment pressure
throughout all 3 positions. The reason being is that considerable
changes in compartment pressures were incidentally observed,
possibly as a result of unintended varus or valgus stress. By adding the
relatively high pressure on the loaded compartment to the lower
pressures on the unloaded opposite compartment, we tried to
2503
compensate for these possible errors. Overall, 12 pressures (6
observed and 6 calculated) were assessed per TKA per measurement.
To avoid a possible learning curve, 10 patients were operated
with the sensor before data collection started. Their data were not
included in this study.
Normally distributed data are presented as mean (standard
deviation) values and not normally distributed data as median and
interquartile range values.
Reliability is calculated using the intraclass correlation coef-
ficient (ICC). ICC estimates and their 95% confidence interval were
calculated with a 2-way mixed-effects model for absolute ag-
reement [12]. The ICC ranges from 0 (poor reliability) to 1 (perfect
reliability). ICC values 0.5 are indicative of poor reliability, values
between 0.5 and 0.75 indicate moderate reliability, values between
0.75 and 0.9 indicate good reliability, and values greater than 0.90
indicate excellent reliability [12]. In addition, Bland-Altman plots
were calculated.
Calculations were performed with R [13] and the irr package
[14].
Results
When blinded for the results, 20 TKAs (60%) were “balanced.”
When the examiner used the sensor for visual feedback, 19/32 TKAs
(59%) were “balanced.” Final adjustments were applied after the
third and final measurement only if deemed necessary.
In 4 TKAs, no second (blind) measurement was performed,
while in 1 TKA, no third (observed) assessment was performed
(Fig. 1). Thus, ICC values between the blind measurements were
calculated in a subgroup of 29 TKAs (presented in Table 1), whereas
ICC values between the blind and observing measurement were
calculated in a subgroup of 32 TKAs (presented in Table 2). The
contact pressures are not normally distributed and are presented as
median (interquartile range) values in both tables.
When comparing both blind measurements, poor reliability (ICC
<0.50) was observed in 2 of the 12 (17%) measurements, moderate
reliability (ICC 0.50-0.75) was observed in 4 of 12 (33%) meas-
urements, and good reliability (ICC 0.75-0.90) was observed in the
remaining 6 of 12 (50%) measurements. Especially measurements in
10 of flexion are associated with poorer reliability, as well as mea-
surements of the intercompartmental difference in 90 of flexion.
When comparing the blind to the observing assessment, poor
reliability (ICC <0.50) was observed in 2 of the 12 (17%) meas-
urements, moderate reliability (ICC 0.50-0.75) was observed in 6 of
12 (50%) measurements, and good reliability (ICC 0.75-0.90) was
observed in the remaining 4 of 12 (33%) measurements. Especially
measurements in 10 of flexion are associated with poorer
Fig. 1. Flowchart of the consecutive measurements. * in 4 TKA, no second blind
measurement was performed. ** in 1 TKA, no third observing measurement was
performed.
2504 J.A. van der Linde et al. / The Journal of Arthroplasty 33 (2018) 2502e2505

Table 1 The fact that especially measurements with the knee in 10 of
The Intraclass Correlation Coefficient (ICC) Between Both Blind Measurements of flexion result in poorer reliability, might be attributed to the sur-
Femorotibial Pressures.
gical setup. The lateral side support could cause unplanned valgus
N ¼ 29 1st Blind Median (IQR) 2nd Blind Median ICC (95% CI) stress, especially while the knee is extended. Although this was
(IQR) noted and consciously corrected for during the measurements, it
Medial compartment might still have influenced the reliability assessment.
10 flexion 13 (8.0-16.0) 14 (9.0-17.0) 0.43 (0.08-0.68) We anticipated unintended varus or valgus stress by calculating
45 flexion 13 (9.0-18.0) 15 (9.0-18.0) 0.84 (0.67-0.92)
the total pressure in both compartments combined; an unloaded
90 flexion 14 (11.0-17.0) 16 (10.0-21.0) 0.82 (0.63-0.92)
Lateral compartment lateral compartment in varus would simultaneously cause overload
10 flexion 22 (15.0-28.0) 25 (19.0-33.0) 0.68 (0.43-0.84) in the medial compartment, whereas their total pressure should
45 flexion 18 (16.0-25.0) 20 (14.0-30.0) 0.81 (0.65-0.91) remain similar. To our surprise, the ICC in measurements of both
90 flexion 16 (11.0-22.0) 15 (11.0-25.0) 0.63 (0.35-0.81)
compartments combined is still lower in 10 of flexion (moderate
Total in both compartments
10 flexion 35 (23.0-44.0) 38 (30.0-54.0) 0.54 (0.23-0.75)
reliability) compared with 45 and 90 of flexion (good reliability).
45 flexion 32 (26.0-37.0) 37 (25.0-43.0) 0.83 (0.65-0.92) Another explanation for the poorer reliability 10 of flexion might
90 flexion 28 (24.0-35.0) 31 (25.0-42.0) 0.80 (0.59-0.90) thus be that the sensor is less accurate in detecting pressures in this
Intercompartmental difference position.
10 flexion 7 (3.0-16.0) 10 (7.0-19.0) 0.61 (0.33-0.80)
Poorer reliability regarding the intercompartmental differences
45 flexion 7 (3.0-17.0) 8 (5.0-20.0) 0.74 (0.52-0.87)
90 flexion 6 (3.0-9.0) 8 (5.0-10.0) 0.40 (0.07-0.66) with the TKA in 45 and 90 of flexion could be attributed to smaller
measurements and subsequent less variation in the measurements.
Pressures are measured in pounds (lb) and presented as median with the inter-
quartile range (IQR).
The error variance becomes large relative to the measurement
CI, confidence interval; IQR, interquartile range. variance and the ICC decreases.
Recently, Nodzo et al [15] assessed reliability of the sensor by
comparing compartment pressures before and after cement fixa-
reliability, as well as measurements of the intercompartmental tion in a cohort of 50 patients. However, we believe that intra-
difference in 45 and 90 of flexion. observer studies are ideally performed with 2 measurements under
Moderate to good reliability was observed between the mea- identical circumstances while any confounding factors, such as the
surements of the total pressure in both compartments combined. application of bone cement, or an additional soft tissue release
Bland-Altman plots are shown in Appendix A, with bounds for between both measurements (reported in 76% of the cases) should
acceptable differences shown by the dashed lines at plus or minus be avoided.
15 pounds difference between the measuring methods. This However, there are some limitations to this study. First, ideally a
showed only a small number of points outside these bounds, second observing measurement was added because this would
however with some points with a greater than 30 pounds differ- have allowed the calculation of the ICC between 2 observing
ence. No pattern was obvious, with mean differences between the 2 measurements. This is interesting to evaluate because femorotibial
methods approximately constant over the range of measurements compartment pressures are normally measured using the visual
and no change in the variance. feedback.
Second, the sample size is relatively small. Although previous
Discussion reliability studies used similar-sized populations [16e18], a small
sample size reduces the chance of detecting a true effect and re-
In this study, we found that the intraobserver variability is duces the likelihood that a statistically significant result reflects a
moderate to good in 83% of the measurements. This accounted both true effect [19].
for comparison between 2 blind observations, as well as for a Third, we have not assessed the interobserver variability.
comparison between 1 blinded and 1 observing observation. Whereas all measurements were performed by the senior author, a
second observer might have held the knee in a slightly different
position (slightly more varus or valgus stress) which could theo-
Table 2 retically lead to different pressures.
The Intraclass Correlation Coefficient (ICC) Between the Blind and Observing Mea-
Because this is a single-surgeon study in a relatively small
surement of Femorotibial Pressures.
sample size, these findings must be interpreted carefully. Future
N ¼ 32 1st Blind Median (IQR) Observing Median ICCs (95% CI) studies should evaluate the reliability between observing mea-
(IQR)
surements and should evaluate the interobserver variability in a
Medial compartment larger cohort with multiple observers.
10 flexion 13 (6.8-17.0) 16 (10.0-23.2) 0.52 (0.20-0.74)
45 flexion 12 (8.0-18.0) 16 (10.8-21.0) 0.68 (0.36-0.85)
90 flexion 14 (9.8-18.0) 15 (10.0-21.5) 0.80 (0.62-0.90)
Lateral compartment Conclusion
10 flexion 22 (14.0-27.0) 24 (18.8-33.0) 0.64 (0.38-0.81)
45 flexion 18 (15.8-24.2) 18 (14.8-27.0) 0.82 (0.67-0.91) The sensor has a moderate to good reliability in 83% of the
90 flexion 16 (11.0-20.5) 16 (12.8-22.0) 0.71 (0.48-0.84)
measurements when the examiner is blinded for the result. Care
Total in both compartments
10 flexion 34 (23.0-44.0) 42 (34.5-51.2) 0.57 (0.16-0.79)
should be taken to avoid unintended varus and valgus stress while
45 flexion 32 (25.5-37.5) 37 (28.8-43.2) 0.77 (0.47-0.89) using the sensor. The sensor is more reliable with the TKA in 45
90 flexion 28 (23.5-35.8) 32 (23.8-39.2) 0.81 (0.63-0.91) and 90 compared with 10 of flexion.
Intercompartmental difference
10 flexion 8 (4.0-16.2) 10 (3.8-20.0) 0.61 (0.33-0.79)
45 flexion 8 (4.0-15.5) 8 (5.8-13.2) 0.33 (0.03-0.60)
90 flexion 6 (2.8-9.2) 9 (4.8-12.0) 0.21 (0.13-0.51)
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 The Journal of Arthroplasty 33 (2018) 2376e2380

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Time Trends in Characteristics of Patients Undergoing Primary

Total Hip and Knee Arthroplasty in California, 2007-2010
Cheongeun Oh, PhD a, *, James D. Slover, MD, MS b, Joseph A. Bosco, MD b,
Richard Iorio, MD b, Heather T. Gold, PhD a, b
a
Department of Population Health, NYU School of Medicine, New York, New York
b
Department of Orthopaedic Surgery, NYU School of Medicine, New York, New York

a r t i c l e i n f o a b s t r a c t

Article history: Background: As the number of total hip and knee arthroplasty cases increases, it is important to
Received 21 June 2017 understand the burden of factors that impact patient outcomes of these procedures. This article exam-
Received in revised form ined the time trends in key demographics, clinical characteristics, comorbidity burden (Deyo-Charlson
19 February 2018
Comorbidity Index [CCI]), and presence of depression in patients undergoing primary total hip arthro-
Accepted 20 February 2018
plasty and total knee arthroplasty using population-based, all-payer inpatient database, California
Available online 6 March 2018
Healthcare Cost and Utilization Project, from 2007 to 2010.
Methods: Chi-square tests and analysis of variance were used. Multivariate logistic regression analyses
Keywords:
total knee arthroplasty (TKA)
were also performed to compare the prevalence of depression in 2007 to later years.
total hip arthroplasty (THA) Results: In the primary total hip arthroplasty cohort, the prevalence of depression significantly increased
time trends by 20%, mean age decreased by 0.4 years, mean length of stay (LOS) decreased by 0.5 days, and having a
depression CCI score of
3 increased by 30% (P value < .001 for all) over the study period. Similarly, in the primary
California Healthcare Cost total knee arthroplasty cohort, the prevalence of depression increased by 23%, the mean age decreased by
Utilization Project 0.4 years, mean LOS decreased by 0.4 days, and the prevalence of CCI score of
3 increased by 35%
(P value < .001 for all).
Conclusion: Despite the younger age of the joint arthroplasty population over time, we found increased
prevalence of depression and comorbidity scores but shorter LOS. Further study is needed to determine
the impact of the changing demographics of the total joint population and the best strategies to optimize
their outcome with these procedures.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) and total knee arthroplasty (TKA)
are highly successful surgeries in terms of cost-effectiveness, pain
reduction, and improvement in quality of life for patients with hip
or knee osteoarthritis [1e5]. The incidence of both surgeries is
increasing and is expected to reach 3.48 million by the year 2030
[6]. The result is an increased demand on hospital resources to
provide adequate care to THA and TKA patients. Therefore, it is
important to understand whether patient characteristics and
Grants: No benefits or funds were received in support of the study.
complexity are changing over time, and if so, how they are
changing in order to better optimize healthcare resources. This is
particularly true as bundled payment reimbursement programs
continue to spread and providers become increasingly responsible
for managing care through an entire care episode.
In an attempt to begin to assess the critical population charac-
teristics of patients undergoing total joint arthroplasty, we exam-
ined the age, prevalence of depression, and medical comorbidity
rates using a large population-based database. The null hypothesis
was that there are no significant trends over time in these THA and
TKA patients' characteristics.

One or more of the authors of this paper have disclosed potential or pertinent Materials and Methods
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which Data Source
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.079.
* Reprint requests: Cheongeun Oh, PhD, Department of Population Health, NYU The data were extracted from the population-based, all-payer
School of Medicine, 650 1st Ave, #556, New York, NY 10016. California Healthcare Cost and Utilization Project database [7] for

https://doi.org/10.1016/j.arth.2018.02.079
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 C. Oh et al. / The Journal of Arthroplasty 33 (2018) 2376e2380 2377

Table 1 drug abuse) [10,11], expressed as CCI categories of 0, 1, 2, and
3

Clinical and Demographic Characteristics of Study Cohorts in 2007-2010. comorbidities as in other work [12].
Variable Primary THA Primary TKA We included demographic data such as age, sex, race/ethnicity,
(N ¼ 65,067) (N ¼ 132,406) and insurance type. The presence of rheumatoid arthritis (RA)/in-
Gender flammatory arthritis and LOS were also considered. Age was cate-
Female 38,222 (59%) 83,074 (63%) gorized in 5-year age-groups: 50-54, 55-59, 60-64, 65-69, 70-74,
Male 26,845 (41%) 49,348 (37%) 75-79, 80 or older. Race/ethnicity was represented by 5 categories
Age, mean (SD), y 68.9 (10.1) 68.9 (9.3)
of white, black, Hispanic, Asian, and others.
50-<59 13,688 (21%) 24,196 (18%)
60-<69 20,531 (32%) 44,982 (34%)
70-<79 19,534 (30%) 44,210 (34%) Statistical Analyses
80þ 11,314 (17%) 19,017(14%)
Race
Summary statistics were calculated as the proportion or the
White 57,011 (88%) 107,752 (81%)
Black 2975 (5%) 6956 (5%)
mean ± standard deviation. The number of patients within each
Hispanic 131 (0.1%) 434 (0.1%) category of the variable was compared over time using a
Asian 1776 (3%) 5749 (4%) chi-squared test. Means of continuous variables were compared
Others 3174 (5%) 11,515 (9%) using analysis of variance in various time periods. We further
Insurance
examined the time trends in the proportion of patients with
Medicaid 1355 (2%) 3541 (3%)
Private 23,245 (36%) 40,272 (30%) comorbid depression using multivariate logistic regression. The
Others 40,467 (62%) 88,593 (67%) earliest year, 2007, was considered the reference year. The overall P
Length of stay, mean (SD), d 3.4 (2.2) 3.4 (1.6) value for the variable was considered an indicator of whether there
Deyo-Charlson Comorbidity 0.5 (1.0) 0.6 (1.0) was a period effect. The odds ratio in the multivariate logistic
Index, mean (SD)
0 42,839 (66%) 79,321 (60%)
regression was used in the assessment of a time trend. We analyzed
1 14,569 (22%) 35,852 (27%) THA and TKA groups separately. All P values were 2-sided with
2 4791 (7%) 10,824 (8%) statistical significance evaluated at the a ¼ .05 level. P values were

3 2868 (4%) 6409 (5%) further corrected for multiple comparisons with the Bonferroni
Depression 5483 (8.4%) 11,878 (9%)
method. Statistical analyses were performed using R statistical
Alcohol abuse 822 (1.3%) 1149 (0.9%)
Drug abuse 397 (0.6%) 660 (0.5%) software version 3.1.3 (www.R-project.org). [13].
RA/inflammatory arthritis 2041 (3.1%) 4401 (3.3%)

Values are the number (%) unless indicated otherwise.

THA, total hip arthroplasty; TKA, total knee arthroplasty; SD, standard deviation; RA,
rheumatoid arthritis.
hospital discharges after primary, unilateral TKA (n ¼ 132,406;
International Classification of Diseases, Ninth Revision, Clinical
Modification [ICD-9-CM] procedure 81.54) or THA (n ¼ 65,067;
ICD-9-CM procedure 81.51) for adults aged 50 and older from 2007
to 2010, the most recent data available for this large, diverse state.
We included subjects with osteoarthritis (ICD-9-CM diagnosis
codes: 715.0(0, 4, 9), 715.1(0-8), 715.2(0-8), 715.3(0-8), 715.8(0, 9),
715.9(0-8)) and excluded subjects who underwent more than one
knee or hip arthroplasty within a year. This exclusion required us to
use data from 2006 to allow for a look back period for previous
surgeries for subjects undergoing treatment in 2007. Therefore,
subjects who underwent surgery in 2006 were not included as
index cases.
Study Outcome and Covariates
The primary comorbidity of interest was depression. Comorbid
depression present during the index admission was identified using
the algorithm described by Elixhauser [8] according to the ICD-9-CM
diagnosis code at time of discharge for surgery. We modified the
depression comorbidity by adding 2 ICD-9-CM codes for major
depressive episode, 296.2(0-6) and 296.3(0-6), which were not
included in Elixhauser method [8]. Additionally, medical
comorbidity, alcohol and drug abuse, hospital length of stay (LOS),
patient demographics including age, sex, race, and insurance type
were examined. Overall medical comorbidity burden was assessed
with the Deyo-Charlson Comorbidity Index (CCI) [9] based on the
presence of ICD-9-CM codes at the time of surgery, a validated
measure of comorbidity, consisting of a weighted scale of 17
comorbidities (including cardiac comorbidity, pulmonary
comorbidity, renal comorbidity, hepatic disease, diabetes mellitus,
cancer, hemiplegia, and not including depression, or alcohol and
Results
Table 1 summarizes the characteristics of THA and TKA patients
in 2007-2010. The primary THA cohort consisted of 65,067
patients; 59% were women, 17% were
80 years old, 88% were
white, 3% were Medicaid-insured, 3.1% had an additional diagnosis
of RA/inflammatory arthritis, 8.4% had comorbid depression, and
1.3% and 0.6% had an alcohol or drug abuse diagnosis, respectively.
The mean LOS was 3.4 days. The mean CCI was 0.54, and 4% of
patients had CCI scores
3.
The primary TKA cohort consisted of 132,406 patients; 63% were
women, 14% were
80 years old, 81% were white, 2% were
Medicaid-insured, 3.3% had an additional diagnosis of RA/inflam-
matory arthritis, 9% had comorbid depression, and 0.9% and 0.5%
had an alcohol or drug abuse diagnosis, respectively. The mean LOS
was 3.4 days. The mean CCI was 0.6, and 5% of patients had CCI
scores
3.
Time Trends in Demographic and Clinical Characteristics
In THA group, the mean age decreased by 0.4 years (69.0 to
68.6 years). While there was an increase in the proportion of the
2 youngest age-groups of 50-59 years and 60-69 years, there was
a reduction in those aged
70 years over the 4-year study
period. A significantly higher proportion of patients had a CCI
score
3 in the most recent year compared with the earliest
year, increasing approximately by 30% (from 3.8% to 4.9%). LOS
decreased from an average of 3.7 days in 2007 to 3.2 days in
2010 (P < .001; Table 2). We noted a significant increase in the
prevalence of comorbid depression over the study period,
increasing 20% (from 7.5% to 9.0%; Table 2). During the same
period, alcohol and drug abuse rates increased from 1.1% to 1.5%
and from 0.5% to 0.8%, which were slight but statistically sig-
nificant increases.
Similarly, in TKA group, we note the greatest increase in
proportion of patients with a CCI score
3 in the most recent year
compared with the earliest year by 35% (4.0% to 5.4%) and a
2378 C. Oh et al. / The Journal of Arthroplasty 33 (2018) 2376e2380

Table 2
Time Trends in Demographics and Clinical Characteristics of Patients Undergoing Primary THA (N ¼ 65,067).

Variables 2007 2008 2009 2010 P Value

(N ¼ 15,037) (N ¼ 15,526) (N ¼ 16,829) (N ¼ 17,675)

Age category, y <.001a

50-<59 21.3 20.6 21.2 21.4
60-<69 30.0 31.1 31.9 33.0
70-<79 31.4 30.4 29.8 29.4
80þ 17.3 17.9 17.0 16.2
Mean age (SD), y 69.0 (10.2) 69.1 (10.2) 68.8 (10.2) 68.6 (10.0) <.001a
Female gender 58.2 59.2 59.2 58.3 .132
Insurance .908
Medicaid 2.0 2.1 2.2 2.1
Private 35.9 35.6 35.5 35.9
Others 62.1 62.3 62.3 62.0
Mean length of stay (SD), d 3.7 (3.3) 3.5 (1.8) 3.3 (1.7) 3.2 (1.7) <.001a
Depression 7.5 8.2 8.9 9.0 <.001a
Alcohol abuse 1.1 1.2 1.3 1.5 .002a
Drug abuse 0.5 0.6 0.6 0.8 .003a
Deyo-Charlson Comorbidity Index
0 66.9 66.2 64.9 65.5 <.001a
1 22.7 22.4 22.5 22.0
2 6.6 7.3 7.9 7.6

3 3.8 4.1 4.7 4.9
RA/inflammatory arthritis 3.1 3.1 3.3 3.1 .809

Values are the percentage unless indicated otherwise. We used analysis of variance for continuous variables and chi-squared test for categorical variables.
THA, total hip arthroplasty; SD, standard deviation; RA, rheumatoid arthritis.
a
Significant P values at a ¼ .005.

significant increase in the prevalence of comorbid depression by
23% (8.0% to 9.8%; Table 3). The mean age decreased by 0.4 years
(69.2 to 68.8 years) over the study period. LOS decreased from an
average of 3.6 days in 2007 to 3.2 days in 2010 (Table 3). During the
same period, alcohol and drug abuse rates increased from 0.8% to
1.0% and from 0.4% to 0.6%, a slight but statistically significant
increase. The proportion of patients who had RA/inflammatory
arthritis in addition to osteoarthritis as the underlying diagnosis
did not change significantly over the study period, nor did
insurance types (Table 3).
Unadjusted and Adjusted Odds of Presence of Comorbid Depression
Over Time
In primary THA and TKA patients, the odds ratios of patients
with comorbid depression in each period were compared with the
first period as shown in Figure 1. In unadjusted analyses, compared
with 2007, the odds ratios of patients with comorbid depression
were 1.10, 1.20, and 1.22 in the respective next 3 time periods
(Fig. 1) in THA patients. After adjustment for age, LOS, and CCI in
multivariate models, we noted minimal amplification of the odds

Table 3
Time Trends in Demographics and Clinical Characteristics of Patients Undergoing Primary TKA (N ¼ 132,406).

Variables 2007 2008 2009 2010 P Value

(N ¼ 30,898) (N ¼ 32,245) (N ¼ 33,551) (N ¼ 35,712)

Age category, y <.001a

50-<59 21.1 20.5 21.2 21.3
60-<69 30.0 31.1 31.9 33.0
70-<79 31.3 30.1 29.6 29.2
80þ 17.6 18.3 17.3 16.4
Mean age (SD), y 69.2 (9.4) 68.8 (9.4) 68.7 (9.3) 68.8 (9.3) <.001a
Female gender 63.3 62.8 62.8 62.2 .0213
Insurance .115
Medicaid 2.7 2.6 2.8 2.6
Private 29.9 30.8 30.5 35.9
Others 67.4 66.5 66.7 67.0
Mean length of stay (SD), d 3.6 (1.7) 3.5 (1.6) 3.3 (1.5) 3.2 (1.5) <.001a
Depression 8.0 8.5 9.5 9.8 <.001a
Alcohol abuse 0.8 0.8 0.8 1.0 .0149
Drug abuse 0.4 0.4 0.5 0.6 <.001a
Deyo-Charlson Comorbidity Index
0 61.0 60.0 59.6 59.1 <.001a
1 27.5 27.4 26.9 26.6
2 7.5 7.8 8.5 8.8

3 4.0 4.8 5.1 5.4
RA/inflammatory arthritis 3.2 3.3 3.4 3.4 .352

Values are the percentage unless indicated otherwise. We used analysis of variance for continuous variables and chi-squared test for categorical variables.
TKA, total knee arthroplasty; SD, standard deviation; RA, rheumatoid arthritis.
a
Significant P values at a ¼ .005.
 C. Oh et al. / The Journal of Arthroplasty 33 (2018) 2376e2380
Fig. 1. Unadjusted and adjusted odds of depression over time. Reference year category
has an odds ratio of 1.0. *P < .05; **P  .01; ***P  .001. THA, total hip arthroplasty; TKA,
total knee arthroplasty; CI, confidence interval; CCI, Deyo-Charlson Comorbidity Index;
LOS, length of stay.
ratios. On the other hand, in primary TKA patients, the odds ratios
of patients with comorbid depression were 1.06, 1.20, and 1.24 in
the next 3 time periods, compared with 2007, which were
minimally attenuated but remained significant after adjustment for
age, LOS, and CCI in the multivariate models (Fig. 1).
Discussion
This study used a population-based inpatient database to
examine the time trends in important demographic and clinical
characteristics of patients undergoing THA and TKA from 2007 to
2010 in California, the most recent data available. We found an
increasing prevalence of younger ages, depression, patients with
alcohol and drug abuse, and higher CCI scores, with a simultaneous
reduction in mean LOS over time, for these patient populations.
Despite the importance of patient characteristics and
complexity in explaining healthcare resource use in this popula-
tion, few studies have attempted to describe temporal trends in
utilization and outcomes after primary THA and TKA, and each has
limitations [14e18]. Although previous studies provided initial
insight into the time trends in age and comorbidity burden, other
important characteristics of patients undergoing TKA have not been
examined. Most of these studies have been based on Medicare data
[19], non-US populations [20,21], or relatively small nationally
representative surveys [15], thus limiting the generalizability of
findings to narrow groups. As the incidence of depression has
increased over time in the general US population [22e24], a study
of the prevalence of depression in the total joint arthroplasty
population merits special attention in order to elucidate further the
potentially changing impact of depression on outcomes after TKA
and THA [25]. Time trends in key patient characteristics, including
patient psychiatric comorbidity [15,26e30], which have all been
linked to THA and TKA outcomes, have not been studied in detail,
and our study fills this gap.
The challenge of taking care of patients with increased incidence
of depression, alcohol and drug abuse, and overall comorbidity
burden, while concurrently decreasing LOS and taking re-
sponsibility for managing an entire episode of care is self-evident.
This means that more has to be done to minimize risk and reduce
complications in patients undergoing total joint arthroplasty and
that much of these efforts will need to be focused outside the acute
2379
care hospital stay, either before surgery in an attempt to optimize
the patient or after discharge in order to minimize complications
and hospital readmissions and achieve the best possible patient
outcomes. In addition, increased resources and care redesign
pathways designed to manage the entire episode of care need to
contain the elements needed to manage and care for patients with
these increased comorbidities. Depression is specifically of interest
because it is potentially treatable before an elective total joint
procedure. Furthermore, appropriate management of depression
throughout the episode may improve outcomes after total joint
arthroplasty.
While this retrospective study provides novel data regarding time
trends in the characteristics in a large primary TKA and THA
populations, this study has some limitations. Study limitations
include nonresponse bias and the use of diagnostic codes, which may
be associated with underdiagnosis of conditions. Because depression
was captured based on presence of a diagnostic code, and psycho-
logical comorbidities may be under-recognized and underdiagnosed,
it is likely that we missed some cases. This might have biased our
estimates toward null. Unfortunately, a retrospective study design did
not allow us to have confirmation of depression diagnosis by
examination by a psychologist or psychiatrist. Therefore, the direction
of impact of this bias on our study findings overall is unclear. In order
to validate diagnosis of depression, some gold standard such as a
chart review may be desirable, which unfortunately was not feasible
due to the limited resources available to us. In our future study, we
will endeavor to direct our focus to a more granular examination of
the specifics of ICD-9 coding and its potential flaws. A misclassifica-
tion bias due to the temporal change of diagnostic codes should also
be assessed in our future studies.
Finally, while the sample size was very large, the detection of
statistical differences needs to be interpreted with caution, as they
may not necessarily be clinically relevant for all measures.
However, unfortunately, clinical significance is not well defined or
understood, and many research consumers mistakenly relate
statistically significant outcomes with clinical relevance. That is
why the concept of minimum clinically important difference has
become more and more important over recent years in medical
researches and has been noticeably studied in orthopedics surgery
[31,32]. We believe that our findings will help to address how
suitable it is to advise depressed patients to undergo primary TKA
and THA in USA.
The strengths of this population-based dataset are that we
analyzed all-payer data of a large sample size with adequate
number of events to study the question of interest, used validated
measures to perform multivariable-adjusted analyses, examined
yearly change of patients' characteristics in primary THA and TKA
patients, and highlighted trends concerning the changing burden of
comorbid conditions on total joint arthroplasty patients.
Conclusion
Patients undergoing primary total joint arthroplasty are
younger, are presenting with a higher prevalence of depression,
drug or alcohol abuse, and have more medical comorbidities as
measured by the CCI index. Despite these findings, LOS was found
to decrease over the study period. Surgeons must be cognizant of
their patient populations and the burden of comorbid conditions
that could affect quality of care and utilization of healthcare re-
sources [25]. Further study is needed to determine the impact of
the overall increased prevalence of these comorbidities noted in the
total joint arthroplasty population and to develop care pathways
that enable their management throughout the entire care episode.
2380 C. Oh et al. / The Journal of Arthroplasty 33 (2018) 2376e2380

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 The Journal of Arthroplasty 33 (2018) 2546e2555

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Total Hip Arthroplasty for Periacetabular Metastatic Disease. An

Original Technique of Reconstruction According to the Harrington
Classification
Julien Wegrzyn, MD, PhD a, b, c, d, *, Matthieu Malatray, MD a, Turki Al-Qahtani, MD a,
Vincent Pibarot, MD a, Cyrille Confavreux, MD, PhD b, c, d, e, Gilles Freyer, MD, PhD d
a
Department of Orthopedic SurgerydPavillon T, Ho ^pital Edouard Herriot, Hospices Civils de Lyon, Lyon, France
b
INSERM UMR 1033, Universit e de Lyon, Lyon, France
c
Centre Expert des Metastases OsseusesdCEMOS, Hospices Civils de Lyon, Lyon, France
d
Lyon Cancer Institute, Hospices Civils de Lyon, Lyon, France
e
Department of Rheumatology, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France

a r t i c l e i n f o a b s t r a c t

Article history: Background: Periacetabular metastatic disease requires complex acetabular reconstruction. The
Received 22 January 2018 complication rate for these frail patients is high. Various cement-rebar reinforced techniques allowing
Received in revised form cemented total hip arthroplasty (THA) have been described. The optimal procedure has not yet been
17 February 2018
identified.
Accepted 27 February 2018
Available online 17 March 2018
Methods: A continuous series of 131 THAs performed in 126 patients with periacetabular metastatic
disease was prospectively included in this study. After bone metastasis curettage and cementation, an
original technique of acetabular reconstruction was performed using a dual mobility cup cemented into
Keywords:
total hip arthroplasty
an acetabular reinforcement device (ie, Kerboull cross-plate or Burch-Schneider antiprotrusio cage) ac-
bone metastasis cording to the Harrington classification. Functional outcome for independent ambulation in the com-
acetabular reconstruction munity, pain relief, and occurrence of dislocation or mechanical failure of the acetabular reconstruction
Kerboull cross-plate were assessed.
cemented dual mobility cup Results: At a mean follow-up of 33 ± 17 months, the improvement in the preoperative to postoperative
functional outcome and pain relief was significant (P < .001). The dislocation rate was 2%. Two of the 3
Level of evidence:
therapeutic study e level IV
cases of dislocation occurred in acetabular reconstructions associated with a proximal femoral arthro-
plasty. No mechanical failure or aseptic loosening of the acetabular reconstruction was observed.
Conclusion: This study emphasized that our original technique combining bone metastasis curettage and
cementation, acetabular reinforcement device and cemented dual mobility cup was effective to restore a
painless functional independence and ensure a durable acetabular reconstruction able to face to adjuvant
radiation therapy and mechanical solicitations for long survivors. In addition, dual mobility cup limited
the risk of dislocation in patients undergoing THA for periacetabular metastatic disease.
© 2018 Elsevier Inc. All rights reserved.

Metastases represent the most frequent malignancy of the
skeleton with the bone being the third leading site after the lungs
and the liver [1]. The pelvis and proximal femur represent
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.096.
* Reprint requests: Julien Wegrzyn, MD, PhD Department of Orthopedic
SurgerydPavillon T, Ho ^pital Edouard Herriot Hospices Civils de Lyon 5, place
d’Arsonval 69437, Lyon, France.
preferential locations accounting for almost 10% of all the bone
metastases [1]. The treatment of metastatic bone disease, except
exceptional cases, is not aimed at curing the patient, but rather
relieving symptoms, restoring functional independence, and
improving quality of life of patients with terminal disease and
limited lifespan [1e5]. Besides severe pain, periacetabular bone
metastasis results in major disability with loss of function and
limitation of daily living activities [3e8]. Advances in anticancer
treatments have improved the survival length of patients with
metastatic disease. As a result, the need of surgical treatments of
periacetabular metastasis will increase, urging surgeons to perform
stable acetabular reconstructions allowing for immediate weight-

https://doi.org/10.1016/j.arth.2018.02.096
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
bearing while lasting patients’ lifespan with minimal complications
[2,3,8]. By contrast, these aims place significant demands and
complexity on these procedures far beyond conventional primary
total hip arthroplasty (THA) because of extensive bone loss, irra-
diated bone and soft tissues, and immunocompromised status
[1e4,6,8]. Most surgical procedures are primarily aimed at recon-
structing the acetabulum by transmitting forces to the intact pelvic
bone with restoration of the iliofemoral weight-bearing axis [4,6].
However, the optimal technique of management for periacetabular
metastatic disease has not yet being defined. Historically, Har-
rington technique has proved to be an efficient procedure for
acetabular reconstruction [6]. Various technical modifications have
been proposed thereafter; all consisting in cement-rebar reinforced
hip reconstruction to allow cemented THA. However, these are
technically complex reconstructions performed in very frail pa-
tients with reported rates of dislocation up to 21%, deep infection
up to 11%, revision for aseptic loosening up to 7%, and intra-
operative death up to 6% [4,6,9e21].
Most of the previous series were retrospective and/or included a
limited number of patients over more than 10 years and/or re-
ported various techniques of acetabular reconstruction [4,9e21]. To
our knowledge, the present study reported the largest prospective
cohort of patients with periacetabular metastatic disease under-
going an original technique of acetabular reconstruction combining
bone metastasis curettage and cementation, and dual mobility cup
cemented into an acetabular reinforcement device (ie, Kerboull
cross-plate or Burch-Schneider antiprotrusio cage) according to the
Harrington classification. Therefore, this study aimed to demon-
strate that this technique (1) was effective for reconstructing per-
iacetabular metastatic bone defects with minimal complication
risks, (2) restored the ability to ambulate with immediate full
weight-bearing allowing these patients to be functionally inde-
pendent in the community, (3) achieved significant pain relief with
decreased consumption of narcotic analgesics, and (4) provided
durable reconstruction that was likely to face to adjuvant radiation
therapy and mechanical solicitations for long survivors. We hy-
pothesized that such a technique could ensure a durable acetabular
reconstruction while limiting the risk of dislocation in patients
undergoing THA for periacetabular metastatic disease.
Materials and Methods
From January 2010 to December 2016, a continuous series of 131
THAs performed in 126 patients (women ¼ 78, men ¼ 48, mean
age ¼ 64 ± 13 years, mean body mass index ¼ 24 ± 4 kg/m2, right
hip ¼ 64 patients, left hip ¼ 57 patients, bilateral ¼ 5 patients) with
periacetabular metastatic disease were prospectively included in
this study. Exclusions included the following: patients with a pro-
jected life expectancy <3 months and patients with pelvic or
proximal femoral metastasis without acetabular involvement. The
primary tumor was a carcinoma of the breast in 50 THAs (38%), lung
in 29 THAs (22%), kidney in 14 THAs (11%), prostate in 8 THAs (6%),
thyroid in 6 THAs (4%), digestive tract in 4 THAs (3%), throat in 2
THAs (2%), and a multiple myeloma in 18 THAs (14%). The patients’
preoperative performance status was 2 ± 0.6 according to the
Eastern Cooperative Oncology Group scale and 53 ± 13 according to
the Karnofsky index. Forty-one patients (33%) had concomitant
visceral metastases and 69 patients (55%) had multiple bone me-
tastases. Bone metastasis around the hip revealed the primary tu-
mor in 43 patients (34%) with a clinical presentation of metastatic
pathologic fracture of the proximal femur in 5 cases and the ace-
tabulum in 2 cases. The extent of the acetabular metastatic disease
was systematically evaluated preoperatively with pelvis and hip
anteroposterior radiographs, lateral radiograph of the hip, and
positron emission tomography/computed tomography scan of the
2547
whole pelvis and femur. In case of bone metastasis of the femur,
anteroposterior and lateral radiographs of the entire femur were
prescribed. Metastatic acetabular bone defect was graded accord-
ing to the Harrington classification [6]. Nineteen THAs (15%) were
performed for Harrington class I defect (ie, articular surface
disruption with intact acetabular dome, lateral cortices, and medial
wall), 63 THAs (48%) for Harrington class II defect (ie, bone defect
involving the acetabular medial wall and quadrilateral plate), and
49 THAs (37%) for Harrington class III defect (ie, severe defect
involving the dome, lateral cortices, and/or columns). Combined
acetabular and proximal femoral bone metastasis was diagnosed in
51 THAs (39%) involving the femoral head and neck in 25 cases
(19%), the intertrochanteric part of the femur in 15 cases (11%), and
the subtrochanteric part of the femur in 11 cases (8%). Preopera-
tively, 83 patients (66%) were treated with chemotherapy, immu-
notherapy, and/or hormonal therapy. Preoperative radiation
therapy was performed on the affected hip in 9 THAs (7%). Owing to
the French regulation, institutional review board's approval was
not required to be included in this study at the time of the inclusion.
However, informed consent was obtained from all patients
included in this study.
All the procedures were performed by a single senior surgeon
specialized in joint reconstruction and treatment of bone metas-
tasis. Before surgery, all the cases were discussed in a bone
metastasis multidisciplinary tumor board meeting (Centre Expert
des M etastases Osseuses de Lyon) on the behalf of our Cancer Insti-
tute to coordinate medical and surgical therapeutic sequences. The
indications for THA were severe pain and loss of function in 108
hips (82%), a major risk of proximal femoral fracture with Mirel
score 9 in 16 hips (12%), and a pathologic fracture in 7 hips (6%, 5
proximal femoral fractures and 2 acetabular fractures) [22]. To
reduce perioperative blood loss, a preoperative selective arterial
embolization was performed in all the cases of bone metastasis
related to kidney and thyroid carcinoma, and in 2 THAs implanted
for multiple myeloma with Harrington class III defect (22 THAs,
17%) [4,6]. In addition, systemic anticancer treatments were sys-
tematically discontinued before surgery according to their phar-
macokinetic elimination to reduce the risk of postoperative sepsis
and delayed wound healing. All the THAs were performed under
general anesthesia through a posterolateral approach, eventually
extended proximally to expose the supra-acetabular region and
posterior column and/or distally to expose the proximal third of the
femur. The acetabular reconstruction was performed using an
original technique following an algorithm based on the Harrington
classification. For Harrington class I defect, the acetabulum was
reconstructed using a Kerboull cross-plate and a cemented dual
mobility cup (Novae Stick/K; SERF, De cines, France). For Harrington
class II defect, the acetabulum was reconstructed using a Kerboull
cross-plate and a cemented dual mobility cup (Novae Stick/K) after
bone metastasis curettage and intraoperative cementation of the
underlying bone defect (Fig. 1A and B). For Harrington class III
defect, acetabular bone metastasis curettage was performed pre-
serving the structurally intact bone to maintain anatomical land-
marks and also to increase structural support for the
reconstruction. The underlying bone defects were cemented and
the acetabulum reconstructed using a Kerboull cross-plate and a
cemented dual mobility cup in 42 of the 49 Harrington class III
defects (Novae Stick/K; Fig. 2A-C). In the 7 of 49 Harrington class III
defects associated with pelvic discontinuity, the acetabular recon-
struction was performed using a Burch-Schneider antiprotrusio
cage (Burch-Schneider Reinforcement Cage; Zimmer Biomet,
Warsaw, IN) with multiple screw fixation and a cemented dual
mobility cup (Novae Stick) (Fig. 3A and B). To avoid cement extru-
sion into the pelvis or periarticular soft tissues, multiple layers of
resorbable hemostatic collagen dressings (Pangen; Urgo Medical,
2548 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555

Fig. 1. Anteroposterior radiographs of the pelvis illustrating acetabular reconstruction of a Harrington class II defect of the right hip related to breast carcinoma. (A) Preoperative
radiograph with white arrows showing the medial wall metastatic osteolysis and (B) postoperative radiograph 36 months after the acetabular reconstruction with dashed white
arrows showing metastasis cementation.

Cheno^ve, France) were packed at the bottom of the bone defects
when required. Polymethylmethacrylate bone cement with 0.5 g of
active gentamicin (PALACOS RþG; Heraeus Medical GmbH, Wehr-
heim, Germany) was used to cement bone defects and the dual
mobility cup into the acetabular reinforcement device. Dual
mobility cups were cemented at 20 of anteversion and 40 of
abduction with a particular attention to ensure a 2- to 3-mm
uniform thickness of the cement mantle [23,24]. On the femoral
side, the femoral reconstruction was performed using a proximal
femoral resection arthroplasty (Proximal Femoral GMRS; Stryker,
Mahwah, NJ) in cases associated with intertrochanteric or sub-
trochanteric femoral metastasis [5,25,26]. The abductor mecha-
nism continuity was preserved with cable wire fixation of a great
trochanter medallion onto the prosthetic metaphysis (Fig. 4A-C). All

Fig. 2. Radiographs illustrating acetabular reconstruction of a Harrington class III defect of the left hip related to prostate carcinoma. (A) Preoperative anteroposterior radiograph of
the pelvis illustrating metastatic bone condensation of the acetabular dome, medial wall, and posterior column, (B) preoperative computed tomography scan illustrating combi-
nation of bone osteolysis and condensation, and (C) postoperative anteroposterior radiograph of the pelvis 30 months after the acetabular reconstruction.
 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
Fig. 3. Anteroposterior and lateral radiographs of the hip illustrating acetabular reconstruction of a Harrington class III defect associated with pelvic discontinuity of the left hip
related to breast carcinoma. (A) Preoperative radiographs illustrating severe metastatic involvement of the whole posterior column, medial wall, and dome leading to pelvic
discontinuity and (B) postoperative radiographs 16 months after the acetabular reconstruction.
the other cases were managed with a conventional nonmodular
cemented femoral stem (Hype; SERF) [5,25]. Conventional low-
molecular-weight heparin antithrombotic prophylaxis was pre-
scribed for 45 days. Intraoperative antibiotic prophylaxis was pur-
sued during 2 days after surgery until drain removal. Postoperative
structured physical therapy was begun the day after surgery. Pa-
tients were then mobilized fully weight-bearing with the help of 2
crutches or a walker depending on their general condition. The
mean postoperative in-hospital length of stay was 6 ± 2 days.
Systemic anticancer treatments were restored after complete
wound healing 3-4 weeks after surgery. Antiresorptive treatment
with bisphosphonates or denosumab was administered to all the
patients postoperatively [27]. In addition, a postoperative adjuvant
radiation therapy extended to the whole surgical site (30 Gy given
in 10 treatment fractions over 2 weeks) was performed in all the
cases after complete wound healing, except for the 9 hips preop-
eratively irradiated [28,29].
Patients returned for postoperative follow-up visits at 3 weeks,
6 weeks, 3 months, 6 months, and every 6 months until death
thereafter. Patients underwent a physical examination by the
operating surgeon, and anteroposterior and lateral radiographs of
the pelvis and the hip were obtained. The postoperative visit at 3
weeks was dedicated to wound healing control to restore systemic
anticancer treatments and set up the postoperative adjuvant radi-
ation therapy. The radiographs at 6 weeks were considered as
baseline radiographs for follow-up comparison. Clinical evaluation
was performed using the Harris hip score (HHS). Patients were
evaluated with a particular attention to the comparisons of the
preoperative to postoperative functional independence for walking
and functioning during daily living activities in the community and
the preoperative to postoperative pain relief as determined by the
consumption of narcotic analgesics. Occurrence of a dislocation
event was systematically evaluated. Baseline and latest follow-up
radiographs were compared for radiological evaluation. Clinical
failure was defined as the inability to restore a painless functional
independence for ambulation in the community and as the occur-
rence of dislocation. Radiographic failure of the acetabular recon-
struction was defined as a loosening of the cemented dual mobility
cup and/or a mechanical failure of the reinforcement device with
migration, rupture, screw setback or breakage, and/or a fragmen-
tation of the bone metastasis cementation [24].
2549
Data are presented as mean ± standard deviation. Preoperative
to postoperative variable comparisons were performed using Stu-
dent t tests for continuous quantitative variables and chi-squared
tests for qualitative variables. Pearson coefficients of correlation
were used for the analysis of the relationship between 2 continuous
quantitative variables. Statistical analyses were performed using
IBM SPSS Statistics, version 22.0 (IBM Corp, Armonk, NY) with a
level of significance set at P < .05.
Results
The mean follow-up of the entire series was 33 ± 17 months
with 25 patients (20%) being alive at the time of this writing (mean
follow-up ¼ 19 ± 4 months). No patient was lost to follow-up. The
mean period of survival after THA was significantly lower in pa-
tients with visceral metastases compared with patients without
visceral metastases (18 ± 15 months vs 39 ± 21 months, respec-
tively, P < .001). The preoperative to postoperative HHS increased
significantly at the latest follow-up (37 ± 8 to 84 ± 7, respectively, P
< .001) without significant correlation detected between the
follow-up length and the improvement in HHS (r ¼ 0.2, P ¼ .7). In
addition, the preoperative to postoperative functional outcome for
walking and functioning during daily living activities improved
significantly after surgery with no patient functionally worst at the
latest follow-up (P < .001; Table 1). The pain relief as determined by
the preoperative to postoperative consumption of narcotic anal-
gesics comparison was significant after THA with no patient
experiencing worst pain at the latest follow-up (P < .001; Table 2).
Regarding the surgical procedure, one patient (0.8%) deceased
intraoperatively because of a bone cement implantation syndrome
during the cementation of a proximal femoral arthroplasty in a
context of breast carcinoma [30]. Two patients (2%) deceased
within the first postoperative monthdone 2 days after surgery
because of an uncontrolled malignant hypercalcemia in a context of
multiple myeloma, and one 9 days after surgery because of an
uncontrolled paraneoplastic hyponatremia in a context of lung
carcinoma. Among the postoperative complications, early acute
periprosthetic sepsis occurred in 4 THAs (3%) requiring debride-
ment, irrigation, mobile-bearing exchange, and systemic intrave-
nous antibiotic therapy during 6 weeks to 3 months depending on
the pathogen bacteria, patient’s general condition, and systemic
 2550 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
web 4C=FPO

Fig. 4. Radiographs illustrating a combined acetabular and proximal femoral metastatic disease of the right hip with pathological femoral fracture revealing lung carcinoma. (A)
Preoperative anteroposterior radiograph of the pelvis without obvious periacetabular metastatic osteolysis, (B) preoperative positron emission tomography/computed tomography
axial view of the right acetabulum which demonstrated Harrington class III defect with medial wall and posterior column involvement that highlighted the need of an exhaustive
preoperative radiographic work-up, and (C) postoperative anteroposterior and lateral radiographs of the pelvis 24 months after the acetabular reconstruction and proximal femoral
arthroplasty with preservation of the abductor mechanism continuity.

anticancer treatment requirements. Importantly, early acute peri-
prosthetic sepsis occurred in 3 of the 9 THAs (33%) implanted after
preoperative radiation therapy of the hip. In addition, the disloca-
tion rate was 2% (3 THAs). Two of the 3 cases of dislocation were
associated with a proximal femoral arthroplasty and characterized
by dislocation recurrence, although no version or abduction
malpositioning of the cemented dual mobility cup was diagnosed
after computed tomography scan evaluation. These cases were
managed by closed reduction under general anesthesia and hip
abduction bracing with full weight-bearing during 2 months
without recurrence until death. The third case of dislocation
occurred after a traumatic fall during stair descent and was

Table 1
Preoperative to Postoperative Comparison of the Functional Independence for Walking (n THA, %).

Preoperative Functional Postoperative Functional

Independence (131 hips) Independence (128 hips)

Not able to walk or use a walker only in their home 99 (76%) 2 (2%)
Walk with 2 crutches for a distance less than 30 min 20 (15%) 11 (8%)
Walk with 1 crutch or without for a distance more than 30 min 12 (9%) 115 (90%)

THA, total hip arthroplasty.

 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
Table 2
Preoperative to Postoperative Comparison of the Pain Level as Determined by the Consumption of Narcotic Analgesics (n THA, %).
Severe hip pain requiring continuous use of narcotic analgesics
Moderate hip pain requiring occasional use of narcotic analgesics
Mild hip pain requiring use of non-narcotic drugs
Light or no pain with occasional use of acetaminophen
THA, total hip arthroplasty.
managed by closed reduction without recurrence until death. No
postoperative deep hematoma requiring reoperation or sciatic
nerve palsy was reported. Deep venous thrombosis was reported in
5 THAs (4%) and was treated with curative antivitamin K treatment.
At the latest follow-up, there were no mechanical failures. None
of the cemented dual mobility cups loosened. There was no cement
fragmentation. However, a local progression of the metastatic dis-
ease was reported in 1 THA (0.8%; Fig. 5A and B). In this case, a
selective arterial embolization of acetabular and proximal femoral
bone metastasis of a kidney carcinoma had been performed pre-
operatively. A Harrington class III defect was reconstructed using a
Kerboull cross-plate and cemented dual mobility cup after metas-
tasis curettage and cementation of the acetabular dome and pos-
terior column. A cemented femoral proximal arthroplasty with
preservation of the abductor mechanism continuity had been per-
formed for intertrochanteric femoral bone metastasis. Despite
postoperative adjuvant radiation therapy and anticancer immu-
notherapy, a local progression occurred within 6 months after
surgery. However, this metastatic kidney carcinoma was known as
poorly sensitive to radiation therapy. The patient died 7 months
after THA because of a severe pulmonary lymphangitic carcino-
matosis without hip-related symptoms or failure of the acetabular
reconstruction.
Discussion
The most important finding of this prospective cohort study was
that acetabular reconstruction combining bone metastasis curet-
tage and cementation, and dual mobility cup cemented into a
Kerboull cross-plate or Burch-Schneider antiprotrusio cage ac-
cording to the Harrington classification provided a durable
construct for periacetabular metastatic disease. This is a relatively
straightforward, safe, and reproducible technique that lasted pa-
tients’ lifespan with no mechanical failure or loosening while
Fig. 5. Anteroposterior radiographs of the pelvis illustrating acetabular reconstruction of a Harrington class III defect associated with subtrochanteric metastasis of the right hip
related to kidney carcinoma. (A) Postoperative radiograph 3 months after the acetabular reconstruction with white arrows showing metastasis cementation and (B) postoperative
radiograph at 6 months with white arrows showing local progression of the metastatic disease without mechanical failure of the acetabular reconstruction.
2551
Preoperative Analgesics Postoperative Analgesics
Consumption (131 hips) Consumption (128 hips)
122 (93%) 4 (3%)
9 (7%) 18 (14%)
0 (0%) 81 (63%)
0 (0%) 25 (20%)
limiting the risk of dislocation (Table 3). The hospital stay was not
excessive. No patients required a revision procedure. In addition,
this original technique ensured a dramatic pain relief with a sig-
nificant decrease in narcotic analgesics consumption, and allowed
patients to functional independence in the community that was
immediate without correlation with the length of follow-up
(Tables 1 and 2).
Historically, Harrington proposed a reconstruction algorithm to
manage periacetabular metastatic disease based on an anatomic
classification according to the location of bone defects [6]. The
principle of the Harrington technique was to restore the iliofemoral
weight-bearing axis using a cement-rebar reinforced acetabular
reconstruction technique to allow cementing an all-polyethylene
cup in an anatomical position with transmission of weight-
bearing forces into the intact pelvic bone [4,6]. Various technical
modifications have been proposed including antegrade rebar
placement, retrograde rebar placement through the ischium,
exchanging Steinmann pins for custom threaded pins or screws,
using metal-back cups, or adding flanged protrusio acetabular shell
or antiprotrusio cages [9e21]. All these technical modifications
were developed in an attempt to decrease construct failure, implant
loosening, and dislocation, although none has successfully elimi-
nated both issues with rates of mechanical failure up to 29% in
modern literature (Table 3) [6,9e21]. As a result of the improve-
ment in cancer screening with earlier diagnosis and advances in
anticancer treatments, the average lifespan has consistently
increased for patients with metastatic disease [2,7,8]. Therefore,
orthopedic surgeons have to manage metastasis in patients who
may survive a long time. This may lead to complications related to
local disease progression or mechanical failure of the reconstruc-
tion [8]. Jacofsky et al [31] reported that one of the most concerning
complications of surgical procedures for metastatic disease was
acute early periprosthetic sepsis which occurred in nearly 10% of all
the patients and in 21% of the patients with prior radiation therapy.
Table 3
Comparison of Outcome and Rate of Mechanical Failures and Complications Between Different Reconstruction Techniques for Metastatic Acetabular Disease.
Study
Harrington. JBJS Am 1981 [6]
Kunisada et al. Acta Orthop
Scand 2000 [16]
Marco et al. JBJS Am 2000 [18]
Ghert et al. CORR 2007 [12]
Tillman et al. JBJS Br 2008 [20]
Philippeau et al. Orthop
Traumatol Surg
Res 2010 [19]
Clayer. CORR 2010 [11]
Ho et al. J Surg Oncol
2010 [13]
Hoell et al. Arch Orthop
Trauma Surg 2012 [14]
Bernthal et al. Ann Surg
Oncol 2015 [10]
Kiatisevi et al. World
J Surg Oncol 2015 [15]
Tsagozis et al. Acta
Orthop 2015 [21]
Lozano-Calderon et al.
J Arthroplasty 2016 [17]
Bagsby and Wurtz.
J Arthroplasty 2017 [9]
2552
Technique of Acetabular Reconstruction Number of THA Mean Rate of Mechanical Other Significant Complications Functional Outcome Use of Narcotic
Included Follow-Up, mo Failure Analgesics
Original Harrington procedures with 58 (retrospective) 19 5/56 (9%) 2 perioperative deaths 45/56 (80%) ambulated Significant
cemented all-PE cup (class I), Harris-Ho Loosening ¼ 5 1 complete iatrogenic femoral decrease
protrusio acetabular shell and cemented all- Dislocation ¼ not nerve palsy (Steinmann pin)
PE cup (class II), and cement-rebar mentioned
reinforced hip reconstruction associated
with Harris-Ho protrusio acetabular shell
and cemented all-PE cup (class III)
Modified Harrington procedures with 40 (retrospective) 8 1/40 (3%) 1 intraoperative death 38/40 (95%) ambulated Significant
cemented all-PE cup (class I), Kerboull Loosening ¼ 0 decrease
cross-plate and cemented all-PE cup (class Dislocation ¼ 1
II), and cement-rebar reinforced hip
reconstruction associated with Kerboull
cross-plate and cemented all-PE cup (class
III)
J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
Modified Harrington procedures with 55 (retrospective) 9 6/55 (11%) 1 perioperative death 19/33 (58%) ambulated Significant
cemented all-PE cup (various techniques) Loosening ¼ 5 3 wound infections decrease
Dislocation ¼ 1 1 disseminated intravascular
coagulopathy
Various techniques of reconstruction with 63 (prospective) 20 3/61 (5%) 2 perioperative deaths 52/53 (98%) ambulated Not evaluated
cemented all-PE cup, antiprotrusio cage and Loosening ¼ 1
modified Harrington technique Dislocation ¼ 2
Modified Harrington procedures with 19 (retrospective) 25 2/19 (11%) None 19/19 (100%) ambulated Not evaluated
cemented all-PE cup Loosening ¼ 2
Dislocation ¼ 0
Dual mobility cup (various techniques of 38 (retrospective, 15 3/38 (8%) 3 acute early periprosthetic sepsis 37/38 (97%) ambulated Significant
reconstruction) multicentric) Loosening ¼ 1 decrease
Dislocation ¼ 2
Burch-Schneider-like antiprotrusio cage 29 (prospective) 12 6/29 (21%) 3 acute early periprosthetic sepsis 27/29 (93%) ambulated Not evaluated
and cemented all-PE cup Loosening ¼ 1
Dislocation ¼ 5
Modified Harrington procedures with 37 (retrospective) 24 6/35 (17%) 6 acute early periprosthetic sepsis 25/35 (71%) ambulated Significant
cemented all-PE cup Loosening ¼ 0 2 perioperative death decrease
Dislocation ¼ 6 4 revisions for instability
3 reoperations because of prominent
hardware over the iliac crest
Burch-Schneider antiprotrusio cage and 15 (retrospective) 14 3/15 (20%) 1 acute early periprosthetic sepsis Not evaluated Not evaluated
cemented all-PE cup Loosening ¼ 2
Dislocation ¼ 1
Cement-screw-rebar all-PE cup technique 52 (retrospective) 18 5/52 (10%) 1 intraoperative death 48/50 (96%) ambulated Not evaluated
Loosening ¼ 4 1 hematoma with sciatic
Dislocation ¼ 1 nerve palsy
Burch-Schneider antiprotrusio cage and 22 (retrospective) 11 1/22 (5%) 1 superficial infection required 20/22 (91%) ambulated Not evaluated
cemented all-PE cup Loosening ¼ 0 reoperation for debridement
Dislocation ¼ 1 1 sciatic nerve palsy
Müller protrusio cage and cemented all-PE 70 (retrospective) 12 20/70 (29%) 7 acute early periprosthetic sepsis 67/70 (96%) ambulated Significant
cup Loosening ¼ 7 decrease
Dislocation ¼ 13
Modified Harrington procedures with 11 (retrospective) 18 0% 1 reoperation because of prominent 8/9 (88%) ambulated Not evaluated
cemented metal-backed cup hardware over the ischial tuberosity
1 acute early prosthetic sepsis
leading to construct removal
Modified Harrington procedure with 68 (retrospective) 10 0% 2 reoperations because of prominent Not evaluated Not evaluated
cemented constrained acetabular hardware over the iliac crest
component 1 pathologic periprosthetic femoral
fracture
 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555 2553

In the present study, the rate of acute early periprosthetic sepsis

was comparable with literature (Table 3) [11,13,19,21]. However,
Significant

septic complications were reported to occur preferentially in pa-

decrease

tients undergoing radiation therapy before surgery leading to

reoperation for debridement, irrigation, and mobile-bearing ex-
change in one-third of these patients. Therefore, according to
literature, we advocate early surgical intervention which was
demonstrated to be more beneficial than conservative treatment
with radiation therapy first [1,6,31,32]. By contrast, postoperative
126/128 (98%)

radiation therapy is required to achieve local control of the meta-

ambulated

static disease and avoid any subsequent failure of the reconstruc-

tion because of metastatic osteolysis progression [28,29]. Indeed,
the unique case of local progression in this study was reported in a
context of radio-resistant kidney carcinoma (Fig. 5A and B). How-
ever, the radio-induced changes in bone have been reported to lead
4 acute early periprosthetic sepsis

to implant fixation failure with rates of aseptic loosening of con-

2 perioperative deaths (medical
1 superficial infection required
reoperation for debridement

ventional cemented and cementless acetabular components

ranging from 44%-52% 2-6 years after THA [33]. Particularly, me-
1 intraoperative death

chanical failure of cementless implants was related to the difficulty

1 wound dehiscence

in achieving primary stability in a bone with insufficient trabecular

complications)

support and a decreased ability for in-growth and remodeling

leading to a biologic fixation interface unable to withstand stress
over time [33e37]. Moreover, radiation-induced changes in bone
quantity, quality, and strength occur both locally and systemically
even after limited field of irradiation with effects of irradiation
increasing with time [32e37]. In other words, bone that appears
Dislocation ¼ 3

adequate at the time of THA may become incompetent after a few

Loosening ¼ 0

years [32,33]. As a result, we advocate reconstructing the acetab-

3/128 (2%)

ulum with the use of a Kerboull cross-plate which does not rely on
bone in-growth for stability and reduces the mechanical forces
applied onto the periacetabular bone with a fixation over a large
surface area of intact pelvic bone given elasticity to the recon-
struction [24,33,38]. In addition, loss of anatomic landmarks related
to metastatic disease makes it difficult to position and secure a
conventional acetabular component. Previously, we demonstrated
33

that Kerboull cross-plate was effective to accurately restore an

anatomical size and location of the acetabulum as well as an
131 (prospective)

anatomical center of rotation of the hip and gluteus medius lever

arm in revision THA associated with major acetabular bone defects
[24]. Placing the inferior hook at the inferior margin of the ace-
tabulum and 4 long 4.5 mm screws passing through the plate and
angled at 45 toward the sacroiliac joint allow force transmission to
the supra-acetabular and infra-acetabular regions, thus restoring
reconstruction combining bone metastasis

the iliofemoral weight-bearing axis with stress discharge at the

mobility cup cemented into a Kerboull
curettage and cementation, and dual

cement-cup interface and acetabular medial wall, dome, and col-

antiprotrusio cage according to the

umns [24,33,38]. In addition, the property of load dispersion

Original technique of acetabular

cross-plate or Burch-Schneider

interface provided by the Kerboull cross-plate ensured viable

cementation of metal-backed shells such as dual mobility cup
Harrington classification

without the potential concerns of early failure as reported with

their direct cementation onto the bony acetabulum [24,38e42].
However, similarly to our experience in revision THA, we strongly
recommend the use of a Burch-Schneider antiprotrusio cage in case
PE, polyethylene; THA, total hip arthroplasty.

of Harrington class III defect associated with pelvic discontinuity or

complete resorption of the acetabular tear drop to avoid mechan-
ical failure with rupture or migration of the Kerboull cross-plate
because of the inability to achieve an optimal tensioning of the
Wegrzyn et al. Current study

Kerboull cross-plate [11,14,15,24]. However, using a Burch-

Schneider antiprotrusio cage requires wider exposure of the
ischium and adds risk of sciatic and obturator nerve injury to place
the inferior flange, although such complication was not observed in
the current series.
Along with ensuring a durable acetabular reconstruction, pre-
venting instability represents an imperative in these frail patients
regarding the potential morbidity related to dislocation. Dislocation
represents a major complication attributable to extended surgical
2554 J. Wegrzyn et al. / The Journal of Arthroplasty 33 (2018) 2546e2555
exposure, large bone defect with suboptimal positioning of the
acetabular component, and altered muscle function caused by the
metastasis itself, sarcopenia, surgical resection, and radiation
therapy [9,11,13,19,21]. Dual mobility cups have demonstrated
effectiveness to prevent instability in revision THA with a rate of
dislocation of 1.5% reported in the largest prospective cohort to date
[39]. In the present study, the dislocation rate was limited to 2%
with 2 of the 3 cases of dislocation associated with a proximal
femoral arthroplasty. With a dislocation rate ranging from 2%-20%
in THA associated with a proximal femoral arthroplasty, the pres-
ervation of the abductor mechanism continuity with cable wire
fixation of a great trochanteric medallion onto the prosthetic
metaphysis is emphasized to achieve stability even with the use of a
dual mobility cup [5,15,21,25,39]. To our knowledge, only the
retrospective series of Philippeau et al [19] reported the use of dual
mobility for metastatic disease with a rate of dislocation of 5% that
compared favorably with modern literature (Table 3). Conversely,
Tsagozis et al [21] reported no improvement in dislocation pre-
vention with the use of large femoral head (32 mm diameter)
rather than small femoral head (28 mm diameter) in these spe-
cific patients. Recently, Bagsby and Wurtz [9] proposed the use of
cemented constrained acetabular components. However, high rates
of mechanical failure were reported with constrained acetabular
components related to failure of the locking ring or early loosening,
and their use was consensually restricted to selected cases of
salvage procedure [39,43,44]. Despite encouraging, the results re-
ported by Bagsby and Wurtz [9] could be likely related to an early
mortality rate and concern could be raised regarding the increased
stress applied onto the implant-cement interface with high risk of
debonding particularly for long survivors [43].
This study presented with some limitations. First, we evaluated
a single reconstruction technique without control group such as a
modified Harrington technique. Second, all the patients were
operated in a referral center for bone metastasis management and
revision THA. However, this technique was derived from proced-
ures routinely used in revision THA associated with major acetab-
ular bone defects for which we previously published midterm to
long-term results [24,39]. As bone grafts are not allowed in meta-
static disease, the technical modification was to cement metastatic
bone defects. Third, this technique required a careful preoperative
and intraoperative assessment of the remaining bone stock to
appropriately select the type of acetabular reinforcement device.
Particularly, Kerboull cross-plate could not be used in all the re-
constructions, particularly when its tensioning is not possible
because of pelvic discontinuity or a complete resorption of the
acetabular tear drop. Consequently, a Burch-Schneider anti-
protrusio cage should be considered in those cases. Fourth, the
patients were selected for surgery with a limited metastatic disease
and projected lifespan 3 months to obtain the longest period of
survival after reconstruction and avoid risk, expense, and incon-
venience of operative treatment that was perhaps unnecessary.
Conclusion
Our original technique based on a Harrington classification al-
gorithm and combining bone metastasis curettage and cementa-
tion, and dual mobility cup cemented into a Kerboull cross-plate or
Burch-Schneider antiprotrusio cage effectively restored painless
functional independence. The reconstruction was durable. Patients
were able to receive adjuvant radiation therapy. There were no
mechanical failures. In addition, dual mobility cup limited the risk
of dislocation in these patients undergoing THA for periacetabular
metastatic disease. The need of acetabular reconstruction for
metastatic disease will probably increase as anticancer cares
improve with patients living long enough to benefit from THA,
urging surgeons to determine stable reconstruction with the
knowledge that even modest reduction in complications during the
limited lifespan of these patients will have significant positive ef-
fects on their quality of life.
Acknowledgments
This study was internally funded by the research laboratory
INSERM UMR1033, Universite  de Lyon, Lyon, France and the
Department of Orthopedic SurgerydPavillon T, Ho ^ pital Edouard
Herriot, Hospices Civils de Lyon, Lyon, France.
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 The Journal of Arthroplasty 33 (2018) 2392e2397

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Health Policy & Economics

Treatment Success Following Joint Arthroplasty: Defining

Thresholds for the Oxford Hip and Knee Scores
David F. Hamilton, PhD a, *, Fanny L. Loth, MSc b, Deborah J. MacDonald, BA a,
Karlmeinrad Giesinger, MD c, James T. Patton, MD a,
A. Hamish Simpson, DPhil, FRCS(Eng and Ed) a, Colin R. Howie, FRCS(Ed) a,
Johannes M. Giesinger, PhD d
a
Department of Orthopaedics and Trauma, University of Edinburgh, Edinburgh, United Kingdom
b
University of Innsbruck, Faculty of Psychology and Sport Science, Innsbruck, Austria
c
Department of Orthopaedics, Kantonsspital St. Gallen, St. Gallen, Switzerland
d
Innsbruck Institute of Patient-centered Outcome Research (IIPCOR), Innsbruck, Austria

a r t i c l e i n f o a b s t r a c t

Article history: Background: Patient-reported outcome scores are the mainstay method for quantifying success following
Received 19 February 2018 arthroplasty. However, it is unclear when a “successful outcome” is achieved. We calculated threshold
Received in revised form values for the Oxford Hip and Knee Score (OHS and OKS) representing achievement of a successful
21 March 2018
treatment at 12-month follow-up.
Accepted 22 March 2018
Available online 30 March 2018
Methods: Questionnaires were administered to patients undergoing total hip (THA) or knee (TKA)
arthroplasty before and 12 months after surgery alongside questions assessing key aspects of treatment
success. A composite success criterion was used to perform receiver operator characteristic analysis.
Keywords:
arthroplasty
Thresholds providing maximum sensitivity and specificity were determined for the total sample and
methodology subgroups defined by presurgery scores.
Oxford Hip Score Results: Data were available for 3203 THA and 2742 TKA patients. Applying the composite treatment
Oxford Knee Score success criterion, 67.3% of the TKA and 77.6% of the THA sample reported treatment success. Accuracy for
treatment success predicting treatment success was high for the OHS and OKS (both areas under the curve, 0.87). For the
thresholds OHS, a threshold value of 37.5 points showed highest sensitivity and specificity in the total sample, while
for the OKS the optimal threshold was 32.5 points. Depending on presurgery scores, optimal thresholds
varied between 32.5 and 38.5 for the OHS and 28.5 and 36.5 for the OKS.
Conclusion: This is the first study to apply a composite “success” anchor to the OHS and OKS to evaluate
outcome following total joint arthroplasty. Notably fewer patients report a “successful outcome” using a
composite outcome threshold than report being “satisfied.”
© 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Total joint arthroplasty is the only effective treatment to address
end-stage osteoarthritis of the hip or knee. Around 100,000 hip and
knee arthroplasties are carried out in the United Kingdom each year
[1], while in the United States the number is >700,000 [2]. Patient-
reported outcome (PRO) scores are the mainstay method for
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.062.
* Reprint requests: David F. Hamilton, PhD, Department of Orthopaedics and
Trauma, University of Edinburgh, Chancellors Building, 49 Little France Crescent,
Edinburgh EH16 4SB, United Kingdom.
quantifying treatment success, evaluating factors such as pain,
stiffness, function, satisfaction, and quality of life. Use of these
metrics evaluates the success of the intervention from the patient's
perspective.
Although there are various merits to evaluating outcomes with
patient-reported scores, PRO measures can be challenging to inter-
pret as they present results as score points on a range (eg, from 0 to
100 [3] or 0 to 48 [4]). These values are difficult to put into context
without additional information. It is possible to use reference pop-
ulations to convert these score points to standardized metrics (such
as T-scores [5]) to facilitate interpretation, but while distribution-
based score methods allow comparison of an individual patient or
group against the reference population, this methodology does not
directly evaluate the success of the intervention. Evaluation of

https://doi.org/10.1016/j.arth.2018.03.062
0883-5403/© 2018 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
 D.F. Hamilton et al. / The Journal of Arthroplasty 33 (2018) 2392e2397
outcome success using PRO scores requires well-defined thresholds
for treatment success that indicates at which point on the score
range the result is associated with a successful outcome. Anchor-
based approaches relate patient-reported scores to external criteria
that denote treatment success and allow identification of thresholds
(essentially cutoff values) for PRO measures that reflect these
external criteria. Clearly, in an anchor-based approach, the definition
and relevance of the external criterion is crucial.
Previous studies have used patient-reported satisfaction as an
anchor to determine acceptable thresholds [6,7]. In recent years,
satisfaction has gained interest as a single overarching metric to
measure surgical outcome [8e11]; however, it is well established
that patient satisfaction is influenced by factors not directly related
to the surgical intervention, such as the experience of the hospital
stay or socioeconomic status [12e16]; an apparently good clinical
outcome does not necessarily predict a satisfied patient [17e21]. As
such satisfaction may be an important but insufficient individual
criterion to represent treatment success. Composite criteria incor-
porating multiple facets of outcome (such as pain resolution,
functional ability, and satisfaction) may better represent successful
outcomes. This composite criteria have previously been applied to
the Western Ontario and McMaster Universities osteoarthritis in-
dex, the EuroQol- 5 dimensions, and the American Knee Society
Score to explore thresholds for treatment success [22]; however,
anchors and thresholds for the well-used Oxford Hip and Knee
Score (OHS and OKS) have not been described.
The aim of this study was to develop thresholds that indicate
postoperative treatment success 12 months after total joint
arthroplasty for the OHS and OKS using a composite anchor to
better reflect patient pain and functional status.
Materials and Methods
Study Design and Setting
We evaluated data from a regional joint arthroplasty registry.
Before surgery, patients provided demographic indicators and
completed the OHS or OKS. One year after surgery, patients
answered individual questions on treatment outcomes (detailed
below) and completed another OHS or OKS.
The OHS and OKS are widely used measures for the assessment
of pain and functioning in patients undergoing lower limb arthro-
plasty [4]. The 12 questions of each joint-specific score can be
answered on a 5-point response scale. The Oxford total scores range
from 0 to 48, while higher scores indicate better ability.
Participants
We assessed prospectively collected data for patients undergoing
lower limb joint arthroplasty at a single National Health Service
teaching hospital during a 5-year period (January 2007-December
2011). The study center is the only hospital receiving adult referrals
for a predominantly urban regional population of around 850,000.
Data had been collected through informed consent for inclusion in a
departmental database, for which regional ethical approval had been
obtained (11/AL/0079).
Definition of Treatment Success
To define thresholds for treatment success measured with the
OKS and OHS, we matched a previously reported composite model
[22] applying the following combination of anchor items as
external criterion:
(1) How satisfied are you with your operated knee/hip?
2393
(2) How well did the surgery relieve pain in your affected joint?
(3) How well did the surgery increase your ability to perform
regular activities?
(4) Would you have this operation again if it was required on
another joint?
The satisfaction question could be answered on a 4-point rating
scale from “very satisfied” to “dissatisfied,” while the questions on
pain relief and increase in functional ability could be answered on
5-point rating scales from “excellent” to “poor,” plus an additional
response option of “I don't know.” The question on undergoing the
procedure again could be answered on a 5-point rating scale from
“definitively yes” to “certainly not,” plus an additional response
option of “I don't know.”
We dichotomized the Likert scale responses to positive or
negative statements (equivocal answers were considered negative).
We considered the outcome to be successful if all 4 criteria were
fulfilled. This strict classification system allowed the creation of the
composite external criterion “treatment success.”
Data from a further 2 patient questions on recommendation and
expectations were available and used as sensitivity analysis;
“Would you recommend this operation to someone else?” and
“Have your expectations been met?” These additional questions
employed the same 6-point scale response from “definitely yes” to
“Certainly not.”
Statistical Analysis
Sample characteristics are given as frequencies, ranges, means,
and standard deviations. Spearman correlation coefficients were
calculated to describe associations between the individual anchor
items. To determine thresholds as predictors for treatment suc-
cess, we performed a receiver operator characteristic analysis,
using the aggregated variable “treatment success” as external
criterion and the OHS and OKS at 12 months as well as score
change since presurgery as predictors. We considered OHS and
OKS values with a Youden’s index (J) indicating the highest
sensitivity and specificity as optimal cutoff value for the 1-year
follow-up assessment and the change scores. We used the area
under the curve (AUC) to determine the diagnostic accuracy of the
OHS and the OKS. While an AUC value of 1.00 signifies perfectly
accurate prediction of the outcome measure, a value between 0.70
and 0.80 is acceptable and values above 0.80 indicate excellent
prediction [23]. For purposes of comparison, analysis was also
performed separately for 3 subgroups defined by baseline OKS or
OHS of each patient sample, differing in Oxford scores before
surgery. We divided each sample into 3 groups (lowest, medium,
highest tercile) using the 33rd percentile and the 67th percentile
of the baseline score. In addition, we conducted a sensitivity
analysis that included further possible external criteria to inves-
tigate the impact of definition of the composite criterion on the
determination of thresholds. Statistical analysis was performed
using IBM SPSS 24.0.
Results
Patient Characteristics
Preoperative and postoperative data were available for 3203
patients following total hip arthroplasty (THA) and 2742 total knee
arthroplasty (TKA) patients, representing 86% of all lower limb
arthroplasty procedures performed at the study center over this
timeframe. Mean age of the THA sample was 68.0 (±11.3) years,
and 58.4% were female. Mean OHS before surgery was 19.2
(standard deviation [SD] ¼ 8.5) and 38.6 (SD ¼ 9.4) 1 year after
2394 D.F. Hamilton et al. / The Journal of Arthroplasty 33 (2018) 2392e2397

Table 1 Thresholds for the OKS and OHS

Sample Characteristics and Treatment Success Criteria at Presurgery and at
12-Month Follow-Up.
In receiver operator characteristic analysis, we found the post-
Variable TKA (N ¼ 2742) THA (N ¼ 3203) operative OKS to predict the dichotomous treatment success cri-
Age terion (successful/not successful) in TKA patients with an AUC of
Mean (SD) 70.2 (9.4) 68.0 (11.3) 0.87 (Fig. 1). The cutoff “treatment success” threshold varied with
Range 17.6-92.4 13.3-93.9 preoperative OKS tercile (Table 2), with values in the 3 subgroups
Sex
ranging from 0.85 (highest tercile at baseline) to 0.88 (lowest tercile
Women, N (%) 1578 (57.5) 1870 (58.4)
Men, N (%) 1164 (42.5) 1333 (41.6) at baseline).
Treatment success criteria For the OKS change score (difference between presurgery and
Satisfaction 83.8% 90.1% 12-month follow-up), the AUC was 0.81 in the total sample, with
Pain relief 87.0% 92.3%
values ranging from 0.81 (highest tercile at baseline) to 0.88 (lowest
Increased ability 74.7% 82.8%
Surgery again 80.5% 88.8%
tercile at baseline).
Total anchor 67.3% 77.6% In THA patients, accuracy of the prediction was 0.87 (Fig. 1), with
Lowest tercilea 54.9% 69.0% values between 0.85 (lowest tercile) and 0.88 (medium tercile) for
Medium tercilea 66.7% 78.0% the subgroups defined by baseline score (Table 3). The OHS change
Highest tercilea 77.8% 84.0%
score had an AUC of 0.78 in the total sample, with values in the
Oxford score presurgery: mean (SD) 19.0 (7.5) 19.2 (8.5)
Oxford score 12 months postsurgery: 34.5 (10.0) 38.6 (9.4) respective terciles ranging from 0.82 (highest tercile at baseline) to
mean (SD) 0.87 (medium tercile at baseline).
Recommendation to someone else 86.6% 93.7% For the TKA sample, a cutoff value of 32.5 showed the highest
Expectations fulfilled 78.3% 85.6% sensitivity and specificity. According to the preoperative OKS, the
TKA, total knee arthroplasty; THA, total hip arthroplasty; SD, standard deviation. cutoff value for the lowest tercile was 28.5. Patients in the medium
a
Grouping according to OKS/OHS baseline scores. tercile showed highest sensitivity and specificity at 33.5 points,
while an optimal cutoff for the highest tercile was 36.5 (Table 2 and
surgery. In the TKA sample, mean age was 70.2 (±9.4) years, and
Fig. 2). For the OKS change score, optimal cutoff was a change
57.5% were female. Preoperative OKS was 19.0 (SD ¼ 7.5) and 34.5
of þ17.5 points for the lowest baseline tercile, þ13.5 points for the
(SD ¼ 10.0) at 1-year follow-up. Based on the baseline scores, we
medium tercile, and þ9.5 points for the highest tercile.
categorized patients into 3 terciles as follows: OKS lowest tercile
In the THA sample, optimal cutoff in terms of Youden's J was
(0-14.9), OKS medium tercile (15-21.9), and OKS highest tercile
37.5. Cutoffs for the subgroups were 32.5 for the lowest tercile, 37.5
(22-48); OHS lowest tercile (0-13.9), OHS medium tercile (14-
for the medium tercile, and 38.5 for patients in the highest tercile at
22.9), and OHS highest tercile (23-48). For further details, see
baseline (Table 3 and Fig. 3). For the OHS change score, the optimal
Table 1.
cutoff was an improvement of þ23.5 points in the lowest
tercile, þ15.5 points in the medium tercile, and þ12.5 points in the
Treatment Success After TKA highest tercile.

In the TKA sample, 83.8% of patients reported to be satisfied or Sensitivity Analysis

very satisfied 1 year after their joint arthroplasty (Table 1). And
87.0% reported good to excellent relief from pain and 74.7% good to
excellent increased functional ability. Being asked to undergo the
same procedure again, 80.5% were willing to do so. The combined
(4-part) external criterion “treatment success” was met by 67.3% of
the TKA patients (Table 1). Correlations between the 4 treatment
success criteria were ranging from 0.55 (increased ability with
surgery again) to 0.74 (pain relief with increased ability). Treatment
success at 12 months was achieved in 54.9% of the patients with a
preoperative OKS in the first tercile. And 66.7% of the patients in the
medium tercile met the external criterion for treatment success.
Finally, 77.8% of the patients in the highest tercile of baseline scores
achieved our classification of treatment success.
Treatment Success After THA
Most of the patients (90.1%) reported to be satisfied with their
hip arthroplasty, being relieved from pain (92.3%), and to have
more functional ability (82.8%). Also, 88.8% were willing to undergo
the same operation again, if needed (Table 1). In the THA sample,
the external criterion “treatment success” was met by 77.6%
(Table 1). Correlations between the 4 treatment success criteria
were ranging from 0.49 (pain relief with surgery again) to 0.70
(pain relief with increased ability). And 69.0% of patients with a
preoperative OHS in the lowest tercile reported treatment success 1
year after surgery. In the medium tercile, 78.0% of the patients met
the combined criterion, while 84.0% of the patients in the highest
tercile of baseline scores reported treatment success.
To analyze the impact of the anchor composition on obtained
cutoff scores, we conducted a sensitivity analysis varying the
included items. We included 2 further analyses adding either the
question “Would you recommend this operation to someone else?”
to the composite criterion from the main analysis or the question
“Have your expectations been met?” Both questions could be
answered on a 6-point rating scale ranging from “definitely yes” to
“certainly not” and were dichotomized for the analysis the same
way as the other anchor items. In the TKA group, adding the
question on fulfilled expectations resulted in the same AUC of 0.87
(95% confidence interval [CI], 0.86-0.89), while the optimal cutoff
increased from 32.5 to 33.5. In the THA group, adding this question
altered neither the AUC (0.87; 95% CI, 0.86-0.89) nor the optimal
cutoff of 37.5 points. Adding the question on recommendation
instead resulted again in an increase in the optimal cutoff point to
33.5 points in TKA patients, but did not change the AUC (0.87; 95%
CI, 0.85-0.88). In THA patients, the results remained unchanged
(optimal cutoff, 37.5 points; AUC ¼ 0.87; 95% CI, 0.85-0.88). The
question on recommending the procedure correlated with at least
0.48 (correlation with increased ability in THA patients) with all
other anchor questions. Fulfilled expectations correlated at least
with 0.54 (correlations with undergoing surgery again in THA
patients).
Discussion
This study provides threshold values for identifying whether
patients achieved “treatment success” following THA and TKA
 D.F. Hamilton et al. / The Journal of Arthroplasty 33 (2018) 2392e2397 2395

Fig. 1. ROC curves for the Oxford Knee Score (left) and Oxford Hip Score (right) predicting treatment success. ROC, receiver operator characteristic.

using the OHS and OKS; achieving 32.5 points on the OKS and 37.5
points on the OHS reflected a successful outcome.
Typically studies report that 90% of THA and 80% of TKA patients
are satisfied with the outcome of surgery [13,24,25]. We required
satisfaction, pain relief, functional improvement, and willingness to
undergo the procedure again to be affirmed to constitute success.
Applying this composite anchor resulted in approximately three-
quarters (77.6%) of hip arthroplasty patients and two-thirds
(67.3%) of knee arthroplasty patients reporting a successful
outcome. It is currently difficult to assess the impact of new in-
terventions and implant technologies in joint arthroplasty as, using
current questionnaire assessment methodologies, most patients
report high levels of outcome. As such, there is interest in deriving
scoring systems without marked ceiling effects to better differen-
tiate highly performing patients [26e28]. That this composite an-
chor approach “lowers” the proportion of patients reporting
successful outcomes following joint arthroplasty may be beneficial
as it allows for a greater “high” outcome range using existing scores.
Previous studies have proposed thresholds for the OHS and OKS
by applying a single satisfaction criterion; these demonstrate
notable variation in the cutoff values derived. Judge et al [7] sug-
gested that the threshold for high satisfaction 6 months following
surgery was 30 points for the OKS and 35 points for the OHS,
whereas Keurentjes et al [29] reported thresholds of 37 points for
the OKS and 42 points for the OHS at 3 years. This discrepancy in
threshold value may be reflective of the single anchor approach,
which is susceptible to variation in response, and the studies uti-
lized different follow-up time points.
Irrespective of the criteria employed to denote “treatment suc-
cess,” it may be misleading to apply the same score threshold value
to all patients. We used the well-defined methodology of grouping
patients by preoperative score tercile to evaluate variation in
threshold value by patient case-mix factors [30]. In both hip and
knee arthroplasty patients, the postoperative Oxford score required
to meet the success criteria varied with preoperative tercile. A
lesser absolute postoperative Oxford score was required to achieve
the patient's report of “treatment success” in those with low pre-
operative Oxford scores.
Interestingly, the opposite pattern was observed when
comparing thresholds for change in scores (between preoperation
and postoperation) across the patient terciles. In patients with low
baseline scores, more change was needed to qualify for treatment
success than in patients with high baseline scores. The variation in
threshold values derived for “change scores” was substantially
larger than the variation in threshold values for absolute scores.
This suggests that patients may rely on their current status as
opposed to perceived improvement when reporting satisfaction
postoperatively. This may reflect recall bias of their presenting
symptom state. As such, postoperative absolute scores accounting
for preoperative status may be more suitable for assessing treat-
ment success than change scores.

Table 2 Table 3
Accuracy of Predicting Treatment Success With the Oxford Knee Score. Accuracy of Predicting Treatment Success With the Oxford Hip Score.

AUC 95% Confidence Cutoff Sensitivity Specificity AUC 95% Confidence Cutoff Sensitivity Specificity
Interval Interval
Oxford Knee Score: Oxford Hip Score:
absolute score absolute score
at 12 mo at 12 mo
Total sample 0.87 0.85-0.89 32.5 0.84 0.76 Total sample 0.87 0.85-0.89 37.5 0.80 0.81
Lowest tercilea 0.88 0.86-0.90 28.5 0.81 0.81 Lowest tercilea 0.85 0.83-0.88 32.5 0.80 0.77
Medium tercilea 0.86 0.83-0.88 33.5 0.85 0.75 Medium tercilea 0.88 0.86-0.91 37.5 0.81 0.83
Highest tercilea 0.85 0.82-0.89 36.5 0.85 0.71 Highest tercilea 0.86 0.82-0.89 38.5 0.90 0.69
Oxford Knee Score: Oxford Hip Score:
change from change from
presurgery to 12 mo presurgery to 12 mo
Total sample 0.81 0.79-0.82 þ12.5 0.80 0.68 Total sample 0.78 0.76-0.81 þ16.5 0.74 0.71
Lowest tercilea 0.88 0.86-0.90 þ17.5 0.82 0.81 Lowest tercilea 0.85 0.82-0.88 þ23.5 0.77 0.78
Medium tercilea 0.85 0.82-0.88 þ13.5 0.87 0.70 Medium tercilea 0.87 0.85-0.90 þ15.5 0.87 0.74
Highest tercilea 0.81 0.77-0.85 þ9.5 0.79 0.71 Highest tercilea 0.82 0.78-0.86 þ12.5 0.71 0.79
AUC, area under the curve. AUC, area under the curve.
a a
According to OKS baseline scores. According to OHS baseline scores.
2396 D.F. Hamilton et al. / The Journal of Arthroplasty 33 (2018) 2392e2397
Fig. 2. Treatment success thresholds for the Oxford Knee Score in the total sample and
in the 3 subgroups defined by presurgery scores.
Strengths and Limitations
The relatively large sample size and application of a composite
criterion for treatment success can be regarded as strengths of our
study. Although this is (to our knowledge) the most comprehensive
anchor applied to the Oxford scores, we cannot be sure that the
criteria employed encapsulates all facets of “success” following
arthroplasty. Our sensitivity analysis indicated that the Oxford
score thresholds we report are fairly robust toward changes to the
individual anchor components. We had 6 potential anchor items
available for analysis with this dataset but, however, opted to
mirror the 4-item selection previously described [22] for reasons of
consistency. We were able to use the additional responses to the
questions of “expectations met” and “recommendation to a friend”
as sensitivity analyses to explore the value of incorporating these
additional factors to the composite anchor. Adding further criteria
had minimal impact, with no changes to the THA threshold patients
and varying the TKA threshold by 1 point. This finding reflects the
Fig. 3. Treatment success thresholds for the Oxford Hip Score in the total sample and
in the 3 subgroups defined by presurgery scores.
strong correlations between the various anchor questions that may
reflect overlapping content.
A limitation is that we describe thresholds for success at a single
postoperative time point of 12 months. Extrapolation cannot be
drawn to threshold values at different timeframes nor any longi-
tudinal changes over the postoperative period. The 12-month
postoperative time point is however the timeframe most
commonly reported in arthroplasty outcome evaluation, accepted
to reflect the completion of postoperative recovery.
Conclusion
This study provides thresholds for identifying “treatment suc-
cess” following THA and TKA using the OHS and OKS. We employed
a comprehensive definition of treatment success comprising pa-
tient satisfaction, functional improvement, pain relief, and will-
ingness to undergo the same procedure again. Using this composite
criterion, approximately three-quarters of hip arthroplasty patients
and two-thirds of knee arthroplasty patients reported a successful
treatment.
Acknowledgments
This work was supported by an institutional award from Stryker
to the University of Edinburgh [RB0415] and an international
scholarship for short-term scientific projects from the University of
Innsbruck.
D.F.H., J.M.G., K.G., and C.R.H. conceived the study objective. All
authors participated in the study design. D.J.M.D. coordinated data
collection. F.L.L and J.M.G. performed the statistical analysis. D.H.,
F.L.L., and J.M.G. interpreted the results. All authors helped to
outline the manuscript. F.L.L., J.M.G., and D.F.H. drafted the manu-
script. All authors edited and approved the final version.
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 The Journal of Arthroplasty 33 (2018) 2566e2570

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Revision Arthroplasty

Tritanium Acetabular Cup in Revision Hip Replacement: A Six

to Ten Years of Follow-Up Study
Hazem A.H. Hosny, MCh (Orth), PhD, FRCS (Orth) a, b, *,
Ahmed El-Bakoury, MCh (Orth), PhD, FRCS (Orth) a, b,
Sreebala C.M. Srinivasan, FRCS (Orth) c, Rathan Yarlagadda, FRCS (Orth) a,
Jonathan Keenan, FRCS (Orth) a
a
Department of Trauma and Orthopaedics, Derriford Hospital, Plymouth, United Kingdom
b
Department of Trauma and Orthopaedics, El-Hadra Hospital, Alexandria University, Alexandria, Egypt
c
Department of Orthopaedic surgery, King’s Mill Hospital, Nottinghamshire, United Kingdom

a r t i c l e i n f o a b s t r a c t

Article history: Background: The use of highly porous acetabular components has shown to produce good results in
Received 30 January 2018 revision acetabular surgery. Their surface characteristics enhance initial fixation and bone ingrowth
Received in revised form which are prerequisites for adequate osseointegration. The purpose of this study is to analyze the mid-
5 March 2018
term to long-term survival, clinical and radiological outcomes using the Tritanium cup (Stryker, Mahwah,
Accepted 17 March 2018
NJ) in revision hip surgery.
Available online 27 March 2018
Methods: This is a retrospective review of all patients who underwent acetabular revision surgery using
“Tritanium revision cup” between April 2007 and November 2010 at our institution. Sixty-two patients
Keywords:
highly porous cups
were included with a mean age of 67.5 years (32-86). According to Paprosky classification, 10 patients
Tritanium had type I defect, 8 had type IIA, 27 had type IIB, 7 had type IIC, and 10 suffered from type IIIA defect. A
uncemented cups Kaplan-Meier analysis was used to determine the survival of the cup. Functional outcomes were assessed
osseointegration using Oxford Hip Score. Plain radiographs were performed to assess implant fixation and
revision hip arthroplasty osseointegration.
Results: The acetabular cup aseptic survivorship was 98.4% at a mean follow-up of 87.6 months. The
mean Oxford Hip Score improved from 14.5 (3-31) preoperatively to 38.5 (12-48) at the final follow-up.
Two cups were revised (3.2%): 1 for aseptic loosening and 1 for infection.
Conclusion: Tritanium revision acetabular cup has shown excellent mid-term to long-term clinical and
radiographic results with low failure rate and minimal complications. Longer term follow-up would be of
value to assess the ongoing survival of this implant construct.
© 2018 Elsevier Inc. All rights reserved.

Aseptic loosening (AL) with subsequent failure of the acetabular
component is the most common indication for revision hip surgery
and demand for this surgery is expected to grow substantially in
the coming years [1,2]. Major goals in revision acetabular surgery
are to obtain primary as well as long-term stable fixation of the cup
[3]. The excellent results of the uncemented hemispherical cups in
revision total hip arthroplasty (THA) and the inconsistent reported
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.040.
* Reprint requests: Hazem A.H. Hosny, MCh (Orth), PhD, FRCS (Orth), Department
of Trauma and Orthopaedics, Derriford Hospital, Derriford Road, Plymouth, Devon,
United Kingdom, PL6 8DH.
survival for cemented acetabular components have resulted in a
shift toward the use of uncemented acetabular constructs in revi-
sion surgery [4e8]. The longevity and survival of these implants
depend on their design, stability of initial fixation, and the biologic
surface favoring bony ingrowth [9,10].
The development of highly porous acetabular components gave
a high coefficient of friction and improved surface characteristics,
which enhanced initial fixation and bone ingrowth which are
prerequisites for adequate osseointegration [7,11]. Excellent results
have been achieved using these implants even in the setting of
complex revisions with massive bone loss [3,12e15].
The Tritanium hemispherical acetabular cup (Stryker, Mahwah,
NJ) is a highly porous, hemispherical, multihole design shell with a
roughened surface for biologic fixation. It has pure titanium coating

https://doi.org/10.1016/j.arth.2018.03.040
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 H.A.H. Hosny et al. / The Journal of Arthroplasty 33 (2018) 2566e2570
(CPTi) on top of a titanium alloy shell with an average porosity of
72%. The average major and interconnecting pore sizes are 616 ± 73
and 275 ± 54 mm respectively, which are considered optimal for
early osseointegration which is crucial to guard against AL [8].
The purpose of this study is to analyze the survival, and the mid-
term to long-term clinical and radiological outcomes using this cup
in acetabular revision surgery in comparison to the published re-
sults in the literature.
Patients and Methods
We performed 187 acetabular cup revision surgeries in our insti-
tution between April 2007 and November 2010. Different recon-
struction options were used including hemispherical Tritanium
revision cup in 66 hips, impaction grafting and cemented cup with or
without additional structural graft or metal augment in 92 hips, while
cages were used in more complex cases with severe bone defects (29
hips). We retrospectively reviewed all patients in whom the multi-
hole Tritanium revision acetabular component was used (66 pa-
tients). Four patients died in the first 2 postoperative years for various
medical reasons and were excluded from this mid-term to long-term
follow-up study. In the remaining 62 patients; we had equal male to
female ratio with 31 patients in each group. The average age at sur-
gery was 67.5 years (range 32-86). The reasons for revision were AL in
43 cases, infection and septic loosening in 13 (2-stage revisions),
instability in 3, and adverse reaction to metal debris in 3 metal-on-
metal THA. The index operation was a first THA revision in 52 pa-
tients, a second revision in 8, and a third revision in 2 patients.
Preoperatively
Patients were examined clinically and Oxford Hip Score (OHS) was
obtained [16]. Standard biochemical and hematological tests
including C-reactive protein were obtained for all patients, and if
suggestive of infection, a preoperative hip aspiration was performed.
Plain radiographs were assessed for preoperative cup fixation and
position. Acetabular deficiencies were classified radiologically using
the Paprosky classification [17]. The defect was classified as type I in
10 hips, IIA in 8 hips, IIB in 27 hips, IIC in 7 hips, and IIIA in 10 hips.
Surgical Technique
All procedures were performed by 5 revision hip arthroplasty
surgeons in a laminar flow operating room using posterior
approach. Aseptic patients had intravenous antibiotic prophylaxis
with Teicoplanin and Gentamicin at induction. Patients undergoing
revision for infection received targeted intravenous antibiotic
treatment following microbiology advice. An intermittent calf
compression device was applied in all patients for intraoperative
mechanical thromboprophylaxis.
After exposure, the failed component and granulation tissue
were removed. The acetabulum was sequentially reamed using
dedicated hemispherical reamers according to the manufacturer’s
described operative technique. Line to line reaming was performed
in hard sclerotic acetabula, while under reaming by 1 mm was
performed if the bone quality was found to be poor. At this point, the
bone stock was reassessed for the possible need of bone grafting to
fill the cavitary defects. Trial components were used to assess
coverage, impingement, and stability. The indication for the use of
the Tritanium hemispherical cup was the achievement of satisfac-
tory rim fit, initial stability, and more than 50% contact between
viable host bone and the trial component without the need of
structural support (metal augment or structural graft). The defini-
tive cup was then inserted and reinforced by screws in all but 3 cases.
The range and mean number of screws used in each Paprosky group
2567
Table 1
Range and Mean Number of Screws Used in Each Paprosky Group.
Paprosky Group Number of Screws Used/Case
Minimum Maximum Mean
I 0 4 2
IIA 0 4 2.8
IIB 2 5 3.2
IIC 2 5 3.2
IIIA 2 7 4
are summarized in Table 1. Satisfactory intraoperative initial sta-
bility was achieved in all cases without the need of augments. The
cup sizes utilized in this study ranged from 54 to 72 mm. The femoral
head sizes used were either 32 or 36 mm. Metal on highly cross-
linked polyethylene liner (X3; Stryker) was the bearing couple
used in 49 hips, ceramic on X3 polyethylene liner was used in 7 hips,
while ceramic-on-ceramic articulation was used in the remaining 6
hips. Femoral head allograft bone was used in 12 cases to reconstruct
the cavitary defects. Forty-two patients had both components
revised, while 20 patients had only the acetabular cup revised.
Postoperatively
Enoxaparin was used for chemical thromboprophylaxis and
continued for the first postoperative month. Patients were made
partial weight bearing until 6 weeks, then to fully weight bear
thereafter. Patients were routinely followed up clinically and
radiologically at 0 weeks, 6 weeks, 6 months, and yearly thereafter.
OHS was obtained at 1 year postoperatively and at the end of
follow-up and compared to the preoperative score. Cup fixation and
osseointegration were assessed in relation to DeLee and Charnley
zones [18] as described by Moore et al [19]. Three or more of the
following signs would indicate radiological osseointegration:
superolateral buttress formation, presence of an inferomedial
buttress, medial stress shielding, radial trabeculae, and absence of
radiolucent lines.
Statistical Analysis
Data were analyzed statistically using statistical package SPSS
version 24 (SPSS version 20; IBM Corporation). Results were
analyzed using t-test, Spearman’s correlation analysis between the
Fig. 1. Kaplan-Meier survivorship analysis for Tritanium cup with revision as the end
point is shown. Each step symbol represents a censored case. Dotted lines ¼ 95% CIs. CI,
confidence interval.
2568 H.A.H. Hosny et al. / The Journal of Arthroplasty 33 (2018) 2566e2570

Table 2
Details of the Failed Revisions.

Patient Age Gender Indication of Time to Pre Re-Revision Number of Indication of Implant Used for
Index Revision Failure (mo) OHS Screws Used Re-Revision Re-Revision

1 32 Female AL 29 15 3 AL Tritanium cup

2 74 Female AL 25 10 2 Infection Tritanium cup

independent variables. Statistical significance was defined as P <
.05. A Kaplan-Meier analysis with 95% confidence intervals was
used to analyze implant survival. The Tritanium cup revision or
removal for any reason or intension to revise (patient awaiting
revision) was defined as the end point.
Results
The mean duration of follow-up period was 87.6 months (range
72-120). No patients were lost to follow-up.
Clinical Results
The acetabular cup survivorship with revision or intension to
revision for AL as an end point was 98.4%. The all-cause survivor-
ship of the Tritanium acetabular cup was 96.8% (Fig. 1). Two cups
were revised (3.2%): 1 for AL and 1 for infection with the details
summarized in Table 2. The mean OHS improved significantly from
14.5 (range 3-31) preoperatively to 38.5 (range 12-48) at the final
follow-up (P < .001).
Radiological Results
The average acetabular cup inclination angle was 43.7 ± 4.2
(35 -52 ). Radiographic evidence of osseointegration (minimum of
3 radiological signs as described by Moore et al) was demonstrated
in 60 of the 62 hips (Figs. 2 and 3). Radiographic zonal evaluation of
the Tritanium cups revealed nonprogressive radiolucent lines in 1
DeLee and Charnley zone in 4 hips, and in 2 zones in 5 hips (Fig. 4).
The position and alignment of these 9 cups did not change, and
there was no significant statistical difference between the mean
OHS in this group (36.5) compared to patients who had no radio-
lucent lines in their follow-up X-rays (37.8, P ¼ .54). However,
progressive radiolucencies in all 3 zones were observed in the 2
failed hips (Fig. 5).
Excluding the 2 failure cases, there was no osteolysis or pro-
gressive radiolucency noted at the final follow-up radiographic
evaluation.
There was one intraoperative complication for a patient who
had a vertical undisplaced periprosthetic femoral fracture at the tip
of a long uncemented stem which was treated with protected
weight bearing and united completely in 6 weeks’ time with no
sequelae. No intraoperative complications related to the acetabular
construct were encountered. Two patients with deficient hip ab-
ductors suffered from recurrent postoperative dislocation, and
underwent exchange of the X3 polyethylene liner to the con-
strained type. We had no further reported cases of infection, no
heterotopic ossification or neurovascular injuries. In addition, there
were no documented cases of psoas impingement.
Discussion
There has been a steady increase in the use of uncemented cups
in revision THA over the last 3 decades [3,12]. Achieving primary
mechanical stability and the presence of a favorable biological
environment to allow bone ingrowth are the key elements to
achieve long-term stability and survival of these constructs
[3,20,21].
Excellent short to mid-term results have been reported in the
literature using the highly porous acetabular shells in primary and
revision THA [8,22e27]. They have a bonelike microstructure and a
modulus of elasticity between that of cortical and cancellous bone.
They also have a high coefficient of friction providing a suitable
environment for bone ingrowth, bone graft remodeling, and better
initial stability [11,28,29].
Using highly porous tantalum Trabecular Metal (Zimmer Bio-
met, Warsaw, IN), Van Kleunen et al [23] had no aseptic failures in

Fig. 3. (A) Preoperative X-ray of 54-year-old patient with AL of acetabular component.

Fig. 2. (A) Preoperative X-ray of 84-year-old patient with AL of left hip components. (B) Eight-year follow-up X-rays post revision using Tritanium cup þ in-cement revision
(B) Six-year follow-up X-ray post revision using Tritanium cup and cone-conical stem. stem.
 H.A.H. Hosny et al. / The Journal of Arthroplasty 33 (2018) 2566e2570
Fig. 4. Radiolucencies in relation to DeLee and Charnley zones.
their series of 97 revisions at a minimum of 2 years. Other studies
showed AL of 2% or less at mean follow-up of 3-4 years for patients
with Paprosky type II and III bone defects [24,30]. A relatively
inferior outcome was achieved by Kosashvili et al [31] in a smaller
series of 15 hips using tantalum Trabecular Metal hemispheric
acetabular shells. Their report showed aseptic survivorship of 80%
at a mean follow-up of 4 years. They related their higher re-revision
rate for AL to the complex nature of their revisions and that sur-
geries were performed on patients who had failed cages or roof
rings.
The use of the highly porous titanium-based acetabular shells in
revision hip surgery has been previously evaluated in relatively few
studies (Table 3). Ramappa et al [8] reported excellent early results
in 43 revision cases using the titanium Tritanium acetabular shell in
revision THA at mean follow-up of 18.2 months. They had 1 failed
hip and cup osseointegration was noted as early as 6 weeks with
98% of cups integrated within 3 months after surgery. Delanois et al
[21] in their recent study of 35 Tritanium acetabular components
reported similar excellent results of 97% aseptic survivorship and
excellent functional scores at a mean follow-up of 6 years. This
study, with a larger number of patients and a longer term follow-
up, shows similar excellent results with implant survivorship of
98.4% for AL at a mean follow-up of 87 months with only 1 of 62
patients requiring re-revision (Table 3).
It is important to note that there are contradictory results in the
literature using the Tritanium primary solid back or cluster hole
shell vs the multihole revision cup. Carli et al [32] reported unfa-
vorable clinical and radiographic outcomes associated with the use
of Tritanium primary cup in primary THA. Over one-third of their
patients had 2 zones radiolucencies at minimum 5-year follow-up
associated with significant decline in Harris hip score. In addition,
progression of radiolucencies was observed in 13.8% of their pa-
tients. On the contrary, this study showed excellent outcomes
similar to the reported results in the 2 previous studies using the
Tritanium revision shell [8,21]. Nonprogressive radiolucent lines
were observed in 2 DeLee and Charnley zones in 5 of our patients
(8%) with no clinical sequelae.
Table 3
Results of Different Studies Using Highly Porous Acetabular Components.
Study Acetabular Implant Number
of Hips
Ramappa et al 2009 [8] Tritanium (Titanium) 43
Delanois et al 2017 [21] Tritanium (Titanium) 35
Lakstein et al 2009 [3] Trabecular Metal (Tantalum) 53
Unger et al 2005 [25] Trabecular Metal (Tantalum) 60
This study Tritanium (Titanium) 62
2569
Fig. 5. (A) Immediate postoperative X-ray of 32-year-old patient using Tritanium cup.
(B) Final follow-up X-ray with radiolucent lines in the 3 zones and AL of the cup. (C)
Immediate postoperative X-ray of 74-year-old patient using Tritanium cup. (D) Final
follow-up X ray prior to re-revision for infection.
Carli et al [32] related this discrepancy in the performance of the
Tritanium primary and revision cups to the unique manufacturing
process of the Tritanium primary component surface. This involves
the mixing of titanium, a pore former, and a binding agent which
could unfavorably affect the final surface topography and subse-
quent osseointegration. On the other hand, the multihole Tritanium
revision cup is manufactured differently and has different surface
characteristics from the primary shell. This begins with machining
polyurethane foam into a scaffold which is then coated with pure
titanium. Subsequent sintering in a vacuum furnace removes the
polyurethane, keeping the titanium in a scaffold-like pattern.
Expansion in size is achieved through consecutive applications of a
polymeric binder and titanium coating followed by sintering cycles
to remove the binder and interconnect the layers of titanium.
The risk of periprosthetic joint infection (PJI) is higher in revi-
sion compared to primary THA [33,34]. Previous reports have
demonstrated a lower incidence of PJI in revision THA using
tantalum cups compared to titanium implants [7,35]. In a large
series of revision THA patients, Tokarski et al [35] showed an
Mean Aseptic Survival Complications Related
Follow-Up (y) Rate (%) to Reconstruction
1.5 97% 1 AL
6 97% 1 AL, 2 deep infection,
1 sciatic nerve palsy
4 96% 2 AL, 4 dislocations, 1 sciatic nerve palsy
3.5 98% 1 AL, 7 dislocations
7.3 98% 1 AL, 2 deep infection, 2 dislocations
2570 H.A.H. Hosny et al. / The Journal of Arthroplasty 33 (2018) 2566e2570
incidence of PJI with 2.9% with tantalum and 5% with low porosity
titanium cups. Their titanium cups group contained a mixture of
various implants designed mainly with on-growth rather than in-
growth surfaces. They principally attributed the lower infection
rate associated with highly porous tantalum cups to the increased
potential of tantalum to osseointegrate thereby obliterating any
dead space needed for micro-organism proliferation. Their infec-
tion rate associated with titanium cups (5%) was much higher
compared to the current series which showed only one case of
septic loosening and an overall incidence of PJI of 1.6%. This is likely
to be due to the higher porosity of the Tritanium titanium cups used
in this study which allows early bone ingrowth and osseointegration
similar to the tantalum implants in the study by Tokarski et al [35].
This study had limitations in that it was retrospective, and lacks
a control group in which alternate devices had been used. In
addition, there was heterogeneity to the acetabular defects
included in this series. However, to our knowledge, this current
patients’ series is the largest in the literature with the longest
follow-up using this implant.
In conclusion, the use of the highly porous Tritanium unce-
mented acetabular cup in revision hip surgery has shown excellent
clinical and radiographic results at 6 to 10-year follow-up with
minimal complications. Adequate intraoperative stability is a
mandatory prerequisite for osseointegration and successful
outcome following this procedure. However, longer term follow-up
would be of value to assess the ongoing survival of this implant
construct.
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 The Journal of Arthroplasty 33 (2018) 2512e2517

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The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Primary Arthroplasty

Using a Tibial Short Extension Stem Reduces Tibial Component

Loosening After Primary Total Knee Arthroplasty in Severely
Varus Knees: Long-term Survival Analysis With Propensity
Score Matching
Min-ho Park, MD a, Seong-Il Bin, MD a, *, Jong-Min Kim, MD a, Bum-Sik Lee, MD a,
Chang-Rack Lee, MD b, Young-Hee Kwon, APN a
a
Department of Orthopedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
b
Department of Orthopedic Surgery, Inje University, Busan Paik Hospital, Busan, Republic of Korea

a r t i c l e i n f o a b s t r a c t

Article history: Background: Patients with severe preoperative varus deformity have been reported to have high rates of
Received 24 January 2018 loosening after total knee arthroplasty (TKA), primarily on the tibial side. This study investigated
Received in revised form whether a short extension stem for the tibial component in severely varus knees would reduce the
11 March 2018
failure rate due to loosening on the tibial side.
Accepted 22 March 2018
Methods: Patients who underwent TKA, performed by a single surgeon using a single implant between
Available online 30 March 2018
November 1998 and January 2009, were retrospectively evaluated. Patients diagnosed with primary
osteoarthritis, having a hip-knee-ankle axis greater than varus 8
on preoperative long-film radiographs,
Keywords:
total knee arthroplasty
and postoperatively followed up for more than 2 years were included. Patients were divided into “stem”
short extension stem and “nonstem” groups, followed by 1:1 propensity score matching according to age, gender, body mass
severe varus deformity index, preoperative mechanical axis, and postoperative alignment. Tibial loosening rates in the 2 groups
survivorship were compared.
propensity score matching Results: The study cohort included 602 patients, divided into “stem” and “nonstem” groups. Propensity
score matching yielded 88 pairs of patients. Mean follow-up duration was similar in the stem and
nonstem groups (109.22 vs 103.81 months, P ¼ .451). None of the patients in the stem group, compared
with 5 in the nonstem group, experienced aseptic loosening. The overall implant survival rate was
significantly higher in the stem group than in the nonstem group (P ¼ .0201).
Conclusion: Using a short extension stem for the tibial component in primary TKA in patients with severe
varus deformity greater than 8
may reduce the rate of loosening of the tibial side and increase the
longevity of the implant.
Level of evidence: Level III.
© 2018 Elsevier Inc. All rights reserved.

Total knee arthroplasty (TKA) is the standard treatment for pa-
tients with end-stage osteoarthritis. Although the development of
advanced instrumentation and operative techniques has increased
implant survival rate [1e4], the reported 10-year survival rate of
primary TKA remains 95.3%-97.7% with a failure rate of 5%-7%
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.058.
* Reprint requests: Seong-Il Bin, MD, Department of Orthopedic Surgery, Asan
Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil,
Songpa-gu, Seoul 05505, Republic of Korea.
[5e8]. The most frequent cause of implant failure, other than
prosthetic joint infection, has been reported to be aseptic loosening
[9,10], particularly on the tibial side [11,12]. Some studies have
shown that the rate of tibial loosening is significantly higher in
patients with severe varus than in patients with less severe pre-
operative deformity [13]. Severe preoperative varus deformity is
one of the most important risk factors for failure of these implants,
especially tibial component loosening, because soft tissue
balancing is difficult [14e16] and the tibial side of severely varus
knees is subjected to high strain [17,18].
Connection of a short extension stem to the tibial component
may reduce the rate of loosening by better distributing the load and

https://doi.org/10.1016/j.arth.2018.03.058
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 M.-h. Park et al. / The Journal of Arthroplasty 33 (2018) 2512e2517 2513

Table 1
Demographic Characteristics of Patients Undergoing TKA With or Without the Use of Short Stems.

Before Propensity Score Matching; Total 602 After Propensity Score Matching; Total 176

Without Stem With Stem SMD P Without Stem With Stem SMD P

n 503 99 88 88
Age, y, mean (SD) 66.75 (6.73) 67.36 (5.34) 0.100 .395 67.28 (6.69) 67.18 (5.47) 0.017 .912
Gender 0.218 .169 <0.001 1.000
Male 23 1 1 1
Female 480 98 87 87
BMI, kg/m2, mean (SD) 27.29 (3.46) 27.83 (3.91) 0.147 .164 27.12 (3.66) 27.60 (3.69) 0.132 .382
Preoperative axis,
mean (SD) 13.40 (3.86) 17.05 (5.53) 0.767 <.001 15.90 (4.54) 16.08 (4.62) 0.040 .792
Postoperative axis,
mean (SD) 2.43 (3.13) 2.72 (2.97) 0.095 .396 2.57 (3.30) 2.86 (2.95) 0.094 .532
Aseptic failure, n 20 0 5 0

SMDs, standardized mean differences; SD, standard deviation; TKA, total knee arthroplasty.

resisting strain [18,19]. Gopalakrishnan et al [19] reported that
prophylactic use of a 30-mm extension stem in obese patients has
been found to reduce the compressive stress by 136% and the shear
force by 92% at the cement-bone interface. But, few studies have
evaluated the effects of tibial short extension stems on post-
operative tibial component loosening rates in patients with severe
varus deformity undergoing primary TKA. In addition, these were
not long-term follow-up studies and evaluated only obese patients
with preoperative varus deformity, limiting its general application
to other patients.
We retrospectively analyzed patients who underwent TKA at
our institution to determine the effect of the tibial short extension
stem on implant survival rate. We hypothesized that using a tibial
short extension stem would reduce the risk of loosening on the
tibial side. In the present study, we evaluated long-term survivor-
ship free from tibial side loosening in preoperative severe varus
deformity greater than 8
.
Materials and Methods
From November 1998 to January 2009, the 1348 patients who
were diagnosed with primary osteoarthritis had a preoperative
varus deformity greater than 8
, underwent TKA, and were fol-
lowed up for at least 2 years were evaluated. We performed a
retrospective review using prospectively collected data. All opera-
tions were performed by a single senior orthopedic surgeon, using a
single instrument system (Zimmer Nexgen, Legacy Posterior Sta-
bilized). A total of 746 patients were excluded, including 17 who
underwent TKA for osteonecrosis or rheumatoid arthritis, 49 who
required revision surgery owing to infection or trauma, 262 who
were followed up for less than 2 years, and 629 with a preoperative
mechanical axis <9
. Thus, a total of 602 patients were finally
included in the study. Of the 602 patients, 503 underwent TKA
without a stem and 99 with a stem. The mean ages of patients in the
nonstem and stem groups were 66.75 ± 6.73 years and 67.36 ± 5.34
years, respectively. Their average body mass indexes (BMIs) were
27.29 ± 3.46 kg/m2 and 27.83 ± 3.91 kg/m2, respectively, and their
mean preoperative hip-knee-ankle (HKA) axes were 13.40 ± 3.86

and 17.05 ± 5.53
, respectively, and differed significantly (P < .001).
However, postoperative alignment was similar in the nonstem
(2.43 ± 3.13
) and stem (2.72 ± 2.97
) groups (Table 1).
Patients were divided into a stem and a nonstem control group,
followed by 1:1 propensity score (PS) matching (caliper 0.2) to
control for any indication bias for using a stem during surgery.
Following 1:1 PS matching, 88 patients were selected from each
group. The matched stem and nonstem groups had similar mean
ages (67.18 ± 5.47 vs 67.28 ± 6.69 years), mean BMIs (27.60 ± 3.69 vs
27.12 ± 3.66 kg/m2), and mean postoperative mechanical axis (2.86
± 2.95
vs 2.57 ± 3.30
). In all categories, the 2 groups were well
balanced without statistically significant differences (standardized
mean difference < 0.2, Table 1).
PSs were used to minimize selection bias between the stem and
nonstem groups, allowing for comparison of tibial loosening rates.
PSs generated using logistic regression were used to adjust for
confounding variables of age, gender, BMI, preoperative HKA axis,
and postoperative alignment. Each patient within the stem group
was matched to the patient in the nonstem group who had the
closest estimated PS (1:1). This matching allowed us to design and
analyze a retrospective study which mimics some of the charac-
teristics of a randomized controlled trial [20e22]. Patients with
preoperative severe varus deformity were more likely to have used
a stem. Therefore, for a fair comparison between the stem and
nonstem groups, PS matching was used to minimize selection bias
and remedy the shortcomings of a retrospective study.
Although studies have defined the parameters for severe varus
deformity, no consensus has yet been established. For example,
severe varus deformity has been defined as >16
and as 20

[23,24]. In comparison, our study defined severe varus deformity as
>8
because an HKA axis of approximately 9
varus makes the
mechanical axis of the lower limb connecting the center of the hip
joint and the center of the ankle joint pass within the medial 10% of
the tibial plateau.
Radiographs, including preoperative long films of the lower
extremities and anteroposterior and lateral views of both knees,
operative records, postoperative radiographs, and routine follow-
up radiographs, were evaluated. All patients were evaluated at
the outpatient clinic 1, 6, and 12 months postoperatively, and
annually thereafter. Aseptic implant loosening was defined as a
progressive radiolucent lesion >2 mm, an increase in the
Fig. 1. A 30-mm long short stem was connected to the tibial component.
2514 M.-h. Park et al. / The Journal of Arthroplasty 33 (2018) 2512e2517

Fig. 2. X-rays of a 65-year-old woman. (A) Preoperative varus was 20
. (B) Postoperative alignment was acceptable at 1.04
. (C) Five years and 5 months after surgery, the tibial
component inclination had increased to 6.47
. (D) Revision was performed 6 years after surgery. (E) After revision, alignment was maintained at 0.26
.

inclination of the implant compared with immediate postoperative
radiographs or the implant subsidence on follow-up radiographs.
Radiographs were evaluated, and angle measurements were per-
formed using the image archiving and communication system of
our institution. Varus and valgus deformities were expressed as
positive and negative values, respectively, in the notation of
alignment. Angles were measured by 2 experienced orthopedic
surgeons, and inter-observer reliability had an intraclass correla-
tion coefficient of 0.889 (95% confidence interval [CI]: 0.867-0.909,
P < .001).
 M.-h. Park et al. / The Journal of Arthroplasty 33 (2018) 2512e2517
Fig. 3. X-rays of a 62-year-old woman. (A) Preoperative varus was 21
. (B) Postoperative alignment was good at 1.89
. (C) Alignment remains well maintained 11 years after surgery.
Surgical Procedure
All operations were performed by a medial parapatellar
approach. The deep medial collateral ligament and posteromedial
capsules were released subperiosteally, and the distal femur and
proximal tibia were resected using an intramedullary guide. PS-
type instruments were used, and the posterior cruciate ligament
was resected in all knees. Medial and lateral symmetry was
confirmed by manual distraction after insertion of the trial
component, and medial release was performed by gradually
inserting thicker trial inserts. When the flexion gap was greater
than the extension gap, a thicker polyethylene insert was inserted,
and the distal femur was further cut. Pie-crusting technique for
superficial medial collateral ligament release or medial femoral
epicondylectomy was not performed. In most cases, the medial and
lateral ligaments were balanced to within 2-3 mm, and bone de-
fects >5 mm were augmented with a metal block. Patellar resur-
facing was not performed. Each extension stem was 15 mm in
diameter and 30 mm in length (Fig. 1). The final decision to use a
stem was made by the senior surgeon based on the degree of varus
deformity measured on the preoperative long-film radiograph or
the bone density of the proximal tibial cut surface observed during
surgery.
Statistical Analysis
PSs were estimated using multiple logistic regression analysis
with all prespecified covariables listed in Table 1 (age, gender, BMI,
preoperative HKA axis, postoperative alignment). Categorical vari-
ables were compared using Fisher's exact test or Pearson's chi-
square test, whereas continuous variables were analyzed using
the Mann-Whitney U test or Student's t test. Model discrimination
was assessed with c-statistics (c ¼ 0.549) and model calibration
with Hosmer-Lemeshow statistics (P ¼ 1.000). After PS estimation,
stem and nonstem groups were matched according to PS in a 1:1
2515
ratio without replacement (greedy-matching algorithm), with a
caliper equal to 0.2 of the standard deviation of the logit of the PS.
Standardized mean differences were estimated for all the baseline
covariates before and after matching to assess prematch imbalance
and postmatch balance. The comparative risks of failure-free sur-
vivals were compared using log-rank test in matched sample. All
statistical analyses were performed using SPSS, version 21.0 (SPSS
Inc., Chicago, Illinois) for Windows and R version 2.14.2.
Results
Before PS matching, failure occurred in 20 of 503 knees without
a stem (Fig. 2) but in 0 of 99 knees with a stem (Fig. 3). The esti-
mated 10-year implant survival rate was 95.3% (95% CI: 92.6%-
98.1%) in the nonstem group and 100% in the stem group (Fig. 4).
Following PS matching, implant failure occurred in 0 of the 88
patients in the stem group and 5 of 88 in the nonstem group
(Table 1). The estimated 10-year implant survival rate was higher in
the stem (100%) than in the nonstem group (97.50%; 95% CI: 94.1%-
100%; P ¼ .0013; Fig. 5).
The overall survival rate of the stem group confirmed by the log-
rank test was significantly higher than the nonstem group (P ¼
.0201; Table 2).
Discussion
The most important finding of this study was that the use of a
short extension stem for the tibial component in patients with
severe preoperative varus deformity undergoing primary TKA was
associated with a significantly lower rate of loosening on the tibial
side.
In a number of studies, one of the most important cause of
failure after TKA has been reported to be aseptic loosening of the
implant, which occurs mainly on the tibial side [12,25,26]. Ritter
et al [13] reported that the failure rate of implant is much higher in
2516 M.-h. Park et al. / The Journal of Arthroplasty 33 (2018) 2512e2517

Fig. 4. Kaplan-Meier implant survival curves of all patients who underwent TKA with and without a stem implant. Ten-year survival rates of the 2 groups were 100% and 95.3% (95%
CI: 92.6%-98.1%).

patients with severe preoperative varus deformity. In general,
medial compartment bone loss and medial-lateral ligament
imbalance in knees with severe varus deformity makes the TKA
procedure more challenging than in knees without deformity, and
the failure rate is subsequently higher [27,28]. Methods are there-
fore needed to prevent the failure of the tibial component and
increase long-term implant survival in patients with severe varus
deformity [23]. We found that the use of a short extension stem
significantly reduced the loosening of the tibial side after surgery
and further improved the 10-year survival rate.
Most previous studies on the use of stems in primary TKA were
based on the usage of long stems in revision surgery [29e31]. Fewer

Fig. 5. Kaplan-Meier implant survival curves of propensity scoreematched patients who underwent TKA with and without a short extension stem. Ten-year survival rates of the 2
groups were 100% and 97.5% (95% CI: 94.1%-100%).
 M.-h. Park et al. / The Journal of Arthroplasty 33 (2018) 2512e2517
Table 2
Comparison of Survival Rates in the Propensity-Matched Stem and Nonstem Groups.
Chi Square Degrees of Freedom P Value
Log rank (Mantel-Cox) 5.403 1 .0201
studies have evaluated short stems, with only a small number or
reports on the prophylactic use of tibial stems to prevent varus
collapse in patients with high BMI [19]. Angers-Goulet et al [32]
reported the radiologic and clinical outcomes of 91 cases in
which short extension stems were used in primary TKA in their
study but this done without a comparison group who did not use
the stem. In addition, Lachiewicz and Soileau [33] reported that the
use of a 30-mm short extension stem results in a very excellent
fixation of the tibial component. But because their study is focused
on the use of short extension stem on revision surgery, so that is
different from our report about primary TKA. Therefore, the result
of our study has not been previously reported and may have sub-
stantial clinical value.
This study had several limitations, including its retrospective
study design followed by prospective data collection. Although our
institution provides prospectively collected data, the lack of
randomization could introduce bias into the study. In addition,
there is an indication bias for the use of short extension stem during
surgery. We attempted to limit such indication bias with PS
matching to account for other possible confounding factors in this
study, such as age, gender, BMI, preoperative HKA axis, post-
operative alignment, thus ensuring a certain degree of homoge-
neity. Another limitation was our definition of implant failure using
radiologic parameters, such as subsidence, increased inclination, or
progressive radiolucent lesions. However, we failed to investigate
or consider the patient's subjective symptoms or clinical scores. The
occurrence of race and gender bias in the composition of the pa-
tient group is also part of the limitation. All patients were of Asian
ethnicity, and the majority of patients who underwent TKA were
female. Finally, we did not consider bone density to be a factor that
could affect implant failure. This could be a potential topic for
future research. Despite these limitations, we believe that pro-
phylactic use of a short extension stem would be a good surgical
option during TKA for patients with severe varus deformity. The
results from our study have not, to the author's knowledge, been
reported in previously published literature and hold substantial
clinical value.
Conclusion
Using a short extension stem for the tibial component in pri-
mary TKA in patient with severe varus deformity greater than 8

may reduce the rate of loosening of the tibial side and increase the
longevity of the implant.
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 The Journal of Arthroplasty 33 (2018) 2636e2639

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Variability in Elongation and Failure of the Medial Collateral

Ligament After Pie-Crusting With 16- and 18-Gauge Needles
Spencer H. Amundsen, MD a, Kathleen N. Meyers, MS b, *, Timothy M. Wright, PhD b,
Geoffrey H. Westrich, MD a
a
Department of Orthopedics, Hospital for Special Surgery, New York, New York
b
Department of Biomechanics, Hospital for Special Surgery, New York, New York

a r t i c l e i n f o a b s t r a c t

Article history: Background: In knee arthroplasty with preoperative varus deformity, medial collateral ligament (MCL)
Received 8 November 2017 release may be needed to achieve balance. Pie-crusting allows for controlled release, but questions
Received in revised form remain regarding its ability to obtain predictable results. We compared 16- vs18-gauge needle punctures
23 February 2018
and determined the number of punctures required to (1) lengthen the MCL by 1 mm and (2) cause
Accepted 11 March 2018
ligament failure.
Available online 17 March 2018
Methods: Thirteen knees were dissected, leaving the femur and tibia with an isolated MCL, and randomly
assigned to 16- or 18-gauge groups. Initial stiffness was assessed by cycling the ligament to 300 N for 5
Keywords:
total knee arthroplasty
cycles. The selected needle was used to make 10 punctures centered over the area of greatest tension.
ligament balance Cyclic testing was repeated after each set of punctures. Changes in MCL length and stiffness were
pie-crusting measured. This process was repeated until failure.
medial collateral ligament Results: No differences occurred between the 16- and 18-gauge groups in cross-sectional area, initial
stiffness, number of punctures to lengthen the MCL by 1 mm, or number of punctures to failure. As the
number of punctures increased, a linear increase in elongation and decrease in stiffness occurred.
Conclusion: Needle size was not the influencing factor. Variability in number of punctures, regardless of
needle size, to elongate or fail the MCL shows the difficulty in developing a reproducible pie-crusting
technique. This suggests that a standard number of punctures do not achieve controlled MCL length-
ening for all patients, but that the number of punctures needed can be calculated for an individual knee
based on the initial elongation after 10 punctures.
© 2018 Elsevier Inc. All rights reserved.

Soft tissue balancing during total knee arthroplasty (TKA)
decreases early failure and optimizes kinematics and function
[1]. In the face of preoperative varus deformity, the medial
collateral ligament (MCL) and medial soft tissue sleeve (MSS)
often require release to obtain balance. Insall et al popularized
release of the MSS from the proximal-medial tibia with a sub-
periosteal peel [2]; however, this technique does not allow for
selective release to target flexion or extension gaps [3] and
Ethical board review statement: institutional ethical board review was obtained
for the present study.
No author associated with this paper has disclosed any potential or pertinent
conflicts which may be perceived to have impending conflict with this work. For
full disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.021.
* Reprint requests: Kathleen N. Meyers, MS, Department of Biomechanics, Hos-
pital for Special Surgery, 535 East 70th Street, New York, NY 10021.
extensive release in the presence of severe deformity can result
in instability [4].
Pie-crusting is an alternative or addition to the traditional
subperiosteal MSS release. With studies demonstrating its efficacy
and safety, pie-crusting has been used increasingly to lengthen
tight or contracted medial tissues [5]. Pie-crusting of the MCL has
been described using multiple tools: a #11 scalpel blade [6e8], a
19-gauge spinal needle [9], and an 18-gauge needle [10]. Pie-
crusting has been compared to the traditional tibial subperiosteal
peel [5,11], but to our knowledge no study has compared the results
of pie-crusting using different gauge needles.
The purposes of our study are to compare the effects of pie-
crusting with 16- vs 18-gauge needles in elongating the MCL and
in affecting the remaining strength of the MCL after pie-crusting.
Specifically, we examined the number of needle punctures
required to lengthen the ligament by 1 mm with 16- and 18-gauge
needles; the number of punctures with these 2 needles that led to

https://doi.org/10.1016/j.arth.2018.03.021
0883-5403/© 2018 Elsevier Inc. All rights reserved.
 S.H. Amundsen et al. / The Journal of Arthroplasty 33 (2018) 2636e2639
failure of the MCL; and the effect of pie-crusting on ligament
stiffness within and between the 2 needle groups.
Materials and Methods
Thirteen fresh-frozen cadaver knees (10 from matched pairs of
legs) with an average age of 75 years (range from 56 to 85 years)
were tested. All specimens were dissected leaving only the femur
and tibia connected by a carefully isolated MCL. Distal femoral and
proximal tibial bone cuts were made in a similar fashion as would
be performed during primary TKA. The proximal end of the femur
and distal end of the tibia were potted in epoxy using custom
fixtures. Specimens were stored frozen and then thawed over a
24-hour period before testing. Specimens were kept moist with
saline from thawing through to completion of mechanical testing.
The specimens were randomly assigned to either a 16-gauge (n ¼ 7)
or an 18-gauge (n ¼ 6) needle group. In the case of the 5 matched
pairs, left and right knees from each pair were randomized to
separate groups.
Specimens were placed into a servo-hydraulic test system using
custom fixtures (Fig. 1). Under a tensile preload of 25 N applied by
the test system, 3 measurements were taken of the width and
thickness of the MCL at both the proximal and distal joint lines
using digital calipers. Due to the flattened cross-sectional shape of
the ligament, the cross-sectional area was assumed to be
rectangular.
The initial stiffness of each specimen was assessed by cycling in
tension from 25 to 300 N for 5 cycles at 0.5 Hz. The maximum of
300 N is equal to approximately 50% of the sMCL failure load [12].
This maximum load was high enough to reach the linear region of
the load/displacement curve while allowing for repeated cyclic
testing without reaching a load level that would cause catastrophic
ligament failure. Load and elongation were continuously moni-
tored; data from the fifth cycle were used to determine stiffness.
The ligament was again held in tension at 25 N. The clinician felt
along the width of the ligament for fibers or groups of fibers that
Fig. 1. Isolated MCL in mechanical test setup. MCL, medial collateral ligament.
2637
felt more stiff, that is, were areas under greatest tension. The
appropriate needle (16 or 18 gauge) was then used to make 10
puncture holes centered over the area of greatest tension. Punc-
tures were directed from outside the joint ending inside the joint.
Cyclic testing was repeated, and the change in length of the bone-
ligament-bone construct from the initial condition and the change
in MCL stiffness from the initial condition were calculated. The
process was then repeated (cyclic loading followed by 10 more
punctures followed by more cyclic testing) until the specimen
failed.
As with the initial assessment, the fifth cycle of each test after
each round of cyclic testing was analyzed to determine the elon-
gation (the change in piston location at 25 N of tension as compared
to the initial test condition) and the stiffness (the slope of the linear
portion of the load-displacement curve). We also recorded the
number of punctures to increase the elongation by 1 mm and the
number of punctures that resulted in failure. These comparisons
were evaluated using t-tests with alpha <0.5. A linear fit was per-
formed for each specimen for elongation and stiffness. Average R2
values are reported.
Results
Both groups were similar in cross-sectional area (16 gauge: 71.8
mm2, 18 gauge: 84.7 mm2, P ¼ .33) and initial ligament stiffness (16
gauge: 61.3 N/mm, 18 gauge: 54.3 N/mm, P ¼ .12). No differences
were found between the 16- and 18-gauge groups in elongation
after 10 punctures (0.6 ± 0.4, range 0.2-1.4 mm vs 0.7 ± 0.4 mm,
range 0.1-1.2 mm, respectively, P ¼ .55), in the number of punctures
to increase elongation by 1 mm (28 ± 17, range 10-60 vs 30 ± 32,
range 10-90, respectively, P ¼ .91), or in the number of punctures
that resulted in failure (51 ± 29 vs 82 ± 51, respectively, P ¼ .21). The
change in elongation and stiffness with each set of needle punc-
tures varied from specimen to specimen, but a linear increase in
elongation (average R2, 0.93 ± 0.09) and decrease in stiffness
(average R2, 0.89 ± 0.11) occurred with increasing punctures for all
specimens (Fig. 2).
Considerable variability was observed in the number of punc-
tures needed for 1 mm of elongation, even between the paired
specimens (Fig. 3), in the amount of elongation relative to the
number of punctures among all specimens, and in the number of
punctures needed to cause failure (Fig. 4).
Discussion
Soft tissue balance remains elusive and subjective, yet crit-
ical to prevent early failure in TKA [1]. Pie-crusting has tradi-
tionally been used for lateral soft tissue release [11]. Recent
cadaveric and in vivo studies demonstrated its effectiveness and
safety on the medial side of the knee as well [5,11]. But pro-
gressive medial release for significant varus deformity can lead
to instability necessitating a constrained polyethylene insert
with the increased potential of subsequent aseptic loosening
and increased cost [5].
The variability in elongation among all specimens and the lack
of statistical difference between groups showed that the size of the
needle was not the determining factor in pie-crusting. We found
difficulty in predicting the contribution of each set of punctures to
ligament elongation and MCL failure across all specimens. Dubois
de Mont-Marin et al [13] also reported large deviations in their
elongation measurements of the medial joint space in cadaveric
knees subjected to MCL pie-crusting. Although they did not show
the individual elongation values as we did (Fig. 4), the standard
deviations for both studies are similar in magnitude to the means
showing that the effect of pie-crusting varies from specimen to
2638 S.H. Amundsen et al. / The Journal of Arthroplasty 33 (2018) 2636e2639
Fig. 2. These example graphs show that both stiffness decreased and elongation increased in a linear fashion with increasing number of punctures.
specimen. Given that elongation was linearly related to the number
of punctures, it would be tempting to calculate the number of
punctures needed to increase the gap to a desired amount for an
individual patient’s ligament, but these large variabilities make that
impossible without knowledge of the specific ligament’s initial
stiffness.
Our study has limitations. The sample size for this study is
small, but over 1000 specimens per group would need to be
tested to reach a desired power of 80%. This highlights the
variability in the mechanical properties of the MCL across
individuals. The use of bone-to-bone elongation does not cap-
ture local changes in the MCL, but the clinical goal of pie-
crusting is to increase the length of the overall structure. The
location of the needle punctures was determined by feel and
not in a set pattern. This subjective method likely led to vari-
ability in the concentration of punctures, but we chose this
approach because it is the method used clinically. Finally, the
properties of our specimens might have been altered by the
freeze-thaw cycle that they experienced before testing,
although the literature suggests that such a cycle has little
impact [14]. These properties might also be altered in the
presence of knee deformity, which could alter our findings,
Fig. 3. The number of punctures needed to obtain 1 mm of ligament elongation was
not consistent between right and left knees from the same pair.
because we used well-aligned cadaveric knees as the sources for
our specimens.
We observed with both gauges of needle that some punctures
were accompanied by a tactile sense of fibers being severed, while
at other times this feedback was lacking. The MCL is a broad, flat
ligament composed of both superficial and deep layers with fibers
that differ in orientation from anterior to posterior [15,16]. We
postulate that punctures lacking feedback disrupt the adhesion
between fibers without causing significant structural damage to the
fibers themselves. The tubular nature of the fibers may create a
tendency for the fiber to roll away from the needle when not
tethered to surrounding fibers. This difference in puncture outcome
(damage between instead of through fibers) could explain some of
the variability in our results. While not borne out in our study, a
larger bore needle and certainly a scalpel would be less likely to
pass between fibers and might result in more ligament lengthening
per puncture.
In summary, the number of punctures needed to balance the
knee without compromising MCL structural integrity is patient
specific. However, the linear effect of each successive puncture on
Fig. 4. Great variability was found among all 13 specimens regardless of the gauge of
the needle.
 S.H. Amundsen et al. / The Journal of Arthroplasty 33 (2018) 2636e2639
stiffness and elongation of the ligament (Fig. 2) demonstrates that if
the initial stiffness were known, indeed the number of punctures
needed to increase the gap could be calculated. As expected, cyclic
loading added to the elongation of the MCL after punctures was
made. This suggests that without intraoperative cycling of the knee
during a pie-crusting procedure to assess the full impact of the
punctures on elongating the ligament, a surgeon could perform too
many punctures, resulting in a loose MCL.
References
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[7] Meftah M, Blum YC, Raja D, Ranawat AS, Ranawat CS. Correcting fixed varus
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[11] Meneghini RM, Daluga AT, Sturgis LA, Lieberman JR. Is the pie-crusting
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[13] Dubois de Mont-Marin G, Babusiaux D, Brilhault J. Medial collateral ligament
lengthening by standardized pie-crusting technique: a cadaver study. Orthop
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[14] Woo SL-Y, Orlando CA, Camp JF, Akinson WH. Effects of postmortem storage
by freezing on ligament tensile behavior. J Biomech 1986;19:399e404.
[15] Chen L, Kim PD, Ahmad CS, Levine WN. Medial collateral ligament injuries of
the knee: current treatment concepts. Curr Rev Musculoskelet Med 2008;1:
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 The Journal of Arthroplasty 33 (2018) 2671e2676

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Basic Science

Wear Kinetics of Highly Cross-Linked and Conventional

Polyethylene Are Similar at Medium-term Follow-Up After
Primary Total Hip Arthroplasty
Constantin Mayer, MD a, b, *, Moritz Rommelmann a, Michael Behringer, MD c,
€ger, MD, PhD b, Rüdiger Krauspe, MD, PhD a, Christoph Zilkens, MD a
Marcus Ja
a
Department of Orthopedics, Heinrich Heine University Medical School, Duesseldorf, Germany
b
Department of Orthopedics and Trauma Surgery, University Medical School, Essen, Germany
c
Institute of Sports Sciences, Goethe University Frankfurt, Frankfurt, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Background: Wear debris is a major factor in aseptic loosening of total hip arthroplasty. Ultra high
Received 14 August 2017 molecular weight polyethylene inlays are known for significant wear, and the following generation,
Received in revised form highly cross-linked polyethylene (HCLPE), has shown promising in vitro and short-term in vivo results.
9 March 2018
This study aimed to investigate wear debris of HCLPE liners with ceramic heads after 9 years to reveal the
Accepted 11 March 2018
Available online 17 March 2018
in vivo wear kinetics of this common bearing combination.
Methods: Fifty-seven patients (72 hips; 46.5 ± 15.5 years; range 16-76 years) who underwent hip arthro-
plasty with an HCLPE liner (28- or 32-mm Biolox forte ceramic head) were followed up (mean 9.1 ± 2.4 years;
Keywords:
wear
range 3.9-13.8 years). Conventional anteroposterior X-rays were analyzed using Hip Analysis Suite software.
HCLPE Results: Volumetric wear had a mean of 38.67 ± 22.09 mm3/year, 333.08 ± 183.93 mm3 overall, and
PE linear wear was 0.063 ± 0.03 mm/year and 0.546 ± 0.27 mm overall. Male patients had a significantly
hip higher wear rate (46.42 ± 27.68 mm3/year) and total wear (400.71 ± 235.21 mm3). Larger femoral heads
arthroplasty had a significantly higher wear rate (43.10 ± 23.93 mm3/year) and total wear (364.23 ± 203.68 mm3).
Regression analysis showed a significant cubic relationship (R2 ¼ 0.307) with increasing yearly wear after
approximately 108 months postoperatively.
Conclusions: HCLPE liners show significant in vivo wear after 9 years. While the total wear compared to
ultra high molecular weight polyethylene liners was decreased, the wear kinetics show a comparable
course. The increase in wear rate after only 108 months postoperatively is especially alarming. Longer
term follow-up is needed to distinguish the long-term superiority of HCLPE liners in polyethylene-
ceramic paired hip arthroplasty.
© 2018 Elsevier Inc. All rights reserved.

Total hip arthroplasty (THA) has shown excellent clinical results
over the past 40 years [1]. However, the durability and longevity of
implants are limited, and aseptic implant loosening remains a
major concern in the context of an aging society with an increasing
activity level [2e4]. Aiming to reduce polyethylene (PE) wear,
highly cross-linked polyethylene (HCLPE) has shown promising
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.03.027.
* Reprint requests: Constantin Mayer, MD, Department of Orthopedics, University
of Duesseldorf, Moorenstraße 5, 40225 Duesseldorf, Germany.
in vitro [5e8] and short-term in vivo results [9] with low friction
rates and decreased reduced wear debris [10]. Smaller particles are
not associated with particle disease [11,12], and significantly lower
wear rates have promised excellent long-term results [13e15]. In
contrast, Al2O3 ceramic heads are known for their outstanding
in vitro properties because of their hard, plain surface and, so far,
excellent clinical results [16e18]. Their use in THA has increased
over the past decades, especially as this higher density composite
ceramic with a smaller grain size shows reduced microcracking and
fewer phase transformations [19,20]. Today, ceramic failure is most
often caused by fracture, with fracture rates ranging from 0.004%
[21] to 1.7% in a ceramic-ceramic bearing combination [22]. Settings
for PE and ceramic have been well studied, but there is a lack of
evidence regarding the long-term in vivo results of the HCLPE-

https://doi.org/10.1016/j.arth.2018.03.027
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2672 C. Mayer et al. / The Journal of Arthroplasty 33 (2018) 2671e2676

ceramic bearing combination [23,24]. Assessment of HCLPE wear
over repeated assessments on the same patient can give informa-
tion about the progression of debris formation and the kinetics
(wear kinetics). The aim of this present study was to assess the
course and the long-term clinical and radiographic outcomes of
THAs with ceramic heads (28 and 32 mm) and HCLPE inserts over a
time course of 3.9-13.8 years.
Materials and Methods
This is a long-term follow-up study of our initial medium-term
prospective study on HCLPE wear [9]. This prospective study
included 110 THAs (96 patients) performed at our institution be-
tween 2002 and 2009. All patients were treated through an ante-
rolateral approach with the following implant combination: a
porous-coated press-fit cup (Duraloc Sector Type; DePuy Ortho-
paedics Inc./Johnson & Johnson, Warsaw, IN) with 2 cranial fixation
screws, an HCLPE liner (Marathon; DePuy Orthopaedics Inc.), a
modular titanium stem allowing a metaphyseal fixation (S-ROM;
DePuy Orthopaedics Inc.), and a standard 32-mm (n ¼ 50) or 28-
mm (n ¼ 22) ceramic (Al2O3) femoral head (Biolox forte; DePuy
Orthopaedics Inc.). During the study period, 39 patients were lost to
follow-up. Of these, 1 patient died from a cause unrelated to the
surgical procedure, 3 patients had to be revised surgically (insert
and head change due to early infection in 2 hips, stem change in 1
case due to trauma, not associated with wear), and 36 patients did
not show up for routine examination. Furthermore, 6 THAs were
included as these procedures were performed on the contralateral
side of already included patients within the initial time period
(Fig. 1). Therefore, 72 hips in 57 patients could be included in this
study (28 men with 32 hips and 29 women with 40 hips), 38 left
hips and 34 right hips, 50 hips with a 32-mm head, and 22 hips
with a 28-mm head. Fifteen patients underwent THA on both sides
with the described combination of implants. The mean follow-up
period was 9.1 ± 2.4 years (range 3.9-13.8 years), the mean pa-
tient age at the time of surgery was 46.6 ± 15.5 years (range 16.1-
76.0 years), and the mean body mass index (BMI) was 26.43 ± 5.01
kg/m2 (range 14.86-40.9 kg/m2).
In our clinical routine, clinical and radiographic examinations
are performed once per year for each patient. Therefore, we had
several consecutive anteroposterior radiographs with the patient in
a supine position and the X-ray beam centered on the pubic sym-
physis for each patient, with the number of X-rays depending on
the length of the follow-up period. Patients were seen after
approximately 1 year (n ¼ 51), 4 years (n ¼ 49), 8 years (n ¼ 51), and
a final/maximum follow-up (n ¼ 37).
Stem sizes varied from 14  9 mm (n ¼ 12), 16  11 mm (n ¼ 22),
18  13 mm (n ¼ 29) to 20  15 mm (n ¼ 9). Cups ranging from 48
mm (n ¼ 16) to 62 mm (n ¼ 1) were implanted (50 mm, n ¼ 7; 52
mm, n ¼ 22; 54 mm, n ¼ 13; 56 mm, n ¼ 7; 58 mm, n ¼ 4; and 60
mm, n ¼ 2). A 10-degree liner was used in 18 cases.
The indication for surgery was osteoarthritis in 33 cases, avas-
cular necrosis of the femoral head in 23 cases, developmental
dysplasia of the hip in 14 cases, and prior arthrodesis in 2 cases.
Fourteen patients (19.4%) had undergone surgical interventions
before the implantation of the THA (osteotomy, n ¼ 9; osteosyn-
thesis, n ¼ 2; arthrodesis, n ¼ 2; and coxitis, n ¼ 1).
As described previously [9], a semiautomatic, computer-
assisted, edge-detection Martell method [25] was used to deter-
mine the cup orientation and linear femoral head penetration and
to calculate the volumetric PE wear debris by performing a 2-
dimensional vector wear analysis (Hip Analysis Suite, version
8.0.4.4) [26]. The magnitude of femoral head penetration was
calculated by the software and expressed as the annual rate in
millimeters (2-dimensional) and as the volumetric annual wear
rate in cubic millimeters (3-dimensional). Algebraic signs were
used by the software to indicate the direction of the calculated
vector but were excluded from calculations with only absolute
values being used for statistical analysis. The presence of osteolyses
was assessed by an independent observer. Femoral osteolyses were
classified into zones described by Gruen et al [27] and those of the
acetabulum in the zones defined by DeLee and Charnley [28].
Osteolysis was not considered relevant unless it exceeded 2 mm.
Heterotrophic ossifications (HTOs) were categorized according to
the study by Brooker et al [29]. According to the results of the
Kolmogorov-Smirnov and Shapiro-Wilk tests for normality, we
used nonparametric tests including the Mann-Whitney U test,
Spearman rank correlation coefficient, and Kruskal-Wallis test. To
confirm significant changes in wear rates between the specific
measurement points, the Friedman and Wilcoxon signed-rank tests
were applied. Statistical evaluation was performed using SPSS,
version 22.0 (released 2013; IBM SPSS Statistics for Macintosh; IBM
Corp., Armonk, NY).

Results

Overall yearly linear head penetration, and thus the HCLPE wear,
was 0.063 ± 0.03 mm/year, adding up to a total of 0.546 ± 0.27 mm
after 9 years on average. The calculated volumetric abrasion was
38.67 ± 22.09 mm3/year and 333.08 ± 183.93 mm3 on average over
the follow-up period. Implant and patient characteristics were
similar between male and female patients in regard to age at
operation, BMI, cup inclination, and anteversion (Table 1). Annual

Table 1
Clinical Details and Patient Characteristics.

Female Male Total

Persons/number (N) 29/40 28/32 57/72

BMI (kg/m2) 26.2 ± 5.6 26.2 ± 4.9 26.4 ± 5.0
Age at operation (y) 43.4 ± 15.3 50.1 ± 14.3 46.6 ± 15.5
Cup inclination ( ) 37.1 ± 12.0 36.0 ± 8.3 36.6 ± 10.5
Cup anteversion ( ) 17.0 ± 7.2 16.4 ± 6.0 16.8 ± 6.7
Head size (28 mm/32 mm) 21/19 1/31 22/50
Follow-up (y) 9.21 ± 2.59 8.96 ± 2.26 9.1 ± 2.43

Fig. 1. Flowchart of patient enrollment. BMI, body mass index.

 C. Mayer et al. / The Journal of Arthroplasty 33 (2018) 2671e2676
Fig. 2. Calculated volumetric wear vs follow-up for HCLPE-Al2O3. Blue dots: 28-mm HCLPE liners; yellow dots 32-mm HCLPE liners. Black graph represents combined wear kinetics
of 28- and 32-mm HCLPE liner.
wear rates from consecutive radiographs of each patient revealed a
significantly higher (P < .001) linear yearly wear rate during the
first 12 months (0.23 ± 0.14 mm/year) than those calculated for the
second to fourth year (0.13 ± 0.12 mm/year; calculated by sub-
tracting the wear after 1 year from the total wear after 4 years,
divided by 3). The volumetric measurements demonstrated similar
development within the first year (92.67 ± 58.66 mm3/year) and
the consecutive follow-up analyses for wear from the second to
fourth year (38.59 ± 39.01 mm3/year). Analyses of further follow-
up revealed decreased mean volumetric wear (P < .052) for years
4 to 8 (24.45 ± 27.31 mm3/year; calculated by subtraction of total
volumetric wear after 8 years from wear after 4 years, divided by 4)
compared to the calculated mean wear for years 2 to 4. The
calculated mean yearly wear rate for years 5 to 8 was increased
compared to the wear rate at over 8 years (45.63 ± 33.72 mm3/year,
P < .004; calculated by subtraction of volumetric wear of the
longest follow-up measurement minus wear at 8 years, divided by
the number of years in between).
Time Course
Regression analysis was performed for 2-dimensional and 3-
dimensional wear. A triphasic process (cubic function) showed the
largest coefficient of determination (r2) for data of total wear (mm3)
at follow-up time (months). Regression analysis showed a good
correlation (r2 ¼ 0.307) with y ¼ 42.44 þ 5.042x  0.035x2 þ
0.0001082x3. The data are presented in Figure 2. This mathematical
function includes a “plateau phase” emerging after approximately 48
months (4 years), followed by a later increase in total wear values
after approximately 107.8 months (approx. 9 years). Yearly wear
rates were best matched using a quadratic function (y ¼ 109.319 
1.317x þ 0.0055x2) with the minimum (mathematical vertex) at
approximately 119.7 months (approx. 9.8 years) indicating the
lowest yearly wear. These results are presented in Figures 2 and 3.
Head Size
Femoral head size showed significantly higher yearly (P > .02)
and overall volumetric (P < .038) wear for the 32-mm heads
2673
compared with the 28-mm heads (43.10 ± 23.93 vs. 28.58 ± 12.67
mm3/year and 364.23 ± 203.68 vs. 262.26 ± 100.08 mm3, respec-
tively), although the follow-up measurements for both subgroups
were comparable (8.84 ± 2.59 vs. 9.68 ± 1.98 years, respectively).
Notably, 27 of 28 male patients were fitted with a 32-mm femoral
head. When only women were analyzed, patients who received 28-
mm femoral heads (n ¼ 19) had significantly higher linear head
penetration (0.58 ± 0.30 mm) than women who received 32-mm
femoral heads (n ¼ 21; 0.45 ± 0.17 mm) after 9.21 ± 2.59 years
(P > .025).
Patient Characteristics
No significant difference (P > .05) was found regarding BMI
subgroups (<18.5 kg/m2, n ¼ 2; <25 kg/m2, n ¼ 29; <30 kg/m2, n ¼
24; <35 kg/m2, n ¼ 14; and <40 kg/m2, n ¼ 3). The total volumetric
wear and yearly volumetric wear were significantly higher (P < .03)
for men (mean follow-up of 8.96 ± 2.26 years) than for women
(mean follow-up of 9.21 ± 2.59 years; 46.42 ± 27.68 vs. 32.47 ±
13.82 mm3/year and 400.71 ± 235.21 vs. 278.97 ± 104.21 mm3,
respectively). Age at operation (P > .160), preoperative diagnosis (P
> .41), prior operations (P > .164), and component size variables
(excluding head size) did not significantly influence the measured
outcome parameters. Radiologic signs for bone demineralization
(atrophy) showed a negative correlation with linear wear rates (r ¼
P ¼ .42).
Cup Positioning
Regarding cup positioning, the acetabular component ante-
version (mean 16.73 ± 6.69 ) and inclination (mean 36.64 ± 10.47 )
were calculated by the software. Although some cups (<30 , n ¼ 17;
and >50 , n ¼ 5) were implanted outside the so-called safe zone
[30], none of the patients experienced a dislocation. Moreover, cup
anteversion did not have a significant impact on yearly linear wear
(P > .235). Cup inclination angles of 40 to 45 were associated with
lower yearly linear head penetration (0.05 ± 0.19 mm/year)
compared to steeper (45e49.9 , 0.06 ± 0.04 mm/y; >50 , 0,07 ±
0.03 mm/year) as well as flatter (35e39.9 , 0.06 ± 0.3 mm/y;
2674 C. Mayer et al. / The Journal of Arthroplasty 33 (2018) 2671e2676

Fig. 3. Calculated volumetric wear per year vs follow-up for HCLPE-Al2O3. Blue dots: 28-mm HCLPE liners; yellow dots 32-mm HCLPE liners; graph represents combined yearly
wear kinetics of 28- and 32-mm HCLPE liners.

30e34,9 , 0.06 ± 0.01 mm/y; <30 , 0.08 ± 0.04 mm/y) cups
(Spearman's rho P < .042). Calculated volumetric wear per year
revealed a trend (P < .061) when the inclination angles were sub-
grouped into 6 zones (<30 , n ¼ 17; <35 , n ¼ 9; <40 , n ¼ 18;
40e45 , n ¼ 16; 45e50 , n ¼ 7; >50 , n ¼ 5).
Osteolyses and Heterotrophic Ossification
Nine THAs showed osteolytic lesions in at least 1 Gruen zone of
the femoral bone interface, while no pelvic osteolyses were
observed (Fig. 4). One focal osteolysis was detected in Gruen zone 7.
Furthermore, 25 THAs developed HTOs after surgery. These were
classified according to the study by Brooker et al [29] as either class
1 (n ¼ 15), class 2 (n ¼ 7), or class 3 (n ¼ 3), with men (n ¼ 20) being
4 times more likely to develop an HTO. The incidence of HTO was
not associated with increased 2-dimensional and 3-dimensional
wear (P > .431).
vitamin E or subsequent annealing to retain the mechanical prop-
erties [37].
The results of our study are in line with previous studies of
HCLPE. The linear head penetration observed in the present study
was lower than the values measured by Hopper et al [31] after 2.9
years (0.08 ± 0.24 mm/year); however, these authors not only used
a different software but also included negative penetration values.
Bitsch et al [14], using the same software used by Martell and
Berdia [25], found 0.031-mm linear penetration and 15.4 mm/year
volumetric wear rate after a minimum of 5 years, reflecting the
decreasing wear trend after bedding-in and considering the pos-
sibility of overestimation of true wear when creep is not accounted
for [38,39]. Other authors who also used Martell's method, such as
Reynolds et al [34], found a mean penetration rate of 0.339 ± 0.224
mm after an average of 9 years of follow-up of HCLPE liners, with a
yearly penetration rate of 0.037 ± 0.022 mm/year. This is compa-
rable to our data, especially the calculated penetration rates for the
second to fourth year of implant survival. On the other hand,

Discussion

Wear debris studies of HCLPE have shown good to excellent

results for short-term in vivo surveillance and improved in vivo and
in vitro wear [7,8,10,12,14,24,31,32]; however, long-term data are
still limited, and the results are ambiguous [33,34].
This study is the first to report a 9-year follow-up, on average, of
more than 70 THAs with a HCLPE liner. Our data clearly show sig-
nificant wear in HCLPE liners, including the progression over time
(wear kinetics), which was found to be comparable to the degra-
dation of conventional PE liners. In addition, we detected a
considerable difference in wear between 32- and 28-mm heads,
with more wear observed in bearings with larger heads.
HCLPE liners, such as the Marathon liner, were introduced to
optimize the wear rates of known PEs [35]. The cross-linking of PE,
a key procedure to improve resistance, generates free radicals.
Subsequent remelting aims to neutralize these free radicals, but it
cannot achieve complete elimination [36]. Second-generation Fig. 4. Location (dark gray) and number (light gray) of osteolytic lesions wider than 2
HCLPE tries to avoid the loss of crystallinity by the addition of mm according to Gruen [36] and DeLee [37] zones.
 C. Mayer et al. / The Journal of Arthroplasty 33 (2018) 2671e2676
Bookman et al [40] found slightly increased wear rates (0.092 ±
0.055 mm/y) after 10 years of follow-up using the same liner as in
our study. Alarmingly, Dowd et al [41] reported a strong correlation
of osteolysis with increased wear rates, with 43% of patients treated
with CoCr-PE bearings showing wear rates of 0.1e0.2 mm/year after
9 years. In our series, this amount of HCLPE wear was not uncom-
mon, with the majority of our patients with HCLPE liners showing
this amount of wear over the first 4 years.
Most commonly, research has evaluated the improvement of
PEs based on the differences in wear between nonecross-linked
ultra high molecular weight polyethylene (UHMWPE) and HCLPE
[24]. The Marathon liner was the focus of 2 randomized controlled
trials [42,43] with 4-7 years of follow-up. Linear head penetration
of the 209 cases included in the study by Engh et al [42], who also
used the Martell method in anteroposterior radiographs, was 0.24
± 0.42 mm after an average follow-up of 5.5 years. This was 81% less
than the randomized Enduron liner group but is almost comparable
to the 9-year follow-up values of females who received the 28-mm
head in our cohort (0.58 ± 0.30 mm), although a cobalt-chrome
femoral head is compared to a Biolox head. Nevertheless, other
studies comparing similar products manufactured by other com-
panies in a randomized manner were all in favor of HCLPE in regard
to wear debris. Glyn-Jones et al [44] compared Trilogy with
Longevity liners in 54 cases over a 24-month follow-up, observing
decreased liner penetration and Garcia-Rey et al [23] compared
Sulene and Durasul liners in 90 cases over 63 months with similar
results and concluded that UHMWPE liners show increased wear,
especially after 2 years, considered “true wear.”
Interestingly, Manning et al [8] not only compared the overall and
yearly wear using Martell's method for UHMWPE and HCLPE
(Durasul and Longevity) match-pairs (including 28-mm CoCr heads)
but also tested for a “steady-state” phase in the wear of HCLPE liners
after 2 (up to 3.5) years of follow-up, accounting for a possible de-
viation in wear characteristics. These authors concluded that
“steady-state wear was unchanging as a function of time.” Similarly,
although mentioning annual X-rays, Bookman et al [40] analyzed
only 2 time points (1 postoperative and 1 at the latest follow-up) and
did not find a “large increase in wear.” In contrast, our study con-
sisted of twice as many implants and a much younger population,
and we analyzed several consecutive X-rays per individual.
For UHMWPE, after bedding-in [45], there is known to be a
“plateau” phase which is said to represent true wear. This has been
reported to be approximately 0.08-0.13 mm for UHMWPE and
0.031 mm for HCLPE per year [14]. For conventional PE, a rapid
increase in wear has been described after 9 to 10 years [33,46,47],
and the HCLPE liners in our cohort resembled these kinetics (Fig. 2).
The calculated turning point for that function was at 118 months,
just short of 9 years after implantation, representing the start of a
period of increasing wear debris for HCLPE liners. Our results are
similar to a recent study performed by Tsukamoto et al [33], who
found increased wear rates of HCLPE in 41 cases after 15 years of
implantation. The reasons for this might be smaller particles with
increased inflammation [11,48], later oxidation [49], and a decrease
in cross-linking because of exposure to cholesterol [50,51].
The promising qualities of HCLPE so far have encouraged sur-
geons to use larger diameter articulations to reduce the risk of
dislocation [52] and improve the range of motion [53]. The short-
term results for the use of large-diameter heads has failed to
prove high wear debris, but have most often reported reduced wear
of large heads with HCLPE liners in comparison to conventional PE
[54]. Contradictory to this, the results of this present study
demonstrated that 32-mm heads were associated with significantly
higher wear (mm3) compared to the 28-mm heads overall, while
the linear head penetration (mm) was slightly increased for the 28-
mm heads compared to 32-mm heads in women after the complete
2675
follow-up. As a smaller surface area is more likely to penetrate, this
is possibly due to the reduced diameter. Earlier results of HCLPE
in vitro studies are ambiguous. Howie et al [55] surprisingly found
no difference in wear between 36- and 28-mm cobalt-chrome
femoral heads on HCLPE liners after 3 years. Other authors have
found significantly more volumetric wear of HCLPE liners in com-
bination with titanium or cobalt-chrome alloy femoral heads of 36
or 40 mm in diameter [56]. These differences in wear rates may be
of greater importance in a young and active patient cohort with
long-standing implants and a high demand, despite the advantages
of large-diameter heads.
This study has some limitations. There was a significant number
of patients lost to follow-up (39 of 96 patients), and patient char-
acteristics such as preoperative diagnosis were heterogeneous. In
addition, owing to the impaired numbers, we were unable to
determine the effect of liner thickness on calculated wear, which
might affect the amount of wear. Moreover, we exclusively studied
a single product (Marathon liner) of a group of highly cross-linked
PE liners. These are produced by several companies, also with dif-
ferences in the manufacturing process itself. Therefore, as a matter
of evidence-based medicine, our findings only apply to this specific
product, and may not necessarily be applied to similar products. In
addition, no clinical assessment of activity or symptoms associated
with wear was made over the course of follow-up. After all, no
patient had undergone revision surgery for wear debris or osteol-
ysis. Finally, our results are reliant on and a product of a comput-
erized process and the well-evaluated Martell method.
Conclusion
In summary, the results of this cohort and the associated
implant confirm the well-known wear rates of HCLPE and
demonstrate an alarming increase in wear rates comparable to
conventional PE after an average of 9-year follow-up. The critical
milestones after 9 years and the long-term results should neces-
sarily be monitored very closely. Unmindful implantation of HCLPE
should be carefully considered, especially in young and active pa-
tients, with a trend toward larger diameter articulations.
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 The Journal of Arthroplasty 33 (2018) 2575e2581

Contents lists available at ScienceDirect

The Journal of Arthroplasty

journal homepage: www.arthroplastyjournal.org

Complications - Infection

What Is the Role of Diagnostic and Therapeutic Sonication in

Periprosthetic Joint Infections?
Rita Hameister, MD a, Chin T. Lim, MD, FRCS(Ed) b, Christoph H. Lohmann, MD c,
Wilson Wang, MD, FRCS(Glas) b, Gurpal Singh, MD, FRCS(Ed) b, *
a
Department of Anatomy, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
b
National University Health System, University Orthopaedics, Hand and Reconstructive Microsurgery Cluster, Singapore, Singapore
c
Department of Orthopaedic Surgery, Otto von Guericke University Magdeburg, Magdeburg, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Background: Periprosthetic joint infection (PJI) is one of the most dreaded complications in joint
Received 30 November 2017 replacement surgery. Diagnosis and treatment can be difficult and biofilms are of major concern due to
Received in revised form their low susceptibility toward antibiotics.
17 February 2018
Methods: This review focuses on the use of sonication as an evolving diagnostic and adjunct treatment mo-
Accepted 20 February 2018
Available online 28 February 2018
dality in the context of PJI. Therapeutic application of sonication is discussed separately for its (i) direct action on
bacteria, (ii) synergistic effects with antibiotics, and (iii) effects on release of antibiotics from bone cement.
Results: Used as a diagnostic tool, sonication shows promising results with respect to sensitivity and
Keywords:
periprosthetic joint infection
specificity when compared to conventional methods, notably after previous administration of antibiotics.
sonication As an adjunct treatment modality, the chemical, physical, and mechanical effects of sonication are
biofilm primarily driven by cavitation and recognized as the main cause for bactericidal effects but the exact
arthroplasty underlying mechanisms have not been identified yet. Sonication alone does not have the ability to
diagnosis completely eradicate biofilms but synergistic effects when used in conjunction with antibiotics have
treatment been reported. There is also evidence for enhanced antibiotic release from bone cement.
Conclusion: Sonication is as an evolving modality in the context of PJIs. As a diagnostic tool, it has not
been introduced in routine clinical practice and sonication as a treatment modality in PJIs is still in an
experimental stage. Factors such as frequency, pressure, chemical activity, intensity, and exposure time
need to be evaluated for optimal application of sonication and may also improve study comparison.
© 2018 Elsevier Inc. All rights reserved.

Infection Is a Dreaded Complication in Total Joint
Arthroplasty
Periprosthetic joint infection (PJI) (Table 1) is one of the most
dreaded complications in joint replacement surgery. Currently, the
This work was supported by the National Medical Research Council (NMRC)
Singapore under grant agreement NMRC/CNIG/1147/2016.
One or more of the authors of this paper have disclosed potential or pertinent
conflicts of interest, which may include receipt of payment, either direct or indirect,
institutional support, or association with an entity in the biomedical field which
may be perceived to have potential conflict of interest with this work. For full
disclosure statements refer to https://doi.org/10.1016/j.arth.2018.02.077.
* Reprint requests: Gurpal Singh, MD, FRCS(Ed), Division of Musculoskeletal
Oncology & Hip and Knee Surgery, Hand and Reconstructive Microsurgery Cluster,
National University Health System, 1E, Kent Ridge Road, Singapore 119228,
Singapore.
overall risk for implant-associated infection in orthopedic surgery
is below 1%-2% [3]. A complication-based analysis using worldwide
registry data has demonstrated that in total hip arthroplasty, total
knee arthroplasty, and total ankle arthroplasty, septic revision
accounts for 7.5%, 14.8%, and 9.8% of all revision surgeries, respec-
tively [4]. With increasing numbers of patients undergoing joint
replacement surgery, the absolute number of implant-associated
infections has increased [3], representing a trend that is counter-
intuitive to the expected decrease in infection rates over time.
Biofilms are fundamental with respect to the pathogenesis and
persistence of PJIs. Biofilms are defined as “a microbially derived
sessile community, characterized by cells that are irreversibly
attached to a substratum or interface or to each other, embedded in a
matrix of extracellular polymeric substances that they have pro-
duced, and exhibit an altered phenotype with respect to growth rate
and gene transcription” [5]. As a result, biofilm bacteria, compared to
free-floating bacteria (planktonic bacteria), display characteristics

https://doi.org/10.1016/j.arth.2018.02.077
0883-5403/© 2018 Elsevier Inc. All rights reserved.
2576 R. Hameister et al. / The Journal of Arthroplasty 33 (2018) 2575e2581
Table 1
Modified MSIS Criteria by the MSIS defining PJI as endorsed by the International
Consensus Meeting on PJIa [1,2].

Two positive periprosthetic cultures with phenotypically identical organisms
OR

Sinus tract communicating with the joint OR

Three of the following minor criteria:
1 Elevated serum C-reactive protein and erythrocyte sedimentation rate
2 Elevated synovial fluid white blood cell count or þþ change on leukocyte
esterase test strip
3 Elevated synovial fluid polymorphonuclear neutrophil percentage
4 Single positive culture
5 Positive histological analysis of periprosthetic tissue
a
PJI may be present without meeting these criteria, specifically in the case of less
virulent organisms [1].
that affect the identification of the causative organisms and antimi-
crobial therapy [6]. Biofilms may be formed by virulent bacteria or
other opportunistic microorganisms, thus increasing the chance of
biofilm formation on dead tissues and medical devices. This is clin-
ically important as various studies have shown that treatment of
biofilm bacteria is much more challenging compared to planktonic
bacteria [7,8]: 100-1000 times the standard concentration of cell wall
active antibiotics, for example, is required when treating biofilm
bacteria [9]. The presence of extracellular matrix, heterogeneity of
bacteria, expression of antibiotic resistance genes, and the commu-
nication system in biofilms, also known as “quorum sensing”, are
some of the factors contributing to the lower susceptibility of biofilm
bacteria toward antibiotics. These bacterial features are reviewed in
detail elsewhere [5,8,10e13].
Sonication as a therapeutic approach in treating biofilms is well
studied in dental literature and has also been reported in the
context of soft tissue infections and wound healing [14e18]. The
concept of sonication has been adopted by orthopedic surgery in
clinical practice with regards to diagnosis of PJIs [19]. Experimental
studies have further investigated the potential use of sonication in
treating biofilms early after implantation of biomaterials [20e22].
This review focuses on sonication as an evolving diagnostic and
adjunct treatment modality in the context of PJI.
Sonication
The application of sound energy is known as sonication. The
chemical, physical, and mechanical effects of sonication are pri-
marily driven by cavitation. Cavitation describes the growth, oscil-
lation, and collapse of microbubbles in a medium that can produce
high-energy phenomena [23,24]. The initiation of cavitation, also
known as cavitation threshold, is determined by various factors
including hydrostatic pressure, dissolved gas tensile strength, the
temperature of the liquid medium, and the volume of gas in the
bubble [25]. According to Joyce et al [26] antimicrobial mechanisms
include (i) cell fatigue secondary to forces from surface resonance of
the bacterial cells, (ii) shear forces induced by microstreaming, and
(iii) chemical effects of radicals in aqueous medium including the
formation of hydrogen peroxide by sonochemical degradation.
These authors pointed out that higher intensities result in superior
cavitational effects. Typically, frequencies between 20 and 200 kHz
are considered as low-frequency, whereas high-frequency ultra-
sound uses frequencies of more than 1 MHz [27]. Ultrasound can be
applied continuously or in a pulsed manner.
Sonication as an Adjunct Diagnostic Option
An early and accurate diagnosis of PJI is crucial for patient
management as a direct correlation between failure in prompt
diagnosis and outcome has been shown [28,29]. The Musculo-
skeletal Infection Society has proposed criteria (MSIS criteria)
based on which a PJI can be diagnosed. These criteria, endorsed and
slightly modified by the Philadelphia Consensus group on PJI, are
outlined in Table 1 [1,2]. Conventional diagnostic methods include
clinical presentation, joint fluid cell count, imaging studies, histo-
pathology, inflammatory markers, and microbiological assessment.
Various new diagnostic options have been recently proposed
including molecular techniques, nuclear imaging modalities, and
other techniques such as microcalorimetry, the alpha-defensin
immunoassay, and the leukocyte esterase colorimetric strip test
[30e32]. Further innovative techniques that are in development
include microarrays, electrical methods, and matrix-assisted laser
desorption/ionization time-of-flight mass spectrometry [30].
Among them, sonication is recognized as a promising entity.
Diagnostic sonication is based on the disruption of the biofilm
from the retrieved prosthetic components with the aim to increase
the yield of cultures and/or histopathology. Although different
protocols for sonication of retrieved prosthetic components have
been described, most studies follow the recommendations by
Trampuz et al [28]. A representative diagnostic sonication process is
illustrated in Figure 1.
To date, different types of implants including modular mega-
prostheses [33] and cement spacers at the time of second-stage revi-
sion surgery [34,35] have been subjected to sonication. Sonication of
spacers might be particularly useful in determining the presence of
(subclinical) infection at the time of second-stage revision surgery.
Prospective studies have shown that sonication results of antibiotic-
loaded cement spacers can predict failure during two-stage revision
[36] and that high bacterial counts from the sonicate are associated
with inferior clinical outcomes [37]. Despite the fact that culture results
of the sonicate are only known postoperatively and, thus, may not
guide intraoperative decision making, these results may be essential for
future management and overall prognosis of the patient [36].
Numerous studies have focused on the diagnostic effect of
sonication by culture of the sonicate fluid alone or in combination
with molecular techniques [28,36,38e48]. The improved sensitivity
of sonication as compared to conventional tissue culture has been
particularly shown in patients who received antibiotic treatment
prior to revision surgery [28,39e42]. Table 2 provides an overview
of studies comparing the effect of previous antibiotic treatment on
the sensitivity of sonication as a diagnostic adjunct in PJIs.
Two meta-analyses comprising 12 and 16 clinical trials showed a
pooled sensitivity of 0.80 (95% confidence interval [CI] 0.74-0.84) and
0.79 (95% CI 0.76-0.81) and a pooled specificity of 0.95 (95% CI 0.90-
0.98) and 0.95 (95% CI 0.94-0.96), respectively [19,49]. Limitations of
these analyses include the incorporation of heterogeneous patient
cohorts and studies that have used PJI definitions which deviate from
the MSIS consensus criteria. A recent diagnostic level III study has
strictly used the MSIS consensus criteria for definition of PJI and
investigated sonicate cultures from patients with revision total hip
arthroplasties and total knee arthroplasties preoperatively and
intraoperatively at each stage. These authors concluded that sonicate
cultures in revision surgeries improved the diagnostic accuracy of
joint infection cultures for both, clinical and occult infections [50].
Sonication has further been combined with other diagnostic
methods such as molecular techniques. Literature suggests that
these combinations are of similar sensitivity and specificity
compared to sonicate fluid culture but superior in detecting PJIs
compared to conventional tissue culture [38,40,51e55].
Limitations and Controversies
Defining the optimal cut-off for the bacterial count from the
sonicate is an inherent problem in any method that is based on
 R. Hameister et al. / The Journal of Arthroplasty 33 (2018) 2575e2581 2577

Fig. 1. A representative sonication process for use in diagnosis of PJIs.

quantitative measurement. So far, there is no general consensus host's immune system and becomes clinically relevant as a
in diagnosing PJIs based on bacterial count, making direct study manifest infection. On the other hand, early detection of bacteria
comparison difficult. It is currently not known at which point an in cases of subclinical colonization may result in overtreatment. A
(asymptomatic) colonization is no longer suppressed by the careful interpretation of obtained results, taking into account the

Table 2
Effect of Previous Antibiotic Treatment on Sensitivity of Sonication as an Adjunct Diagnostic Option in PJIs.

Author (year) Protocol Diagnostic Method Sensitivity Cut-Off Setting for

Administration
No Previous Administration Previous
of Antibiotics
of Antibiotics or Administration
Overall Sensitivity of Antibiotics

Trampuz 30 s vortexing Tissue culture 61% overall 41% 5 CFU Antimicrobial-free

et al (2007) [28] Sonication 40 kHz, 5 min 48% days
30 s vortexing 77% 0-3
Sonicate fluid culture 79% overall 59% 4-14
87% >14
82%
Achermann 30 s vortexing Sonicate fluid culture 77% 42% 1 CFU Preoperative
et al (2010) [38] 1 min, 40 kHz Sonicate fluid multiplex 56% 100% antimicrobial
30 s vortexing PCR treatment for 9 d
Holinka 30 s vortexing Tissue culture 72% 58% Any growth Preoperative
et al (2011) [39] 5 min, 35 kHz Gram staining from 77% 55% antimicrobial
30 s vortexing the sediment of the treatment for 14 d
sonication fluid
Sonicate fluid culture 83% 65%
Cazanave 30 s vortexing Tissue culture 83% overall 70% Any growth Preoperative
et al (2013) [40] 5 min sonication, 40 kHz 76% antimicrobial
30 s vortexing Sonicate fluid culture 73% overall 70% treatment for
78% 14 d28 d
Sonicate fluid PCR 77% overall 88%
86%
Portillo 1 min vortexing Vortexing 40% overall 30% 1 CFU Preoperative
et al (2013) [46] 5 min sonication, 40 kHz Vortexing-sonication 60% overall 39% antimicrobial
1 min vortexing treatment for 24 h
Scorzolini 30 s vortexing Tissue culture 57% 17% 5 CFU Preoperative
et al (2014) [41] 5-7 min sonication, 40 kHz Sonicate fluid culture 80% 75% antimicrobial
Vortexing again for 30 s treatment for 15 d
Portillo 30 s vortexing Tissue culture 65% 55% Any growth Previous
et al (2015) [42] 1 min sonication, 40 kHz Sonicate fluid culture 100% 77% antimicrobial
30 s vortexing Sonication fluid inoculated 100% 100% therapy for 24 h
into blood culture bottles within 14 d
preoperatively
Shen Vortexing 30 s Synovial fluid culture 72% 52% Any growth Preoperative
et al (2015) [47] 10 min, 28 kHz Sonicate fluid culture 93% 81% antimicrobial
30 s vortexing inoculated into blood treatment for 14 d
culture bottles

CFU, colony forming unit; PCR, polymerase chain reaction.

2578 R. Hameister et al. / The Journal of Arthroplasty 33 (2018) 2575e2581
patient's history and clinical symptoms, is therefore
recommended.
Sonication effects during processing may affect bacterial
metabolic activity and proliferation which might translate into
prolonged bacterial recovery. Incubation time of bacterial culture
has therefore been widely discussed, especially since an increased
rate of bacterial recovery has been shown for a longer incubation
time [56]. The majority of studies, however, have applied incuba-
tion times of 7 days for aerobic bacteria and 14 days for anaerobic
specimens.
Species identification may be challenging since sessile bacteria
are known for variations in biochemical reactions and phenotype.
One study noted that in contrast to cultures from synovial fluid
which only showed species with the normal phenotype, some
periprosthetic tissue cultures and all investigated sonication fluids
revealed bacterial variants [57]. Further subcultures then demon-
strated the reversion of most isolates to the normal phenotype.
Thus, the risk of misleading species identification after sonication,
especially with regards to Gram-negative bacteria, needs to be
taken into consideration [57]. Based on analysis of different bacteria
species investigated under various conditions, Monsen et al [58]
proposed an experimental protocol and highlighted four factors
as being important for diagnostic sonication: type of organism,
exposure time, temperature of the sonication buffer, and the
properties of the tube in which sonication is performed. The stan-
dardized use of sterile air-tight and wide-mouthed plastic con-
tainers for collecting sonication fluids has been widely established
after contamination due to leakage of plastic bags has been
recognized [43].
Despite promising emerging evidence for sonication in the
diagnosis of PJI, issues such as cost-effectiveness and availability of
resources need to be considered. The Philadelphia consensus
statement on PJI declared that there is currently no role for routine
sonication of explanted prosthetic material. According to these
recommendations, sonication should be used “only in limited cases
with suspected or proven PJI based upon clinical presentation and
other testing in which preoperative aspiration does not yield
positive culture and antibiotics have been administered within the
previous two weeks” [1]. In summary, sonication of prosthetic
components shows promise as an adjunct diagnostic option in the
context of PJIs in terms of sensitivity and specificity, especially in
Fig. 2. Therapeutic effects of sonication as a result of cavitation leading to inactivation, deagglomeration, and removal of bacteria, synergistic effects with antibiotics, and enhanced
release of antibiotics from bone cements in the context of PJI.
patients who received preoperative antibiotic therapy but
sonication has not been established in routine clinical work-up
of PJIs.
Sonication as an Adjunct Treatment Option
Two-stage exchange arthroplasty is currently widely accepted
as the “gold standard” in treating PJIs [59,60]. This approach is
time-consuming, stressful, and characterized by high costs and
gross patient morbidity [61e63]. The potential alternative, a single-
stage revision surgery, which involves only one surgical procedure
and is associated with less patient morbidity and potentially lower
costs, is therefore appealing [63e65]. Although some studies report
promising results in terms of infection control and functional
outcome, safety concerns remain. Resistance to rifampicin or cip-
rofloxacin has been noted to impede successful one-stage exchange
arthroplasty [66]. According to the Philadelphia consensus state-
ment on PJI, relative contraindications for one-stage revision sur-
gery include failed preoperative identification of the causative
microorganism, the presence of a sinus tract, and/or severe soft
tissue involvement [1]. One-stage exchange arthroplasty has been
further described as a nonviable option in cases where a reduction
of the bioburden is needed [1]. The question arises as to whether
intraoperative sonication treatment can help to eradicate biofilms,
thus reducing the overall bioburden and potentially facilitating
one-stage exchange revision surgery.
In the following section, therapeutic application of sonication is
discussed separately in the context of (i) direct action on bacteria,
(ii) synergistic effects with antibiotics, and (iii) effects on release of
antibiotics from bone cement. An overview of therapeutic effects of
sonication in PJIs is provided in Figure 2.
Direct Action on Bacteria
Three aspects might be differentiated with respect to direct
effects on bacteria following sonication, namely (i) bacterial adher-
ence on surfaces, (ii) bacterial viability/inactivation, and (iii) biofilm
destruction. As mentioned under the section “Sonication as an
Adjunct Diagnostic Option,” bacterial adherence on surfaces is vital
for biofilm formation. Although diagnostic sonication is based on
biofilm disruption and detachment, it does not mean that the reverse
 R. Hameister et al. / The Journal of Arthroplasty 33 (2018) 2575e2581
is necessarily true. Indeed, bacterial adherence to surfaces has been
observed during exposure to low-frequency sonication [67]. This is
important as one may infer that sonication is not effective in pre-
venting the formation of biofilms. In view of the diverse experi-
mental settings with varying sonication parameters, the results for
bacterial adherence and detachment are not contradictory. Matrix
alterations in biofilms due to sonication seem to correlate with
applied intensities. This is evidenced by lack in structural change of
biofilms for low intensity ultrasound [68], whereas high intensities
resulted in mechanical destruction of the biofilm [25].
Conflicting in vitro data have been reported concerning bacterial
inactivity following sonication, with some authors noting no anti-
microbial effects, neither for planktonic nor for biofilm bacteria
[25,69,70]. Others reported sonication-induced reduced bacterial
viability with differences in bacterial species where Gram-positive
bacteria generally appear to be more resistant toward sonication
compared to Gram-negative bacteria [58,71e74].
In vitro experiments have further demonstrated biofilm
destruction but incomplete eradication in response to sonication
[70,74,75]. From a clinical perspective, it is essential to note that
even when high-intensity focused ultrasound has destroyed the
biofilm almost completely, residual bacterial viability has still been
detected [75]. This implies a high likelihood of infection persistence.
In vivo, noncontact, nonthermal, low-frequency ultrasound has
been observed to reduce bacterial counts in chronic wounds [76]. In
line with that are results from another study reporting an almost
2-fold reduction in viable bacterial count in biofilm wounds following
noncontact, low-frequency sonication [77]. In addition to the signif-
icant reduction in biofilm burden, the same study noted a corre-
sponding decrease in inflammatory cytokines along with improved
wound healing [77]. These data collectively suggest that sonication
can induce antimicrobial effects in vivo.
Possible side effects of low-frequency sonication on adjacent
soft tissue have been investigated using human femoral heads that
have been removed during primary total hip arthroplasty. Soni-
cation has been reported to damage cartilage by decreasing carti-
lage thickness and cartilage area [70]. Additionally, implant surface
modifications such as increased surface roughness have been
observed using a noncontact, three-dimensional optical surface
measurement system [70]. This finding is notably relevant in joint
replacement surgery as surface irregularity is an essential deter-
minant in tribology with significant impact on implant longevity
[78]. In view of that, a re-evaluation of the role of sonication in
treating PJIs was suggested by the authors.
Synergistic Effects With Antibiotics
Synergistic effects of sonication and antibiotics have been
investigated in numerous studies, both in vitro and in vivo
[68,79,80]. Sonication was found to increase the potency of various
classes of antibiotics when treating different Gram-positive and
Gram-negative bacteria in vitro [79e81]. Reduced bacterial
viability was noted even for antibiotic concentrations below the
minimal inhibitory concentration when combined with sonication
[82]. Sonication-enhanced bacterial killing, however, appears to be
species dependent [83,84]. This finding might be explained by
differences in bacterial structure and stability [84] since enhanced
uptake of antibiotics through the outer bacterial membrane after
sonication treatment has been reported [83].
Using animal models, synergistic effects of sonication and
systemic antibiotics (aminoglycosides and glycopeptides) for treat-
ment of Gram-positive and Gram-negative bacteria during the early
postoperative period have also been demonstrated [20e22,85].
Reduced bacterial viability in biofilms has further been described in
combination with antibiotic-loaded bone cement [22]. The
2579
noninvasive application of sonication in treatment of biofilms is
attractive and observed synergistic effects are promising. Biofilm
eradication, however, has been found to be incomplete [20e22,85]. It
has therefore been questioned whether the host immune system will
be able to achieve complete bacterial elimination.
No adverse systemic effects such as bacteremia or organ damage
have been reported in response to sonication treatment [20e22,85].
Local adverse tissue effects such as skin damage, however, have been
described by some authors and appear to correlate with sonication
parameters: while no local tissue damage has been observed for
lower power densities (100 mW/cm2), higher power densities (300
mW/cm2), although showing significant antimicrobial effects in
combination with antibiotics, have been observed to cause wound
ulceration and thermal damage. These adverse tissue effects have
been attributed to cavitational effects [20]. No correlation between
tissue damage and the maximum power during a pulse was found
for pulsed ultrasound [21].
These data indicate the overall potential of sonication in treating
PJIs. However, extensive optimization of sonication parameters is
needed. Overall, pulsed ultrasound seems to have superior effects
on antibiotic action compared to continuous ultrasound [21].
Sonication-enhanced antibiotic activity has been observed to
correlate with treatment time [85], intensity [86], low frequency
[86], and high peak power density but not when the average power
density was raised [87].
Underlying mechanisms of synergistic effects with antibiotics
are not fully understood. Specifically for fluoroquinolones, soni-
cation has been reported to induce the formation of reactive oxygen
species [88]. Others have discussed the role of local heat that pro-
motes intercellular reactions which in turn lead to improved
binding between the antibiotic and its target [89] or biofilm
destruction by sonication-induced micropore formation [90] as
mechanisms that may underlie the synergistic effects of sonication
and antibiotics.
Enhanced Release of Antibiotics From Bone Cement
Efficient release of antibiotics from bone cement spacers has the
potential advantage of high local antibiotic concentration and is
therefore relevant for infection control. Sonication has been shown
to enhance the release of antibiotics from cement spacers depend-
ing on the “type and ratio of antibiotics, quantity of antibiotic, type
and porosity of cement, surface characteristics, environmental cir-
cumstances and [the] way the cement is prepared” [91].
Enhanced antibiotic release from bone cement in response to
low-frequency sonication has been observed in vitro for both
planktonic and biofilm bacteria with the latter being more affected
postulated to be due to locally increased concentrations of antibi-
otics within the biofilm [69,92]. The mechanical strength of spacers
after sonication has been reported to remain above international
standards [93].
In vivo studies using animal models confirmed enhanced anti-
microbial effects and enhanced antibiotic release from bone cement
[22,94,95]. Clinical, bacteriological, histological, and radiological
assessments have shown a trend toward decreased bacterial
viability, relieved inflammation with no evidence of sonication-
induced skin lesions [22,94]. There are conflicting data, however,
as to whether sonication prolongs the local drug duration exceeding
the minimal inhibitory concentration [94,95]. Concern has been
raised as to whether the increased concentration of antibiotics in the
fluid of sonicated spacers may impede bacterial growth, potentially
leading to false-negative culture results [96].
One of the mechanisms improving antibiotic release from bone
cement might be a sonication-induced increase in pore size of
antibiotic-loaded cement [97]. Antibiotic release from bone cement
2580 R. Hameister et al. / The Journal of Arthroplasty 33 (2018) 2575e2581
has been reported to be controlled by time, while intermittent
watt-level ultrasonication seems to be superior with regards to
residual specimens [95,98]. Acoustic microstream, which can be
simplified as a flow of fluid due to an ultrasound wave, was
proposed by the authors as an underlying mechanism.
The technique utilized when applying sonication is currently a
subject of much debate and there is no general accepted protocol.
Literature shows that bactericidal effects of sonication are directly
proportional to the duration of exposure and the level of intensity
[73]. Antimicrobial activity has further been reported to be
enhanced with increased drug concentration and solution tem-
perature [88]. The combination of sonication together with other
technologies such as high pressure or heat requires further
investigations as pointed out in a review by Piyasena et al [25].
So far, therapeutic sonication has only been applied in implant-
associated infections in animal models [22,94,95] but has not been
introduced into clinical studies investigating its effects on PJIs yet.
Feasible application of therapeutic sonication is one prerequisite for
its successful implementation in the clinical setting. These would be
some of the potential difficulties: first, there is currently a lack of
formal recommendations or guidelines establishing management
infrastructure for protection against inappropriate exposure to
sonication. Second, sonication is time-consuming. Third, certain
regions in the infected joint are difficult to reach by the sonotrode
such as the back of the knee or areas behind the acetabular cup, thus
impeding the direct exposure of these regions to cavitation and
ultimately limiting the therapeutic potential of sonication.
Conclusion and Perspectives
In summary, sonication is an evolving modality in the context of
PJIs. As a diagnostic tool, it has not been introduced in routine
clinical practice and sonication as a treatment modality in PJIs is
currently still in an experimental stage. Sonication alone is not able
to completely eradicate biofilms but may potentially enhance
antibiotic activity. There is evidence for adverse effects, including
implant modification and tissue alteration. Factors such as
frequency, pressure, chemical activity, intensity, and exposure time
need to be evaluated for optimal application of sonication and may
also improve study comparison. Formal guidelines for safe appli-
cation of sonication are lacking.
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