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Patient Satisfaction and Functional Status After Treatment of Infection

at the Site of a Total Knee Arthroplasty with Use of the PROSTALAC
Articulating Spacer
R.M. Dominic Meek, Bassam A. Masri, David Dunlop, Donald S. Garbuz, Nelson V. Greidanus, Robert McGraw
and Clive P. Duncan
J Bone Joint Surg Am. 2003;85:1888-1892.

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Patient Satisfaction and Functional

Status After Treatment of Infection
at the Site of a Total Knee
Arthroplasty with Use of the
PROSTALAC Articulating Spacer
BY R.M. DOMINIC MEEK, MBCHB, MD, FRCS(TR AND ORTH), BASSAM A. MASRI, MD, FRCSC,
DAVID DUNLOP, MBCHB, FRCS(TR AND ORTH), DONALD S. GARBUZ, MD, MHSC, FRCSC,
NELSON V. GREIDANUS, MD, MPH, FRCSC, ROBERT MCGRAW, MD, FRCSC, AND CLIVE P. DUNCAN, MD, FRCSC
Investigation performed at the Department of Orthopaedics, The University of British Columbia, Vancouver, British Columbia, Canada

Background: Two-stage exchange arthroplasty remains the standard treatment of infection at the site of a total knee
arthroplasty. The clinical and functional outcomes associated with the use of an articulating antibiotic spacer for two-
stage revision for infection are not well established. We conducted a retrospective study to evaluate the outcomes
associated with the use of the PROSTALAC articulating spacer between the first and second stages.
Methods: Fifty-eight patients underwent two-stage revision total knee arthroplasty for infection between January 1997
and December 1999. Of these, fifty-four were alive at the time of follow-up and forty-seven were available for inclusion
in the present retrospective study. In all patients, a prosthesis of antibiotic-loaded acrylic cement (the PROSTALAC
system) was implanted during the first stage after débridement. The amount of osteolysis that occurred between the
stages and the range of motion of the knee joint were measured. After two years of follow-up, outcomes were as-
sessed with use of the WOMAC, Oxford-12, and SF-12 instruments as well as a satisfaction questionnaire.
Results: At a minimum of two years (average, forty-one months) after revision arthroplasty, two patients (4%) had
had a recurrence of infection. The amount of bone loss was unchanged between stages, and the range of movement
of the knee improved from 78.2° before the first stage to 87.1° at two years. The average normalized WOMAC func-
tion and pain scores were 68.9 and 77.1, respectively; the average Oxford-12 score was 67.3; the average SF-12
mental and physical scores were 53.7 and 41.2, respectively; and the average satisfaction score was 71.7.
Conclusion: A revision operation for infection at the site of a total knee replacement with use of an articulating
spacer was associated with reasonable function and satisfaction scores. These findings may be related to the articu-
lating features of the PROSTALAC system, which permits full active movement of the knee in the early postoperative
period.
Level of Evidence: Therapeutic study, Level IV (case series [no, or historical, control group]). See Instructions to Au-
thors for a complete description of levels of evidence.

R
evision total knee arthroplasty has been associated
with poorer outcomes than primary total knee arthro-
plasty has, although these findings are by no means
conclusive1. There have been relatively few published reports
on the functional outcomes of revision total knee arthroplasty
for infection, with most series including multiple implant types
and inadequate outcome markers2-4.
The standard treatment of infection at the site of a total
knee arthroplasty remains a two-staged reimplantation, which
has been associated with a success rate of >90% in several
series5-15. In one series, the functional outcome scores follow-
ing revision for infection were reported to be lower than those
following revision for other causes16; however, a static anti-
biotic spacer block was used in that series.
The advantages of articulation are perceived to be im-
proved function between stages, avoidance of bone loss due to
an unstable static block, and an easier second-stage operation
and subsequent rehabilitation9,17. A higher dose of antibiotic
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can be added to the bone cement in the spacer than can be in all knees (Fig. 1). The first stage consisted of an aggressive
used at the time of a one-stage exchange or definitive reimplan- débridement of all infected or devitalized tissue and insertion
tation, when such a dose would weaken the cement18,19. The of the PROSTALAC articulating spacer. The PROSTALAC
PROSTALAC functional spacer has been reported to allow spacer is an articulating prosthesis composed primarily of Pala-
movement during the interim between stages without com- cos cement (Biomet, Warsaw, Indiana) and is typically loaded,
promising the rate of eradication of infection9. Other articu- by the surgeon, with a combination of 3.6 g of tobramycin and
lating antibiotic spacers have been associated with similar 1.5 g of vancomycin per package of bone cement. In the rare
excellent results4,20-23. case in which this antibiotic combination is inadequate, other
The purpose of the present retrospective study was to as- antibiotics may be added as long as they are thermostable, are
sess the functional outcomes associated with the use of the ar- available in powder form, and have been shown to elute from
ticulating PROSTALAC system. Knowledge of such outcomes bone cement. The femoral and tibial components are molded
will permit more accurate patient counseling with respect to intraoperatively into various sizes and thicknesses. The im-
expectations following revision surgery for an infection at the plant has a small metal-on-polyethylene articular surface and,
site of a knee arthroplasty. in the present series, all implants had a posterior-stabilized de-
sign. Patients were encouraged to actively mobilize the knee
Materials and Methods immediately after surgery. A six-week course of intravenous
Study Group antibiotics was administered between the first and second
ifty-eight consecutive patients underwent two-stage ex- stages under the guidance of an infectious-diseases consultant.
F change arthroplasty for infection at the site of a total knee
arthroplasty between January 1, 1997, and December 31, 1999.
The antibiotics were then stopped, and the erythrocyte sedi-
mentation rate and the C-reactive protein level were measured.
Four patients had died by the time of follow-up. Of the re- While six weeks was not enough time for these serological
maining fifty-four patients, four were unable to be traced and
three failed to complete their functional questionnaires ade-
quately because of cognitive difficulties. Thus, forty-seven (81%)
of the fifty-eight patients were available for inclusion in the
present study. The patients included twenty-seven women and
twenty men with an average duration of follow-up of forty-
one months (range, twenty-four to fifty-eight months). The
diagnosis of infection was confirmed on the basis of positive
cultures of preoperative aspirates and/or intraoperative tissue
specimens and an elevated erythrocyte sedimentation rate and
an increased C-reactive protein level. Three culture specimens
were obtained intraoperatively, and the same organism had to
grow on culture of at least two of these specimens in order for
the result to be considered positive.
Of the forty-seven living patients with adequate follow-
up who had undergone two-stage revision with use of the
PROSTALAC system, forty-three had had an infection at the
site of a primary total knee arthroplasty, three had had an
infection at the site of a second revision total knee arthro-
plasty, and one had had an infection at the site of a third re-
vision total knee arthroplasty. Comorbidity was assessed by
categorizing coexisting conditions as 0, 1, 2, and 3+ with
use of the Charlson index24. A physiotherapist recorded
range of movement preoperatively and at the time of the fi-
nal follow-up.

Radiographic Assessment
Preoperative bone loss was assessed radiographically accord-
ing to the classification system of Engh25 at both the first and
the second stage of the revision. The radiographic assessment
was added to the intraoperative assessment, and the maximum Fig. 1
category of bone loss was recorded. Photograph showing the PROSTALAC articulating spacer system,
which was inserted during the first stage of a two-stage revision
Treatment Protocol procedure in patients who had an infection at the site of a total knee
The PROSTALAC system (DePuy, Warsaw, Indiana) was used arthroplasty.
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markers to return to normal, their levels were lower than they

had been preoperatively. These laboratory investigations were TABLE I Organisms Cultured in the Forty-seven Patients
with Adequate Follow-up
repeated four weeks later. If the levels were declining, the pa-
tient was scheduled to undergo the second-stage procedure at No. of
twelve weeks after the first-stage operation. All patients under- Organism Patients
went a knee aspiration ten weeks after the first-stage proce- Staphylococcus epidermidis 12
dure. No microorganisms grew on any of the cultures of the Staphylococcus aureus
aspirated fluid. The Press-Fit Condylar (PFC) posterior cruci- Methicillin-sensitive 13
ate ligament-substituting knee revision system (DePuy) was Methicillin-resistant 3
then implanted in all patients. A stem was used in all patients:
Streptococcus viridans 2
forty-six patients received a press-fit stem, and one received a
fully cemented stem. All implants were cemented at the level of Streptococcus
the joint line with antibiotic-loaded bone cement (Palacos ce- Group A 1
ment [Biomet] loaded with 0.6 g of tobramycin [Nebcin, Eli- Group B 4
Lily] per package of cement). Group D 1
Group G 1
Evaluation Enterococcus species 5
After the ethics boards of our university and hospital had
Propionibacterium species 2
approved the study, an initial invitation letter was sent to all
patients to inform of them of the study. A questionnaire Peptostreptococcus species 1
packet was sent two weeks later. Any patient who did not re- Serratia liquefaciens 1
turn the packet within six weeks was sent another packet, Corynebacterium species 1
and any patient who failed to respond again was contacted
by telephone. Forty-seven patients returned completed ques-
tionnaires. Outcomes were assessed on the basis of the pa- methicillin-resistant Staphylococcus aureus; this initial infec-
tients’ responses to the Western Ontario and McMaster tion was never controlled, and an above-the-knee amputa-
Universities Arthritis Center (WOMAC) questionnaire, the tion eventually was performed. This patient was one of the
Oxford-12 and Short-Form-12 (SF-12) questionnaires, and a patients who had failed to adequately complete the outcomes
satisfaction questionnaire. The satisfaction score was calcu- questionnaires because of worsening dementia after the op-
lated on the basis of the answers to four questions regarding eration. Because of the patient’s worsening cognitive impair-
the effect of the operation on pain, function, and social ment and rehabilitation potential, the treating surgeon did
activities as well as the patient’s overall impression of the op- not believe that further attempts to salvage the knee were in-
eration. There were four possible responses: very satisfied, dicated. One knee was revised after two years because of pain
somewhat satisfied, somewhat dissatisfied, and very dissatis- in the leg secondary to the tibial stem, and one knee had re-
fied. The total score was normalized, with a score of 100 in- vision of a rotating hinge because of aseptic loosening. The
dicating the most satisfaction. Reinfection was defined as a cement spacer broke in one knee; specifically, the posterior
recurrence of inflammation with a positive culture or clear cruciate ligament-substituting post sustained an undisplaced
serological evidence of infection. The postoperative range of fracture at its junction with the main spacer. However, this
movement was recorded at the time of the final two-year fracture had no consequences for the patient, who was en-
clinical review. couraged to maintain movement of the knee.
After an average duration of follow-up of forty-one
Results months, the average normalized WOMAC function score (and
omorbidity scores of 0, 1, 2, and 3+ were observed for standard deviation) was 68.9 ± 21.9, the average WOMAC
C nineteen patients (40%), seventeen patients (36%), seven
patients (15%), and four patients (9%), respectively. Bone loss
pain score was 77.1 ± 25.2, and the average WOMAC stiffness
score was 70.2 ± 24.2. On the modified WOMAC scale, better
was classified, according to the Engh system, as type 1 for six- function is reflected by higher scores, with the highest possible
teen femora (34%) and twenty-eight tibiae (60%), as type 2 score being 100.
for twenty-nine femora (62%) and sixteen tibiae (34%), and The average postoperative Oxford-12 score was 67.3 ±
as type 3 for two femora (4%) and three tibiae (6%). No knee 24.3. The average SF-12 mental component score was 53.7 ±
had a change in the Engh classification or demonstrated addi- 11.9, and the average SF-12 physical component score was
tional bone loss between the first and second stages. 41.2 ± 13.4. The average satisfaction score, based on the forty-
Staphylococcus infection predominated, occurring in five questionnaires that had been successfully completed, was
twenty-eight patients (Table I). Two patients had a recur- 71.7 ± 33.1.
rence of infection, for a failure rate of 4%. One patient had a The average arc of knee motion increased from 78.2° ±
recurrence of infection with methicillin-sensitive Staphylo- 29.4° preoperatively to 87.1° ± 14.7° at the time of the most re-
coccus aureus. The other patient had an initial infection with cent follow-up.
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Discussion
wo-stage exchange arthroplasty with an antibiotic-
T impregnated cement spacer remains the standard treat-
ment for patients with an infection at the site of a total knee
arthroplasty. However, problems with static spacers have in-
cluded capsular and quadriceps scarring and shortening, with
subsequent difficulty in exposure at the second stage, and the
possibility of additional bone loss. Attempts to overcome these
problems led to the development of articulating spacer blocks
such as the PROSTALAC system. One advantage of this articu-
lating system is that it appears to be associated with less bone
loss between stages, which has been reported to be a substan-
tial problem in patients managed with static spacers21. Several
previous studies have attempted to demonstrate that the use
of an articulating spacer does not compromise the rate of rein-
fection, but those studies involved relatively small numbers of
patients4,9,21,22.
There is scant information on functional outcomes and
patient satisfaction after revision surgery performed either
for infection or for other reasons16. There has been a general
assumption that the outcome after revision for infection is
poor. One previous study suggested that an articulating
spacer has no functional advantage over a static spacer in
the treatment of an infection at the site of a total knee
arthroplasty21. However, that study was limited by a small
sample size and a postoperative protocol that did not permit
early range of motion of the knee in the patients who had
been managed with a PROSTALAC spacer. In contrast, pa-
tients in the present study may have benefited from a more
aggressive physiotherapy protocol, which included immedi-
ate range of motion. Certainly, the need for immediate move-
ment has been established as one of the critical factors in
successful arthrolysis of other joints26. Another advantage of
our study was that the same technique and spacer were used
for every knee and that the procedures were performed by a
limited number of surgeons with use of a consistent surgical
protocol.
One of the shortcomings of the present study was the
fact that outcomes data were not collected preoperatively. An-
other limitation of the present study was the absence of a con-
trol group, perhaps one consisting of patients managed with a
more traditional static spacer, which has been considered to
be the gold standard5,7,12,14,15. Clearly, the ideal study design
with which to assess a new treatment approach would be an
adequately powered randomized, clinical trial. Finally, since
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R.M. Dominic Meek, MBChB, MD, FRCS(Tr and Orth)
12A Sydehham Road, Dowanhill, Glasgow G12 9NP, Scotland
Bassam A. Masri, MD, FRCSC
David Dunlop, MBChB, FRCS(Tr and Orth)
Donald S. Garbuz, MD, MHSc, FRCSC
Nelson V. Greidanus, MD, MPh, FRCSC
Robert McGraw, MD, FRCSC
Clive P. Duncan, MD, FRCSC
Division of Lower Limb Reconstruction and Musculoskeletal Oncology,
Department of Orthopaedics, Vancouver Hospital and Health Sciences
Centre, The University of British Columbia, 910 West Tenth Avenue,
Third Floor, Vancouver, BC V5Z 4E1, Canada. E-mail address for B.A.
Masri: masri@interchange.ubc.ca
The authors did not receive grants or outside funding in support of their
research or preparation of this manuscript. They did not receive pay-
ments or other benefits or a commitment or agreement to provide such
benefits from a commercial entity. A commercial entity (DePuy) paid or
directed, or agreed to pay or direct, benefits to a research fund, founda-
tion, educational institution, or other charitable or nonprofit organiza-
tion with which the authors are affiliated or associated. One of the
authors (R.M.D.M.) would like to acknowledge the financial support of
the John Charnley Trust.
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