EVIDENCE-BASED ORTHOPAEDIC TRAUMA
Treatment of Acute Midshaft Clavicle Fractures:
Systematic Review of 2144 Fractures
On behalf of the Evidence-Based Orthopaedic
Trauma Working Group
Michael Zlowodzki, MD,* Boris A. Zelle, MD,† Peter A. Cole, MD,*
Kyle Jeray, MD,‡ and Michael D. McKee, MD§
Background: Fractures of the clavicle were reported to represent
2.6% of all fractures1 with an overall incidence of 64 per 100,000 per
year (1987, Malmö, Sweden).2 Midshaft fractures account for
approximately 69% to 81% of all clavicle fractures.1–4 Treatment
options for acute midshaft clavicle fractures include nonoperative
treatment (mostly sling or figure-of-eight bandage), open reduction
and internal fixation with plates, and closed or open reduction and
internal fixation with intramedullary pins, wires, or a nail. Most
surgeons prefer nonoperative treatment of nondisplaced midshaft
clavicle fractures. However, the optimal treatment option for
isolated acute displaced midshaft clavicle fractures remains
controversial.
Objectives: This study was designed to systematically summarize
and compare results of different treatment options (nonoperative, op-
erative extramedullary fixation, and operative intramedullary fixa-
tion) in the management of midshaft clavicle fractures, specifically
for displaced fractures.
(J Orthop Trauma 2005;19:504–507)
METHODS
Eligibility Criteria
The English literature was reviewed for articles pre-
senting more than 15 cases with midshaft clavicle fractures.
Obstetric fractures, pediatric fractures, and articles dealing ex-
clusively with floating shoulders were not included. If articles
presented data on acute midshaft fractures mixed with lateral
or medial fractures and/or revision cases, the results for acute
midshaft fractures were extracted. If extraction of the results
was not possible, articles that included .30% lateral fractures
and/or medial fractures and/or revision cases were not
considered.
Accepted for publication May 15, 2005.
From the *University of Minnesota, Minneapolis, MN; †University of
Pittsburgh, PA; ‡Greenville Hospital System, University Medical Center,
SC; and §University of Toronto, ON, Canada.
Reprints: Michael Zlowodzki, MD, University of Minnesota, Department of
Orthopaedic Surgery, Regions Hospital, 640 Jackson Street, St Paul,
Minnesota 55101 (e-mail: zlowi@web.de).
Copyright Ó 2005 by Lippincott Williams & Wilkins
504
Study Identification (January 1975
to April 2005)
1. Cochrane Database: Keywords: ‘‘clavic* AND fracture*’’
in record title: 0 hits in The Cochrane Database of System-
atic Reviews, 0 hits in the Database of Abstracts of Reviews
of Effect, 5 hits in The Cochrane Central Register of Con-
trolled Trials; 2 relevant
2. Pubmed Search: Search query: ‘‘(clavic* [ti] AND Fracture*
[ti]) NOT (‘‘case report’’ OR pediat* [ti] OR newborn* [ti]
OR obstetric* [ti])’’ 558 hits, 8 relevant
3. Review of bibliographies of identified articles: 3 relevant
4. OTA proceedings of the 1996 to 2004 annual meetings:
7 relevant (2 redundant with subsequent publication)
5. AAOS proceedings of the 2003 to 2005 annual meetings:
4 relevant
After review, a total of 22 studies were included.5–26
Available Evidence
1. Two prospective, observational studies investigating factors
associate with nonunion and long-term sequelae after non-
operative treatment (EBM-level 1 prognosis).20,23
2. One randomized controlled trial (RCT) with methodologic
limitations comparing 2 different types of nonoperative
treatment of midshaft fractures (EBM-level 2 therapy).6
3. One RCT with methodologic limitations comparing plating
and nonoperative treatment of displaced midshaft fractures
(EBM-level 2 therapy).25
4. One RCT comparing intramedullary fixation and nonopera-
tive treatment of midshaft fractures (EBM-level 2 therapy).15
5. One nonrandomized, retrospective, cohort study comparing
intramedullary fixation and nonoperative treatment of
midshaft fractures (EBM-level 3 therapy).12
6. One nonrandomized, retrospective, cohort study comparing
nonoperative treatment, intramedullary fixation, and plating
of displaced midshaft fractures (EBM-level 3 therapy).26
7. One nonrandomized, retrospective, cohort study compar-
ing two different plating techniques/locations (superior and
anterior-inferior) for operative treatment of midshaft frac-
tures (EBM-level 3 therapy).16
8. Fourteen case series presenting the results of either non-
operative,13,18,19 intramedullary,7,10,11,14,17 or extramedullary
fixation for the treatment of midshaft clavicle fractures5,8,9,21,22,24
(EBM-level 4 therapy).
J Orthop Trauma  Volume 19, Number 7, August 2005
J Orthop Trauma  Volume 19, Number 7, August 2005 Acute Midshaft Clavicle Fractures

Also, there are currently 2 ongoing multicenter trials

TABLE 1. Results: Acute Midshaft Clavicle Fracture (Displaced
evaluating nonoperative treatment versus operative treatment
and Undisplaced)
of displaced midshaft clavicle fractures:
Infections Infection Fixation
1. A United States-based RCT with 12 centers and a re- Nonunions (Total) (Deep)† Failures‡
cruitment goal of 360 randomized patients evaluating non-
Nonoperative 5.9 N/A N/A 0.1
operative treatment, intramedullary pinning and plating
Plating (n = 635) 2.5 5 2 3.1
(currently randomized: 40 patients).
Intramedullary pinning
2. A Canadian-based RCT with 6 centers and a recruitment (n = 364) 1.6 6 0 4.1
goal of 130 randomized patients evaluating nonoperative Total (N = 2144) 4.2 5.4* 1.3* 1.7
treatment and plating (recruitment completed). (3.4–5.1) (4.2–7) (0.8–2.2) (1.2–2.3)
Data Abstraction N/A, not applicable.
Data are percentages with 95% confidence intervals in parentheses.
The following data was extracted for each identified ar- If results of displaced and undisplaced fractures could not have been separated, they
ticle: study type, level of evidence, mean follow-up, percentage of were included in this table. Therefore, the difference between the results in this table and
displaced fractures, percentage of open fractures, type of the results for displaced fractures only in Table 2 does not represent undisplaced fractures
only.
treatment, nonunion rates, total infection rates, deep infection *Infection rates only include operatively treated fractures.
rates, and fixation failure rates. Bilateral fractures were counted as †Any infection described as deep or superficial requiring irrigation and debridement;
infections of unknown significance were not included.
separate cases. All except for 1 article included only midshaft ‡Includes refractures.
fractures, or we were able to extract the data for midshaft frac-
tures. In 1 prospective, observational cohort study, 60 (28%)
lateral and medial fractures were included.20 The minimal in 460 cases (59%), and 159 cases (21%) were treated non-
inclusion age ranged in most articles between 16 and 18 years. operatively. Overall there was a nonunion rate of 4.8% (95%
However, occasionally some pediatric fractures were included. CI = 3.5–6.5%; Table 2).
Data Analysis
Nonoperative Treatment
All failures of osseous union were documented as
nonunion. Thus, delayed unions requiring a secondary surgical Nonunion Rates
procedure, infected nonunions, and nonhealed fractures as a Nonoperative treatment of 1145 fractures resulted in a
result of fixation failure are documented as nonunions. The nonunion rate of 5.9%. Looking at displaced fractures sep-
fixation failure rate includes infections that led to fixation arately, nonoperative treatment of 159 fractures resulted in a
failures. If the percentage of open fractures was not mentioned, nonunion rate of 15.1%.
we assumed that all fractures of in the series were closed. If
the type of infection was not specified, we assumed that the Predictors of nonunion and long-term sequelae
infection was superficial and did not require a secondary sur- after nonoperative treatment
gical procedure. Plate loosening not resulting in a secondary In a prospective, observational cohort study o 443 diaph-
surgical procedure was not included as fixation failure. Results yseal clavicle fractures a multivariable regression analysis
are presented by study type and level of evidence, type of showed significantly increased nonunion risk (P , 0.05; non-
treatment, and combined. All values were weighted by the union rate, 4.5%) with displacement of the fracture (relative
sample size of each study, and results were summarized. The risk (RR) = 2.3) female gender (RR = 1.4), the presence
relative risk for nonunion was calculated for nonoperative of comminution (RR = 1.4), and advancing age.23
treatment versus plating and nonoperative treatment versus Another prospective observational cohort study of
nailing using Fisher exact test. 208 patients with any clavicle fracture (72% midshaft) treated
nonoperatively showed a nonunion rate of 7% and complete
RESULTS
Overall Results for All Fractures TABLE 2. Results: Displaced Acute Midshaft Clavicle Fracture
A total of 2144 fractures (97% midshaft) were identified. Infections Infection Fixation
Twenty-eight fractures (1.3%) were open. The mean sample- Nonunions (Total) (Deep)* Failures‡
size weighted follow-up was 61 months (based on 1297/2144 Nonoperative (n = 159) 15.1 N/A N/A 0
reported cases). Intramedullary fixation was performed in Plating (n = 460) 2.2 4.6 2.4 2.2
364 cases (17%), plating in 635 cases (30%), and 1145 cases Intramedullary
(53%) were treated nonoperatively. Overall there was a nonunion pinning (n = 152) 2 6.6 0 3.9
rate of 4.2% (95% confidence interval (CI), 3.4–5.1%; Table 1). Total (N = 771) 4.8 5.1 1.8 2.1
(3.5–6.5) (3.6–7.1)† (1–3.2)† (1.3–3.3)
Overall Results for Displaced Fractures Only
N/A, not applicable.
We identified 10 articles that presented data on displaced Data are percentages with 95% confidence intervals in parentheses.
fractures only and 12 articles that presented combined data on *Any infection described as deep or superficial requiring irrigation and debridement;
displaced and undisplaced fractures. In the 10 articles focus- infections of unknown significance were not included.
†Infection rates only include operatively treated fractures.
ing on displaced fractures only, there were 771 cases. Intra- ‡One includes refractures.
medullary fixation was performed in 152 cases (20%), plating

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Zlowodzki et al
recovery as determined by the patient in 54% of the patients
for a 9- to 10-year follow-up.20 To determine long-term se-
quelae versus complete recovery, patients were asked: ‘‘Are
you fully recovered from your clavicle injury?’’ In a univariate
analysis, the following variables were found to be predictive of
long-term sequelae (P , 0.05): Fracture displacement (odds
ratios (OR) = 1.9–3.4 for various measures), fracture comminu-
tion (OR = 2), number of fragments (OR = 1.4), and age.
Sling versus figure-of-eight
Andersen et al6 evaluated a sling or a figure-of-eight
bandage in a RCT. The results favored the sling. All fractures
united (46% had major and 44% minor comminution). Nine of
34 (26%) patients treated with the figure-of-eight bandage
were dissatisfied. When treated with a sling, only 2 of 27
(7%) were dissatisfied (relative chance of satisfaction for sling
treatment = 1.3 (95% CI = 1–1.6); P = 0.09).
Operative Versus Nonoperative Treatment
Plating versus nonoperative
Nonrandomized, noncomparative, pooled data across all
studies showed that plating of 635 fractures resulted in a non-
union rate of 2.5%, which was significantly lower compared
with 5.9% for nonoperative treatment (relative nonunion risk
for nonoperative treatment, 2.4 (95% CI = 1.4–4) / relative
risk reduction for plating, 57% (95% CI = 27–75%); P =
0.001). Looking at displaced fractures separately, plating of
460 fractures resulted in a nonunion rate of 2.2%, which was
significantly lower compared with 15.1% for nonoperative
treatment (relative nonunion risk for nonoperative treatment =
6.9 (95% CI = 3.4–14.2) / relative risk reduction for plating,
86% (95% CI = 71–93%); P , 0.001).
In a RCT comparing plating and nonoperative treatment
of 100% displaced midshaft fractures, Smith et al25 reported
a nonunion rate of 24% (12/50) for nonoperative treatment
and 0% (0/50) for plating. In the nonoperative group, 30%
developed some symptoms of upper extremity neurologic
complaints with overhead use of the arm compared with 6%
in the operative group. In the nonoperative group, 44% had
complaints about the cosmetic appearance of their shoulder.
However, in the plating group, 30% of the patients requested
hardware removal after healing of their fracture.
Plate positioning for midshaft fractures
In a nonrandomized comparison of anterior-inferior ver-
sus superior plating of acute midshaft fractures in 34 patients,
Lim et al16 reported a significantly better Visual Analogue
Scale patient symptoms scores in patients undergoing anterior-
inferior plating (P , 0.05). There were no nonunions in either
group. Two infections and one failed fixation were recorded in
the superior plating group. One delayed union was reported
in the anterior-inferior plating group.
Intramedullary pin fixation versus
nonoperative treatment
Nonrandomized, noncomparative pooled data across all
studies showed that intramedullary fixation of 364 fractures
resulted in a nonunion rate of 1.6%, which was significantly
lower compared with 5.9% for nonoperative treatment (Rela-
506
J Orthop Trauma  Volume 19, Number 7, August 2005
tive nonunion risk for nonoperative treatment, 3.6 (95% CI,
1.6–8.2) / relative risk reduction for intramedullary pinning,
72% (95% CI, 36–88%); P , 0.001). Looking at displaced
fractures separately, intramedullary fixation of 152 fractures
resulted in a nonunion rate of 2%, which was significantly
lower compared with 15.1% for nonoperative treatment (rel-
ative nonunion risk for nonoperative treatment = 7.6 (95%
CI = 2.4–24.9) / relative risk reduction for intramedullary
pinning, 87% (95% CI = 57–96%); P , 0.001).
Based on a nonrandomized comparison of intramedul-
lary fixation versus plating versus nonoperative treatment of
17 displaced midshaft fractures in each group, Thyagarajan26
recommended intramedullary pin fixation over plating and
over nonoperative treatment. He reported no nonunions for pin
fixation or plating compared with 4 of 17 (24%) nonunions for
nonoperative treatment. Four of 17 (24%) patients treated with
a plate reported scar related pain and 3 of 17 (18%) prominent
hardware. In the nonoperative group, 5 of 17 (29%) patients
had cosmetic complaints.
In contrast, 2 comparative studies presented favorable
results for nonoperative treatment compared with pin fixation.
Judd et al15 randomized 57 patients with a midshaft clavicle
fracture to be treated with intramedullary pin fixation (n = 29)
or nonoperative treatment (n = 28). Complications were higher
for the operative treatment group. There was 1 nonunion
(3.4%) and 2 refractures (6.9%) in the pin fixation group com-
pared with 0 nonunions (0%) and 1 refracture (3.4%) in the
nonoperative treatment group.
Grassi et al12 performed a nonrandomized, cohort com-
parison of intramedullary pin fixation and nonoperative treat-
ment with 40 patients in each group who sustained a displaced
midshaft fracture. At an average follow-up of 64 months after
intramedullary pin fixation, there were 8 superficial infections
(20%), 2 pin breakages (5%), 3 refractures after pin removal
(7.5%), and 1 secondary plate fixation (2.5%). There were no
nonunions and no secondary surgical procedures after non-
operative treatment.
ARE THE RESULTS OF THESE STUDIES VALID?
The available literature includes only 3 randomized, con-
trolled trials, 3 additional cohort studies with a control group,
and 2 prospective observational studies. The majority of all
identified studies was retrospective (18/23), had no control
group (15/21), and didn’t use any randomization if there was
a control group (3/6). The results need to be interpreted with
caution because the validity of observational studies is lim-
ited by the lack of a control group (case series), imbalances
between comparison groups because of the lack of random-
ization (cohort studies), and potentially biased assessment of
outcome measures because of lack of blinding.
EVIDENCE-BASED BOTTOM LINE
Based on the current available evidence, we report the
following:
 Nonoperative treatment of acute midshaft clavicle
fractures (Grade C evidence from pooled nonrandomized,
noncomparative data)
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J Orthop Trauma  Volume 19, Number 7, August 2005
8 Nonoperative treatment of acute midshaft clavicle
fractures results in an overall nonunion rate of 5.9%.
The nonunion rate for displaced fractures is 15.1%.
 Factors associated with nonunion after nonoperative
treatment of acute midshaft clavicle fractures (evidence
from prospective, observational study)
8 Fracture displacement (relative risk = 2.3) Fracture commi-
nution (relative risk = 1.4) Female gender (relative risk =
1.4) Advancing age
 Factors associated with long-term sequelae after nonop-
erative treatment of acute midshaft clavicle fractures
(evidence from prospective observational study)
8 Fracture displacement (odds ratio = 1.9–3.4 for various
measures)
8 Fracture comminution (odds ratio = 2)
8 Number of fracture fragments (odds ratio = 1.4)
8 Advancing age
 Sling versus figure-of-eight for nonoperative treatment
of acute midshaft clavicle fractures (Grade B evidence
from RCT with methodologic limitations)
8 Patients treated with a sling were more satisfied (93% vs.
74%; relative chance of satisfaction, 1.3; P = 0.09)
 Plating versus nonoperative treatment of acute midshaft
clavicle fractures (Grade B/C evidence from pooled
nonrandomized, noncomparative data and 1 RCT with
methodologic limitations)
8 A relative risk reduction of 57% for nonunion can be
achieved when using a plate compared with nonoperative
treatment (86% for displaced fractures). One RCT with
methodologic limitations reported a nonunion rate of 0%
(0/50) for plating and 24% (12/50) for nonoperative
treatment of 100% displaced fractures
 Anterior-inferior versus superior plate positioning
(Grade C evidence from nonrandomized, comparative study)
8 Anterior-inferior plate placement is associated with fewer
symptoms
 Intramedullary fixation versus nonoperative treatment
of acute midshaft clavicle fractures (Grade B/C evidence
from pooled nonrandomized, noncomparative data, 2
nonrandomized comparative studies, and 1 RCT with
methodologic limitations)
8 A relative risk reduction of 72% for nonunion can be
achieved when using intramedullary fixation compared
with nonoperative treatment (87% for displaced fractures).
However, 2 nonrandomized, comparative studies report
results opposite to each other, and 1 RCT with
methodologic limitations suggests lower nonunion and
refracture rates for nonoperative treatment, although not
statistically significant.
Future studies need to compare different fixation techniques in
a prospective, randomized manner. Studies should be based on
an adequate sample size to allow meaningful interpretation of
the results.
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