Nonoperative Treatment Compared With Plate Fixation of Displaced Midshaft Clavicular Fractures

McKee.
fm Page 1 Thursday, December 7, 2006 1:44 PM
1
COPYRIGHT © 2007 BY THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED
Nonoperative Treatment Compared

with Plate Fixation of
Displaced Midshaft Clavicular Fractures
A Multicenter, Randomized Clinical Trial
By the Canadian Orthopaedic Trauma Society
Background: Recent studies have shown a high prevalence of symptomatic malunion and nonunion after nonopera-
tive treatment of displaced midshaft clavicular fractures. We sought to compare patient-oriented outcome and compli-
cation rates following nonoperative treatment and those after plate fixation of displaced midshaft clavicular fractures.
Methods: In a multicenter, prospective clinical trial, 132 patients with a displaced midshaft fracture of the clavicle
were randomized (by sealed envelope) to either operative treatment with plate fixation (sixty-seven patients) or nonop-
erative treatment with a sling (sixty-five patients). Outcome analysis included standard clinical follow-up and the Con-
stant shoulder score, the Disability of the Arm, Shoulder and Hand (DASH) score, and plain radiographs. One hundred
and eleven patients (sixty-two managed operatively and forty-nine managed nonoperatively) completed one year of
follow-up. There were no differences between the two groups with respect to patient demographics, mechanism of in-
jury, associated injuries, Injury Severity Score, or fracture pattern.
Results: Constant shoulder scores and DASH scores were significantly improved in the operative fixation group at all
time-points (p = 0.001 and p < 0.01, respectively). The mean time to radiographic union was 28.4 weeks in the non-
operative group compared with 16.4 weeks in the operative group (p = 0.001). There were two nonunions in the oper-
ative group compared with seven in the nonoperative group (p = 0.042). Symptomatic malunion developed in nine
patients in the nonoperative group and in none in the operative group (p = 0.001). Most complications in the opera-
tive group were hardware-related (five patients had local irritation and/or prominence of the hardware, three had a
wound infection, and one had mechanical failure). At one year after the injury, the patients in the operative group were
more likely to be satisfied with the appearance of the shoulder (p = 0.001) and with the shoulder in general (p = 0.002)
than were those in the nonoperative group.
Conclusions: Operative fixation of a displaced fracture of the clavicular shaft results in improved functional outcome
and a lower rate of malunion and nonunion compared with nonoperative treatment at one year of follow-up. Hardware
removal remains the most common reason for repeat intervention in the operative group. This study supports primary
plate fixation of completely displaced midshaft clavicular fractures in active adult patients.
Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
C
lavicular fractures are common injuries, accounting nonunions in 2235 patients in another3,4. Clavicular malunion
for 2.6% of all fractures1, and they occur most com- was described as being of radiographic interest only, with no
monly in young active individuals2. Fractures of the clinical importance1-4.
middle third (or midshaft) account for approximately 80% of However, more recent studies of displaced midshaft
all clavicular fractures1,2, and they have traditionally been clavicular fractures have shown a nonunion rate of 15% (eight
treated nonoperatively, even when substantially displaced. This of fifty-two patients) in one series as well as a rate of unsatis-
treatment strategy was based on early reports that suggested factory patient-oriented outcomes of 31% (sixteen of fifty-two
that clavicular nonunion was extremely rare, with a preva- patients) in one report and 32% (twenty-two of sixty-eight
lence of four nonunions in 566 patients in one series and three patients) in another, which are much higher rates than previ-
Disclosure: In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from
the Orthopaedic Trauma Association and Zimmer Inc. None of the authors received payments or other benefits or a commitment or agreement to
provide such benefits from a commercial entity. A commercial entity (Zimmer Inc.) paid or directed, or agreed to pay or direct, benefits to a research
fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
McKee.fm Page 2 Thursday, December 7, 2006 1:44 PM
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THE JOURNAL OF BONE & JOINT SURGER Y · JBJS.ORG N O N O P E R A T IVE TR E A T M E N T C O M P A R E D W I T H P L A T E F I X A T I O N
VO L U M E 89-A · N U M B E R 1 · J A N U A R Y 2007 OF D I S P L A C E D M I D S H A F T C L AV I C U L A R F R A C T U RE S
Fig. 1-A
Anteroposterior radiograph of a displaced midshaft clavicular fracture. Note the difference in di-
ameter of the clavicular shaft of the proximal and distal fragments at the fracture site, suggest-
ing that a substantial degree of rotation has occurred.
Fig. 1-B
Intraoperative photograph of open reduction and internal fixation of a displaced midshaft clavicu-
lar fracture with a contoured small-fragment plate.
ously reported5-7. In addition, clavicular malunion has recently sures), and the elimination of information on children (who
been described by multiple authors as a distinct clinical entity have an inherently good prognosis and remodeling potential)
with characteristic clinical and radiographic features8-12. Possi- from the data analysis13,14.
ble explanations for the increased residual disability seen fol- While it is becoming accepted that the results of closed
lowing the nonoperative care of these fractures may be the treatment are much inferior to those described in early re-
survival of critically injured trauma patients with more severe ports, primary operative intervention has not been shown
fracture patterns5, increased patient expectations, more com- to be superior. Numerous recent studies have examined the
plete follow-up (including patient-oriented outcome mea- safety and efficacy of primary open reduction and internal fix-
3
ation for completely displaced midshaft clavicular fractures participating study centers (seven university-affiliated and one
and have noted a high union rate with a low complication community hospital). Eligible patients (see below) were ran-
rate14-16. However, none of those studies prospectively com- domized to nonoperative or operative care for completely dis-
pared operative fixation with nonoperative care in a random- placed (no cortical contact between the proximal and distal
ized fashion, considered to be the so-called gold standard of fragments) midshaft fractures of the clavicle. Patients with iso-
comparative studies. A recent meta-analysis of available data lated fractures and those with concomitant shoulder girdle
on displaced midshaft clavicular fractures described a re- fractures were included. The primary outcome measure was
duced nonunion rate after primary treatment with plate fixa- the Disability of the Arm, Shoulder and Hand (DASH) score17,
tion (2.2%; ten of 460 patients) compared with nonoperative while secondary outcome measures included the Constant
care (15.1%; twenty-four of 159 patients), a relative risk re- shoulder score, union rate, and complication rates. The null
duction of 86% (95% confidence interval, 71% to 93%)14. The hypothesis was that there would be no differences between the
purpose of the present multicenter, prospective, randomized operative and nonoperative groups with respect to surgeon-
clinical trial was to compare patient-oriented and surgeon- based and patient-based upper extremity outcome scores.
based outcomes after nonoperative treatment with those after
operative treatment of completely displaced midshaft clavicu- Inclusion Criteria
lar fractures. Patients were included in the study if they had (1) a com-
pletely displaced midshaft fracture of the clavicle (no cortical
Materials and Methods contact between the main proximal and distal fragments), (2)
his was a multicenter, prospective, randomized clinical a fracture in the middle third of the clavicle (a fracture amena-
T trial involving eight centers, including St. Michael’s Hospi-
tal, Toronto; Sunnybrook and Women’s College Health Sci-
ble to plate fixation with a minimum of three screws in each
proximal and distal fragment), (3) an age between sixteen and
ences Centre, Toronto; McMaster University Medical Center, sixty years, (4) no medical contraindications to general anes-
Hamilton; Brantford General Hospital, Brantford; London thesia, and (5) provided informed consent.
Health Sciences Centre, London, Ontario; Royal Columbian
Hospital, New Westminster, British Columbia; Montreal Gen- Exclusion Criteria
eral Hospital, Montreal, Quebec; and Foothills Medical Centre, Patients were excluded from the study if they had (1) an age of
Calgary, Alberta, Canada. Institutional approval was obtained less than sixteen years or greater than sixty years, (2) a fracture
from the research ethics board at each participating site prior in the proximal or distal third of the clavicle, (3) a pathologi-
to the initiation of the study. Between April 2001 and Decem- cal fracture, (4) an open fracture, (5) a fracture seen more
ber 2004, 132 patients were enrolled in the study from eight than twenty-eight days after the injury, (6) an associated neu-
Fig. 1-C
Postoperative radiograph after open reduction and internal fixation of the displaced midshaft
clavicular fracture.
4
rovascular injury with objective neurological findings on on the superior surface of the bone, with the goal being a
physical examination, (7) an associated head injury (a Glas- minimum of three screws in the main proximal and distal
gow Coma Scale score of <12), (8) an upper extremity fracture fragments (forty-four patients were managed with limited
distal to the shoulder, (9) an inability to comply with follow- contact dynamic compression plates; fifteen, with 3.5-mm re-
up (a transient or an inability to read or complete forms), (10) construction plates; four, with precontoured plates; and four,
a medical contraindication to surgery and/or anesthesia (such with other plates) (Figs. 1-A, 1-B, and 1-C). Reconstruction
as heart disease, renal failure, or active chemotherapy), and plates were used for physically smaller individuals (<70 kg).
(11) a lack of consent. Comminuted fragments were secured with lag screws if pos-
sible, with care being taken to preserve soft-tissue attachments,
Sample Size Calculation and a longer plate was selected to maintain a minimum of
Before beginning of the study, a power analysis was per- three screws in the primary proximal and distal fragments. If
formed. The choice of sample size was made on the basis of the fragments were too small to accept fixation, they were
the primary outcome of shoulder function scores. Assuming a loosely sutured into place with number-1 absorbable suture
beta error of 0.05 and a power of 0.80, it was anticipated that and positioned under the plate. Bone-grafting was not per-
sixty patients would be required in each group in order to formed. The deltotrapezial fascia was closed with interrupted
demonstrate a 15% difference in the shoulder scores between number-1 absorbable sutures as a distinct layer, followed by
the two groups. skin closure. No drains were used.
A sling was used for comfort for seven to ten days, and
Randomization then a physiotherapist instructed the patient in active range-
In the fracture clinic or emergency room, the attending sur- of-motion exercises that were performed at home. When
geon or orthopaedic resident identified a patient as being eli- fracture union (defined as radiographic union [see below]
gible for the study and the study protocol was introduced. The with no pain or motion with manual stressing of the frac-
patient was then seen by the research nurse, the nature of the ture) was evident, typically at six weeks, strengthening was
study was explained, and consent was obtained. Typically, the allowed, with a return to full activities (including sports) at
patient took a consent form home for perusal and completion. three months. However, compliance with this regimen was
Once consent was obtained, randomization was made by the variable as the patients were predominantly young men, and
research nurse using a sequentially numbered, opaque, sealed many returned to more aggressive recreational and occupa-
envelope to either nonoperative care (a sling) or open reduc- tional activities earlier than recommended.
tion and plate fixation in a 1:1 ratio.
Assessment
Nonoperative Care Following enrollment in the study, the patients were seen at
Patients randomized to nonoperative care received a stan- six weeks and at three, six, and twelve months. Assessment in-
dard sling for six weeks, although compliance was variable: cluded standardized clinical evaluation and completion of the
most patients discarded the sling when the pain subsided. Constant shoulder score and the Disability of the Arm, Shoul-
There is no convincing clinical evidence that a closed reduc- der and Hand (DASH) score. Both an anteroposterior and a
tion of a displaced clavicular fracture can be maintained 18. 20° cephalad radiograph were made for each patient. Radio-
In a prior randomized clinical trial comparing a sling and a graphic union was defined as complete cortical bridging be-
figure-of-eight bandage for displaced clavicular shaft frac- tween proximal and distal fragments on both radiographs as
tures, Andersen et al. showed no functional or radiographic determined by the treating surgeon.
difference at the time of final follow-up and the patients fa-
vored the sling18. Therefore, no attempt was made at a closed Adverse Events and/or Complications
reduction nor was a figure-of-eight bandage applied. Follow- An adverse event or complication was defined as any event
ing healing, a course of physiotherapy for strengthening was that necessitated another operative procedure or additional
prescribed. medical treatment. Nonunion was defined as the lack of ra-
diographic healing with clinical evidence of pain and motion
Operative Technique at the fracture site at one year. Radiographic malunion, de-
Patients randomized to plate fixation had the operation within fined as loss of anatomic contour of the clavicle, was universal
twenty-eight days after the injury. Prophylactic antibiotics were in the nonoperative group. Symptomatic malunion was de-
given. Under a general anesthetic, the patient was positioned fined as union of the fracture in a shortened, angulated, or
in a beach-chair semi-sitting position. The involved shoulder displaced position with weakness, easy fatigability, pain with
was prepared and draped, and an oblique incision was made overhead activity, neurologic symptoms, and shoulder asym-
over the fracture site. Larger branches of the identifiable su- metry with a completed or planned corrective osteotomy.
praclavicular nerves were identified and protected through- Complex regional pain syndrome was diagnosed by the pres-
out the procedure; smaller branches were sacrificed at the ence of dysesthetic pain and hyperesthesia extending into the
surgeon’s discretion. The fracture site was identified, and the hand of the involved limb, vasomotor changes, skin atrophy,
fracture was reduced and fixed with a small-fragment plate and diffuse osteopenia19.
5
Fig. 2
Graphic analysis comparing the mean Constant shoulder scores in the operative and nonopera-
tive groups at six, twelve, twenty-four, and fifty-two weeks of follow-up. The values are improved
for the operative group at each time-point (p < 0.01 for all).
Fig. 3
Graphic analysis comparing the mean Disability of the Arm, Shoulder and Hand (DASH) scores in
the operative and nonoperative groups at six, twelve, twenty-four, and fifty-two weeks of follow-
up. The DASH is a disability score where a “perfect” extremity would typically score 0 (mean val-
ues for a “normal” extremity range from 4 to 8). Values are worse in the nonoperative group at
each time-point (p < 0.01 at six weeks, p = 0.04 at twelve weeks, p = 0.05 at twenty-four weeks,
and p < 0.01 at fifty-two weeks).
6
TABLE I Demographic Data on the Patients and Characteristics of the Fractures
Operative Nonoperative
Parameter Group (N = 62) Group (N = 49) P Value
Male 53 34 0.062
Female 9 15 0.062
Mean age (yr) 33.5 33.5 0.644
(Mean) height (cm) 173.9 167.0 0.213
Mean Injury Severity Score 5.8 7.2 0.232
Associated fractures 8 6 0.756
Dominant arm 26 20 0.561
Smokers 19 16 0.624
Mean fracture angulation (deg) 11.9 12.7 0.563
Mean fracture shortening (mm) 15.7 14.3 0.209
Mean total fracture displacement (mm) 20.1 19.3 0.478
Mechanism of injury (no. of patients) >0.05 for all
Fall 9 7
Sports 9 6
Motor-vehicle or motorcycle accident 16 14
Skiing or snowboarding 7 10
Bicycling 15 8
Other 6 4
Statistical Analysis year. Significantly more patients in the nonoperative group

Statistical analysis was performed with SPSS software (version were lost to follow-up (p = 0.008; see Discussion). Thus, sixty-
13.0; SPSS, Chicago, Illinois). All scale variables were tested for two patients in the operative group and forty-nine in the non-
normality with the Kolmogorov-Smirnov test. The main effect operative group completed the one-year assessment. There
of treatment on the DASH and Constant scores was analyzed were no demographic differences between the operative and
with use of a two-way analysis of variance with treatment (oper- nonoperative groups, and there were no differences with re-
ative or nonoperative) and time (six, twelve, twenty-four, fifty- gard to mechanism of injury, associated fractures and/or inju-
two, and 104 weeks) as independent factors and the Tukey post ries, or ISS between the groups (Table I).
hoc method for the comparison of means. The Student t test
was used for the comparison of means for parametric scale vari- Constant Shoulder Scores
ables in independent groups. Nominal variables were tested by The operative group had significantly superior Constant
the chi-square or Fisher exact test. The Pearson correlation co- shoulder scores at all time-points (p < 0.01) (Fig. 2). This dif-
efficient was used for comparison of the DASH scores at one ference persisted at one year (p = 0.001), and the magnitude of
year with the Injury Severity Scores (ISS) and total vertical and the difference was approximately 10 points, which is consid-
horizontal displacement (total xy). All tests were two-sided. The ered a clinically measurable amount21.
results were considered to be significant at p < 0.05.
DASH Scores
Results The operative group had significantly superior (i.e., lower)
ne hundred and thirty-two patients with 132 fractures DASH scores at all time-points (Fig. 3), persisting to one year
O were entered in the study between April 2001 and De-
cember 2004. Sixty-seven patients were randomized to the op-
(p < 0.01). The magnitude of this difference was approximately
10 points, which is considered a clinically relevant amount17.
erative group and sixty-five to the nonoperative group. One
patient randomized to operative repair declined surgery, and Patient Satisfaction
one patient randomized to nonoperative treatment insisted on At each assessment, patients were asked “Are you satisfied with
operative repair. Both were followed in their original groups your shoulder?” At each assessment, patients in the operative
with use of the intention-to-treat principle20. One patient in group were more likely to reply “yes” to this question (p =
the nonoperative group died in a subsequent motor-vehicle 0.02, odds ratio = 3.8 at six weeks; p = 0.001, odds ratio = 4.4
accident, and fifteen were lost to follow-up by one year. Five at twelve weeks; p = 0.03, odds ratio = 3.2 at twenty-four
patients in the operative group were lost to follow-up at one weeks; and p = 0.002, odds ratio = 3.5 at fifty-two weeks).
7
TABLE II Complications
Adverse Event Group (N = 62) Group (N = 49) P Value
Nonunion 2* 7 0.042
Malunion requiring further treatment 0 9 0.001
Wound infection and/or dehiscence 3 0 0.253
Hardware irritation requiring removal 5 0 0.065
Complex regional pain syndrome 0 1 0.441
Surgery for impending open fracture 0 2 0.192
Transient brachial plexus symptoms 8 7 0.690
Abnormality of the acromioclavicular or 2 3 0.653
sternoclavicular joint
Early mechanical failure 1 0 1.000
Other 2 2 0.784
Total 23 (37%) 31 (63%) 0.008
*One patient who was randomized to operative fixation declined surgery. He had a nonunion of the fracture at one year. According to the “in-
tention-to-treat” principle, the complication was included in the operative group as a nonunion. See text.
Range of Motion plications in the operative group tended to be hardware-

Range of motion was well maintained, and there were no sig- related (plate irritation and removal, and wound problems).
nificant differences in measured range of motion between the Wound infection and dehiscence following plate fixation of
two groups. No patient lost >10° of motion in any plane. the clavicle has been a feared complication. We had three pa-
tients with such complications, and all were managed with
Fracture Union antibiotics and local wound care. Once fracture union had
The mean time to union was 16.4 weeks in the operative occurred, each patient underwent hardware removal and ir-
group and 28.4 weeks in the nonoperative group (p = 0.001). rigation and/or débridement with successful resolution of
Nonunion occurred in two patients in the operative group the infection (Table II). One patient in the operative group
and in seven in the nonoperative group (Table II). One non- experienced premature hardware failure in an all-terrain ve-
union in the operative group was in the patient who had been hicle accident six weeks after fixation and required repeat
randomized to operative fixation but declined surgery and fixation.
had subsequent development of the nonunion. He was fol-
lowed with the intention-to-treat principle20, although techni- Appearance of the Shoulder
cally this was not a failure of operative intervention. Patients were specifically questioned about their satisfaction
or dissatisfaction regarding the appearance of the shoulder
Adverse Events and/or Complications (and incision, if applicable) at one year following the injury
Complications, including nonunion and symptomatic mal- (Table III). Patients in the operative group were more likely to
union, were more frequent in the nonoperative group. Com- be satisfied with the appearance of the shoulder (p = 0.001).
TABLE III Appearance of Shoulder
Condition Group (N = 62) Group (N = 49) P Value
“Droopy” shoulder 0 10 0.001
Bump and/or asymmetry 0 22 0.001
Scar 3 0 0.253
Sensitive and/or painful fracture site 9 10 0.891
Hardware irritation and/or prominence 11 0 0.001
Incisional numbness 18 0 0.001
Satisfaction with appearance 52 26 0.001
8
Radiographic Outcome ten years after the injury, ninety-six patients (46%) still had
Anatomic reduction was obtained and maintained in all sixty- symptoms despite the fact that only fifteen (7%) had a non-
two patients in the operative group except for one in whom union24. McKee et al. described the typical inferior, shortened,
early mechanical failure of the plate occurred at six weeks. and anteriorly rotated position of the distal fragment in clavic-
Correlating displacement and outcome in the operative ular malunion and the symptoms that resulted from it8. Cor-
group was not possible since anatomic reduction was ob- rective osteotomy and plate fixation improved the DASH score
tained and maintained in all patients, but an association was from 32 to 11, with fourteen of fifteen patients who were sat-
found between total displacement at the fracture site (vertical isfied with the procedure25. Similar results were found with
displacement and shortening combined) and DASH scores at corrective osteotomy for clavicular malunion in studies by Basa-
one year in the nonoperative group (r = 0.326, p = 0.05); that mania, Bosch et al., and Chan et al.9-11. In the forty-nine patients
is, greater displacement correlated with a higher DASH score in our study who were treated nonoperatively and had a healed
or more patient-related disability. With the numbers avail- fracture, many (nine; 18%) had the typical symptoms of
able, patients with multiple shoulder girdle injuries did not malunion develop and they elected corrective osteotomy26-29.
demonstrate significantly worse scores than those with iso- Most of the malunions were associated with substantial clavic-
lated injuries (p = 0.24). ular displacement and shortening, although the effect of short-
ening on function remains controversial30,31. Our study found
Discussion (in the nonoperative group) a direct relationship between in-
raditionally, clavicular fractures have been treated nonop- creased displacement and a worse DASH score.
T eratively. In the 1960s, Neer and Rowe reported on the
nonoperative treatment of clavicular fractures3,4. Neer re-
While it is unclear why there is such a dramatic differ-
ence between the outcome of clavicular fractures in previous
ported nonunion in only three of 2235 patients with middle- reports and those in contemporary studies, there are several
third fractures treated by closed methods3, while Rowe re- possibilities. The initial reports often included data on clavic-
ported nonunion in four of 566 clavicular fractures4. This in- ular fractures in children, who have inherent healing abilities
formation dominated the clinical approach to displaced and remodeling potential, and their data may have artificially
clavicular fractures. These studies also suggested a higher non- improved the overall results1-4. Second, the use of patient-
union rate with operative care. However, more recent studies oriented outcome measures, as in the studies by Hill et al. and
have shown that the union rate for displaced midshaft frac- McKee et al., has been shown to reveal functional deficits in
tures of the clavicle may not be as favorable as once thought. the upper extremity that are not detected by traditional sur-
In a prospective, observational cohort study, Robinson et al. geon-based scores; it is unlikely that such patient dissatisfac-
described a consecutive series of 868 patients with clavicular tion would be detected in a 1960 study that focused on
fractures, 581 of whom had a midshaft diaphyseal fracture22. radiographic outcome6,8. A related issue is changing patient
They found a significantly higher nonunion rate (21%) for the expectations: most active clinicians are acutely aware that a
displaced, comminuted midshaft fractures (p < 0.05). In a let- patient today is more likely to expect a rapid return to pain-
ter to the editor, Brinker et al. analyzed the data in that study free function following a fracture (and be more vocal when
and suggested a nonunion rate ranging between 20% and 33% this does not occur) than his or her 1960 counterpart. Last, it
for displaced, comminuted fractures in males23. Similarly, in a may be that injury patterns are changing. In one study of clav-
study of fifty-two displaced midshaft clavicular fractures, Hill icular shaft fractures in patients with polytrauma, the pres-
et al. reported that eight patients had a nonunion and sixteen ence of a clavicular fracture was found to be associated with a
patients had an unsatisfactory outcome on the basis of pa- mortality rate of 32% (thirty-four of 105 patients) (mainly
tient-oriented measures6. They concluded that displacement due to concomitant chest and head injuries)5. Survivors dis-
of the fracture fragments by >2 cm was associated with an un- played a substantial level of residual disability in the involved
satisfactory result. A meta-analysis of recent studies revealed shoulder. Most studies have revealed a correlation between
that the rate of nonunion for displaced midshaft clavicular fracture comminution (and displacement) and worse out-
fractures was 2.2% (ten of 460 patients) after plate fixation come, and these fracture features are associated with higher-
compared with 15.1% (twenty-four of 159 patients) after energy trauma5,6,14,22. Thus, there are surviving patients with
nonoperative care, a relative risk reduction for nonunion of clavicular fractures who have an intrinsically worse prognosis
86%14. That meta-analysis also showed that primary plate and in whom long-term sequelae may be more common.
fixation was, contrary to prevailing opinion, a safe and reli- In contradistinction to earlier case series, modern stud-
able procedure14. ies on primary plate fixation of acute midshaft clavicular frac-
Previously, malunion of the clavicle (which is typical tures have described high rates of successful results with rates
with displaced fractures) was thought to be of radiographic in- of union ranging from 94% to 100% and low rates of infection
terest only and required no treatment. However, it is becoming and surgical complications: a recent meta-analysis of plate fix-
increasingly apparent that clavicular malunion is a distinct ation for 460 displaced fractures revealed a nonunion rate of
clinical entity with radiographic, orthopaedic, neurologic, and only 2.2%14-16. With improved implants, prophylactic antibiot-
cosmetic features. Nowak et al. examined the late sequelae in ics, and better soft-tissue handling, plate fixation has been a
208 adult patients with clavicular fractures and found that, at reliable and reproducible technique.
9
Our study examined 111 patients with completely dis- of patients lost to follow-up in our study is comparable with
placed midshaft clavicular fractures randomized to either tra- that in other studies and we do not believe that it jeopardizes
ditional sling treatment or open reduction and internal our results. Specifically, the greatest concern in a study such
fixation with a plate. There was a clear superiority of operative as ours is that a number of complications in the (experimen-
fixation, with significantly superior surgeon-based (Constant tal) operative group would be missed because of lack of follow-
shoulder score) and patient-based (DASH) outcome measures up. However, we followed sixty-two of sixty-seven operative
at every time-point in the study. The improvement in scores patients to definitive outcome. We believe that the patients
(approximately 10 points for each) was clinically relevant as who did not undergo surgery were less likely to feel commit-
well as significantly superior. Patients who underwent opera- ted to the study, did not return because of a lack of a require-
tive fixation also had an earlier return to normal function. In ment for postoperative care, or were potentially unhappy
addition, there was a significant reduction in the risk of non- with their allocated treatment. We know of at least two such
union in the operative group (two of sixty-two patients had a individuals who obtained operative treatment for a non-
nonunion) compared with the nonoperative group (seven of union elsewhere. Lastly, with time, our reintervention rate
forty-nine patients had a nonunion) (p = 0.001). Complica- may increase, especially in the operative group (i.e., for
tions in the operative group were typically hardware-related hardware removal).
(plate irritation and wound complications) and were cor- In conclusion, our study shows that early primary plate
rected by plate removal in all cases. Refracture was not seen, fixation of completely displaced midshaft clavicular fractures
despite the fact that many patients returned to heavy contact results in improved patient-oriented outcomes, improved sur-
and so-called extreme sports (fifty-five of 111 patients in the geon-oriented outcomes, earlier return to function, and de-
study sustained the fracture during sports, bicycling, or skiing creased rates of nonunion and malunion. There were no
and/or snowboarding). Most of the plates used in our study catastrophic complications in the operative group such as
were straight plates contoured to fit the clavicle. More re- brachial plexus palsy, vascular injury, or pneumothorax; hard-
cently, we changed to anatomically designed s-shaped con- ware removal was the most common reason for reinterven-
toured plates25. Our preliminary experience with these plates tion. Patients were more satisfied with the shoulder (and its
suggests a dramatically reduced prevalence (and severity) of appearance) following operative intervention. While we stress
soft-tissue irritation, and it is possible that this may decrease that our findings are applicable only to a specific subset of
the need for plate removal in the operative group. clavicular injuries, our data support primary plate fixation of
Appearance is important to patients, and an unsightly completely displaced midshaft clavicular fractures in active
scar has been a traditional deterrent to operative treatment of adults.
clavicular fractures. We specifically investigated this compo-
NOTE: The authors acknowledge the advice and knowledge of Lynn A. Crosby and Carl J.
nent of patient satisfaction in our study (see Table III). Despite Basamania.
the prevalence of hardware prominence and incisional com- This manuscript was prepared by the Canadian Orthopaedic Trauma Society, c/o Michael D.
plications (numbness and sensitivity) in the operative group, McKee, MD, FRCS(C), 55 Queen Street East, Suite 800, Toronto, ON M5C 1R6, Canada. E-mail
address: [email protected]
more patients in this group (fifty-two of sixty-two patients)
Principal Investigator: Michael D. McKee
answered “yes” to the question “Are you satisfied with the ap-
Lead Investigators (Site): Michael D. McKee (St. Michael’s Hospital), Hans J. Kreder (Sunny-
pearance of your shoulder?” than in the nonoperative group brook and Women’s Health Science Center), Scott Mandel (McMaster University), Robert Mc-
Cormack (Royal Columbian Hospital), Rudolph Reindl (Montreal General Hospital), David M.W.
(twenty-six of forty-nine; p = 0.001). In this group of predom- Pugh (Brantford Hospital), David Sanders (London Health Science Center), and Richard Buckley
inantly young male patients, a droopy shoulder (nonopera- (Foothills Hospital). Study Design: Michael D. McKee, Emil H. Schemitsch, Lisa M. Wild, Hans
J. Kreder, Robert McCormack, Scott Mandel, Rudolph Reindl, and Edward Harvey. Data Analy-
tive group) seemed to be of greater cosmetic concern than a sis: Jeremy A. Hall, Lisa M. Wild, Milena V. Santos, Michael D. McKee, Christian J. Veillette,
and Daniel B. Whelan. Radiographic Analysis: Lisa M. Wild, Milena V. Santos, and Michael D.
scar (operative group). McKee. Manuscript Preparation: Michael D. McKee, Jeremy A. Hall, Lisa M. Wild, Emil H. Sche-
mitsch, Rudolph Reindl, Robert McCormack, David Sanders, and Christian J. Veillette. Patient
One of the weaknesses of our study is that we used Enrollment and Assessment: Michael D. McKee, Emil H. Schemitsch, James P. Waddell, Lisa M.
Wild, Milena V. Santos, Hans J. Kreder, David J.G. Stephen, Terrence A. Axelrod, Edward Har-
only plate fixation in the operative group: intramedullary vey, Rudolph Reindl, Gregory Berry, Bertrand Perey, Kostas Panagiotopolous, Robert McCor-
mack, Beverly Bulmer, Mauri Zomar, Karyn Moon, Elizabeth Kimmel, Carla Erho, Elena Lakoub,
fixation is also an option32-34. A direct comparison between Patricia Leclair, Christian J. Veillette, Bonnie Sobchak, David M.W. Pugh, Richard Buckley, Scott
Mandel, David Sanders, and Trevor B. Stone.
the two techniques in a prospective trial is required. Another
weakness of our study is the number of patients who did not
complete the assessment period. However, in a group of frac-
ture patients who were predominantly young men, the rate doi:10.2106/JBJS.F.00020
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Nonoperative Treatment Compared With Plate Fixation of Displaced Midshaft Clavicular Fractures

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Nonoperative Treatment Compared With Plate Fixation of Displaced Midshaft Clavicular Fractures

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Nonoperative Treatment Compared With Plate Fixation of Displaced Midshaft Clavicular Fractures

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McKee.

fm Page 1 Thursday, December 7, 2006 1:44 PM

Nonoperative Treatment Compared

TABLE I Demographic Data on the Patients and Characteristics of the Fractures

Statistical Analysis year. Significantly more patients in the nonoperative group

Range of Motion plications in the operative group tended to be hardware-

TABLE III Appearance of Shoulder

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