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Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures

A Multicenter, Randomized Clinical Trial

 Canadian Orthopaedic Trauma Society

The Journal of Bone & Joint Surgery: January 2007 - Volume 89 - Issue 1 - p 1-10
doi: 10.2106/JBJS.F.00020
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Abstract

Clavicular fractures are common injuries, accounting for 2.6% of all fractures1, and they occur most commonly in young active individuals2. Fractures of the middle third (or midshaft) account for approximately 80% of all clavicular fractures1,2, and they have traditionally been treated nonoperatively, even when substantially displaced. This treatment strategy was based on early reports that suggested that clavicular nonunion was extremely rare, with a prevalence of four nonunions in 566 patients in one series and three nonunions in 2235 patients in another3,4. Clavicular malunion was described as being of radiographic interest only, with no clinical importance1-4.

However, more recent studies of displaced midshaft clavicular fractures have shown a nonunion rate of 15% (eight of fifty-two patients) in one series as well as a rate of unsatisfactory patient-oriented outcomes of 31% (sixteen of fifty-two patients) in one report and 32% (twenty-two of sixty-eight patients) in another, which are much higher rates than previously reported5-7. In addition, clavicular malunion has recently been described by multiple authors as a distinct clinical entity with characteristic clinical and radiographic features8-12. Possible explanations for the increased residual disability seen following the nonoperative care of these fractures may be the survival of critically injured trauma patients with more severe fracture patterns5, increased patient expectations, more complete follow-up (including patient-oriented outcome measures), and the elimination of information on children (who have an inherently good prognosis and remodeling potential) from the data analysis13,14.

Figs. 1-A, 1-B, and 1-C

Anteroposterior radiograph of a displaced midshaft clavicular fracture. Note the difference in diameter of the clavicular shaft of the proximal and distal fragments at the fracture site, suggesting that a substantial degree of rotation has occurred. Intraoperative photograph of open reduction and internal fixation of a displaced midshaft clavicular fracture with a contoured small-fragment plate. Postoperative radiograph after open reduction and internal fixation of the displaced midshaft clavicular fracture.

fig1a
fig1b
fig1c

While it is becoming accepted that the results of closed treatment are much inferior to those described in early reports, primary operative intervention has not been shown to be superior. Numerous recent studies have examined the safety and efficacy of primary open reduction and internal fixation for completely displaced midshaft clavicular fractures and have noted a high union rate with a low complication rate14-16. However, none of those studies prospectively compared operative fixation with nonoperative care in a randomized fashion, considered to be the so-called gold standard of comparative studies. A recent meta-analysis of available data on displaced midshaft clavicular fractures described a reduced nonunion rate after primary treatment with plate fixation (2.2%; ten of 460 patients) compared with nonoperative care (15.1%; twenty-four of 159 patients), a relative risk reduction of 86% (95% confidence interval, 71% to 93%)14. The purpose of the present multicenter, prospective, randomized clinical trial was to compare patient-oriented and surgeon-based outcomes after nonoperative treatment with those after operative treatment of completely displaced midshaft clavicular fractures.

Materials and Methods

This was a multicenter, prospective, randomized clinical trial involving eight centers, including St. Michael's Hospital, Toronto; Sunnybrook and Women's College Health Sciences Centre, Toronto; McMaster University Medical Center, Hamilton; Brantford General Hospital, Brantford; London Health Sciences Centre, London, Ontario; Royal Columbian Hospital, New Westminster, British Columbia; Montreal General Hospital, Montreal, Quebec; and Foothills Medical Centre, Calgary, Alberta, Canada. Institutional approval was obtained from the research ethics board at each participating site prior to the initiation of the study. Between April 2001 and December 2004, 132 patients were enrolled in the study from eight participating study centers (seven university-affiliated and one community hospital). Eligible patients (see below) were randomized to nonoperative or operative care for completely displaced (no cortical contact between the proximal and distal fragments) midshaft fractures of the clavicle. Patients with isolated fractures and those with concomitant shoulder girdle fractures were included. The primary outcome measure was the Disability of the Arm, Shoulder and Hand (DASH) score17, while secondary outcome measures included the Constant shoulder score, union rate, and complication rates. The null hypothesis was that there would be no differences between the operative and nonoperative groups with respect to surgeon-based and patient-based upper extremity outcome scores.

Inclusion Criteria

Patients were included in the study if they had (1) a completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments), (2) a fracture in the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment), (3) an age between sixteen and sixty years, (4) no medical contraindications to general anesthesia, and (5) provided informed consent.

Exclusion Criteria

Patients were excluded from the study if they had (1) an age of less than sixteen years or greater than sixty years, (2) a fracture in the proximal or distal third of the clavicle, (3) a pathological fracture, (4) an open fracture, (5) a fracture seen more than twenty-eight days after the injury, (6) an associated neurovascular injury with objective neurological findings on physical examination, (7) an associated head injury (a Glasgow Coma Scale score of <12), (8) an upper extremity fracture distal to the shoulder, (9) an inability to comply with follow-up (a transient or an inability to read or complete forms), (10) a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy), and (11) a lack of consent.

Sample Size Calculation

Before beginning of the study, a power analysis was performed. The choice of sample size was made on the basis of the primary outcome of shoulder function scores. Assuming a beta error of 0.05 and a power of 0.80, it was anticipated that sixty patients would be required in each group in order to demonstrate a 15% difference in the shoulder scores between the two groups.

Randomization

In the fracture clinic or emergency room, the attending surgeon or orthopaedic resident identified a patient as being eligible for the study and the study protocol was introduced. The patient was then seen by the research nurse, the nature of the study was explained, and consent was obtained. Typically, the patient took a consent form home for perusal and completion. Once consent was obtained, randomization was made by the research nurse using a sequentially numbered, opaque, sealed envelope to either nonoperative care (a sling) or open reduction and plate fixation in a 1:1 ratio.

Nonoperative Care

Patients randomized to nonoperative care received a standard sling for six weeks, although compliance was variable: most patients discarded the sling when the pain subsided. There is no convincing clinical evidence that a closed reduction of a displaced clavicular fracture can be maintained18. In a prior randomized clinical trial comparing a sling and a figure-of-eight bandage for displaced clavicular shaft fractures, Andersen et al. showed no functional or radiographic difference at the time of final follow-up and the patients favored the sling18. Therefore, no attempt was made at a closed reduction nor was a figure-of-eight bandage applied. Following healing, a course of physiotherapy for strengthening was prescribed.

Operative Technique

Patients randomized to plate fixation had the operation within twenty-eight days after the injury. Prophylactic antibiotics were given. Under a general anesthetic, the patient was positioned in a beach-chair semi-sitting position. The involved shoulder was prepared and draped, and an oblique incision was made over the fracture site. Larger branches of the identifiable supraclavicular nerves were identified and protected throughout the procedure; smaller branches were sacrificed at the surgeon's discretion. The fracture site was identified, and the fracture was reduced and fixed with a small-fragment plate on the superior surface of the bone, with the goal being a minimum of three screws in the main proximal and distal fragments (forty-four patients were managed with limited contact dynamic compression plates; fifteen, with 3.5-mm reconstruction plates; four, with precontoured plates; and four, with other plates) (Figs. 1-A, 1-B, and 1-C). Reconstruction plates were used for physically smaller individuals (<70 kg). Comminuted fragments were secured with lag screws if possible, with care being taken to preserve soft-tissue attachments, and a longer plate was selected to maintain a minimum of three screws in the primary proximal and distal fragments. If the fragments were too small to accept fixation, they were loosely sutured into place with number-1 absorbable suture and positioned under the plate. Bone-grafting was not performed. The deltotrapezial fascia was closed with interrupted number-1 absorbable sutures as a distinct layer, followed by skin closure. No drains were used.

A sling was used for comfort for seven to ten days, and then a physiotherapist instructed the patient in active range-of-motion exercises that were performed at home. When fracture union (defined as radiographic union [see below] with no pain or motion with manual stressing of the fracture) was evident, typically at six weeks, strengthening was allowed, with a return to full activities (including sports) at three months. However, compliance with this regimen was variable as the patients were predominantly young men, and many returned to more aggressive recreational and occupational activities earlier than recommended.

Assessment

Following enrollment in the study, the patients were seen at six weeks and at three, six, and twelve months. Assessment included standardized clinical evaluation and completion of the Constant shoulder score and the Disability of the Arm, Shoulder and Hand (DASH) score. Both an anteroposterior and a 20° cephalad radiograph were made for each patient. Radiographic union was defined as complete cortical bridging between proximal and distal fragments on both radiographs as determined by the treating surgeon.

Adverse Events and/or Complications

An adverse event or complication was defined as any event that necessitated another operative procedure or additional medical treatment. Nonunion was defined as the lack of radiographic healing with clinical evidence of pain and motion at the fracture site at one year. Radiographic malunion, defined as loss of anatomic contour of the clavicle, was universal in the nonoperative group. Symptomatic malunion was defined as union of the fracture in a shortened, angulated, or displaced position with weakness, easy fatigability, pain with overhead activity, neurologic symptoms, and shoulder asymmetry with a completed or planned corrective osteotomy. Complex regional pain syndrome was diagnosed by the presence of dysesthetic pain and hyperesthesia extending into the hand of the involved limb, vasomotor changes, skin atrophy, and diffuse osteopenia19.

fig2
Fig. 2:
Graphic analysis comparing the mean Constant shoulder scores in the operative and nonoperative 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).
fig3
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 values 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).

Statistical Analysis

Statistical analysis was performed with SPSS software (version 13.0; SPSS, Chicago, Illinois). All scale variables were tested for normality with the Kolmogorov-Smirnov test. The main effect of treatment on the DASH and Constant scores was analyzed with use of a two-way analysis of variance with treatment (operative or nonoperative) and time (six, twelve, twenty-four, fifty-two, and 104 weeks) as independent factors and the Tukey post hoc method for the comparison of means. The Student t test was used for the comparison of means for parametric scale variables in independent groups. Nominal variables were tested by the chi-square or Fisher exact test. The Pearson correlation coefficient was used for comparison of the DASH scores at one year with the Injury Severity Scores (ISS) and total vertical and horizontal displacement (total xy). All tests were two-sided. The results were considered to be significant at p < 0.05.

Results

One hundred and thirty-two patients with 132 fractures were entered in the study between April 2001 and December 2004. Sixty-seven patients were randomized to the operative group and sixty-five to the nonoperative group. One patient randomized to operative repair declined surgery, and one patient randomized to nonoperative treatment insisted on operative repair. Both were followed in their original groups with use of the intention-to-treat principle20. One patient in the nonoperative group died in a subsequent motor-vehicle accident, and fifteen were lost to follow-up by one year. Five patients in the operative group were lost to follow-up at one year. Significantly more patients in the nonoperative group were lost to follow-up (p = 0.008; see Discussion). Thus, sixty-two patients in the operative group and forty-nine in the non-operative group completed the one-year assessment. There were no demographic differences between the operative and nonoperative groups, and there were no differences with regard to mechanism of injury, associated fractures and/or injuries, or ISS between the groups (Table I).

TABLE I - Demographic Data on the Patients and Characteristics of the Fractures
Parameter Operative Group (N = 62) Nonoperative 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

Constant Shoulder Scores

The operative group had significantly superior Constant shoulder scores at all time-points (p < 0.01) (Fig. 2). This difference persisted at one year (p = 0.001), and the magnitude of the difference was approximately 10 points, which is considered a clinically measurable amount21.

DASH Scores

The operative group had significantly superior (i.e., lower) DASH scores at all time-points (Fig. 3), persisting to one year (p < 0.01). The magnitude of this difference was approximately 10 points, which is considered a clinically relevant amount17.

Patient Satisfaction

At each assessment, patients were asked “Are you satisfied with your shoulder?” At each assessment, patients in the operative group were more likely to reply “yes” to this question (p = 0.02, odds ratio = 3.8 at six weeks; p = 0.001, odds ratio = 4.4 at twelve weeks; p = 0.03, odds ratio = 3.2 at twenty-four weeks; and p = 0.002, odds ratio = 3.5 at fifty-two weeks).

Range of Motion

Range of motion was well maintained, and there were no significant differences in measured range of motion between the two groups. No patient lost >10° of motion in any plane.

Fracture Union

The mean time to union was 16.4 weeks in the operative group and 28.4 weeks in the nonoperative group (p = 0.001). Nonunion occurred in two patients in the operative group and in seven in the nonoperative group (Table II). One non-union in the operative group was in the patient who had been randomized to operative fixation but declined surgery and had subsequent development of the nonunion. He was followed with the intention-to-treat principle20, although technically this was not a failure of operative intervention.

TABLE II - Complications
Adverse Event Operative Group (N = 62) Nonoperative 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 sternoclavicular joint 2 3 0.653
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 “intention-to-treat” principle, the complication was included in the operative group as a nonunion. See text

Adverse Events and/or Complications

Complications, including nonunion and symptomatic mal-union, were more frequent in the nonoperative group. Complications in the operative group tended to be hardware-related (plate irritation and removal, and wound problems). Wound infection and dehiscence following plate fixation of the clavicle has been a feared complication. We had three patients with such complications, and all were managed with antibiotics and local wound care. Once fracture union had occurred, each patient underwent hardware removal and irrigation and/or débridement with successful resolution of the infection (Table II). One patient in the operative group experienced premature hardware failure in an all-terrain vehicle accident six weeks after fixation and required repeat fixation.

Appearance of the Shoulder

Patients were specifically questioned about their satisfaction or dissatisfaction regarding the appearance of the shoulder (and incision, if applicable) at one year following the injury (Table III). Patients in the operative group were more likely to be satisfied with the appearance of the shoulder (p = 0.001).

TABLE III - Appearance of Shoulder
Condition Operative Group (N = 62) Nonoperative 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

Radiographic Outcome

Anatomic reduction was obtained and maintained in all sixty-two patients in the operative group except for one in whom early mechanical failure of the plate occurred at six weeks. Correlating displacement and outcome in the operative group was not possible since anatomic reduction was obtained and maintained in all patients, but an association was found between total displacement at the fracture site (vertical displacement and shortening combined) and DASH scores at one year in the nonoperative group (r = 0.326, p = 0.05); that is, greater displacement correlated with a higher DASH score or more patient-related disability. With the numbers available, patients with multiple shoulder girdle injuries did not demonstrate significantly worse scores than those with isolated injuries (p = 0.24).

Discussion

Traditionally, clavicular fractures have been treated nonoperatively. In the 1960s, Neer and Rowe reported on the nonoperative treatment of clavicular fractures3,4. Neer reported nonunion in only three of 2235 patients with middle-third fractures treated by closed methods3, while Rowe reported nonunion in four of 566 clavicular fractures4. This information dominated the clinical approach to displaced clavicular fractures. These studies also suggested a higher non-union rate with operative care. However, more recent studies have shown that the union rate for displaced midshaft fractures of the clavicle may not be as favorable as once thought. In a prospective, observational cohort study, Robinson et al. described a consecutive series of 868 patients with clavicular fractures, 581 of whom had a midshaft diaphyseal fracture22. They found a significantly higher nonunion rate (21%) for the displaced, comminuted midshaft fractures (p < 0.05). In a letter to the editor, Brinker et al. analyzed the data in that study and suggested a nonunion rate ranging between 20% and 33% for displaced, comminuted fractures in males23. Similarly, in a study of fifty-two displaced midshaft clavicular fractures, Hill et al. reported that eight patients had a nonunion and sixteen patients had an unsatisfactory outcome on the basis of patient-oriented measures6. They concluded that displacement of the fracture fragments by >2 cm was associated with an unsatisfactory result. A meta-analysis of recent studies revealed that the rate of nonunion for displaced midshaft clavicular fractures was 2.2% (ten of 460 patients) after plate fixation compared with 15.1% (twenty-four of 159 patients) after nonoperative care, a relative risk reduction for nonunion of 86%14. That meta-analysis also showed that primary plate fixation was, contrary to prevailing opinion, a safe and reliable procedure14.

Previously, malunion of the clavicle (which is typical with displaced fractures) was thought to be of radiographic interest only and required no treatment. However, it is becoming increasingly apparent that clavicular malunion is a distinct clinical entity with radiographic, orthopaedic, neurologic, and cosmetic features. Nowak et al. examined the late sequelae in 208 adult patients with clavicular fractures and found that, at ten years after the injury, ninety-six patients (46%) still had symptoms despite the fact that only fifteen (7%) had a non-union24. McKee et al. described the typical inferior, shortened, and anteriorly rotated position of the distal fragment in clavicular malunion and the symptoms that resulted from it8. Corrective osteotomy and plate fixation improved the DASH score from 32 to 11, with fourteen of fifteen patients who were satisfied with the procedure25. Similar results were found with corrective osteotomy for clavicular malunion in studies by Basa-mania, Bosch et al., and Chan et al.9-11. In the forty-nine patients in our study who were treated nonoperatively and had a healed fracture, many (nine; 18%) had the typical symptoms of malunion develop and they elected corrective osteotomy26-29. Most of the malunions were associated with substantial clavicular displacement and shortening, although the effect of shortening on function remains controversial30,31. Our study found (in the nonoperative group) a direct relationship between increased displacement and a worse DASH score.

While it is unclear why there is such a dramatic difference between the outcome of clavicular fractures in previous reports and those in contemporary studies, there are several possibilities. The initial reports often included data on clavicular fractures in children, who have inherent healing abilities and remodeling potential, and their data may have artificially improved the overall results1-4. Second, the use of patient-oriented outcome measures, as in the studies by Hill et al. and McKee et al., has been shown to reveal functional deficits in the upper extremity that are not detected by traditional surgeon-based scores; it is unlikely that such patient dissatisfaction would be detected in a 1960 study that focused on radiographic outcome6,8. A related issue is changing patient expectations: most active clinicians are acutely aware that a patient today is more likely to expect a rapid return to pain-free function following a fracture (and be more vocal when this does not occur) than his or her 1960 counterpart. Last, it may be that injury patterns are changing. In one study of clavicular shaft fractures in patients with polytrauma, the presence of a clavicular fracture was found to be associated with a mortality rate of 32% (thirty-four of 105 patients) (mainly due to concomitant chest and head injuries)5. Survivors displayed a substantial level of residual disability in the involved shoulder. Most studies have revealed a correlation between fracture comminution (and displacement) and worse outcome, and these fracture features are associated with higher-energy trauma5,6,14,22. Thus, there are surviving patients with clavicular fractures who have an intrinsically worse prognosis and in whom long-term sequelae may be more common.

In contradistinction to earlier case series, modern studies on primary plate fixation of acute midshaft clavicular fractures have described high rates of successful results with rates of union ranging from 94% to 100% and low rates of infection and surgical complications: a recent meta-analysis of plate fixation for 460 displaced fractures revealed a nonunion rate of only 2.2%14-16. With improved implants, prophylactic antibiotics, and better soft-tissue handling, plate fixation has been a reliable and reproducible technique.

Our study examined 111 patients with completely displaced midshaft clavicular fractures randomized to either traditional sling treatment or open reduction and internal fixation with a plate. There was a clear superiority of operative fixation, with significantly superior surgeon-based (Constant shoulder score) and patient-based (DASH) outcome measures at every time-point in the study. The improvement in scores (approximately 10 points for each) was clinically relevant as well as significantly superior. Patients who underwent operative fixation also had an earlier return to normal function. In addition, there was a significant reduction in the risk of non-union in the operative group (two of sixty-two patients had a nonunion) compared with the nonoperative group (seven of forty-nine patients had a nonunion) (p = 0.001). Complications in the operative group were typically hardware-related (plate irritation and wound complications) and were corrected by plate removal in all cases. Refracture was not seen, despite the fact that many patients returned to heavy contact and so-called extreme sports (fifty-five of 111 patients in the study sustained the fracture during sports, bicycling, or skiing and/or snowboarding). Most of the plates used in our study were straight plates contoured to fit the clavicle. More recently, we changed to anatomically designed s-shaped contoured plates25. Our preliminary experience with these plates suggests a dramatically reduced prevalence (and severity) of soft-tissue irritation, and it is possible that this may decrease the need for plate removal in the operative group.

Appearance is important to patients, and an unsightly scar has been a traditional deterrent to operative treatment of clavicular fractures. We specifically investigated this component of patient satisfaction in our study (see Table III). Despite the prevalence of hardware prominence and incisional complications (numbness and sensitivity) in the operative group, more patients in this group (fifty-two of sixty-two patients) answered “yes” to the question “Are you satisfied with the appearance of your shoulder?” than in the nonoperative group (twenty-six of forty-nine; p = 0.001). In this group of predominantly young male patients, a droopy shoulder (nonoperative group) seemed to be of greater cosmetic concern than a scar (operative group).

One of the weaknesses of our study is that we used only plate fixation in the operative group: intramedullary fixation is also an option32-34. A direct comparison between 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 fracture patients who were predominantly young men, the rate of patients lost to follow-up in our study is comparable with that in other studies and we do not believe that it jeopardizes our results. Specifically, the greatest concern in a study such as ours is that a number of complications in the (experimental) operative group would be missed because of lack of follow-up. However, we followed sixty-two of sixty-seven operative patients to definitive outcome. We believe that the patients who did not undergo surgery were less likely to feel committed to the study, did not return because of a lack of a requirement for postoperative care, or were potentially unhappy with their allocated treatment. We know of at least two such individuals who obtained operative treatment for a non-union elsewhere. Lastly, with time, our reintervention rate may increase, especially in the operative group (i.e., for hardware removal).

In conclusion, our study shows that early primary plate fixation of completely displaced midshaft clavicular fractures results in improved patient-oriented outcomes, improved surgeon-oriented outcomes, earlier return to function, and decreased rates of nonunion and malunion. There were no catastrophic complications in the operative group such as brachial plexus palsy, vascular injury, or pneumothorax; hardware removal was the most common reason for reintervention. Patients were more satisfied with the shoulder (and its appearance) following operative intervention. While we stress that our findings are applicable only to a specific subset of clavicular injuries, our data support primary plate fixation of completely displaced midshaft clavicular fractures in active adults. ▪

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.

Note: The authors acknowledge the advice and knowledge of Lynn A. Crosby and Carl J. Basamania.

This manuscript was prepared by the Canadian Orthopaedic Trauma Society, c/o Michael D. McKee, MD, FRCS(C), 55 Queen Street East, Suite 800, Toronto, ON M5C 1R6, Canada. E-mail address: [email protected]

Principal Investigator: Michael D. McKee

Lead Investigators (Site): Michael D. McKee (St. Michael's Hospital), Hans J. Kreder (Sunny-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. Pugh (Brantford Hospital), David Sanders (London Health Science Center), and Richard Buckley (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 Analysis: 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. McKee. Manuscript Preparation: Michael D. McKee, Jeremy A. Hall, Lisa M. Wild, Emil H. Schemitsch, Rudolph Reindl, Robert McCormack, David Sanders, and Christian J. Veillette. Patient 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 Harvey, Rudolph Reindl, Gregory Berry, Bertrand Perey, Kostas Panagiotopolous, Robert McCormack, Beverly Bulmer, Mauri Zomar, Karyn Moon, Elizabeth Kimmel, Carla Erho, Elena Lakoub, Patricia Leclair, Christian J. Veillette, Bonnie Sobchak, David M.W. Pugh, Richard Buckley, Scott Mandel, David Sanders, and Trevor B. Stone.

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