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Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures

A Multicenter, Randomized Clinical Trial

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: mckeem{at}smh.toronto.on.ca

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.

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 nonoperative treatment with a sling (sixty-five patients). Outcome analysis included standard clinical follow-up and the Constant 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 injury, 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 operative 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 operative 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.

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