Nonoperative Treatment Compared with Plate Fixation of Displaced Midshaft Clavicular Fractures: A Multicenter, Randomized Clinical Trial

Background: Recent studies have shown a high prevalence of symptomatic malunion and nonunion after nonoperative treatment of displaced midshaft clavicular fractures. We sought to compare patient-oriented outcome and complication 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 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 \textless 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.