Sling Compared with Plate Osteosynthesis for Treatment of Displaced Midshaft Clavicular Fractures: A Randomized Clinical Trial


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Abstract

Background:Few randomized controlled trials have compared operative with nonoperative treatment of clavicular fractures.Methods:Patients with displaced midshaft clavicular fractures were randomized either to nonoperative treatment with a sling or to operative treatment with a stainless steel 3.5-mm reconstruction plate. Outcome measures were the Constant shoulder score, DASH (Disabilities of the Arm, Shoulder and Hand) score, pain, fracture-healing, and complications. The null hypothesis was that the Constant and DASH scores would not differ between the groups at the one-year follow-up evaluation.Results:In accordance with the power analysis, we included sixty patients in the study; thirty-two were randomized to the nonoperative group and twenty-eight to the operative group. We found no difference in the Constant score (p = 0.75), the DASH score (p = 0.89), or pain (p = 0.98) between the groups at the one-year follow-up evaluation. All fractures in the operative group healed, but six nonunions (24%) occurred in the nonoperative group.Conclusions:One year after a displaced midshaft clavicular fracture, nonoperative treatment resulted in a higher nonunion rate but similar function and disability compared with operative treatment.Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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