Sling compared with plate osteosynthesis for treatment of displaced midshaft clavicular fractures: a randomized clinical trial.

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.