Operative vs. Non-operative Treatment of Acute Displaced Distal Clavicle Fractures: A Multicentre Randomized Controlled Trial.

Objectives To evaluate the differences in patient outcomes following operative or non-operative treatment for displaced, Type II distal clavicle fractures. Design Multi-centre, prospective, randomized controlled trial. Setting Level I trauma centresPatients/Participants: Patients with completely displaced type II distal clavicle fractures. Fifty-seven patients were randomized: twenty-seven to the operative group and thirty to the non-operative group. Intervention Patients randomized to non-operative care received a standard shoulder sling, followed by pendulum or gentle range of motion shoulder exercises at any time as directed by the attending surgeon. Patients randomized to the operative group received plate fixation with a precontoured distal clavicular plate or a "hook" plate within 28 days from injury. Main outcome measure Disabilities of the Arm, Shoulder and Hand (DASH) scores at one year. Results There were no between group differences in DASH or Constant scores at one year. More patients in the operative group went on to union (95% vs 64% p=0.02) within one year. Twelve patients in the operative group underwent a second operation for hardware removal (12/27, 44%). In the non-operative group, six patients (6/30, 20%) subsequently underwent eight operative procedures. Conclusion Although this study failed to demonstrate a difference in functional outcomes between operative and non-operative treatment of Neer type II distal clavicle fractures, non-operative management led to more complications including a moderate rate of non-union, which often required secondary surgery to correct, a higher rate of early dissatisfaction with shoulder appearance and a delayed return to activities in the first 6 months. Operative management provided a safe and reliable treatment option with few complications, but often required secondary hardware removal, especially with hook plate fixation. Level of evidence Level I, Therapeutic.