Objective: To compare elastic stable intramedullary nailing (ESIN) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults.
Design: The study was a randomized, controlled, clinical trial.
Setting: Level 1 trauma center.
Patients and methods: Sixty patients between 18 and 65 years of age participated and completed the study. They were randomized to either operative or nonoperative treatment with a 2-year follow-up.
Intervention: Thirty patients were treated with a simple shoulder sling and 30 patients with ESIN within 3 days after trauma.
Main outcome measurement: Complications after operative and nonoperative treatments, Disabilities of the Arm, Shoulder and Hand (DASH) score and Constant Shoulder Score for outcome measurement, and clavicular shortening.
Results: Fracture union was achieved in all patients in the operative group, whereas nonunion was observed in 3 of 30 patients of the nonoperative group. Two symptomatic malunions required corrective osteotomy in the nonoperative group. Medial nail protrusion occurred in 7 cases in the operative group. Implant failure with revision surgery was necessary in 2 patients after an additional adequate trauma. DASH scores were lower in the operative group throughout the first 6 months and 2 years after trauma, with a significant difference during the first 18 weeks. Constant scores were significantly higher after 6 months and 2 years after intramedullary stabilization. Patients in the operative group showed a significant improvement of posttraumatic clavicular shortening; they were also more satisfied with cosmetic appearance and overall outcome.
Conclusions: ESIN of displaced midshaft clavicular fractures resulted in a lower rate of nonunion and delayed union, a faster return to daily activities, and a better functional outcome. Clavicular shortening was significantly lower, and overall satisfaction was higher in the operative group.