Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial.

BACKGROUND: Previous studies have shown good clinical results in patients with midshaft clavicular fractures treated with reconstruction plate fixation or elastic stable intramedullary nailing. The objective of this study was to compare these methods in terms of clinical and radiographic results.

METHODS: In this prospective, randomized controlled trial, fifty-nine patients with displaced midshaft clavicular fractures were randomly assigned to receive fixation with either a reconstruction plate (thirty-three patients), known as the plate group, or elastic stable intramedullary nailing (twenty-six patients), known as the nail group. The primary outcome was the six-month Disabilities of the Arm, Shoulder and Hand (DASH) score. The secondary outcomes included the Constant-Murley score, time to fracture union, residual shortening, level of postoperative pain, percentage of satisfied patients, and complication rates.

RESULTS: The mean six-month DASH score was 9.9 points in the plate group and 8.5 points in the nail group (p = 0.329). Similarly, there were no differences in the twelve-month DASH and Constant-Murley scores. Time to union was equivalent (p = 0.352) between the groups at 16.8 weeks for the plate group and 15.9 weeks for the nail group, whereas the residual shortening was 0.4 cm greater in the plate group (p = 0.032). The visual analog scale pain score and the satisfaction rate were similar between the groups. Implant-related pain was more frequent in the nail group (p = 0.035). There were no differences in terms of major complications.

CONCLUSIONS: Reconstruction plates and elastic stable intramedullary nailing yielded similar functional results, time to union, level of postoperative pain, and patient satisfaction rates. Both methods were safe in terms of major complications.