Acute operative stabilization versus nonoperative management of clavicle fractures.

We conducted a prospective, randomized study to determine if patients with midshaft clavicle fractures would benefit from immediate operative stabilization with a modified Hagie pin in comparison with a matched group treated with nonoperative therapy. At a level II trauma center, patients with closed midshaft clavicle fractures were prospectively randomized to receive either operative or nonoperative treatment. Fifty-seven (29 operative, 28 nonoperative) patients were enrolled in the study. Operative patients underwent open reduction and internal fixation of the clavicle using a modified Hagie pin; nonoperative patients were treated with a sling for comfort. All patients were followed at regular intervals for 1 year. They were evaluated for radiographic healing and complications and were scored with the Single Assessment Numeric Evaluation and L'Insalata instruments. Injury severities and radiographs were not statistically significantly different between the 2 groups. Functional scores in the operative group were slightly higher at 3 weeks, and the nonoperative group had slightly higher scores at 6 months and 1 year. The only statistically significant difference between the groups was at 3 weeks. Percentage follow-up at 1 year was 93% for the operative group and 82% for the nonoperative group. One patient in each group developed a nonunion, and 1 patient in each group had a refracture. Complications were higher in the operative group, and most were related to pin prominence at the posterior shoulder. Results of this study suggest that, though patients with midshaft clavicle fractures had higher functional scores at short-term follow-up after internal fixation, functional scores were similar at 6 months and 1 year. In addition, internal fixation with a modified Hagie pin was associated with a higher complication rate.

RCT Entities:   Population Interventions Outcomes