Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: a randomized clinical trial.

摘要

BACKGROUND: Recent literature supports surgical intervention for shortened, displaced, mid-shaft clavicle fractures. We present the results of a randomized clinical trial comparing locked intramedullary fixation and plate fixation for short, displaced, mid-shaft clavicle fractures. MATERIALS AND METHODS: Local ethical approval was obtained and power analysis and sample size calculations were performed prior to commencement. Patients randomized to 2 groups to be treated with either locked intramedullary fixation or plating. Patients regularly followed up to clinical and radiographic union. The primary outcome measure was the Constant score, secondary outcome measures included the Oxford shoulder score, union rate, and complication rates. RESULTS: Seventeen patients were randomized to locked intramedullary fixation and 15 randomized to plating. Mean age was 29.3 years. Mean follow-up was 12.4 months. There was no significant difference in either Constant scores (P = .365) or Oxford scores (P = .773). There was 100% union in both groups. In the intramedullary group, 1 case of soft tissue irritation settled after the pin removal; 1 pin backed out and was revised. Three superficial wound infections resulted in plate removal and 8 plates (53%) were removed. DISCUSSION: Intramedullary fixation has the theoretical advantage of preserving the periosteal blood supply, but carries the morbidity of pin removal. Clavicle plates are not routinely removed but require greater exposure and may compromise periosteal blood supply. CONCLUSION: Both locked intramedullary fixation and plating produce good functional results; however, metalwork may need to be removed as a second procedure.