The Effectiveness of a Flexible Locked Intramedullary Nail and an Anatomically Contoured Locked Plate to Treat Clavicular Shaft Fractures: A 1-Year Randomized Control Trial.

Abstract

Displaced and shortened clavicular shaft fractures can be treated operatively with intramedullary or extramedullary fixation. The aim of the present study was to compare the union rates and functional outcomes of displaced and/or shortened clavicular shaft fractures treated with a flexible locked intramedullary nail or with an anatomically contoured locked plate. Seventy-two patients with acute displaced and/or shortened clavicular shaft fractures underwent randomly assigned management with either an intramedullary locked nail or an anatomically contoured locked plate. The same surgeon performed all surgical procedures, and all patients underwent identical postoperative treatment regimens. Incision length, surgical time, and union rate were recorded, and the functional outcome of the shoulder was assessed with use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Constant Shoulder (CS) scores. Data were analyzed with use of traditional statistical methods as well as Cohen effect sizes, which were based on the minimal clinical important differences. Thirty-seven patients were managed with an anatomically contoured locked plate, and 35 patients were managed with a Sonoma CRx intramedullary flexible locked nail. There were no differences in general patient characteristics, fracture type, or displacement between treatment groups. The nailing group had significantly better outcomes (p < 0.001) than the locked plating group for surgical time (mean and standard deviation [SD], 45 ± 12 compared with 65 ± 21 minutes, respectively) and incision size (mean and SD, 37 ± 9 compared with 116 ± 18 mm). A union rate of 100% was observed in both groups. DASH scores were similar between groups at 1.5, 3, and 6 months, whereas the nailing group had significantly better DASH scores at 12 months (p = 0.022); however, this difference had only a moderate effect size. Overall, individual variation in DASH and CS scores was substantially higher in the plating group compared with the nailing group. Both the precontoured locked plate and the flexible locked intramedullary nail effectively treated displaced and/or shortened clavicular shaft fractures. Similar outcomes were achieved at 1.5, 3, and 6 months after surgical intervention, and better DASH scores were found in the nailing group at 12 months. Cohen effect sizes suggested that slightly better outcomes were potentially achieved in the nailing group. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.