A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

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研究概要

Four hundred and ninety patients with extra-articular distal tibial fractures were randomized to intramedullary nailing (IMN; n=245) or plate fixation (n=245) treatments. The primary outcome of interest was the disability rating index (DRI) at 12-months follow-up. Secondary outcomes include the following: the Olerud-Molander Ankle Score (OMAS), Short Form-12 (SF-12) questionnaire, and the DRI, evaluated at 3, 6, and 9 months follow-up. Other outcomes measured included incidence of complications (i.e. deep vein thrombosis [DVT], delayed union, superficial infection, malunion, nonunion, and deep infection). As well, time to return to work and weight bearing was also evaluated at final follow-up. Results revealed that the DRI score at 6-months follow-up was statistically significantly in favour of the plate fixation compared to the IMN group (p=0.008) but not at 3, 9, and 12-months follow-up (p>0.05 for all). Moreover, SF-12 and the Olerud-Molander Ankle scores were not statistically significantly different between the 2 groups at all timepoints (p>0.05 for all). The incidence of delayed union was statistically significantly in favour of the IMN group (p=0.023) while the incidence of malunion was statistically significantly in favour of the plate fixation group (p=0.006). All other outcomes were not statistically significantly different between the IMN and plate fixation group (p>0.05 for all).