Functional Outcomes After Modern External Ring Fixation or Internal Fixation for Severe Open Tibial Shaft Fractures.

研究概要

In this multicenter randomized clinical trial of 254 patients aged 18–64 years with severe open tibial shaft fractures (Gustilo-Anderson Type-IIIB and severe-Type IIIA), patients were randomized to either internal fixation (IF) (n=132) or modern external ring fixation (EF) (n=122). The primary outcome was patient-reported physical function measured by the Short Musculoskeletal Function Assessment (SMFA) Dysfunction and Bother scores and the Veterans RAND 12-Item Health Survey (VR-12) Physical Component Score (PCS). Secondary outcomes included ambulatory status and assistive device use, assessed up to 12 months post-randomization. Overall, the results of the study revealed no clinically important differences in SMFA scores between IF and EF groups at 6 and 12 months. VR-12 PCS was slightly higher for IF at 3 months, but no difference was seen at 12 months. EF was associated with higher assistive device use at 6 months. These findings suggest that functional outcomes at 1 year are similar between treatments, but EF patients had more device use early on.