Taylor Spatial Frame or Reamed Intramedullary Nailing for Closed Fractures of the Tibial Shaft: A Randomized Controlled Trial.

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研究概要

Sixty-five patients with closed tibial shaft fractures were randomized to receive fracture fixation using a Taylor Spatial Frame (TSF) ring fixator (n=32) or reamed intramedullary (IM) nailing (n=33). The primary outcome of interest was the Short-Form 36 (SF-36) physical component summary score at 2 years post-operation. Secondary outcomes of interest included SF-36 mental component scores, SF-36 sub-scores, knee pain, fracture site pain, and ankle pain on a Visual Analog Scale (VAS), return to work outcomes, and the incidence of adverse events. Outcomes were assessed up to 2 years post-operation. No statistically significant differences in SF-36 mental and physical component scores, as well as all sub-scores, were observed between the TSF ring fixator group and IM nailing group at 2 years post-operation. Moreover, VAS knee pain scores were statistically significantly lower in the TSF ring fixator group compared to the IM nailing group, up to 1 year post-operation (p<0.01 for all). No statistically significant differences in VAS fracture site pain or ankle pain were observed between the two groups, up to 2 years post-operation (p>0.05 for all). Patients in the IM nailing group had a statistically significantly lower incidence of superficial skin infection (p<0.001), and higher rates of return to work within 3 months (p=0.008) when compared to the TSF ring fixator group.