Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advanced^TM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population.

ABSTRACT:

Purpose

To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II.

Methods

The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such

SUBMITTER: Zhang L 

PROVIDER: S-EPMC10229738 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature