Lidan Zhang, Zhijun Pan, Xiaohui Zheng, Qiugen Wang, Peifu Tang, Fang Zhou, Fan Liu, Bin Yu, Frankie K L Leung, Alex Wu, Suzanne Hughson, Zhuo Chen, Michael Blauth, Anthony Rosner, Charisse Sparks, Manyi Wang
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...
February 13, 2023: European Journal of Trauma and Emergency Surgery: Official Publication of the European Trauma Society