Introduction
fracture, fractures, Femoral Nailing Antirotation, femoral trochanteric fractures
SECONDARY
Several types of cephalomedullary nails are commercially available. The Proximal Femoral Nailing Antirotation (PFNA; DePuy Synthes, Oberdorf, Switzerland) manufactured from a titanium alloy (Ti-6Al-7Nb) is an advanced version of the previous PFN nail featuring an anti-rotation helical blade and currently available for clinical use in China. The PFNA-II, also available in China, is a smaller version of the PFNA designed for the reduced femur size of typical Asian populations [The TFN-AdvancedThe PFNA-II was selected as the comparator device for this study. The PFNA-II is an appropriate reference product for the TFNA, as its intended use as well as clinical, technical, and biological parameters are similar. The intended uses of PFNA-II and TFNA are the treatment of proximal femur fractures and combination proximal and shaft fractures of the femur.This study was undertaken to collect pre-market data on TFNA to support a marketing application in China. The goal was to compare the effectiveness and safety of the TFNA system with the commercially available PFNA-II for the treatment of proximal femoral trochanteric fractures. The primary objective was to evaluate fracture union at 24 weeks postoperatively with secondary measures pertaining to the quality of life and safety. In terms of convenience and presumed time and cost savings, the noninferiority trial was designed according to specific, established protocols [