• 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, and Manyi Wang.
• Beijing Jishuitan Hospital, No.31 Xinjiekou East Road, Xicheng District, Beijing City, China.
• Eur J Trauma Emerg Surg. 2023 Jun 1; 49 (3): 156115751561-1575.

PurposeTo 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.MethodsThe 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 as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates.ResultsBoth TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively.ConclusionIn terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups.RegistrationRegistration was completed at ClinicalTrials.gov NCT03635320.© 2023. The Author(s).

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