Study design
AO 31-B, fractures, 31-A2, 31-A3), or trochanteric fracture, femur fracture, femoral head and neck fractures
MAY, PATHOLOGIC FRACTURE
One hundred eighty-eight participants were enrolled, beginning November 2018 and concluding September 2019 across nine sites in China. The last patient visit occurred May 2020, and the database was locked September 2020. The ethics committees approved the protocol and informed consent at each participating site. The study was registered on ClinicalTrials.gov (identifier: NCT03635320). Eligible men and women were aged 18 years or older and had sustained a unilateral proximal femur fracture (AO 31-A1, 31-A2, 31-A3), or trochanteric fracture with diaphyseal extension. Key exclusion criteria included fractures where the operative treatment occurred 3 weeks after surgery, femoral head and neck fractures (AO 31-B and 31-C), pathologic fracture, revision surgeries, serious soft tissue injury, and multiple systemic injuries. The complete list of inclusion and exclusion criteria is found in Table Inclusion and exclusion criteriaPatients enrolled at each study site were informed in advance that they would be randomized in a 1:1 ratio to either the investigational group (TFNA) or the control group (PFNA-II) using a separate block group randomized schedule at each study site, ensuring the consistent distribution of patients in the treatment group and control group. Eligible patients were randomly assigned to the TFNA, or PFNA-II study group using a centralized computer-generated randomization system (Medidata Balance, Dassault Systèmes, Shanghai). Patients were blinded to the treatment they had received until study completion; study personnel were not blinded. Patients and investigators were unaware of block sizes.The study’s null and alternative hypotheses were as follows: