Hip Fractures Clinical Trial
Official title:
A Multicenter, Post Market, Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nails (10S Models) for the Treatment of Femoral Fracture in Chinese Subjects
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).
Background: The INTERTAN nail was designed to improve upon existing intramedullary nail systems. INTERTAN nails utilize two interlocking screws, thereby improving controlled intertochanteric fracture compression and post-surgical stability. Purpose: Evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation Objectives: - Primary Objective: To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation - Secondary Objective: To generate safety and effectiveness evidence for INTERTAN 10S Nails via the collection of functional outcomes, quality of life, and safety data Research participants / locations: The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites in China are involved. ;
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