A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Femoral Fractures
- Hip Fractures
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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, t...
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.
Tracking Information
- NCT #
- NCT04865146
- Collaborators
- Not Provided
- Investigators
- Study Director: Astrid Yung Smith & Nephew Medical (Shanghai) Co., Ltd
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