Trials / Withdrawn
WithdrawnNCT04865146
A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed 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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TRIGEN™ INTERTAN™ | Femoral fracture treated with INTERTAN 10S Nail |
Timeline
- Start date
- 2022-06-23
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2021-04-29
- Last updated
- 2024-02-07
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04865146. Inclusion in this directory is not an endorsement.