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NCT05272631 · ClinicalTrials.gov registry record
Depuy Synthes Lower Extremity Shaft Nail Registry
A clinical trial, sponsored by DePuy Synthes Products.
- Completed
- Registry status
- 241
- Enrollment target
NCT05272631: Completed study, sponsored by DePuy Synthes Products.
NCT05272631 is a clinical trial that has completed, run by DePuy Synthes Products. The registered enrollment target is 241 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05272631 has completed, sponsored by DePuy Synthes Products.
- COMPLETED
- Registry status
- 241 participants
- Enrollment target
Study Summary
The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have experienced femoral or tibial fractures, respectively, requiring fixation and stabilization or who require a revision due to a malunion or a nonunion.
Primary Outcome
Time to union will be reported. Union is defined as a combination of radiographic and clinical assessment, where union will be considered achieved based on radiographic images, and no pain at the fracture site indicative of nonunion.
Interventions
- DEVICE Retrograde Femoral Nail Advanced
- DEVICE Tibial Nail Advanced
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2022-05-04 |
| Est. Completion | 2025-10-31 |
What the finished NCT05272631 record still lists
NCT05272631 is an observational study that tracks outcomes without assigning an intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Retrograde Femoral Nail Advanced is the first listed.
NCT05272631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05272631 about?
NCT05272631 is a clinical study titled "Depuy Synthes Lower Extremity Shaft Nail Registry". The purpose of this post-market registry is to monitor the clinical safety and performance (union rates and time to union) of two DePuy Synthes lower extremity shaft nails: RFN-Advanced Retrograde Femoral Nailing System (RFNA) and TN-Advanced Tibial Nailing System (TNA) in participants who have expe...
What is the current status of trial NCT05272631?
This trial is currently completed. The enrollment target is 241 participants. The study started on 2022-05-04. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT05272631?
The interventions under investigation include: Retrograde Femoral Nail Advanced (DEVICE), Tibial Nail Advanced (DEVICE).
Who is sponsoring clinical trial NCT05272631?
This trial is sponsored by DePuy Synthes Products, which has 3 total clinical trials registered on ClinicalTrials.gov.
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