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NCT04903106 · ClinicalTrials.gov registry record
Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations
A clinical trial, sponsored by Smith & Nephew.
- Completed
- Registry status
- 63
- Enrollment target
NCT04903106: Completed study, sponsored by Smith & Nephew.
NCT04903106 is a clinical trial that has completed, run by Smith & Nephew. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04903106 has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study Summary
This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.
Primary Outcome
Count of participants with reoperations due to meniscal repair failure at 12 months postoperative. Failure was defined as revision surgery at the primary site of the tear.
Interventions
- DEVICE FAST-FIX FLEX Meniscal Repair System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2022-01-20 |
| Est. Completion | 2024-11-26 |
What the finished NCT04903106 record still lists
NCT04903106 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which FAST-FIX FLEX Meniscal Repair System is the first listed.
NCT04903106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04903106 about?
NCT04903106 is a clinical study titled "Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations". This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prio...
What is the current status of trial NCT04903106?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2022-01-20. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT04903106?
The interventions under investigation include: FAST-FIX FLEX Meniscal Repair System (DEVICE).
Who is sponsoring clinical trial NCT04903106?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
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