CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
FAST-FIX FLEX Meniscal Repair System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04903106
NCT04903106N/ACompleted
CompareCT.gov

A Prospective, Multi-center Clinical Study to Evaluate the Safety and Performance of the FAST-FIX FLEX System for Meniscal Repairs (MR) and Meniscal Allograft Transplantations (MAT)

Smith & Nephew, Inc.·observational·Posted May 26, 2021·Updated Mar 18, 2026

In Brief

An observational study evaluating FAST-FIX FLEX Meniscal Repair System for Meniscus Tear. Completed, enrolled 63 participants across 5 sites in 4 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMeniscus Tear
CountriesAustralia, France, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 26, 2021
Enrollment StartJan 20, 2022
Primary CompletionNov 26, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.1 years ago

Interventions

FAST-FIX FLEX Meniscal Repair Systemdevice

Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.

FAST-FIX FLEX Meniscal Repair Systemdevice

Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.