Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

Completed

Conditions studied: Meniscus Tear

In brief

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.

Key facts

Study ID

NCT04903106

Run by

Smith & Nephew, Inc.

People needed

63

Starts

2022-01-20

Expected to finish

2024-11-26

Last updated by the study team

2026-03-18

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Hospital for Special Surgery — New York, New York, United States
• Fremantle Hospital — Fremantle, Western Australia, Australia
• Ambroise Paré Clinic — Paris, Neuilly-Sur-Seine, France
• Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry, Shropshire, United Kingdom

Full record on ClinicalTrials.gov

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