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

Meniscus Tear Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

This PMCF study is to satisfy the post-market surveillance obligations to the European Medical Device Regulation (EU MDR 2017/745). 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. The objectives of the study are to assess the clinical success rate of both clinical indications (meniscal repair and meniscal allograft transplantations) and the performance and safety of the FAST-FIX FLEX meniscal repair system. The sample size for this study is precision-based and not based on statistical power considerations. Thus, no formal statistical hypothesis is formulated. The sample size for this study is determined based on the feasibility of recruitment, enrolment and follow-up considerations. The primary endpoint upon which the sample size is determined is defined by the rate of reoperation after at 12 months. Additionally, secondary endpoints in this study assess success rate, meniscus healing and clinical performance of Patient Reported Outcomes (PRO) for meniscal repair and meniscal allograft transplantations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04903106
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase
Start date January 20, 2022
Completion date May 25, 2025
View Details
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