NCT04903106

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 primary endpoint for the study upon which sample size is determined is meniscal repair success rate in the study device 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.

Conditions

• Meniscus Tear

Interventions

Type	Name	Description
DEVICE	FAST-FIX FLEX Meniscal Repair System	Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.
DEVICE	FAST-FIX FLEX Meniscal Repair System	Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-11-26
• Completion: 2024-11-26
• First posted: 2021-05-26
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

5 sites across 4 countries: United States, Australia, France, United Kingdom

Regulatory

• FDA-regulated device study