Safety and Performance Study of the FAST-FIX FLEX Repair System
Research type
Research Study
Full 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)
IRAS ID
301886
Contact name
Andrew John Barnett
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
49416, CPMS ID
Duration of Study in the UK
2 years, 0 months, 24 days
Research summary
Background: The meniscus is a tissue that acts like cushion within the knee joint. Meniscal tears are common injuries that result in pain, stiffness, and swelling in the knee joint. These injuries can be treated with medications, injections, and physical therapy. However, when symptoms continue despite these treatments surgery is often recommended to repair or in certain cases to replace the meniscus. The FAST-FIX FLEX Meniscal Repair System device is intended to provide a secure repair of soft tissue tears, particularly meniscal tears, or to support meniscal transplantation.
The FAST-FIX FLEX system has been cleared by the Food and Drug Administration (FDA) and is commercially available on the market (CE marked).
Purpose: The purpose of this study is to collect safety and clinical outcomes data from patients who underwent meniscal repair or meniscal allograft transplantation with the next generation FAST-FIX FLEX Meniscal Repair System.
Objectives: 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.
Recruitment/locations: Several doctors at up to 6 sites globally (United States, United Kingdom, Australia, France and Germany) will be collecting study data from 130 patients, approximately up to 25 patients will be recruited at each site. Overall, 97 patients requiring a meniscal repair and up to 33 patients requiring a meniscal transplant will be included in this study.
Patient participation will last for about 12 months. Patients will be asked to return to the hospital for a follow-up at 2 weeks, 3 months, 6 months and 12 months after the surgery.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0213
Date of REC Opinion
29 Jul 2021
REC opinion
Favourable Opinion