REGENETEN™ Bioinductive Implant System in Full-thickness Tears
Research type
Research Study
Full title
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR augmented with REGENETEN™ Bioinductive Implant System in Full-thickness Tears (large or massive) Repair versus ARCR alone
IRAS ID
286092
Contact name
Abigail Murphy
Contact email
Sponsor organisation
Smith+Nephew Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
46217, CPMS ID
Duration of Study in the UK
3 years, 8 months, 31 days
Research summary
The rotator cuff is a group of muscles and their tendons that act to hold the shoulder in place.Torn rotator cuff tendons are common injuries that result in shoulder weakness and pain.These injuries can be treated with medications, injections, and physical therapy.However, when symptoms continue despite these treatments, surgery is often recommended to repair the injured tendon.
One option for repairing torn rotator cuff tendons involves applying a protective layer of collagen over the injured tendons to aid in healing and stop disease progression. Collagen is the most commonly found protein in the body and is present in the skin, bones, tendons and ligaments.The REGENETEN™ Bioinductive Implant, which has been cleared by the Food and Drug Administration and is commercially available on the market(CE marked),is inserted during surgery to provide a layer of collagen over injured tendons.
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant is better than standard repair techniques for surgically treating full-thickness rotator cuff tears. Several doctors at up to 20 sites globally will be collecting study data from 300 patients(approximately 30 patients per site). Overall, 260 patients needing a full-thickness rotator cuff repair and up to 40 patients needing a recurrent full-thickness rotator cuff revision repair will be included. All patients will be assigned randomly either to surgical repair with REGENETEN™ or standard surgical repair without the use of REGENETEN™.The patient will be informed if surgical repair was done with the REGENETEN™ after the surgery. All patients needing a recurrent full-thickness rotator cuff revision repair will be treated with the REGENETEN™. Patient participation will last for about 2 years. Patients will be asked to return to the hospital for a follow-up at 2- and 6 weeks, and at 3-, 6-, 12- and 24 months after the surgery.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0223
Date of REC Opinion
26 Oct 2020
REC opinion
Further Information Favourable Opinion