IMPACT Study
Research type
Research Study
Full title
Evaluation of safety and efficacy of a resorbable collagen IMplant in treatment of High Grade PArtial ThiCkness Tears; A prospective, multicenter, randomized, control trial (IMPACT Study).
IRAS ID
313910
Contact name
Ali Narvani
Contact email
Sponsor organisation
Smith + Nephew, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 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 approved to be used in patients and is commercially available on the market (CE marked), is put in the shoulder during surgery to provide a layer of collagen over injured tendons.
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique ‘Completion and Repair’ for surgically treating partial-thickness rotator cuff tears. Several doctors at up to 25 sites globally will be collecting study data from 156 patients. All patients will be assigned randomly either to be treated with REGENETEN™ or standard surgical repair without the use of REGENETEN™. The treatment received will be blinded to the patient and they will be told which treatment they received when they finish in the study. Patient participation will last for about 2 years.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0147
Date of REC Opinion
26 Jul 2022
REC opinion
Further Information Favourable Opinion