This study is looking at two ways to repair full-thickness rotator cuff tears (a tear in the group of muscles and tendons that surround the shoulder joint). Researchers want to see if adding the BioBrace® Implant to standard arthroscopic rotator cuff repair (a minimally invasive surgery using small incisions) is safer and more effective than the standard surgery alone. You might be able to join if you are between 40 and 70 years old, have chronic shoulder pain for at least three months, and have an MRI showing a full-thickness tear of your supraspinatus and/or infraspinatus tendons (two of the rotator cuff muscles) that is between 2 cm and 5 cm. The main goal is to see how many people experience a re-tear of their rotator cuff six months after surgery. The current recruitment status is unclear, and the study plans to enroll 268 participants.

Study design

This is a randomized study, meaning participants are assigned by chance to receive either the BioBrace® Implant augmentation or standard repair. It is also single-blind, so you would not know which treatment you are receiving, and will involve 268 participants across multiple centers.

What's involved

You would have clinical evaluations before surgery and then at 6 weeks, 3 months, 6 months, and 12 months after surgery. These evaluations will include patient-reported outcome measures and MRI scans.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 12 months after their surgery to assess repair integrity and re-tear rates.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.