Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty Using BioBrace Device Compared to Standard Repair with Sutures

What this Trial Is About

Researchers are evaluating if adding a Biobrace device to the repair of the subscapularis tissue during total shoulder replacement surgery both reverse and anatomic types improves tissue healing as seen on ultrasound images and if it leads to any clinical differences. The study compares the standard subscapularis repair with stitches alone to repair augmented with the Biobrace, a biocomposite scaffold made of synthetic and biological materials. This investigation aims to improve surgical techniques and patient outcomes in shoulder arthroplasty. During the shoulder replacement surgery, the subscapularis muscle is detached from the upper arm bone and repaired to restore shoulder function. Participants are randomly assigned to one of two groups one receiving the standard repair with sutures, and the other receiving the standard repair plus augmentation with the BioBrace device to reinforce the tissue. The Biobrace acts as a scaffold to support the healing muscle. Both groups receive treatment during the surgery and are monitored afterward. Participants will be followed for up to two years after surgery, with ultrasound assessments to examine the continuity and thickness of the repaired subscapularis tissue at multiple time points, including 6 weeks, 3 months, 6 months, 1 year, and 2 years. Shoulder X-rays will also be taken to assess arthritis and implant wear or loosening. Clinical evaluations include shoulder range of motion and the American Shoulder Elbow Surgeons Score ASES at regular intervals. This comprehensive follow-up aims to understand how the repair methods affect shoulder healing and function over time.

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty