RecruitingNot ApplicableNCT05487677

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Sponsor

Stanford University

Enrollment

100 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Shoulder Injuries

Summary

The primary purpose of this research is to compare the images obtained by ultrasound between a standard repair of the subscapularis tissue and after repair with a Biobrace. The secondary purpose is to determine if there are any clinical differences.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines a technique to reinforce the repair of the subscapularis tendon during total shoulder arthroplasty (shoulder replacement surgery). The subscapularis is a key muscle that can be weakened during surgery, and augmenting its repair may improve recovery. You may be eligible if: - You are 18 or older - You are scheduled for total shoulder arthroplasty (shoulder replacement) You may NOT be eligible if: - You are considered a vulnerable population (as defined by the study team) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioBrace Augmentation

During shoulder replacement surgery, the subscapularis (rotator cuff muscle) is sometimes repaired back again. This will be stitched and augmented with a BioBrace. The Biobrace is a biocomposite scaffold meaning both synthetic and biologic, compared to other traditional implants that are either synthetic or biologic. The stitch in the BioBrace group will be anchored to and reinforced by this material.

PROCEDUREStandard Repair with Sutures

During shoulder replacement surgery, the Subscapularis (rotator cuff muscle) is sometimes repaired back again. This is usually repaired with stitches per standard of care treatment.