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RECRUITING
NCT05487677
NA

Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-12-01

Completion Date

2028-12-01

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DEVICE

BioBrace 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.

PROCEDURE

Standard 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.

Locations (1)

Stanford University

Redwood City, California, United States