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

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

Inclusion Criteria1

  • Total Shoulder Arthroplasty

Exclusion Criteria1

  • Vulnerable population

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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.


Locations(1)

Stanford University

Redwood City, California, United States

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NCT05487677


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