Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Stanford University

Status: Enrolling

Conditions: Shoulder Injuries

Treatments: Procedure: Standard Repair with Sutures; Device: BioBrace Augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT05487677

64618

Details and patient eligibility

About

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.

Full description

The investigators would like to learn if subscapularis repair augmentation with the Biobrace in total shoulder arthroplasty (reverse and anatomic) will result in sonographic and/or clinical improvements. This will allow for improvements in technique and better outcomes for patients going forward.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Total Shoulder Arthroplasty

Exclusion criteria

• Vulnerable population

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

BioBrace Augmentation

Experimental group

Description:

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to the BioBrace, patient will receive BioBrace augmentation of the standard subscapularis repair.

Treatment:

Device: BioBrace Augmentation

Standard Repair with Sutures

Active Comparator group

Description:

During the shoulder replacement surgery (arthroplasty) in order to access the shoulder, the subscapularis is removed from its insertion in your upper arm bone. It is repaired in reverse total shoulder arthroplasty, but is sometimes not as robust as we would like based on tissue quality and other factors. A shoulder arthroplasty is when the ball and socket are replaced with prosthetic components. If randomized to standard repair, patient will receive the standard repair with sutures.

Treatment:

Procedure: Standard Repair with Sutures