Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

August 18, 2026 updated by: Michael T. Freehill, Stanford University

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Michael Freehill, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Total Shoulder Arthroplasty

Exclusion Criteria:

  • Vulnerable population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Repair with Sutures
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.
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.
Other Names:
  • Stitch Group
Experimental: BioBrace Augmentation
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.
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.
Other Names:
  • Implant Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in thickness of the subscapularis tissue on ultrasound
Time Frame: 3 months, 1 years after surgery
Thickness of subscapularis tissue on ultrasound
3 months, 1 years after surgery
Evaluate arthritis on shoulder x-ray
Time Frame: Surgery
Amount of arthritis or wear patterns on shoulder x-Ray
Surgery
Difference in signs of loosening or wear patterns in shoulder X-Ray
Time Frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Signs of loosening or wear patterns on shoulder x-ray
2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Difference in continuity of subscapularis tissue on ultrasound
Time Frame: 6 weeks, 6 months after surgery
Continuity of subscapularis tissue on ultrasound
6 weeks, 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder & Elbow Surgeons Score (ASES) score
Time Frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
is a 100-point scale that consists of two dimensions: pain and activities of daily living. 0 indicates worse shoulder condition and 100 indicates best shoulder condition. The greater the score, the lower the level of shoulder disability
2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Passive Range of Motion
Time Frame: 2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Examining passive range of motion - forward flexion, external rotation, abduction
2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Shoulder examination for the difference in Active Range of Motion
Time Frame: 3 months, 6 months, 1 year, 2 years after surgery
Examining active range of motion - internal rotation up posterior thorax. Strength- Jobes, external rotation, lift-off and belly-press
3 months, 6 months, 1 year, 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Tulane University

Investigators

  • Principal Investigator: Michael T Freehill, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64618

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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