Recruiting

Subscapularis Repair

Sponsor:

Stanford University

Code:

NCT05487677

Conditions

Shoulder Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BioBrace Augmentation

Standard Repair with Sutures

Study Details

Brief 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.

Conditions

Shoulder Injuries

Study ID

NCT05487677

Start date

Dec 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Total Shoulder Arthroplasty

Exclusion Criteria:

  • Vulnerable population

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Difference in continuity of subscapularis tissue on ultrasound [ Time Frame: 6 weeks, 6 months after surgery ]
  • Difference in thickness of the subscapularis tissue on ultrasound [ Time Frame: 3 months, 1 years after surgery ]
  • Evaluate arthritis on shoulder x-ray [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Redwood City, California, United States, 94063

Contacts

Principal Investigator:

Michael Freehill, MD

More Information

Sponsor

Stanford University

Last update posted

Aug 19, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-19.