Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

NCT05487677 | Recruiting FDA Device

• 1 other identifier: 64618
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Difference in continuity of subscapularis tissue on ultrasound

  Continuity of subscapularis tissue on ultrasound

  6 weeks, 6 months after surgery

• Difference in thickness of the subscapularis tissue on ultrasound

  Thickness of subscapularis tissue on ultrasound

  3 months, 1 years after surgery

• Evaluate arthritis on shoulder x-ray

  Amount of arthritis or wear patterns on shoulder x-Ray

  Surgery

• Difference in signs of loosening or wear patterns in shoulder X-Ray

  Signs of loosening or wear patterns on shoulder x-ray

  2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

Secondary Outcomes (3)

• American Shoulder & Elbow Surgeons Score (ASES) score

  2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

• Shoulder examination for the difference in Passive Range of Motion

  2 weeks, 3 months, 6 months, 1 year, 2 years after surgery

• Shoulder examination for the difference in Active Range of Motion

  3 months, 6 months, 1 year, 2 years after surgery

Study Arms (2)

BioBrace Augmentation

EXPERIMENTAL

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

Standard Repair with Sutures

ACTIVE COMPARATOR

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

Interventions

BioBrace Augmentation DEVICE

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.

Also known as: Implant Group

BioBrace Augmentation

Standard Repair with Sutures PROCEDURE

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.

Also known as: Stitch Group

Standard Repair with Sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total Shoulder Arthroplasty

You may not qualify if:

• Vulnerable population

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Michael T Freehill, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Nguyen

CONTACT

650-725-0003; jessn16@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The physician performing the ultrasound evaluation will be blinded to which treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Model Details: Patients undergoing reverse shoulder arthroplasty will be recruited, consented, \& enrolled. Patient will be randomized to standard repair with sutures versus standard repair with BioBrace augmentation of the repair.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 4, 2022
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)