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NCT Number: NCT05487677

Subscapularis Repair Augmentation for 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.

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Key information

Conditions

Shoulder Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Redwood City, California, 94063, United States

Location status: Recruiting

Location contact

Jessica Nguyen

CONTACT

jessn16@@stanford.edu

650-725-0003

Michael Freehill, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total Shoulder Arthroplasty

Exclusion criteria

  • Vulnerable population

Treatment and study plan

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.

Other names: Implant Group

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.

Other names: Stitch Group

Primary outcomes

  1. Difference in continuity of subscapularis tissue on ultrasound

    Time frame: 6 weeks, 6 months after surgery

    Continuity of subscapularis tissue on ultrasound

  2. Difference in thickness of the subscapularis tissue on ultrasound

    Time frame: 3 months, 1 years after surgery

    Thickness of subscapularis tissue on ultrasound

  3. Evaluate arthritis on shoulder x-ray

    Time frame: Surgery

    Amount of arthritis or wear patterns on shoulder x-Ray

  4. 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

Secondary outcomes

  1. 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. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Nguyen

CONTACT

[email protected]

650-725-0003

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Aug 4, 2022
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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