Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Shoulder Injuries Clinical Trial

Official title:

Augmentation of Subscapularis Repair in Total Shoulder Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05487677
• Other study ID #: 64618
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: Elizabeth Jameiro
• Phone: 650-725-5978
• Email: ejameiro[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total Shoulder Arthroplasty

Exclusion Criteria:

• Vulnerable population

Related Conditions & MeSH terms

• Shoulder Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana
United States	Stanford University	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in continuity of subscapularis tissue on ultrasound	Continuity of subscapularis tissue on ultrasound	6 weeks, 6 months after surgery
Primary	Difference in thickness of the subscapularis tissue on ultrasound	Thickness of subscapularis tissue on ultrasound	3 months, 1 years after surgery
Primary	Evaluate arthritis on shoulder x-ray	Amount of arthritis or wear patterns on shoulder x-Ray	Surgery
Primary	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	American Shoulder & Elbow Surgeons Score (ASES) score	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
Secondary	Shoulder examination for the difference in Passive Range of Motion	Examining passive range of motion - forward flexion, external rotation, abduction	2 weeks, 3 months, 6 months, 1 year, 2 years after surgery
Secondary	Shoulder examination for the difference in Active Range of Motion	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