Subscapularis Repair Augmentation for Total Shoulder Arthroplasty

Not Applicable

Recruiting

• Conditions: Shoulder Injuries

• Registration Number: NCT05487677
• Lead Sponsor: Stanford University

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.

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 Timeline

• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-04
• Study Start: 2023-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2026-09-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Total Shoulder Arthroplasty

Exclusion Criteria

• Vulnerable population

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Shoulder examination for the difference in Active Range of Motion	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
American Shoulder & Elbow Surgeons Score (ASES) score	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
Shoulder examination for the difference in Passive Range of Motion	2 weeks, 3 months, 6 months, 1 year, 2 years after surgery	Examining passive range of motion - forward flexion, external rotation, abduction

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States