Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Shoulder Osteoarthritis Clinical Trial

Official title:

Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05341518
• Other study ID #: STU00215591
• Status: Withdrawn
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-site study involving Northwestern Medicine, Beaumont Health, and Loyola Medicine seeks to answer the following question: do patients who undergo subscapularis (SSc) repair during reverse total shoulder arthroplasty (RSA) have better post-operative outcomes than patients who do not undergo SSc repair during RSA? The investigators hypothesize that patients who do not undergo SSc repair during RSA have better post-operative outcomes than patients who undergo SSc repair during RSA. This study will address the controversy surrounding SSc repair during RSA via a multi-institutional randomized controlled trial that will compare clinical outcomes of patients who receive SSc repair during RSA to those who do not.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

1. Primary RSA procedure with repairable (intact) SSc

2. Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant

3. Diagnosis with imaging of arthropathy with rotator cuff insufficiency

4. Surgical approach: Deltopectoral

5. Fluent English speakers/readers

Exclusion Criteria:

1. Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)

2. Revision surgery

3. Oncologic surgery

4. non-ZB CRSS implants

5. Unrepairable SSc

Related Conditions & MeSH terms

• Arthropathy Shoulder
• Joint Diseases
• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

Procedure:
• Subscapularis repair
To complete reverse total shoulder arthroplasty, the surgeon must cut through the subscapularis muscle. In this arm of the study, the muscle will be repaired, rather than left to heal itself.

Locations

Country	Name	City	State
United States	Loyola Medicine	Maywood	Illinois
United States	Beaumont Health	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The American Shoulder and Elbow Surgeons (ASES) Shoulder Score	Scored from 0 (worst shoulder condition) to 100 (best shoulder condition)	up to 12 months post-surgery
Secondary	Internal Rotator (IR) Strength	IR at the side and supported IR at 90° scapation; percent of nonsurgical side	up to 12 months post-surgery
Secondary	PROMIS Bank v1.1 - Pain Interference	PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population).	up to 12 months post-surgery
Secondary	Shoulder Range of Motion	shoulder extension, flexion, internal rotation, abduction, adduction; percent of nonsurgical side	up to 12 months post-surgery