Subscapularis Repair During Reverse Total Shoulder Arthroplasty
Key facts
- Who runs it
- Northwestern University
- Where
- Maywood and Royal Oak, United StatesSee the 2 sites
- Trial code
- Status
- Withdrawn
- Started
- 2 Jan 2023
- Ended
- Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Subscapularis repair
- Record updated
- 15 March 2024
- Why it stopped
- Participating sites failed to secure funding and study was not feasible at one site.
Who can take part
- Age
- 18 years to 88 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Primary RSA procedure with repairable (intact) SSc
- Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant
- Diagnosis with imaging of arthropathy with rotator cuff insufficiency
- Surgical approach: Deltopectoral
- Fluent English speakers/readers
Who cannot take part
- Revision surgery
- Oncologic surgery
- non-ZB CRSS implants
- Minor (<18 y/o)/vulnerable populations (pregnant women, prisoners, adults unable to consent)
- Unrepairable SSc
Where in United States
- Loyola MedicineMaywood, United States
- Beaumont HealthRoyal Oak, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Subscapularis repairTreatment being tested
Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair
- No repairNo study treatment, for comparison
Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Subscapularis Repair During Reverse Total Shoulder Arthroplasty: a Randomized Control Trial
- Record updated
- 15 March 2024