Actively Recruiting
A Randomized Control Trial to Evaluate Release Versus Non-release of Pectoralis Minor During Reverse Shoulder Arthroplasty
Led by Emory University · Updated on 2025-10-23
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial involves patients undergoing reverse shoulder arthroplasty (RSA) to investigate if releasing the pectoralis minor muscle at the time of surgery improves pain relief, shoulder range of motion, and patient-reported outcomes. It addresses persistent anterior shoulder pain and altered scapula biomechanics that may occur after RSA, a surgery increasingly used to treat shoulder conditions like rotator cuff tear arthropathy and advanced glenohumeral osteoarthritis. Participants will be randomly assigned to one of two groups: one receiving RSA with an open release of the pectoralis minor muscle through the same surgical incision and the other receiving standard RSA without this muscle release. The pectoralis minor release involves cutting the muscle's insertion on the coracoid process while protecting nearby nerves and vessels. This procedure aims to reduce muscle tension that may affect shoulder function after surgery. Throughout the study, participants will be assessed for pain using the Visual Analog Scale at baseline and six months post-surgery. Researchers will also evaluate shoulder movement and patient-reported outcomes to compare the effects of muscle release versus no release. The study includes informed consent, regular follow-ups, and safety monitoring, with a total participation period extending at least six months after surgery.
CONDITIONS
Brief Title
Pectoralis Minor Release Versus Non-release in RSA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing surgery for reverse total shoulder arthroplasty
- Patients willing and able to provide informed consent
You will not qualify if you...
- Revision arthroplasty procedures
- Reverse shoulder arthroplasty performed for proximal humerus fractures
- Adults unable to provide informed consent
- Individuals under 18 years of age
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo reverse shoulder arthroplasty (RSA) surgery, with or without pectoralis minor release, followed by immediate post-operative care.
1 surgical visit and immediate post-operative care
Duration - 6 months
Participants have follow-up visits to assess pain levels and shoulder function, including evaluation at baseline and 6 months post-surgery.
2 visits (baseline and 6 months post-surgery)
Trial Site Locations
Total: 2 locations
1
Emory Clinic
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
E
Eric Wagner, MD
M
Musab Gulzar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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