Comparing pectoralis minor release with no release during shoulder surgery
A Randomized Control Trial to Evaluate Release Versus Non-release of Pectoralis Minor With Reverse Shoulder Arthroplasty
This study tests if releasing a specific shoulder muscle during surgery can help people feel less pain and move their shoulder better after getting a reverse shoulder replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06292169 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of releasing the pectoralis minor muscle during reverse shoulder arthroplasty (RSA) on postoperative pain and functional outcomes. Participants will be randomly assigned to either receive RSA with pectoralis minor release or without it. The study will measure pain relief, range of motion, and patient-reported outcomes to determine if the release provides any significant benefits. The research addresses a common issue of persistent anterior shoulder pain following RSA, which may be influenced by muscle tensioning.
Who should consider this trial
Good fit: Ideal candidates include adults scheduled for reverse total shoulder arthroplasty who can provide informed consent.
Not a fit: Patients undergoing revision arthroplasty, those with proximal humerus fractures, or individuals unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and functional recovery for patients undergoing reverse shoulder arthroplasty.
How similar studies have performed: While the specific approach of pectoralis minor release in RSA is novel, similar studies have shown that optimizing surgical techniques can lead to improved outcomes in shoulder surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing surgery for reverse total shoulder arthroplasty * Patients willing and able to provide informed consent Exclusion Criteria: * Revision arthroplasty * Reverse shoulder arthroplasty for proximal humerus fractures * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory Clinic — Atlanta, Georgia, United States (Recruiting)
- Emory Healthcare Orthopaedics and Spine Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Eric Wagner, MD — Emory University
- Study coordinator: Eric Wagner, MD
- Email: eric.r.wagner@emory.edu
- Phone: 404-778-7249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.