Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06292169

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing surgery for reverse total shoulder arthroplasty
  • Patients willing and able to provide informed consent
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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