RecruitingNot ApplicableNCT06292169

Pectoralis Minor Release Versus Non-release in RSA

A Randomized Control Trial to Evaluate Release Versus Non-release of Pectoralis Minor With Reverse Shoulder Arthroplasty


Sponsor

Emory University

Enrollment

90 participants

Start Date

Aug 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are: * whether releasing the pectoralis minor prophylactically could have better pain relief * whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes * whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • All patients undergoing surgery for reverse total shoulder arthroplasty
  • Patients willing and able to provide informed consent

Exclusion Criteria6

  • 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

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Interventions

PROCEDUREPectoralis Minor Release

The pectoralis minor is a muscle on the anterior chest wall attaching to the coracoid process. In the group undergoing pectoralis minor release, through the same deltopectoral incision that will not be extended or different as compared to the RSA only group, the pec minor will be exposed on the medial aspect of the coracoid at the upper part of the incision. It will be cut from its insertion on the coracoid while being careful to protect any neurovascular structures.

PROCEDURERSA

RSA is the current Standard of Care (SOC)


Locations(2)

Emory Clinic

Atlanta, Georgia, United States

Emory Healthcare Orthopaedics and Spine Center

Atlanta, Georgia, United States

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NCT06292169


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