Pectoralis Minor Release Versus Non-release in RSA

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06292169
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Glenohumeral Osteoarthritis
  • Reverse Total Shoulder Arthroplasty
  • Rotator Cuff Tear Arthropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pectoralis Minor Release — PROCEDURE
    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.
  • RSA — PROCEDURE
    RSA is the current Standard of Care (SOC)

Study Details

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.

Key Dates

Start date
Aug 7, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RSA with pectoralis minor release
  • Active Comparator: RSA without pectoralis minor release

Primary Outcome Measure

Visual analog Scale (VAS) pain scores [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30322
Eric Wagner, MD
[email protected]
404-778-7249
Musab Gulzar
[email protected]
201-344-0298
Michael Gottschalk, MD (SUB_INVESTIGATOR)
Emory Healthcare Orthopaedics and Spine CenterAtlantaGeorgia30329
Eric Wagner, MD
[email protected]
404-778-7249
Musab Gulzar
[email protected]
201-344-0298

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By research site
Emory Clinic· Atlanta, GAEmory Healthcare Orthopaedics and Spine Center· Atlanta, GA

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