RECRUITING

Pectoralis Minor Release Versus Non-release in RSA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-07
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06292169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients undergoing surgery for reverse total shoulder arthroplasty
  2. * Patients willing and able to provide informed consent
  1. * Revision arthroplasty
  2. * Reverse shoulder arthroplasty for proximal humerus fractures
  3. * Adults unable to consent
  4. * Individuals who are not yet adults (infants, children, teenagers)
  5. * Pregnant women
  6. * Prisoners

Contacts and Locations

Study Contact

Eric Wagner, MD
CONTACT
404-778-7249
eric.r.wagner@emory.edu
Musab Gulzar
CONTACT
201-344-0298
mgulzar@emory.edu

Principal Investigator

Eric Wagner, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Clinic
Atlanta, Georgia, 30322
United States
Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • Eric Wagner, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Reverse Total Shoulder Arthroplasty
  • Reverse Shoulder Arthroplasty
  • American Shoulder and Elbow
  • Range of motion
  • Pectoralis Minor

Additional Relevant MeSH Terms

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