protocolSection identificationModule nctId: NCT06292169, orgStudyIdInfo id: STUDY00007201, briefTitle: Pectoralis Minor Release Versus Non-release in RSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Reverse Total Shoulder Arthroplasty, conditions: Rotator Cuff Tear Arthropathy, conditions: Advanced Glenohumeral Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Electronic random number generator Single-blinded (concealed to the study participant only, Investigator blinded not feasible), whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Pectoralis Minor Release, interventions name: RSA, outcomesModule primaryOutcomes measure: Visual analog Scale (VAS) pain scores, otherOutcomes measure: Visual analog Scale (VAS) pain scores, otherOutcomes measure: American Shoulder and Elbow Score (ASES), otherOutcomes measure: Subjective Shoulder Value (SSV), otherOutcomes measure: Change in Range of motion (ROM), otherOutcomes measure: Change in Scapulohumeral Rhythm (SHR) on Digital Dynamic Radiography (DDR), otherOutcomes measure: Number of complications, otherOutcomes measure: Number of reoperations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Clinic, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Eric Wagner, MD, role: CONTACT, phone: 404-778-7249, email: eric.r.wagner@emory.edu, contacts name: Musab Gulzar, role: CONTACT, phone: 201-344-0298, email: mgulzar@emory.edu, contacts name: Michael Gottschalk, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.749, lon: -84.38798, locations facility: Emory Healthcare Orthopaedics and Spine Center, city: Atlanta, state: Georgia, zip: 30329, country: United States, contacts name: Eric Wagner, MD, role: CONTACT, phone: 404-778-7249, email: Eric.r.wagner@emory.edu, contacts name: Musab Gulzar, role: CONTACT, phone: 201-344-0298, email: mgulzar@emory.edu, geoPoint lat: 33.749, lon: -84.38798, hasResults: False