protocolSection identificationModule nctId: NCT06323980, orgStudyIdInfo id: DSM202108, briefTitle: INHANCE Stemless Reverse Shoulder IDE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-15, primaryCompletionDateStruct date: 2027-11-10, completionDateStruct date: 2028-04-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: DePuy Orthopaedics, class: INDUSTRY, descriptionModule briefSummary: 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder., conditionsModule conditions: Arthroplasty, conditions: Replacement, conditions: Shoulder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 Randomized (Stemless to Stemmed), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 168, type: ESTIMATED, armsInterventionsModule interventions name: Reverse Total Shoulder, outcomesModule primaryOutcomes measure: Constant Murley Score (CMS), primaryOutcomes measure: Removal of any system component, primaryOutcomes measure: Revision of any system component, primaryOutcomes measure: Reoperation of any system component, primaryOutcomes measure: Supplemental Fixation of any system component, primaryOutcomes measure: Radiolucent Lines (Humeral & Glenoid), primaryOutcomes measure: Migration and Tilt (Humeral & Glenoid), secondaryOutcomes measure: Constant Murley Score (CMS), secondaryOutcomes measure: EQ-5D-5L and EQ-VAS, secondaryOutcomes measure: Simple Shoulder Test, secondaryOutcomes measure: Single Assessment Numeric Evaluation (SANE) Score, secondaryOutcomes measure: Survivorship, secondaryOutcomes measure: Complications, otherOutcomes measure: Constant Murley Score (CMS), otherOutcomes measure: EQ-5D-5L and EQ-VAS, otherOutcomes measure: Simple Shoulder Test, otherOutcomes measure: Single Assessment Numeric Evaluation (SANE) Score, otherOutcomes measure: Range of Motion, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hoag Orthopedic Institute, city: Irvine, state: California, zip: 92618, country: United States, geoPoint lat: 33.66946, lon: -117.82311, locations facility: Atlantis Orthopaedics, city: Lake Worth, state: Florida, zip: 33463, country: United States, geoPoint lat: 26.61708, lon: -80.07231, locations facility: Boston Sports & Shoulder Center, city: Waltham, state: Massachusetts, zip: 02451, country: United States, geoPoint lat: 42.37649, lon: -71.23561, locations facility: Trinity Health Grand Rapids, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: Missouri Orthopaedic Institute (MOI), city: Columbia, state: Missouri, zip: 65201, country: United States, geoPoint lat: 38.95171, lon: -92.33407, locations facility: Lindner Research Center, city: Cincinnati, state: Ohio, zip: 45219, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Cleveland Clinic, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Slocum Center for Orthpaedics and Sports Medicine, city: Eugene, state: Oregon, zip: 97401, country: United States, geoPoint lat: 44.05207, lon: -123.08675, locations facility: Rothman Orthopaedics Institute, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: TOSH- The Orthopedic Specialty Hospital, city: Murray, state: Utah, zip: 84107, country: United States, geoPoint lat: 40.66689, lon: -111.88799, locations facility: University of Utah, city: Salt Lake City, state: Utah, zip: 84108, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False