protocolSection identificationModule nctId: NCT06319911, orgStudyIdInfo id: AETOS 2022.04, briefTitle: AETOS Shoulder System, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-08-30, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Smith & Nephew, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization, conditionsModule conditions: Shoulder Osteoarthritis, conditions: Shoulder Arthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: AETOS, outcomesModule primaryOutcomes measure: Implant Survivorship, secondaryOutcomes measure: Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years, secondaryOutcomes measure: Radiographic Assessment - Glenoid Migration/Subsidence, secondaryOutcomes measure: Radiographic Assessment - Glenoid Radiolucency, secondaryOutcomes measure: Radiographic Assessment - Humeral Radiolucency, secondaryOutcomes measure: Radiographic Assessment - Humeral Migration/Subsidence, secondaryOutcomes measure: Radiographic Assessment - Humeral Head Centeredness, secondaryOutcomes measure: Radiographic Assessment - Bone Remodeling, secondaryOutcomes measure: Radiographic Assessment - Glenohumeral Subluxation, secondaryOutcomes measure: Radiographic Assessment - Device Condition: Anatomic, secondaryOutcomes measure: Radiographic Assessment - Device Condition: Reverse, secondaryOutcomes measure: American Shoulder and Elbow Score (ASES), secondaryOutcomes measure: Constant Murley Score, secondaryOutcomes measure: Simple Shoulder Test (SST), secondaryOutcomes measure: Single Assessment Numeric Evaluation (SANE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: California Pacific Orthopedics, status: RECRUITING, city: San Francisco, state: California, zip: 94118, country: United States, contacts name: Katie Sheehi, role: CONTACT, phone: 415-668-8010, email: ksheehi@calpacortho.com, contacts name: James Kelly, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Western Orthopaedics, status: NOT_YET_RECRUITING, city: Denver, state: Colorado, zip: 80210, country: United States, contacts name: Libby Mauter, role: CONTACT, phone: 303-321-1333, email: lmauter@western-ortho.com, contacts name: Armand Hatzidakis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Hughston Foundation, status: NOT_YET_RECRUITING, city: Columbus, state: Georgia, zip: 31909, country: United States, contacts name: Cholly Minton, role: CONTACT, phone: 706-494-3330, email: cminton@hughston.com, contacts name: Brent Ponce, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.46098, lon: -84.98771, locations facility: Center for Orthopedics and Neurosurgical Care, status: RECRUITING, city: Bend, state: Oregon, zip: 97701, country: United States, contacts name: Cody Manriquez, role: CONTACT, phone: 541-420-0774, email: codymanriquez@gmail.com, contacts name: Scott Jacobson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05817, lon: -121.31531, locations facility: Rothman Institute, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Brooke Olin, role: CONTACT, phone: 267-516-9393, contacts name: Matthew Ramsey, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False