[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632979":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":31,"locations":32,"responsibleParty":59,"collaborators":61,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Spaarne Gasthuis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard cemented all-polyethylene pegged glenoid","ACTIVE_COMPARATOR","Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid.",[13],"Procedure: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid",{"label":15,"type":16,"description":15,"interventionNames":17},"Hybrid trabecular titanium central-peg glenoid","EXPERIMENTAL",[18],"Procedure: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid","Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).",[9],[26],"Cemented polyethylene glenoid component",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid","Stemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs.",[15],null,[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Hoofddorp","North Holland","2134 TM","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],4.68889,52.3025,{"lat":44,"lon":43},[47,52,56],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"Arthur van Noort, Md, PHD","CONTACT","+31 6 30693570","AvanNoort@spaarnegasthuis.nl",{"name":53,"role":49,"phone":54,"phoneExt":31,"email":55},"Artin Akchi Masjediy, Bsc","+31 6 42045899","Aakchimasjediy@spaarnegasthuis.nl",{"name":57,"role":58,"phone":31,"phoneExt":31,"email":31},"Arthur van Noort, MD, PHD","PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[62,64],{"name":63,"class":6},"Isala",{"name":65,"class":66},"Enovis","INDUSTRY","100632979","poly-vs-hybrid-glenoid-in-stemless-atsa-100632979",false,"NCT07520721","Poly vs Hybrid Glenoid in Stemless aTSA","A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty","Poly vs hybrid","Inclusion Criteria:\n\n\\-\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Both genders;\n2. Age 18 years old;\n3. Life expectancy over 5 years;\n4. Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;\n5. Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based on physical examination, medical history and X ray examination. (In cases where bilateral aTSA's are indicated, the patient will be included for the second aTSA again when the patient meets the inclusion criteria);\n6. Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;\n7. A diagnosis in the target shoulder of osteoarthritis; according to the classification of Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 degrees.\n8. Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;\n9. Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.\n\nExclusion Criteria:\n\n1. Patient requiring revision shoulder arthroplasty;\n2. Osteoporosis with a history of non-traumatic fractures;\n3. Steroid injections within the previous 6 months;\n4. Contralateral shoulder replacement within the previous 3 months;\n5. Meta-epiphyseal bony defect (including large cysts);\n6. Significant proven or suspicious infection of the target shoulder or any serious infectious disease\n7. Significant neurological or musculoskeletal disorders that may compromise functional recovery;\n8. Known or suspicious hypersensitivity to the metal or other materials of the implant;\n9. Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;\n10. Any systemic disease which may affect outcome.\n11. Active or metastatic neoplastic disease\n12. Chemotherapy and\u002For radiotherapy within the last 6 months\n13. Previous organ transplant\n14. Participation in any clinical research study that may interfere with this study\n15. A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.\n16. Current substance use disorder (excluding nicotine\u002Ftabacco use disorder) or moderate or severe alcohol use disorder.\n17. Imminent suicide risk.\n18. Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment","ALL","18 Years",{"count":78,"type":79},94,"ESTIMATED","INTERVENTIONAL",[82],"NA","Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.",[85],"Glenohumeral Osteoarthritis",[87,88,89,90,91,92,93,94,95,96,97,98,99],"Osteoarthritis","Shoulder Joint","Arthroplasty, Replacement, Shoulder","Shoulder Prosthesis","Prostheses and Implants","Prosthesis Fixation","Prosthesis Failure","Prosthesis Loosening","Bone Cements","Polyethylene","Titanium","Osseointegration","Radiography","2026-04-02",{"date":102,"type":103},"2026-04-09","ACTUAL",{"date":105,"type":103},"2025-06-30",{"date":107,"type":79},"2036-12",{"name":5,"class":6},1]