[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glenohumeral-osteoarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glenohumeral-osteoarthritis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645227","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-shoulder-prosthesis-system-100645227",false,"NCT07678034","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,\n* Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Concurrent participation in any other interventional clinical trial.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","OBSERVATIONAL","This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[24,25,26,27,28],"Glenohumeral Osteoarthritis","Proximal Humerus Fracture","Rotator Cuff Arthropathy","Rheumatoid Arthritis","Avascular Necrosis",[30,31,32,33,34],"Reverse Shoulder Arthroplasty","Shoulder Prosthesis","Shoulder Hemiarthroplasty","Post-Market Clinical Follow-Up (PMCF)","Modified Constant-Murley Score","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-06-16",{"date":43,"type":20},"2030-06-15",{"name":45,"class":46},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100635892","retro-prospective-postmarket-clinical-study-for-fx-shoulder-solutions-shoulder-systems-100635892","NCT07558590","RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS","Inclusion Criteria:\n\n* Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.\n* Patient aged 18 years and above\n* Patient insured with a social security system\n* Has been informed and did consent to participate to the study.\n\nExclusion Criteria:\n\n* Neurological pathologies compromising the shoulder stability\n* Morbid obesity\n* Muscular deficiencies impairing the shoulder joint",{"count":55,"type":20},1004,"This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.\n\nThe included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.\n\nSecondary objectives are\n\n* Revision rate at each post op visit\n* Range of motion at each post op visit\n* Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit\n* Radiological assessment of implant positioning through geometrical parameters at each post op visit\n* Incidence of complications at each post op visit\n* Qualitative feedback from surgeons on the instrumentation",[58,24,59,60,26,61,62],"Humeral Fracture, Proximal","Avascular Necrosis of the Head of Humerus","Rotator Cuff Tear","Inflammatory Arthritis","Revision of a Shoulder Prosthesis","2026-04-24",{"date":65,"type":39},"2026-04-30",{"date":67,"type":39},"2020-06-01",{"date":69,"type":20},"2037-06",{"name":71,"class":46},"FX Solutions",22,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100632979","poly-vs-hybrid-glenoid-in-stemless-atsa-100632979","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",{"count":82,"type":20},94,"INTERVENTIONAL",[85],"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.",[24],[89,90,91,31,92,93,94,95,96,97,98,99,100],"Osteoarthritis","Shoulder Joint","Arthroplasty, Replacement, Shoulder","Prostheses and Implants","Prosthesis Fixation","Prosthesis Failure","Prosthesis Loosening","Bone Cements","Polyethylene","Titanium","Osseointegration","Radiography","2026-04-02",{"date":103,"type":39},"2026-04-09",{"date":105,"type":39},"2025-06-30",{"date":107,"type":20},"2036-12",{"name":109,"class":110},"Spaarne Gasthuis","OTHER",1]