[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645227":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":107,"collaborators":10,"id":109,"slug":10,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":10,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":10,"enrollmentInfo":117,"targetDuration":10,"studyType":120,"phases":10,"briefSummary":121,"conditions":122,"keywords":128,"overallStatus":43,"whyStopped":10,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reverse Shoulder Arthroplasty (RSA) Cohort",null,"Patients who undergo reverse shoulder arthroplasty using the Tipmed™ Reverse Shoulder Prosthesis System components (including Humeral Stem, Humeral Tray, Humeral Cup, Glenosphere, Baseplate, and Screws). Target enrollment: 40 participants.",[13],"Device: Tipmed™ Reverse Shoulder Prosthesis System",{"label":15,"type":10,"description":16,"interventionNames":17},"Shoulder Hemiarthroplasty (HA) Cohort","Patients who undergo shoulder hemiarthroplasty involving isolated replacement of the humeral head, using Tipmed™ Humeral Stems and Modular Humeral Heads interacting with the patient's natural glenoid. Target enrollment: 14 participants",[18],"Device: Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Tipmed™ Reverse Shoulder Prosthesis System","Prospective clinical follow-up and observational data collection for adult patients who have already undergone reverse shoulder arthroplasty using the CE-marked Tipmed™ Reverse Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, the intervention does not involve any experimental surgical assignment. No investigational or nonroutine interventions are performed as part of this observational registry. The tracked device components include a combination of humeral stems available in various dimensional configurations, humeral trays, ultra-high molecular weight polyethylene (UHMWPE) humeral cups, glenospheres, and porous + hydroxyapatite (HA)-coated baseplates with locking or non-locking fixation screws, which were tailored intraoperatively during the index surgery according to the participant's specific shoulder anatomy and bone quality.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)","Prospective clinical follow-up and observational data collection for adult patients who have already undergone shoulder hemiarthroplasty surgery utilizing specific components of the CE-marked Tipmed™ Shoulder Prosthesis System in routine clinical practice. Since participants are enrolled postoperatively, this observational study does not involve any active or experimental surgical intervention assigned by the protocol. No investigational or nonroutine procedures are performed as part of this study. The tracked intervention evaluates the post-surgical performance of the explicitly isolated replacement of the humeral head interacting with the patient's natural glenoid fossa. Observational data tracking focuses on the implanted configuration consisting of a modular humeral stem paired with a modular humeral head connected via a tapered conical assembly, which were selected and tailored intraoperatively during the prior surgery based on patient-specific anatomical requirements.",[15],[30],{"name":31,"affiliation":32,"role":33},"Özgün Karakuş, Assoc. Prof.","Republic of Turkey Ministry of Health Balıkesir Provincial Health Directorate, Atatürk City Hospital","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Yasemin Önel, Sponsor Rep","CONTACT","+90 232 479 33 22","yaseminonel@tipmed.com",[41,62,78,95],{"facility":42,"status":43,"city":44,"state":10,"zip":45,"country":46,"countryCode":10,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital","RECRUITING","Balıkesir","10100","Turkey (Türkiye)",{"type":48,"coordinates":49},"Point",[50,51],27.88611,39.64917,{"lat":51,"lon":50},[54,57,59],{"name":31,"role":37,"phone":55,"phoneExt":10,"email":56},"+90 266 460 4000","ozgunkarakus@hotmail.com",{"name":31,"role":58,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":10,"phoneExt":10,"email":10},"Murat Gök, MD, Spec.","SUB_INVESTIGATOR",{"facility":63,"status":64,"city":65,"state":10,"zip":66,"country":46,"countryCode":10,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Republic of Turkey Ministry of Health, Istanbul Provincial Health Directorate, Kanuni Sultan Suleyman Training and Research Hospital","NOT_YET_RECRUITING","Istanbul","34303",{"type":48,"coordinates":68},[69,70],28.94966,41.01384,{"lat":70,"lon":69},[73,77],{"name":74,"role":37,"phone":75,"phoneExt":10,"email":76},"Oğuzhan Bulut, MD, Spec.","+905424096679","droguzhanbulut@gmail.com",{"name":74,"role":58,"phone":10,"phoneExt":10,"email":10},{"facility":79,"status":64,"city":80,"state":10,"zip":81,"country":46,"countryCode":10,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Republic of Turkey Ministry of Health, Izmir Provincial Health Directorate, Bakircay University Cigli Training and Research Hospital","Izmir","35140",{"type":48,"coordinates":83},[84,85],27.13838,38.41273,{"lat":85,"lon":84},[88,92,93],{"name":89,"role":37,"phone":90,"phoneExt":10,"email":91},"Sercan Çapkın, MD, Spec.","+90506 842 75 96","sercancapkn@gmail.com",{"name":89,"role":58,"phone":10,"phoneExt":10,"email":10},{"name":94,"role":61,"phone":10,"phoneExt":10,"email":10},"Murat Kaan Atalay, MD, Spec.",{"facility":96,"status":64,"city":80,"state":10,"zip":97,"country":46,"countryCode":10,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Dokuz Eylül University Research and Application Hospital","35340",{"type":48,"coordinates":99},[84,85],{"lat":85,"lon":84},[102,106],{"name":103,"role":37,"phone":104,"phoneExt":10,"email":105},"Onur Başçı, Assoc. Prof.","+90533 317 99 50","onur.basci@deu.edu.tr",{"name":103,"role":58,"phone":10,"phoneExt":10,"email":10},{"type":108,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":118,"type":119},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.",[123,124,125,126,127],"Glenohumeral Osteoarthritis","Proximal Humerus Fracture","Rotator Cuff Arthropathy","Rheumatoid Arthritis","Avascular Necrosis",[129,130,131,132,133],"Reverse Shoulder Arthroplasty","Shoulder Prosthesis","Shoulder Hemiarthroplasty","Post-Market Clinical Follow-Up (PMCF)","Modified Constant-Murley Score","2026-06-24",{"date":136,"type":137},"2026-07-01","ACTUAL",{"date":139,"type":137},"2025-06-16",{"date":141,"type":119},"2030-06-15",{"name":5,"class":6},4]