[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641958":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":98,"collaborators":10,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":10,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":10,"enrollmentInfo":109,"targetDuration":10,"studyType":112,"phases":10,"briefSummary":113,"conditions":114,"keywords":120,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tipmed™ Primary Hip Prosthesis",null,"A single prospective cohort of adult patients tracked during routine clinical practice who have undergone primary hip arthroplasty (either total hip arthroplasty or partial hemiarthroplasty) using the Tipmed™ Primary Hip Prosthesis System (including cemented or uncemented stem options based on standard surgical indications).",[13],"Device: Tipmed™ Primary Hip Prosthesis System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Tipmed™ Primary Hip Prosthesis System","Post-market utilization of the commercially available Tipmed™ Primary Hip Prosthesis System during routine orthopedic care. Device components include various configurations such as cemented or uncemented stems (anatomic or square cross-section), acetabular cups, bipolar cups, and titanium metal shells fitted according to standard clinical routine and patient anatomy. No investigational or non-routine interventions are performed as part of this observational registry.",[9],[21],{"name":22,"affiliation":23,"role":24},"Ahmet Karakaşlı, Professor","Dokuz Eylul University","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Yasemin Önel, Sponsor Rep","CONTACT","+90 232 479 33 22","yaseminonel@tipmed.com",[32,60,72,86],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":10,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital","RECRUITING","Balıkesir","10100","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],27.88611,39.64917,{"lat":42,"lon":41},[45,49,51,54,56,58],{"name":46,"role":28,"phone":47,"phoneExt":10,"email":48},"Özgün Karakuş, Professor","+90 266 460 4000","ozgunkarakus@hotmail.com",{"name":46,"role":50,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":10,"phoneExt":10,"email":10},"fatih Işık, MD, Spec.","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":10,"phoneExt":10,"email":10},"Fatih Palıt, MD, Spec.",{"name":57,"role":53,"phone":10,"phoneExt":10,"email":10},"Uğur Yüzügüldü, MD, Spec.",{"name":59,"role":53,"phone":10,"phoneExt":10,"email":10},"Mücahit Çelik, MD, Spec.",{"facility":61,"status":34,"city":35,"state":10,"zip":62,"country":37,"countryCode":10,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital","10700",{"type":39,"coordinates":64},[41,42],{"lat":42,"lon":41},[67,71],{"name":68,"role":28,"phone":69,"phoneExt":10,"email":70},"Cemal Aydın, MD, Spec.","+90 266 412 6999","cemalaydın80@hotmail.com",{"name":68,"role":50,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":34,"city":74,"state":10,"zip":75,"country":37,"countryCode":10,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Dokuz Eylül University Research and Application Hospital","Izmir","35330",{"type":39,"coordinates":77},[78,79],27.13838,38.41273,{"lat":79,"lon":78},[82,85],{"name":22,"role":28,"phone":83,"phoneExt":10,"email":84},"+90 (232) 412 22 22","karakasliahmet@gmail.com",{"name":22,"role":50,"phone":10,"phoneExt":10,"email":10},{"facility":87,"status":34,"city":74,"state":10,"zip":88,"country":37,"countryCode":10,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital","35390",{"type":39,"coordinates":90},[78,79],{"lat":79,"lon":78},[93,97],{"name":94,"role":28,"phone":95,"phoneExt":10,"email":96},"Kamil Yamak, Professor","+90 532 722 0852","kamilyamak@hotmail.com",{"name":94,"role":50,"phone":10,"phoneExt":10,"email":10},{"type":99,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100641958","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-primary-hip-prosthesis-system-100641958",false,"NCT07651735","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Subjects who have undergone Primary Hip Arthroplasty (either total or partial) for any indication,\n* Subjects in whose surgical procedure the Tipmed™ Primary Hip Prosthesis System components were utilized.\n* Subjects who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).\n* Subjects who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Subjects currently participating in any other interventional clinical trial.","ALL","18 Years",{"count":110,"type":111},101,"ESTIMATED","OBSERVATIONAL","This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing primary hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[115,116,117,118,119],"Total Hip Arthroplasty (THA)","Hemiarthroplasty","Osteoarthritis (OA) of the Hip","Femoral Neck Fractures","Joint Diseases",[121,122,123,124,125,126],"Hip Prosthesis","Total Hip Prosthesis","Partial Hip Prosthesis","Primary Hip Arthroplasty","Post-Market Clinical Follow-Up (PMCF)","Harris Hip Score (HHS)","2026-06-10",{"date":129,"type":130},"2026-06-16","ACTUAL",{"date":132,"type":130},"2024-03-12",{"date":134,"type":111},"2029-03-31",{"name":5,"class":6},4]