[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641087":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":121,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tıpmed™ Revision Hip Prosthesis",null,"A single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice.",[13],"Device: Tıpmed™ Revision Hip Prosthesis System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Tıpmed™ Revision Hip Prosthesis System","Post-market evaluation of the commercially available, CE-marked Tıpmed™ Revision Hip Prosthesis System during routine revision orthopedic care. Surgeon-directed device configurations are utilized based on patient-specific bone loss and anatomy, incorporating various mono-block or modular femoral stems, modular femoral body components, and femoral necks. Acetabular reconstruction elements encompass various configurations including acetabular cups, bipolar cups, and titanium metal shells with modular inserts, paired with dedicated bone-anchoring options such as acetabular rings, reinforcement cages, and anatomical rings based on standard clinical routine. In strict adherence to the prospective observational design of this registry, no investigational, experimental, or non-routine surgical interventions are performed.",[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 Onel, 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","10900",{"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","100641087","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-revision-hip-prosthesis-system-100641087",false,"NCT07653295","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),\n* Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components 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* Subjects currently participating in any other interventional clinical trial.","ALL","18 Years",{"count":110,"type":111},35,"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™ Revision Hip Prosthesis System in adult participants undergoing revision 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.",[115,116,117,118,119,120],"Revision Hip Arthroplasty","Aseptic Loosening of Prosthetic Joint","Prostheses-related Infections","Joint Instability","Periprosthetic Fractures","Prosthesis Failure",[122,115,123,124,125],"Hip Prosthesis","Revision Hip Prosthesis","Post-Market Clinical Follow-Up (PMCF)","Harris Hip Score (HHS)","2026-06-17",{"date":128,"type":129},"2026-06-18","ACTUAL",{"date":131,"type":129},"2024-03-12",{"date":133,"type":111},"2029-03-31",{"name":5,"class":6},4]