[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640600":3},{"organization":4,"armGroups":7,"interventions":92,"overallOfficials":140,"centralContacts":145,"locations":151,"responsibleParty":201,"collaborators":203,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":208,"sex":214,"minAge":215,"maxAge":10,"enrollmentInfo":216,"targetDuration":10,"studyType":219,"phases":10,"briefSummary":220,"conditions":221,"keywords":230,"overallStatus":154,"whyStopped":10,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.","INDUSTRY",[8,14,19,24,29,34,39,44,49,54,59,64,69,74,79,83,88],{"label":9,"type":10,"description":11,"interventionNames":12},"Cervical Interbody Fusion Cages (Titanium)",null,"Subjects undergoing surgery with \"Titania® Cervical Interbody Fusion Cages (Titanium)\" will be followed for 12 months.",[13],"Device: Titania® Cervical Interbody Fusion Cage (Titanium)",{"label":15,"type":10,"description":16,"interventionNames":17},"Cervical Interbody Fusion Cages (PEEK)","Subjects undergoing surgery with \"Titania® Cervical Interbody Fusion Cages (PEEK)\" will be followed for 12 months.",[18],"Device: Titania® Cervical Interbody Fusion Cage (PEEK)",{"label":20,"type":10,"description":21,"interventionNames":22},"Posterior Cervical Stabilization Systems","Subjects undergoing surgery with \"Titania® Posterior Cervical Stabilization Systems\" will be followed for 12 months.",[23],"Device: Titania® Posterior Cervical Stabilization System",{"label":25,"type":10,"description":26,"interventionNames":27},"Cervical Plate Systems","Subjects undergoing surgery with \"Titania® Cervical Plate System\" will be followed for 12 months.",[28],"Device: Titania® Cervical Plate System",{"label":30,"type":10,"description":31,"interventionNames":32},"Cervical Dynamic Stabilization Systems (Elastic Rod)","Subjects undergoing surgery with \"Titania® Cervical Dynamic Stabilization Systems (Elastic Rod)\" will be followed for 12 months.",[33],"Device: Titania® Cervical Dynamic Stabilization System (Elastic Rod)",{"label":35,"type":10,"description":36,"interventionNames":37},"Cervical Disc Prosthesis (Titanium)","Subjects undergoing surgery with \"Titania® Cervical Disc Prosthesis (Titanium)\" will be followed for 12 months.",[38],"Device: Titania® Cervical Disc Prosthesis (Titanium)",{"label":40,"type":10,"description":41,"interventionNames":42},"Cervical Disc Prosthesis (PEEK)","Subjects undergoing surgery with \"Titania® Cervical Disc Prosthesis (PEEK)\" will be followed for 12 months.",[43],"Device: Titania® Cervical Disc Prosthesis (PEEK)",{"label":45,"type":10,"description":46,"interventionNames":47},"Lumbar Interbody Fusion Cages (Titanium)","Subjects undergoing surgery with \"Titania® Lumbar Interbody Fusion Cages (Titanium)\" will be followed for 12 months.",[48],"Device: Titania® Lumbar Interbody Fusion Cages (Titanium)",{"label":50,"type":10,"description":51,"interventionNames":52},"Lumbar Interbody Fusion Cages (PEEK)","Subjects undergoing surgery with \"Titania® Lumbar Interbody Fusion Cages (PEEK)\" will be followed for 12 months.",[53],"Device: Titania® Lumbar Interbody Fusion Cages (PEEK)",{"label":55,"type":10,"description":56,"interventionNames":57},"Interspinous Fusion Device (Titanium)","Subjects undergoing surgery with \"Titania® Interspinous Fusion Device (Titanium)\" will be followed for 12 months.",[58],"Device: Titania® Interspinous Fusion Device (Titanium)",{"label":60,"type":10,"description":61,"interventionNames":62},"Posterior Thoracolumbar Stabilization Systems","Subjects undergoing surgery with \"Titania® Posterior Thoracolumbar Stabilization Systems\" will be followed for 12 months.",[63],"Device: Titania® Posterior Thoracolumbar Stabilization Systems",{"label":65,"type":10,"description":66,"interventionNames":67},"Posterior Thoracolumbar Clamp Systems","Subjects undergoing surgery with \"Titania® Posterior Thoracolumbar Clamp Systems\" will be followed for 12 months.",[68],"Device: Titania® Posterior Thoracolumbar Clamp Systems",{"label":70,"type":10,"description":71,"interventionNames":72},"Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)","Subjects undergoing surgery with \"Titania® Thoracolumbar Dynamic Stabilization Systems (Elastic Rod)\" will be followed for 12 months.",[73],"Device: Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)",{"label":75,"type":10,"description":76,"interventionNames":77},"Synthetic Bone Grafts (Cervical Application)","Subjects undergoing surgery with \"Bonegraft® Synthetic Bone Grafts\" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., NDI scores) in the cervical region.",[78],"Device: Bonegraft® Synthetic Bone Grafts",{"label":80,"type":10,"description":81,"interventionNames":82},"Synthetic Bone Grafts (Thoracolumbar Application)","Subjects undergoing surgery with \"Bonegraft® Synthetic Bone Grafts\" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.",[78],{"label":84,"type":10,"description":85,"interventionNames":86},"Bone Cement (Cervical Application)","Subjects undergoing surgery with \"Bonegraft® Synthetic Bone Cement\" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the cervical region.",[87],"Device: Bonegraft® Bone Cement",{"label":89,"type":10,"description":90,"interventionNames":91},"Bone Cement (Thoracolumbar Application)","Subjects undergoing surgery with \"Bonegraft® Synthetic Bone Cement\" will be followed for 12 months. The product is evaluated within this group specifically for its application and clinical outcomes (e.g., ODI scores) in the thoracolumbar region.",[87],[93,98,101,104,107,110,113,116,119,122,125,128,131,134,137],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":10},"DEVICE","Titania® Cervical Interbody Fusion Cage (Titanium)","This is a post-market clinical follow-up (PMCF) of the CE-marked device used according to its intended purpose within routine clinical practice. As this is an observational study, the device is selected and applied based on the physician's clinical judgment, and no additional interventions or procedures beyond standard care are performed.",[9],{"type":94,"name":99,"description":96,"armGroupLabels":100,"otherNames":10},"Titania® Cervical Interbody Fusion Cage (PEEK)",[15],{"type":94,"name":102,"description":96,"armGroupLabels":103,"otherNames":10},"Titania® Posterior Cervical Stabilization System",[20],{"type":94,"name":105,"description":96,"armGroupLabels":106,"otherNames":10},"Titania® Cervical Plate System",[25],{"type":94,"name":108,"description":96,"armGroupLabels":109,"otherNames":10},"Titania® Cervical Dynamic Stabilization System (Elastic Rod)",[30],{"type":94,"name":111,"description":96,"armGroupLabels":112,"otherNames":10},"Titania® Cervical Disc Prosthesis (Titanium)",[35],{"type":94,"name":114,"description":96,"armGroupLabels":115,"otherNames":10},"Titania® Cervical Disc Prosthesis (PEEK)",[40],{"type":94,"name":117,"description":96,"armGroupLabels":118,"otherNames":10},"Titania® Lumbar Interbody Fusion Cages (Titanium)",[45],{"type":94,"name":120,"description":96,"armGroupLabels":121,"otherNames":10},"Titania® Lumbar Interbody Fusion Cages (PEEK)",[50],{"type":94,"name":123,"description":96,"armGroupLabels":124,"otherNames":10},"Titania® Interspinous Fusion Device (Titanium)",[55],{"type":94,"name":126,"description":96,"armGroupLabels":127,"otherNames":10},"Titania® Posterior Thoracolumbar Stabilization Systems",[60],{"type":94,"name":129,"description":96,"armGroupLabels":130,"otherNames":10},"Titania® Posterior Thoracolumbar Clamp Systems",[65],{"type":94,"name":132,"description":96,"armGroupLabels":133,"otherNames":10},"Titania® Thoracolumbar Dynamic Stabilization System (Elastic Rod)",[70],{"type":94,"name":135,"description":96,"armGroupLabels":136,"otherNames":10},"Bonegraft® Synthetic Bone Grafts",[75,80],{"type":94,"name":138,"description":96,"armGroupLabels":139,"otherNames":10},"Bonegraft® Bone Cement",[84,89],[141],{"name":142,"affiliation":143,"role":144},"Hasan Kamil Sucu, Professor","Izmir Katip Celebi University Ataturk Training and Research Hospital","STUDY_DIRECTOR",[146],{"name":147,"role":148,"phone":149,"phoneExt":10,"email":150},"Burak Tülü, Sponsor's Representative","CONTACT","+90 (236) 213 10 14","b.tulu@metrosan.com.tr",[152,173,186],{"facility":153,"status":154,"city":155,"state":10,"zip":156,"country":157,"countryCode":10,"cosmosGeoPoint":158,"geoPoint":163,"contacts":164},"Izmir Katip Celebi University Ataturk Training and Research Hospital, Department of Neurosurgery","RECRUITING","Izmir","35150","Turkey (Türkiye)",{"type":159,"coordinates":160},"Point",[161,162],27.13838,38.41273,{"lat":162,"lon":161},[165,168,170],{"name":142,"role":148,"phone":166,"phoneExt":10,"email":167},"+90 (505) 211 8744","hksucu@gmail.com",{"name":142,"role":169,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":171,"role":172,"phone":10,"phoneExt":10,"email":10},"Ismail Ertan Sevin, Asst. Prof.","SUB_INVESTIGATOR",{"facility":174,"status":175,"city":155,"state":10,"zip":176,"country":157,"countryCode":10,"cosmosGeoPoint":177,"geoPoint":179,"contacts":180},"Demokrasi University Buca Seyfi Demirsoy Training and Research Hospital, Department of Neurosurgery","NOT_YET_RECRUITING","35390",{"type":159,"coordinates":178},[161,162],{"lat":162,"lon":161},[181,185],{"name":182,"role":148,"phone":183,"phoneExt":10,"email":184},"Gorkem Yavas, Asst. Prof.","+90 (537) 331 1559","gorkemyavas@gmail.com",{"name":182,"role":169,"phone":10,"phoneExt":10,"email":10},{"facility":187,"status":175,"city":188,"state":10,"zip":189,"country":157,"countryCode":10,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Van Yuzuncu Yil University Dursun Odabas Medical Center, Department of Neurosurgery","Van","65000",{"type":159,"coordinates":191},[192,193],43.38323,38.49457,{"lat":193,"lon":192},[196,200],{"name":197,"role":148,"phone":198,"phoneExt":10,"email":199},"Mehmet Edip Akyol, Assoc. Prof.","+90 (532) 168 2165","mehmetedipakyol@yyu.edu.tr",{"name":197,"role":169,"phone":10,"phoneExt":10,"email":10},{"type":202,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[204],{"name":205,"class":6},"Bonegraft Biyolojik Malzemeler San. ve Tic. A.S.","100640600","pmcf-study-on-the-effectiveness-and-safety-of-metrosan-spinal-systems-and-bonegraft-filling-materials-100640600",false,"NCT07615491","PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials","A Prospective, Multi-Center, Observational Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials Used in Spinal Instrumentation and Fusion Surgery","INFO SPINE","Inclusion Criteria:\n\n* 18 years of age or older.\n* Skeletally mature.\n* Male or female.\n* Undergone spinal surgery (cervical or thoracolumbar) for any indication under current medical practice.\n* Titania® spinal stabilization\u002Ffusion systems and\u002For BONEGRAFT® bone cements or BONEGRAFT® bone graft materials used during the operation.\n* No general health condition contraindicating surgery.\n* No legal restriction (military service, incarceration, or equivalent).\n* Provision of signed and dated Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Participation in another interventional clinical investigation\n* Suspected or confirmed pregnancy\n* Morbid obesity\n* Neurological or psychiatric conditions preventing compliance with postoperative care and instructions\n* Active spinal or systemic infection\n* High fever or leukocytosis\n* Severe osteoporosis and\u002For disease affecting bone metabolism\n* Known allergy or hypersensitivity to PEEK, Titanium, or PMMA\n* Congenital abnormality, tumor, or other condition preventing secure implant fixation or likely to shorten implant useful life\n* Inadequate tissue coverage at the operative site\n* Legally restricted individuals (military personnel, prisoners, etc.)","ALL","18 Years",{"count":217,"type":218},561,"ESTIMATED","OBSERVATIONAL","This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems, and Bonegraft® bone filling materials (synthetic bone grafts and bone cements). The study aims to evaluate short-term (12-month) safety and effectiveness, identify previously unknown side effects, monitor defined complications, and assess risks based on real-world evidence in patients undergoing spinal surgery. All investigated products are used within their intended purpose under routine clinical practice.",[222,223,224,225,226,227,228,229],"Degenerative Disc Disease (DDD)","Spinal Stenosis","Spondylolisthesis","Spinal Deformities","Spinal Tumors","Spinal Infections","Spinal Trauma","Vertebral Fractures",[231,232,233,234,235,236,237,238,239,240,241,242],"Post-Market Clinical Follow-Up (PMCF)","Spinal Instrumentation","Spinal Fusion","Interbody Fusion","Spinal Stabilization","Spinal Cages","Pedicle Screws","Cervical Plate System","Interspinous Fusion Device","Spinal Implants","Synthetic Bone Graft","Bone Cement","2026-05-22",{"date":245,"type":246},"2026-05-29","ACTUAL",{"date":248,"type":246},"2026-04-27",{"date":250,"type":218},"2028-09-26",{"name":5,"class":6},3]