[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-deformities\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-deformities":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"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":20,"type":21},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.",[25,26,27,28,29,30,31,32],"Degenerative Disc Disease (DDD)","Spinal Stenosis","Spondylolisthesis","Spinal Deformities","Spinal Tumors","Spinal Infections","Spinal Trauma","Vertebral Fractures",[34,35,36,37,38,39,40,41,42,43,44,45],"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","RECRUITING","2026-05-22",{"date":49,"type":50},"2026-05-29","ACTUAL",{"date":52,"type":50},"2026-04-27",{"date":54,"type":21},"2028-09-26",{"name":56,"class":57},"Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.","INDUSTRY",3]