[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-trauma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100505056","the-ailliance-post-market-clinical-study-100505056",false,"NCT05856370","The Ailliance Post-Market Clinical Study","The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction","Inclusion Criteria:\n\n1. Subject provides written informed consent per institution and\u002For geographical requirements.\n2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and\u002For spinal indication(s).\n3. Subject is at least 18 years of age or minimum legal age as required by local regulations.\n4. Subject agrees to complete all required assessments per the Schedule of Events.\n\nExclusion Criteria:\n\n1. Subject is currently enrolled or plans to enroll in concurrent drug\u002Fdevice\u002Fbiologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).\n2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.\n3. Subject with exclusion criteria required by local law.\n4. Subject is considered vulnerable at the time of obtaining consent.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and\u002For spinal indication(s).\n\nSubjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.",[26,27,28,29,30],"Spinal Deformity","Spinal Degenerative Disorder","Spinal Fusion Failure","Spinal Trauma","Spinal Tumor Case","RECRUITING","2026-08-13",{"date":34,"type":35},"2026-08-17","ACTUAL",{"date":37,"type":35},"2023-05-01",{"date":39,"type":20},"2031-05",{"name":41,"class":42},"Medtronic Spinal and Biologics","INDUSTRY",29,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100640600","pmcf-study-on-the-effectiveness-and-safety-of-metrosan-spinal-systems-and-bonegraft-filling-materials-100640600","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.)",{"count":53,"type":20},561,"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.",[57,58,59,60,61,62,29,63],"Degenerative Disc Disease (DDD)","Spinal Stenosis","Spondylolisthesis","Spinal Deformities","Spinal Tumors","Spinal Infections","Vertebral Fractures",[65,66,67,68,69,70,71,72,73,74,75,76],"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":79,"type":35},"2026-05-29",{"date":81,"type":35},"2026-04-27",{"date":83,"type":20},"2028-09-26",{"name":85,"class":42},"Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.",3]