[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SPINEVISION SAS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100542430","safety-and-performance-of-the-spinevision-posterior-fixation-systems-in-thoracolumbar-spinal-treatment-100542430",false,"NCT06342765","Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment","Safety and Performance of the SpineVision Posterior Fixation Systems Lumis®, Plus® and Ulis® in Thoracolumbar Spinal Degenerative Pathologies or Degenerative Disc Disease (DDD) Associated Pathologies Treatment - Fixed D3 Study","FixedD3","Inclusion Criteria:\n\n* Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system\n* Patient of 18 years old and more\n* Patient has provided signed informed consent or did not oppose to his\u002Fher data collection, per local regulation\n\nExclusion Criteria: contra-indication\n\n* trauma (i.e., fracture or dislocation)\n* Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)\n* Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count\n* All cases not described in the indications\n* Localized infection of the operative site\n* All patients with insufficient tissue cover of the operative site\n* Local signs of inflammation\n* Fever or leukocytosis\n* Pathological obesity\n* Pregnancy\n* Mental illness\n* Rapidly evolving joint diseases, bone absorption, osteopenia and\u002For osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation\n* All cases not requiring bone graft or bone fusion\n* When pedicular screws are used, absence or malformation of pedicles\n* All cases requiring a combination of different metals\n* All patients not agreeing to comply with post-operative instructions","ALL","18 Years",{"count":20,"type":21},330,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.\n\nPart of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.",[25],"Intervertebral Disc Degeneration",[27,28,29,30,31,32],"Lumbar","Spine","Fusion","Posterior fixation","Oswestry disability index","Visual Analogue Score","RECRUITING","2026-03-16",{"date":36,"type":37},"2026-03-18","ACTUAL",{"date":39,"type":37},"2022-09-22",{"date":41,"type":21},"2028-05-30",{"name":43,"class":44},"SPINEVISION SAS","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100515869","safety-and-performance-of-the-hexanium-tlif-system-in-the-treatment-of-degenerative-disc-disease-100515869","NCT05997121","Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease","Safety and Performance of the Hexanium TLIF System in the Treatment of Skeletally Mature Patients Suffering From Degenerative Disc Disease - Hexanium TLIF Study","TLIF","Inclusion Criteria:\n\n* Patient planned for Hexanium TLIF system implant or patient implant with Hexanium TLIF system (not prior to July 2021)\n* Patient of 18 years old or more\n* Patient has provided signed informed consent, or did not oppose to his\u002Fher data collection, per local regulation\n\nExclusion Criteria: contra-indication\n\n* Infection, local to the operative site\n* Signed of local inflammation\n* Fever or leukocytosis\n* Morbid obesity\n* Pregnancy\n* Paediatric cases, or patient still having general skeletal growth\n* Spondylolisthesis unable to be reduced to Grade I\n* Suspected or documented allergy or intolerance to metal\n* Any case where the implant components selected for use would be too large or too small to achieve a successful result\n* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality\n* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance\n* Prior fusion at the level to be treated\n* Any case not needing a bone graft or fusion\n* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis\n* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count\n* Mental illness\n* Any patient unwilling to cooperate with post-operative instructions",{"count":55,"type":21},187,"The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk break down).\n\nPart of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Hexanium TLIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium TLIF system implant surgery.",[25],[27,28,59,29,60,31,32],"Arthrodesis","Stabilization",{"date":36,"type":37},{"date":63,"type":37},"2021-07-09",{"date":65,"type":21},"2027-10-30",{"name":43,"class":44},6,""]