[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515869":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":114,"collaborators":116,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":7,"enrollmentInfo":130,"targetDuration":7,"studyType":133,"phases":7,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"SPINEVISION SAS","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Transforaminal lumbar interbody fusion","Transforaminal Lumbar Interbody Fusion indicates a surgical approach in the lumbar spine to fuse the discal space between two vertebrae. These are joined by removing the disc and placing a cage in its place to restore the vertebral height. Screws and rods are also added to maintain the level secure while the bones fuse together.",[14],{"name":15,"affiliation":16,"role":17},"Noel Graziani, Professor","Hopital Privé Clairval","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Renaud Duchenes","CONTACT","+33 6 86 16 61 91","r.duchenes@spinevision.com",{"name":25,"role":21,"phone":7,"phoneExt":7,"email":26},"Hanta Ranaivoson","h.ranaivoson@spinevision.com",[28,48,61,73,86,96],{"facility":29,"status":30,"city":31,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Clinique du dos Terrefort","RECRUITING","Bruges","France","FR",{"type":35,"coordinates":36},"Point",[37,38],-0.61222,44.88287,{"lat":38,"lon":37},[41,44,45],{"name":42,"role":21,"phone":7,"phoneExt":7,"email":43},"Ibrahim Obeid, Doctor","ibrahim.obeid@gmail.com",{"name":42,"role":17,"phone":7,"phoneExt":7,"email":7},{"name":46,"role":47,"phone":7,"phoneExt":7,"email":7},"Louis Boissière, Doctor","SUB_INVESTIGATOR",{"facility":49,"status":30,"city":50,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Clinique Saint Charles","Lyon",{"type":35,"coordinates":52},[53,54],4.84789,45.74906,{"lat":54,"lon":53},[57,60],{"name":58,"role":21,"phone":7,"phoneExt":7,"email":59},"Emmanuel Favreul, Doctor","emmanuel.favreul@wanadoo.fr",{"name":58,"role":17,"phone":7,"phoneExt":7,"email":7},{"facility":62,"status":30,"city":63,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hopital privé Clairval","Marseille",{"type":35,"coordinates":65},[66,67],5.38107,43.29695,{"lat":67,"lon":66},[70,72],{"name":15,"role":21,"phone":7,"phoneExt":7,"email":71},"graziani.noel@gmail.com",{"name":15,"role":17,"phone":7,"phoneExt":7,"email":7},{"facility":74,"status":30,"city":75,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"CHRU Nancy","Nancy",{"type":35,"coordinates":77},[78,79],6.18496,48.68439,{"lat":79,"lon":78},[82,85],{"name":83,"role":21,"phone":7,"phoneExt":7,"email":84},"Nacer Mansouri, Doctor","mansouri.nz@gmail.com",{"name":83,"role":17,"phone":7,"phoneExt":7,"email":7},{"facility":87,"status":30,"city":75,"state":7,"zip":7,"country":32,"countryCode":33,"cosmosGeoPoint":88,"geoPoint":90,"contacts":91},"Polyclinique Majorelle",{"type":35,"coordinates":89},[78,79],{"lat":79,"lon":78},[92,95],{"name":93,"role":21,"phone":7,"phoneExt":7,"email":94},"Aurélie Toquart, Doctor","a.toquart@gmail.com",{"name":93,"role":17,"phone":7,"phoneExt":7,"email":7},{"facility":97,"status":98,"city":99,"state":7,"zip":7,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Clinicque Générale Beaulieu","NOT_YET_RECRUITING","Geneva","Switzerland","CH",{"type":35,"coordinates":103},[104,105],6.14569,46.20222,{"lat":105,"lon":104},[108,111,112],{"name":109,"role":21,"phone":7,"phoneExt":7,"email":110},"Frédéric Schils, Doctor","fs@schilsneurosurgery.com",{"name":109,"role":17,"phone":7,"phoneExt":7,"email":7},{"name":113,"role":47,"phone":7,"phoneExt":7,"email":7},"Renato Gondar, Doctor",{"type":115,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[117],{"name":118,"class":119},"EVAMED","OTHER","100515869","safety-and-performance-of-the-hexanium-tlif-system-in-the-treatment-of-degenerative-disc-disease-100515869",false,"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","ALL","18 Years",{"count":131,"type":132},187,"ESTIMATED","OBSERVATIONAL","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.",[136],"Intervertebral Disc Degeneration",[138,139,140,141,142,143,144],"Lumbar","Spine","Arthrodesis","Fusion","Stabilization","Oswestry disability index","Visual Analogue Score","2026-03-16",{"date":147,"type":148},"2026-03-18","ACTUAL",{"date":150,"type":148},"2021-07-09",{"date":152,"type":132},"2027-10-30",{"name":5,"class":6},6]