[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SC Medica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100524233","effectiveness-and-safety-of-the-facet-fixation-ffx-implant-in-the-treatment-of-degenerative-lumbar-spinal-stenosis-100524233",false,"NCT06106061","Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis","FFX® RCT","Inclusion Criteria:\n\n* Age ≥ 50 years.\n* Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.\n* Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);\n* Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).\n* Minimum of 3 months of conservative therapy without improvement of symptoms.\n* Mental \\& physical ability of the subject to follow the protocol (i.e., compliance with time schedule \\& treatment plan, able to fill in questionnaire \\& to undergo further study procedures).\n* Personally signed and dated informed consent document prior to any study-related procedures indicating that the subject has been informed of all pertinent aspects of the clinical investigation.\n\nExclusion Criteria:\n\n* Prior lumbar spine surgery.\n* Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.\n* Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).\n* Degenerative lumbar scoliosis (Cobb angle \\> 25°).\n* Adipositas (obesity); defined as a body mass index (BMI) \\>40.\n* Pregnancy, or wish to get pregnant during the course of the study, or breastfeeding.\n* Known allergy or sensitivity to titanium, titanium alloys, or MRI contrast agents.\n* Active or chronic infection-systemic or local.\n* History of significant peripheral neuropathy.\n* Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses).\n* Paget disease, osteomalacia or other metabolic bone disorders.\n* Cauda equina syndrome.\n* Known or documented history of transmissible disease, including AIDS, HIV and active hepatitis.\n* More than 3 vertebral levels requiring surgery.\n* Disc herniation at any lumbar level requiring surgical intervention.\n* Known osteoporosis (bone mineral density, BMD \\\u003C 120 mg\u002Fcm3).\n* Chronically taking medications or any drug known to potentially interfere with bone\u002Fsoft tissue healing (e.g., steroids), not including a Medrol (methylprednisolone) dose pack.\n* Fixed and complete motor, sensory, or reflex deficit.\n* Rheumatoid arthritis or other autoimmune diseases.\n* Active malignancy: a subject with a history of any invasive malignancy (except non-melanoma skin cancer) unless he\u002Fshe has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years. Subjects with a primary bony tumour are excluded as well.\n* Subject with a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).\n* Bone destruction, demineralisation or any affection potentially affecting fixation of an implant.\n* Spondylodiscitis or spine tumour.\n* Currently seeking or receiving workman's compensation.\n* In active spinal litigation.\n* Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety \\& effectiveness assessment of this trial.\n* Subjects who are lawfully kept in an institution.\n* Subject who, in the opinion of the investigator, will be inappropriate for inclusion in this clinical trial or who will not comply with requirements of the study.\n* Subject under supervision or legal guardianship, or judicial protection.\n* Subject deprived of liberty by judicial or administrative decision.\n* Subject not covered by a social security scheme.","ALL","50 Years",{"count":19,"type":20},320,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.\n\nThe main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.",[26],"Degenerative Lumbar Spinal Stenosis","NOT_YET_RECRUITING","2023-10-24",{"date":30,"type":31},"2023-10-30","ACTUAL",{"date":33,"type":20},"2023-11",{"date":35,"type":20},"2026-11",{"name":37,"class":38},"SC Medica","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":49,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100460606","post-marketing-clinical-follow-up-of-the-medical-device-diva-100460606","NCT05277818","Post-marketing Clinical Follow-up of the Medical Device DIVA®","Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery","Inclusion Criteria:\n\n* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;\n* Patient operated for at least 12 months;\n* Patient able to understand the information related to the study;\n* Patient having indicated his\u002Fher non-opposition to the collection of his\u002Fher personal data.\n\nExclusion Criteria:\n\n* History of pathologies, malformations or surgical interventions on the spine;\n* Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;\n* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);\n* Patient not benefiting from a social security scheme.","18 Years",{"count":48,"type":20},822,"5 Years","OBSERVATIONAL","Observational, ambispective, longitudinal, comparative, open, multicentric study.\n\nThe main objective is to compare the performance of care in patients operated with and without DIVA®.",[53],"Lumbar Disc Herniation","RECRUITING","2022-10-27",{"date":57,"type":31},"2022-10-31",{"date":59,"type":31},"2022-09-07",{"date":61,"type":20},"2027-03-15",{"name":37,"class":38},1,""]