[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524233":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":11,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":11,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":11},{"fullName":5,"class":6},"SC Medica","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group one: Decompression + FFX®","EXPERIMENTAL",null,[13],"Device: Decompression + FFX®",{"label":15,"type":16,"description":11,"interventionNames":17},"Group two: Decompression alone","ACTIVE_COMPARATOR",[18],"Procedure: Decompression alone",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Decompression + FFX®","Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"PROCEDURE","Decompression alone","Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone",[15],{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":42,"type":43},320,"ESTIMATED","INTERVENTIONAL",[46],"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.",[49],"Degenerative Lumbar Spinal Stenosis","NOT_YET_RECRUITING","2023-10-24",{"date":53,"type":54},"2023-10-30","ACTUAL",{"date":56,"type":43},"2023-11",{"date":58,"type":43},"2026-11",{"name":5,"class":6}]