Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-27 @ 5:28 AM
Study NCT ID:
NCT06106061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003664', 'term': 'Decompression'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011312', 'term': 'Pressure'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with composite clinical success (CCS)', 'timeFrame': '2 years', 'description': 'The CCS will be considered as met if ALL of the following criteria are satisfied for a subject:\n\n* Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale)\n* No secondary surgical intervention at the index level (excluding wound problems)\n* No non-surgical lumbar treatment of interest at any lumbar level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Lumbar Spinal Stenosis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 \\< 120 mg/cm3).\n* Chronically taking medications or any drug known to potentially interfere with bone/soft 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/she 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."}, 'identificationModule': {'nctId': 'NCT06106061', 'acronym': 'FFX® RCT', 'briefTitle': 'Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'SC Medica'}, 'officialTitle': 'Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis', 'orgStudyIdInfo': {'id': '2023-A01382-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group one: Decompression + FFX®', 'interventionNames': ['Device: Decompression + FFX®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group two: Decompression alone', 'interventionNames': ['Procedure: Decompression alone']}], 'interventions': [{'name': 'Decompression + FFX®', 'type': 'DEVICE', 'description': 'Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant', 'armGroupLabels': ['Group one: Decompression + FFX®']}, {'name': 'Decompression alone', 'type': 'PROCEDURE', 'description': 'Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone', 'armGroupLabels': ['Group two: Decompression alone']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SC Medica', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}