Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant. The 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.

Official Title
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Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis

Conditions
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Degenerative Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Decompression + FFX®
* Procedure: Decompression alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 years. 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. Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm); Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale). Minimum of 3 months of conservative therapy without improvement of symptoms. 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). 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. Exclusion Criteria: Prior lumbar spine surgery. Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level. Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture). Degenerative lumbar scoliosis (Cobb angle > 25°). Adipositas (obesity); defined as a body mass index (BMI) >40. Pregnancy, or wish to get pregnant during the course of the study, or breastfeeding. Known allergy or sensitivity to titanium, titanium alloys, or MRI contrast agents. Active or chronic infection-systemic or local. History of significant peripheral neuropathy. Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses). Paget disease, osteomalacia or other metabolic bone disorders. Cauda equina syndrome. Known or documented history of transmissible disease, including AIDS, HIV and active hepatitis. More than 3 vertebral levels requiring surgery. Disc herniation at any lumbar level requiring surgical intervention. Known osteoporosis (bone mineral density, BMD < 120 mg/cm3). 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. Fixed and complete motor, sensory, or reflex deficit. Rheumatoid arthritis or other autoimmune diseases. 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. Subject with a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol). Bone destruction, demineralisation or any affection potentially affecting fixation of an implant. Spondylodiscitis or spine tumour. Currently seeking or receiving workman's compensation. In active spinal litigation. Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety & effectiveness assessment of this trial. Subjects who are lawfully kept in an institution. 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. Subject under supervision or legal guardianship, or judicial protection. Subject deprived of liberty by judicial or administrative decision. Subject not covered by a social security scheme.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group one: Decompression + FFX®<br> | Device: Decompression + FFX®<br>* Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression associated with the use of FFX® implant<br>|
| Active Comparator: Group two: Decompression alone<br> | Procedure: Decompression alone<br>* Surgical treatment of degenerative lumbar spinal stenosis by spinal decompression alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with composite clinical success (CCS) | The CCS will be considered as met if ALL of the following criteria are satisfied for a subject: Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale) No secondary surgical intervention at the index level (excluding wound problems) No non-surgical lumbar treatment of interest at any lumbar level | 2 years |