Status:
NOT_YET_RECRUITING
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
Lead Sponsor:
SC Medica
Conditions:
Degenerative Lumbar Spinal Stenosis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06106061
Start Date
November 1 2023
End Date
November 1 2026
Last Update
October 30 2023
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