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

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.