A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

Inclusion Criteria:

• 21-85 years of age and skeletally mature;
• Have undergone 6 months of non-operative treatment prior to surgery;
• Lateral, lateral recess and/or central canal stenosis;
• Disc height measuring ≥ 4 mm at the operative level;
• Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue Scale (VAS) Index;
• A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire (ZCQ) Symptom Severity (SS) Score-Candidate;
• A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF) Score;
• A candidate for a decompression with full facetectomy at the operative level
• Candidate for a posterior lumbar fusion;
• Physically and mentally willing and able to comply evaluations;
• Lives in the immediate area and has no plans to relocate;

Exclusion Criteria:

• Previous surgical procedure at the operative or adjacent level except for one of the following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or interspinous spacer;
• Previous lumbar fusion or disc replacement procedure;
• Osteoporosis;
• greater than Grade I spondylolisthesis or retrolithesis;
• Spondylolisthesis at levels other than at the operative level;
• Scoliosis of the lumbar spine (defined as more than 11 deg sagittal deformity);
• Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or irritated disc or other pathology where the patient exhibits axial back pain from degenerative disc disease;
• Acute traumatic pars fracture at the operative/adjacent level vertebral body;
• Spinal stenosis at more than three lumbar segments;
• Acute trauma to the lumbar spine within the last 24 months;
• Active infection at the operative level, or a systemic infection;
• Physically / mentally compromised;
• Systemic disease that would affect the patient's welfare or the research study.
• Immunologically suppressed or immunocompromised;
• Insulin-Dependent Diabetes Mellitus (Type I Diabetes);
• Currently undergoing long-term steroid therapy;
• Metabolic bone disease;
• Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical signs or symptoms of the malignancy for at least 5 years;
• Known allergy to cobalt chromium or titanium;
• Used any investigational drug or device within the past 30 days;
• Pending litigation or receiving Workers Compensation related to back pain or injury;
• Is a prisoner.