Facet Replacement System to Treat Spinal Stenosis

You may be eligible if*:

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

You may not be eligible if you*:

1. Previous surgical procedure at the operative or adjacent level except for one of the following: Microdiscectomy, laminectomy, lamino / foraminotomy, rhizotomy, IDET, and / or interspinous spacer
2. Previous lumbar fusion or disc replacement procedure
3. Osteoporosis
4. Greater than Grade 1 spondylolisthesis or retrolisthesis
5. Spondylolisthesis at levels other than at the operative level
6. Scoliosis of the lumbar spine (defined as more than 11-degrees sagittal deformity)
7. 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
8. Acute traumatic pars fracture at the operative / adjacent level vertebral body
9. Spinal stenosis at more than 3 lumbar segments
10. Acute trauma to the lumbar spine within the last 24 months
11. Active infection at the operative level or a systemic infection
12. Physically / mentally compromised
13. Systemic disease that would affect the patient's welfare or the research study
14. Immunologically suppressed or immunocompromised
15. Insulin-dependent Diabetes Mellitus (Type 1 Diabetes)
16. Currently undergoing long-term steroid therapy
17. Metabolic bone disease
18. Active malignancy (except non-melanoma skin cancer); unless treated with no clinical signs or symptoms of the malignancy for at least 5 years
19. Known allergy to cobalt chromium or titanium
20. Used any investigational drug or device within the past 30 days
21. Pending litigation or receiving Workers' Compensation related to back pain or injury
22. Is a prisoner