Coflex PS3 Actual Conditions for Use Study

Eligibility Criteria

• 1. Radiographic confirmation of at least moderate lumbar stenosis at one or two contiguous levels from L1-L5 that require surgical decompression.
• 2. Visual Analog Scale back pain score of at least 50 mm on a 100 mm scale.
• 3. Neurogenic claudication as defined by leg/buttocks or groin pain that can be relieved by flexion such as sitting in a chair.
• 4. Subject has undergone at least one lumbar injection at any prior time point, AND/OR at least 6 months of prior conservative care without adequate and sustained symptom relief.
• 5. Skeletally mature
• 6. Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%).
• 7. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.
• 8. Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the trial.
• 1. Prior fusion or decompressive laminectomy at index lumbar level.
• 2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture).
• 3. Severe facet hypertrophy that requires extensive bone removal which would cause instability.
• 4. Isthmic spondylolisthesis or spondylolysis (pars fracture).
• 5. Degenerative lumbar scoliosis (Cobb angle of greater than 25°).
• 6. Osteoporsis or is at increased risk of osteoporosis.
• 7. Back or leg pain of unknown etiology.
• 8. Axial back pain only, with no leg, buttock, or groin pain.
• 9. Morbid obesity defined as a body mass index \> 40.
• 10. Known allergy to titanium, titanium alloys, or MR contrast agents.
• 11. Active or chronic infection - systemic or local.
• 12. Cauda equina syndrome, defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.