Trial Parameters
Brief Summary
A 2 and 5 year evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with additional stabilization using the coflex® Interlaminar Technology for FDA Actual Conditions of Use Study.
Eligibility Criteria
Inclusion 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 asp