Coflex PS3 Actual Conditions for Use Study
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.
| Condition(s) | Spinal Stenosis Lumbar |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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, complet |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Xtant Medical |
| Locations | Phoenix, Arizona, United States; Irvine, California, United States; Sacramento, California, United States; San Luis Obispo, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States (+13 more sites) |
| Start date | 2019-09-09 |
| NCT ID | NCT02555280 |
| Official listing | https://clinicaltrials.gov/study/NCT02555280 |