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 for Use Study.
Xtant Medical
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.
Description
A prospective, multi center, concurrently enrolled, propensity score controlled through Month 60. The purpose is to fully characterize safety and efficacy then the coflex device is used in the intended subject population under actual conditions of use.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Dis…
Interventions
- Devicecoflex® Interlaminar Technology
Decompression plus coflex® Interlaminar Technology
- ProcedureDecompression
Decompression alone
Locations (19)
- Desert Institute for Spine Care (DISC)Phoenix, Arizona
- Hoag OrthopedicsIrvine, California
- Sutter HealthSacramento, California
- Central Cost Neurological SurgerySan Luis Obispo, California
- Cervical Disc Center of Los AngelesSanta Monica, California
- UC Health Spine CenterAurora, Colorado