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LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. Clinical trial sites will enroll solely LimiFlex subjects or solely TLIF/PLF subjects.
Details
| Lead sponsor | Empirical Spine, Inc. |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 299 |
| Start date | Mon Jul 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jan 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Degenerative Spondylolisthesis
- Lumbar Spinal Stenosis
Interventions
- LimiFlex
- Fusion Instrumentation
- Decompression
- Fusion
Countries
United States