Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications. The study hypothesis criteria for demonstrating safety and efficacy requires scientific evidence that patients classified as satisfying the primary study endpoint post device implantation is at least as good for Stabilimax NZ® recipients as that for patients undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup assessment.