Lumbar Spinal Stenosis Clinical Trial
Official title:
A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Comparator Surgical Procedure in Patients With Lumbar Spinal Stenosis
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis
Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a
radiographically-confirmed diagnosis of central canal stenosis, with or without mild or
moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all
inclusion/exclusion criteria, including ≥6 months of non-operative management.
Patients included in the clinical investigation will return for follow-up visits at 1 week
for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months
post-treatment to collect data for evaluation of safety and effectiveness.
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