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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- VertiFlex, Incorporated
- Enrollment
- 180
- Locations
- 19
- Primary Endpoint
- Percentage of Subjects With Clinically Significant Improvement in Outcomes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects greater than or equal to 55 years of age
- •Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion
- •VAS leg symptom severity \>50 (in either leg) during episodes of neurogenic claudication
- •Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms
- •Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence
- •Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy
Exclusion Criteria
- •Significant back, buttock or leg pain from causes other than lumbar central canal stenosis
- •Axial back pain only
- •Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level
- •Severe lateral recess stenosis
- •Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
- •Prior decompressive surgery at index level (s) or fusion at any lumbar level
- •Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments
- •Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1
- •Spondylolysis (pars fracture)
- •Significant degenerative lumbar scoliosis at index level(s)
Outcomes
Primary Outcomes
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Time Frame: Baseline and 6 Months
Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings