The STEPS - Totalis™ Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Totalis
* Procedure: Comparator Surgical Procedure


Participation Criteria
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Eligibility Criteria
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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) Morbid obesity Significant peripheral vascular disease Active significant co-morbidity Undergoing immunosuppressive therapy or long-term steroid use Current spinal cord stimulator or implanted pain pump Life expectancy less than 2 years Evidence of substance abuse within the year Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Totalis™ Direct Decompression Procedure<br>Totalis | Device: Totalis<br> <br> |
| Active Comparator: Comparator Procedure<br>Comparator Surgical Procedure | Procedure: Comparator Surgical Procedure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Clinically Significant Improvement in Outcomes | 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 | Baseline and 6 Months |