The STEPS - Totalis™ Trial

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.

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