The STEPS - Totalis™ Trial

Vertiflex

Status

Completed

Conditions

Lumbar Spinal Stenosis

Treatments

Procedure: Comparator Surgical Procedure

Device: Totalis

Study type

Interventional

Funder types

Industry

Identifiers

NCT02079038

14-TDDS-01

Details and patient eligibility

About

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

Full 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.

Enrollment

180 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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