The STEPS - Totalis™ Trial

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Totalis™ Direct Decompression Procedure	Totalis	Totalis
Comparator Procedure	Comparator Surgical Procedure	Comparator Surgical Procedure

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Clinically Significant Improvement in Outcomes	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

Secondary Outcome Measures

Name	Time	Method

Locations (19): Integrated Pain Management Medical Group, Inc.
🇺🇸
Walnut Creek, California, United States
GWU - Medical Faculty Associates, Inc.
🇺🇸
Washington, District of Columbia, United States
Arizona Pain Specialists
🇺🇸
Scottsdale, Arizona, United States
Performance Spine and Sports Physicians, PC
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Pottstown, Pennsylvania, United States
Spine Team Texas
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Southlake, Texas, United States
Virginia iSpine Physicians PC
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Richmond, Virginia, United States
Florida Pain Institute
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Merritt Island, Florida, United States
Pain Management Associates
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Independence, Missouri, United States
University Pain Medicine Center
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Somerset, New Jersey, United States
Medhat Mikhael, M.D. Inc.
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Fountain Valley, California, United States
Holy Cross Hospital
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Fort Lauderdale, Florida, United States
Penn State Hershey Medical Center
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Hershey, Pennsylvania, United States
Alabama Clinical Therapeutics
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Birmingham, Alabama, United States
Hope Research Institute
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Phoenix, Arizona, United States
Oklahoma Pain Physicians
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Oklahoma City, Oklahoma, United States
SC Pain & Spine Specialists
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Murrells Inlet, South Carolina, United States
Orthopedic Pain Specialists
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Santa Monica, California, United States
American Health Network
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Muncie, Indiana, United States
Pain Care, LLC
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Stockbridge, Georgia, United States