The STEPS - Totalis™ Trial

NCT ID: NCT02079038

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Totalis™ Direct Decompression Procedure

Totalis

Group Type: ACTIVE_COMPARATOR

Totalis

Intervention Type: DEVICE

Comparator Procedure

Comparator Surgical Procedure

Group Type: ACTIVE_COMPARATOR

Comparator Surgical Procedure

Intervention Type: PROCEDURE

Interventions

Totalis

Intervention Type: DEVICE

Comparator Surgical Procedure

Intervention Type: PROCEDURE

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)
• 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VertiFlex, Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Hope Research Institute

Phoenix, Arizona, United States

Arizona Pain Specialists

Scottsdale, Arizona, United States

Medhat Mikhael, M.D. Inc.

Fountain Valley, California, United States

Orthopedic Pain Specialists

Santa Monica, California, United States

Integrated Pain Management Medical Group, Inc.

Walnut Creek, California, United States

GWU - Medical Faculty Associates, Inc.

Washington D.C., District of Columbia, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Florida Pain Institute

Merritt Island, Florida, United States

Pain Care, LLC

Stockbridge, Georgia, United States

American Health Network

Muncie, Indiana, United States

Pain Management Associates

Independence, Missouri, United States

University Pain Medicine Center

Somerset, New Jersey, United States

Oklahoma Pain Physicians

Oklahoma City, Oklahoma, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Performance Spine and Sports Physicians, PC

Pottstown, Pennsylvania, United States

SC Pain & Spine Specialists

Murrells Inlet, South Carolina, United States

Spine Team Texas

Southlake, Texas, United States

Virginia iSpine Physicians PC

Richmond, Virginia, United States

Countries

United States

Other Identifiers

14-TDDS-01

Identifier Type: -

Identifier Source: org_study_id