The STEPS - Totalis™ Trial

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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Totalis; Procedure: Comparator Surgical Procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope research Institute
    • Scottsdale, Arizona, United States, 85260
      • Arizona Pain Specialists
  • California
    • Fountain Valley, California, United States, 92708
      • Medhat Mikhael, M.D. Inc.
    • Santa Monica, California, United States, 90403
      • Orthopedic Pain Specialists
    • Walnut Creek, California, United States, 94598
      • Integrated Pain Management Medical Group, Inc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GWU - Medical Faculty Associates, Inc.
  • Florida
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Hospital
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Pain Care, LLC
  • Indiana
    • Muncie, Indiana, United States, 47304
      • American Health Network
  • Missouri
    • Independence, Missouri, United States, 64055
      • Pain Management Associates
  • New Jersey
    • Somerset, New Jersey, United States, 08773
      • University Pain Medicine Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Pain Physicians
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Pottstown, Pennsylvania, United States, 19464
      • Performance Spine and Sports Physicians, PC
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • SC Pain & Spine Specialists
  • Texas
    • Southlake, Texas, United States, 76092
      • Spine Team Texas
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Ispine Physicians PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Totalis™ Direct Decompression Procedure; Totalis	Device: Totalis
ACTIVE_COMPARATOR: Comparator Procedure; Comparator Surgical Procedure	Procedure: Comparator Surgical Procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VertiFlex, Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 3, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 14-TDDS-01