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The STEPS - Totalis™ Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02079038
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
VertiFlex, Incorporated

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 Surgery in patients with lumbar spinal stenosis

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Device: Totalis Device: Sham Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex® Totalis™ Direct Decompression System Versus a Sham Surgical Procedure in Patients With Lumbar Spinal Stenosis
Study Start Date : May 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Active Comparator: Totalis™ Direct Decompression Procedure
Device: Totalis
Sham Comparator: Sham Surgical Procedure
Device: Sham

Primary Outcome Measures :
  1. The proportion of patients who achieve the minimum clinically important difference (MCID) in any two of three domains of the Zurich Claudication Questionnaire (ZCQ) at 6 months and no interventions through 6 months [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 6 Months ]
    Visual Analogue Scale (VAS): Compared to baseline, an improvement (in leg and/or back pain) of 20 mm (on a 100mm scale) is considered clinically significant

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02079038

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

Responsible Party: VertiFlex, Incorporated Identifier: NCT02079038     History of Changes
Other Study ID Numbers: 14-TDDS-01
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Constriction, Pathologic
Spinal Stenosis
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases