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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
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
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 Comparator Surgical Procedure in patients with lumbar spinal stenosis

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Device: Totalis Procedure: Comparator Surgical Procedure 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 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 Comparator 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
Active Comparator: Comparator Procedure
Comparator Surgical Procedure
Procedure: Comparator Surgical Procedure

Primary Outcome Measures :
  1. Percentage of Subjects With Clinically Significant Improvement in Outcomes [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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Sponsors and Collaborators
VertiFlex, Incorporated
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Responsible Party: VertiFlex, Incorporated Identifier: NCT02079038    
Other Study ID Numbers: 14-TDDS-01
First Posted: March 5, 2014    Key Record Dates
Results First Posted: August 7, 2020
Last Update Posted: August 7, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases