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The STEPS - Totalis™ Trial

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Totalis
Comparator Surgical Procedure
Sponsored by
VertiFlex, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Clinical Therapeutics
  • Hope Research Institute
  • Arizona Pain Specialists
  • Medhat Mikhael, M.D. Inc.
  • Orthopedic Pain Specialists
  • Integrated Pain Management Medical Group, Inc.
  • GWU - Medical Faculty Associates, Inc.
  • Holy Cross Hospital
  • Florida Pain Institute
  • Pain Care, LLC
  • American Health Network
  • Pain Management Associates
  • University Pain Medicine Center
  • Oklahoma Pain Physicians
  • Penn State Hershey Medical Center
  • Performance Spine and Sports Physicians, PC
  • SC Pain & Spine Specialists
  • Spine Team Texas
  • Virginia iSpine Physicians PC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Totalis™ Direct Decompression Procedure

Comparator Procedure

Arm Description

Totalis

Comparator Surgical Procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
August 4, 2020
Sponsor
VertiFlex, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02079038
Brief Title
The STEPS - Totalis™ Trial
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VertiFlex, Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Totalis™ Direct Decompression Procedure
Arm Type
Active Comparator
Arm Description
Totalis
Arm Title
Comparator Procedure
Arm Type
Active Comparator
Arm Description
Comparator Surgical Procedure
Intervention Type
Device
Intervention Name(s)
Totalis
Intervention Type
Procedure
Intervention Name(s)
Comparator Surgical Procedure
Primary Outcome Measure Information:
Title
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Description
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
Time Frame
Baseline and 6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Pain Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Medhat Mikhael, M.D. Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Orthopedic Pain Specialists
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Integrated Pain Management Medical Group, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
GWU - Medical Faculty Associates, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Florida Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Pain Care, LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
American Health Network
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Pain Management Associates
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
University Pain Medicine Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08773
Country
United States
Facility Name
Oklahoma Pain Physicians
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Performance Spine and Sports Physicians, PC
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
SC Pain & Spine Specialists
City
Murrells Inlet
State/Province
South Carolina
ZIP/Postal Code
29576
Country
United States
Facility Name
Spine Team Texas
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Virginia iSpine Physicians PC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The STEPS - Totalis™ Trial

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