Lumbar Spinal StenosisNCT02079038
The STEPS - Totalis™ Trial
A study testing Totalis and Comparator Surgical Procedure in people with Lumbar Spinal Stenosis, run by VertiFlex, Incorporated at 19 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Totalis and Comparator Surgical Procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 19 sitesUnited States
- Study dates
- May 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235
Holy Cross Hospital
Fort Lauderdale, Florida, 33334
Medhat Mikhael, M.D. Inc.
Fountain Valley, California, 92708
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Pain Management Associates
Independence, Missouri, 64055
Florida Pain Institute
Merritt Island, Florida, 32953
American Health Network
Muncie, Indiana, 47304
SC Pain & Spine Specialists
Murrells Inlet, South Carolina, 29576
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, 73120
Hope Research Institute
Phoenix, Arizona, 85018
Performance Spine and Sports Physicians, PC
Pottstown, Pennsylvania, 19464
Virginia iSpine Physicians PC
Richmond, Virginia, 23235
Orthopedic Pain Specialists
Santa Monica, California, 90403
Arizona Pain Specialists
Scottsdale, Arizona, 85260
University Pain Medicine Center
Somerset, New Jersey, 08773
Spine Team Texas
Southlake, Texas, 76092
Pain Care, LLC
Stockbridge, Georgia, 30281
Integrated Pain Management Medical Group, Inc.
Walnut Creek, California, 94598
GWU - Medical Faculty Associates, Inc.
Washington D.C., District of Columbia, 20037
About this study
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
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
Read the 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
- Being tested
- Totalis, Comparator Surgical Procedure
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TotalisDevice
Comparator Surgical ProcedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Totalis™ Direct Decompression Procedure | Active comparator | Totalis Receives: Device: Totalis |
| Comparator Procedure | Active comparator | Comparator Surgical Procedure Receives: Procedure: Comparator Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VertiFlex, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079038
- Sponsor's protocol ID
- 14-TDDS-01
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2014
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02079038
- Acronym / sponsor ID
- 14-TDDS-01
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VertiFlex, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 7 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totalis™ Direct Decompression Procedure | Active comparator | Device: TotalisTotalis |
| Comparator Procedure | Active comparator | Procedure: Comparator Surgical ProcedureComparator Surgical Procedure |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totalis | Device | Totalis™ Direct Decompression Procedure |
| Comparator Surgical Procedure | Procedure or surgery | Comparator Procedure |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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LUMBAR STENOSIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totalis and Comparator Surgical Procedure in people with Lumbar Spinal Stenosis, run by VertiFlex, Incorporated at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Clinically Significant Improvement in Outcomes (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.