The STEPS - Totalis™ Trial
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| ClinicalTrials.gov Identifier: NCT02079038 |
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Recruitment Status :
Completed
First Posted : March 5, 2014
Results First Posted : August 7, 2020
Last Update Posted : August 7, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lumbar Spinal Stenosis | Device: Totalis Procedure: Comparator Surgical Procedure | Not Applicable |
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 : | 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Totalis™ Direct Decompression Procedure
Totalis
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Device: Totalis |
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Active Comparator: Comparator Procedure
Comparator Surgical Procedure
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Procedure: Comparator Surgical Procedure |
- 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
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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
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 ClinicalTrials.gov identifier (NCT number): NCT02079038
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| Responsible Party: | VertiFlex, Incorporated |
| ClinicalTrials.gov 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 |
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Spinal Stenosis Constriction, Pathologic Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |