Clinical trial NCT02079038: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lead sponsor: VertiFlex, Incorporated
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 180
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Subjects With Clinically Significant Improvement in Outcomes
timeFrame: Baseline and 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pain Specialists
state: Arizona
city: Fountain Valley
country: United States
facility: Medhat Mikhael, M.D. Inc.
state: California
city: Santa Monica
country: United States
facility: Orthopedic Pain Specialists
state: California
city: Walnut Creek
country: United States
facility: Integrated Pain Management Medical Group, Inc.
state: California
city: Washington
country: United States
facility: GWU - Medical Faculty Associates, Inc.
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Stockbridge
country: United States
facility: Pain Care, LLC
state: Georgia
city: Muncie
country: United States
facility: American Health Network
state: Indiana
city: Independence
country: United States
facility: Pain Management Associates
state: Missouri
city: Somerset
country: United States
facility: University Pain Medicine Center
state: New Jersey
city: Oklahoma City
country: United States
facility: Oklahoma Pain Physicians
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Pottstown
country: United States
facility: Performance Spine and Sports Physicians, PC
state: Pennsylvania
city: Murrells Inlet
country: United States
facility: SC Pain & Spine Specialists
state: South Carolina
city: Southlake
country: United States
facility: Spine Team Texas
state: Texas
city: Richmond
country: United States
facility: Virginia iSpine Physicians PC
state: Virginia
Study officials:
References: