The STEPS - Totalis™ Trial

Lumbar Spinal Stenosis Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079038
• Other study ID #: 14-TDDS-01
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2020
• Source: VertiFlex, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Totalis

Procedure:
• Comparator Surgical Procedure

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Medhat Mikhael, M.D. Inc.	Fountain Valley	California
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Pain Management Associates	Independence	Missouri
United States	Florida Pain Institute	Merritt Island	Florida
United States	American Health Network	Muncie	Indiana
United States	SC Pain & Spine Specialists	Murrells Inlet	South Carolina
United States	Oklahoma Pain Physicians	Oklahoma City	Oklahoma
United States	Hope Research Institute	Phoenix	Arizona
United States	Performance Spine and Sports Physicians, PC	Pottstown	Pennsylvania
United States	Virginia iSpine Physicians PC	Richmond	Virginia
United States	Orthopedic Pain Specialists	Santa Monica	California
United States	Arizona Pain Specialists	Scottsdale	Arizona
United States	University Pain Medicine Center	Somerset	New Jersey
United States	Spine Team Texas	Southlake	Texas
United States	Pain Care, LLC	Stockbridge	Georgia
United States	Integrated Pain Management Medical Group, Inc.	Walnut Creek	California
United States	GWU - Medical Faculty Associates, Inc.	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VertiFlex, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 6 Months