The STEPS - Totalis™ Trial

Completed · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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

Key facts

Study ID

NCT02079038

Run by

VertiFlex, Incorporated

People needed

180

Starts

2014-05-01

Expected to finish

2017-01-01

Last updated by the study team

2020-08-07

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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