The STEPS - Totalis™ Trial

NCT02079038 | Completed Results

• 1 other identifier: 14-TDDS-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 19

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

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Totalis™ Direct Decompression Procedure

ACTIVE COMPARATOR

Totalis

Device: Totalis

Comparator Procedure

ACTIVE COMPARATOR

Comparator Surgical Procedure

Procedure: Comparator Surgical Procedure

Interventions

Totalis DEVICE

Totalis™ Direct Decompression Procedure

Comparator Surgical Procedure PROCEDURE

Comparator Procedure

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VertiFlex, Incorporated: lead

Study Sites (19)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

Arizona Pain Specialists

Scottsdale, Arizona, 85260, United States

Location

Medhat Mikhael, M.D. Inc.

Fountain Valley, California, 92708, United States

Location

Orthopedic Pain Specialists

Santa Monica, California, 90403, United States

Location

Integrated Pain Management Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

GWU - Medical Faculty Associates, Inc.

Washington D.C., District of Columbia, 20037, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33334, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

Pain Care, LLC

Stockbridge, Georgia, 30281, United States

Location

American Health Network

Muncie, Indiana, 47304, United States

Location

Pain Management Associates

Independence, Missouri, 64055, United States

Location

University Pain Medicine Center

Somerset, New Jersey, 08773, United States

Location

Oklahoma Pain Physicians

Oklahoma City, Oklahoma, 73120, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Performance Spine and Sports Physicians, PC

Pottstown, Pennsylvania, 19464, United States

Location

SC Pain & Spine Specialists

Murrells Inlet, South Carolina, 29576, United States

Location

Spine Team Texas

Southlake, Texas, 76092, United States

Location

Virginia iSpine Physicians PC

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Steve Reitzler
• Organization: Vertiflex

Stephen.reitzler2@bsci.com

442-325-5934

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 5, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 7, 2020
• Results First Posted: August 7, 2020

Record last verified: 2020-07

Locations

US (19)