Investigating Superion™ In Spinal Stenosis

November 12, 2020 updated by: Boston Scientific Corporation

A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.

Study Type

Interventional

Enrollment (Actual)

391

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Arizona Center for Neurosurgery
      • Tucson, Arizona, United States, 85712
        • Tucson Orthopaedic Institute
    • California
      • Beverly Hills, California, United States, 90211
        • D.I.S.C. Sports and Spine Center
      • Beverly Hills, California, United States, 90211
        • Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
      • Laguna Hills, California, United States, 92653-3665
        • Orange County Neurosurgical Associates
      • Los Angeles, California, United States, 90027
        • Brain and Spine Research Institute
      • Oceanside, California, United States, 92056
        • Pacific Pain Medicine Consultants/Pacific Surgery Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
      • Durango, Colorado, United States, 81301
        • Durango Orthopedic Associates, P.C./Spine Colorado
      • Littleton, Colorado, United States, 80122
        • Colorado Spine And Scoliosis Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington Universtiy Medical Facility
    • Florida
      • DeLand, Florida, United States, 32720
        • Florida Research Associates, LLC
      • Fort Lauderdale, Florida, United States, 33316
        • Shrock Orthopedic Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Neurosurgical Associates at GBMA
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Sports Medicine North
    • Minnesota
      • Minneapolis, Minnesota, United States, 55425
        • Institute for Low Back and Neck Care
    • New Jersey
      • Phillipsburg, New Jersey, United States, 08865
        • Orthopedics Associates of the Greater Lehigh Valley
      • Roseland, New Jersey, United States, 07068
        • Spine Care and Rehabilitation, Inc.
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center, Dept. of Neurological Surgery
      • Syracuse, New York, United States, 13202
        • Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates
    • Oregon
      • Eugene, Oregon, United States, 97401
        • NeuroSpine Institute, LLC
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19464
        • Performance Spine and Sports Physicians
      • Willow Grove, Pennsylvania, United States, 19090
        • OrthopaediCare (Abington Orthopaedic Specialists)
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Brain & Spine Center
    • Texas
      • Plano, Texas, United States, 75093
        • Texas Back Institute
    • Washington
      • Seattle, Washington, United States, 98104
        • Orthopedics International Spine
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • The Center for Pain Relief, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects ≥ 45 years of age
  • Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
  • Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
  • Must be able to sit for 50 minutes without pain and to walk 50 feet or more

Exclusion Criteria:

  • Axial back pain only
  • Fixed motor deficit
  • Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
  • Unremitting pain in any spinal position
  • Significant peripheral neuropathy or acute denervation secondary to radiculopathy
  • Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
  • Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
  • Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
  • Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
  • Spondylolysis (pars fracture)
  • Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
  • Insulin-dependent diabetes mellitus
  • Prior surgery of the lumbar spine
  • Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
  • Infection in the disc or spine, past or present
  • Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
  • Tumor in the spine or a malignant tumor except for basal cell carcinoma
  • Involved in pending litigation of the spine or worker's compensation related to the back

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Interspinous Process Spacer Device
Device: Superion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
ACTIVE_COMPARATOR: 2
Interspinous Process Spacer Device
Device: X-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Time Frame: Baseline and 24 months

Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following:

  • At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains]

    • Improvement in physical function by ≥0.5 points
    • Improvement in symptom severity by ≥0.5 points
    • "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain
  • No re-operations, revisions, removals or supplemental fixation at the index level(s)

  • No major implant- or procedure-related complications:

    • No dislodgement, migration, or deformation
    • No new or persistent worsened neurological deficit at the index level
    • No spinous process fractures
    • No deep infection, death, or other permanent device attributed disability

  • No clinically significant confounding treatments:

    • No epidural injections or nerve block proc
Baseline and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Collaborators

VertiFlex, Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (ESTIMATE)

June 6, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-VISS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intermittent Claudication

Clinical Trials on Superion™ Interspinous Spacer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe