Wallis Stabilization System for Low Back Pain

October 3, 2011 updated by: Zimmer Spine

A Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine

The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.

This study will assess the safety and efficacy of the Wallis® System compared to commercially available lumbar TDR with respect to individual subject success rates at 24 months postoperative follow-up.

Study participants will receive all study related test articles and surgical procedures at no charge. Please scroll down to the "Locations" section to find a doctor in your area that is participating in this study. If you are interested in participating in this study and do not see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Phase 3

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
    • California
      • Beverly Hills, California, United States, 90212
        • Spine Source
      • Encinitas, California, United States, 92024
        • CORE Orthopaedic Medical Center
    • Colorado
      • Boulder, Colorado, United States, 80504
        • Boulder Neurosurgical Associates
      • Greenwood Village, Colorado, United States, 80111
        • Denver Spine
    • Illinois
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone & Joint Institute
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Orthopaedics
    • North Carolina
      • Charleston, North Carolina, United States, 29425
        • Medical University of South Carolina
      • Durham, North Carolina, United States, 27302
        • Triangle Orthopaedic Associates, P.A.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-60 (inclusive) and skeletally mature.
  • Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.
  • Minimum of six months of failed conservative treatment.
  • Pre-operative visual analog (VAS) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain.
  • Preoperative baseline Oswestry Disability Index (ODI) score of ≥ 40 on a 100 point scale.
  • Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
  • Voluntarily signs the patient informed consent form.
  • Patient is a surgical candidate for an anterior approach to the lumbar spine (< 3 abdominal surgeries).

Exclusion Criteria:

  • The investigator believes that the L1-L2, L2-L3, L3-L4, or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI, or discography.
  • Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.
  • Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score < -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.
  • Congenital lumbar spinal stenosis.
  • Bony lumbar stenosis.
  • Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40kg/m2).
  • A history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (IDET) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels.
  • Prior participation in study of any investigational spinal implant or investigational spinal treatment.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Wallis Stabilization System
Device: Interspinous process and dynamic stabilization (Wallis System)
Interspinous stabilization
Active Comparator: 2
Total Disc Replacement
Device: Total Disc Replacement
Total disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-inferior to commercially available lumber TDR after 24 months.
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

Zimmer Spine

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: John J. Regan, MD, Spine Source
  • Principal Investigator: Christopher Bergin, MD, Illinois Bone & Joint Institute

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

January 1, 2007

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 3, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6000-1006-P1-R1

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.

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