Wallis Stabilization System for Low Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Zimmer Spine
ClinicalTrials.gov Identifier:
NCT00484458
First received: June 7, 2007
Last updated: October 3, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Low Back Pain
Device: Interspinous process and dynamic stabilization (Wallis System)
Device: Total Disc Replacement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zimmer Spine:

Primary Outcome Measures:
  • Non-inferior to commercially available lumber TDR after 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 340
Study Start Date: January 2007
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484458

Locations
United States, California
Spine Source
Beverly Hills, California, United States, 90212
Core Orthopaedic Medical Center
Encinitas, California, United States, 92024
United States, Colorado
Boulder Neurosurgical Associates
Boulder, Colorado, United States, 80504
Denver Spine
Greenwood Village, Colorado, United States, 80111
United States, Illinois
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Indiana
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States, 46804
United States, North Carolina
Medical University of South Carolina
Charleston, North Carolina, United States, 29425
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, United States, 27302
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Utah
University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
Zimmer Spine
Zimmer, Inc.
Investigators
Principal Investigator: John J. Regan, MD Spine Source
Principal Investigator: Christopher Bergin, MD Illinois Bone & Joint Institute
  More Information

No publications provided

Responsible Party: Zimmer Spine
ClinicalTrials.gov Identifier: NCT00484458     History of Changes
Other Study ID Numbers: 6000-1006-P1-R1
Study First Received: June 7, 2007
Last Updated: October 3, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Zimmer Spine:
Degenerative Disc Disease
Total Disc Replacement

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Low Back Pain
Bone Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Spinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014