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Wallis Stabilization System for Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Interspinous process and dynamic stabilization (Wallis System)
Total Disc Replacement
Sponsored by
Zimmer Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Degenerative Disc Disease, Total Disc Replacement

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Spine Source
  • Core Orthopaedic Medical Center
  • Boulder Neurosurgical Associates
  • Denver Spine
  • Illinois Bone & Joint Institute
  • Fort Wayne Orthopaedics
  • Medical University of South Carolina
  • Triangle Orthopaedic Associates, P.A.
  • Lehigh Valley Hospital
  • University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
  • Aurora BayCare Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Wallis Stabilization System

Total Disc Replacement

Outcomes

Primary Outcome Measures

Non-inferior to commercially available lumber TDR after 24 months.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2007
Last Updated
October 3, 2011
Sponsor
Zimmer Spine
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00484458
Brief Title
Wallis Stabilization System for Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Spine
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Degenerative Disc Disease, Total Disc Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Wallis Stabilization System
Arm Title
2
Arm Type
Active Comparator
Arm Description
Total Disc Replacement
Intervention Type
Device
Intervention Name(s)
Interspinous process and dynamic stabilization (Wallis System)
Intervention Description
Interspinous stabilization
Intervention Type
Device
Intervention Name(s)
Total Disc Replacement
Intervention Description
Total disc
Primary Outcome Measure Information:
Title
Non-inferior to commercially available lumber TDR after 24 months.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J. Regan, MD
Organizational Affiliation
Spine Source
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Bergin, MD
Organizational Affiliation
Illinois Bone & Joint Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spine Source
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Core Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Boulder Neurosurgical Associates
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80504
Country
United States
Facility Name
Denver Spine
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Illinois Bone & Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Fort Wayne Orthopaedics
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Triangle Orthopaedic Associates, P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27302
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States

12. IPD Sharing Statement

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Wallis Stabilization System for Low Back Pain

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