Wallis Stabilization System for Low Back Pain

NCT00484458 | Unknown Phase 3 DMC

• 1 other identifier: 6000-1006-P1-R1
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 11

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

Conditions

Low Back Pain

Keywords

Degenerative Disc Disease; Total Disc Replacement

Outcome Measures

Primary Outcomes (1)

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

  24 months

Study Arms (2)

1

EXPERIMENTAL

Wallis Stabilization System

Device: Interspinous process and dynamic stabilization (Wallis System)

2

ACTIVE COMPARATOR

Total Disc Replacement

Device: Total Disc Replacement

Interventions

Interspinous process and dynamic stabilization (Wallis System) DEVICE

Interspinous stabilization

1

Total Disc Replacement DEVICE

Total disc

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Spine: lead
• Zimmer Biomet: collaborator

Study Sites (11)

Spine Source

Beverly Hills, California, 90212, United States

Location

Core Orthopaedic Medical Center

Encinitas, California, 92024, United States

Location

Boulder Neurosurgical Associates

Boulder, Colorado, 80504, United States

Location

Denver Spine

Greenwood Village, Colorado, 80111, United States

Location

Illinois Bone & Joint Institute

Morton Grove, Illinois, 60053, United States

Location

Fort Wayne Orthopaedics

Fort Wayne, Indiana, 46804, United States

Location

Medical University of South Carolina

Charleston, North Carolina, 29425, United States

Location

Triangle Orthopaedic Associates, P.A.

Durham, North Carolina, 27302, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery

Salt Lake City, Utah, 84132, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• John J. Regan, MD

  Spine Source

  PRINCIPAL INVESTIGATOR

• Christopher Bergin, MD

  Illinois Bone & Joint Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 11, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

US (11)