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Wallis Stabilization System for Low Back Pain

NCT00484458 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2011-10-04

No results posted yet for this study

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 [email protected]

Conditions

  • Low Back Pain

Interventions

DEVICE

Interspinous process and dynamic stabilization (Wallis System)

Interspinous stabilization

DEVICE

Total Disc Replacement

Total disc

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Zimmer Spine

    lead INDUSTRY

Principal Investigators

  • John J. Regan, MD · Spine Source

  • Christopher Bergin, MD · Illinois Bone & Joint Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484458 on ClinicalTrials.gov