← Back to Search

Total Disc Replacement

1 for Lower Back Pain

Phase 3
Waitlist Available
Led By John J. Regan, MD
Research Sponsored by Zimmer Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.
Minimum of six months of failed conservative treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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 jose.naveira@abbottspine.com

Eligible Conditions
  • Lower Back Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-inferior to commercially available lumber TDR after 24 months.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
Wallis Stabilization System
Group II: 2Active Control1 Intervention
Total Disc Replacement

Find a Location

Who is running the clinical trial?

Zimmer SpineLead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
Zimmer BiometIndustry Sponsor
373 Previous Clinical Trials
67,093 Total Patients Enrolled
John J. Regan, MDPrincipal InvestigatorSpine Source

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~19 spots leftby Mar 2025