Low Back Pain Clinical Trial
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
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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