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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Interspinous stabilization
Total disc
Spine Source
Beverly Hills, California, United States
Core Orthopaedic Medical Center
Encinitas, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
Denver Spine
Greenwood Village, Colorado, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States
Medical University of South Carolina
Charleston, North Carolina, United States
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
Salt Lake City, Utah, United States
...and 1 more locations
Non-inferior to commercially available lumber TDR after 24 months.
Time frame: 24 months
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