Wallis Clinical Trial

Who May be a Candidate

The Wallis study is intended for people with mild to moderate degenerative disc disease (DDD) in the lumbar spine. Your doctor can help determine if your back pain is a result of mild to moderate DDD. The cost of the Wallis or disc replacement procedure will be covered by the study sponsor.

Product Being Studied

The Wallis device is a spinal implant that is surgically inserted between the bones in your back (called vertebrae). The device is designed to relieve low back pain caused by degeneration or damage to a disc in your spine. Disc degeneration can change the normal movement and overall strength of the spine. Additionally, a degenerated disc may lose its ability to act as a shock absorber, which is important for day-to-day, pain-free living. Unlike fusion surgeries, the Wallis device is designed to stabilize your spine without joining or “fusing” vertebrae.

Wallis System (interspinous process implant)

Currently, the Wallis device is not available in the U.S. except for patients who participate in a clinical trial. A clinical trial helps determine if a device or pharmaceutical product is safe and effective. The Food and Drug Administration oversees these trials and an Institutional Review Board (IRB) reviews the study from beginning to end. The IRB works to maintain the rights, safety and welfare of the patients involved in the trial.

If you are eligible and choose to participate in the trial, you will be randomly selected to receive the Wallis device or an artificial disc. Both treatments will be paid for by the study sponsor.

Clinical Trial Sponsor

This clinical trial is sponsored by Abbott Spine, the company responsible for developing the Wallis device.

Official Website: www.wallisdevice.com

E-mail: jose.naveira@abbottspine.com

Purpose and Objective

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.

Potential Benefits

• May relieve pain without requiring spinal fusion
• Surgery is relatively conservative when compared to other surgical choices like fusion or disc replacement
• The procedure does not prevent another procedure (e.g. fusion or disc replacement) if problems persist

Potential Risks

• May not rid patient of back pain
• Patient may have instability after surgery
• As with all surgeries, related complications may occur

Recruiting Locations (United States)

Eligibility, Inclusion and Exclusion Criteria

Men and women ages 40- to 80-years who meet the following criteria are eligible to participate in this clinical trial.

E-mail: jose.naveira@abbottspine.com

ClinicalTrials.gov Identifier: NCT00484458

Study ID Numbers: 6000-1006-P1-R1

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Office Title: A Prospective, Mult-Center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine

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