The Scoliosis Research Society 22nd International Meeting on Advanced Spine Techniques

Friday, July 10, 2015 | Kuala Lumpur, Malaysia

At this leading and prestigious scientific meeting on spinal surgery, Dr. McConnell presented the results of a clinical study involving the Prestige-LP cervical disc arthroplasty device. The FDA investigational device exemption (IDE) clinical trial compared the Prestige-LP total disc device to replace two consecutive discs in the neck versus the traditional surgery of two level disc fusion. At 24 months follow-up, patients who received the Prestige-LP two level artificial disc replacement achieved superior overall clinical results when compared to the fusion patients.

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Two-level Total Disc Replacement with PRESTIGE LP Cervical Disc vs Anterior Discectomy and Fusion: A Prospective, Randomized, Controlled Multicenter Clinical Trial with 24 Month Results

Jeffrey McConnell, Randall Dryer, Todd Lanman, Matthew Gornet, Scott D. Hodges

OAA Orthopaedic Specialists, Central Texas Spine Institute, Cedars-Sinal Medical Center, The Orthopedic Center of St. Louis, Center for Sports Medicine & Orthopaedics

Summary

Cervical anthroplasty at two contiguous levels using the PRESTIGE LP disc showed superior results to 2-level ACDF based on overall success criteria and NDI success.

Hypothesis

If the overall success rate for investigational cervical total disc replacement (TDR) is statistically non-inferior to the control ACDF at 2 years, TDR will be considered safe and effective.

Design

Prospective, randomized, controlled multicenter FDA IDE clinical trial.

Introduction

Cervical TDR is intended to treat symptomatic cervical disc disease (SCDD) while preserving motion. ACDF has been the standard treatment, but at the expense of lost motion. Few studies have focused on the safety and efficacy of cervical TDR at 2 levels. The primary objective of this study was to compare outcomes using PRESTIGE LP or ACDF for treatment of SCDD at 2 contiguous cervical levels.

Methods

An FDA IDE trial of the PRESTIGE LP disc was conducted at 30 centers in the US. 397 patients with 2-level SCDD from C3-C7 were randomized and treated with cervical TDR (n=209) or the control treatment, ACDF (n=188). Overall clinical success was defined as improvement in NDI ≥ 15 points, maintenance or improvement of neurological status, no implant or surgical related adverse events (AE), and no additional surgical procedures at the index level. NDI, numerical pain scales for neck and arm pain, SF36, radiographic outcomes and patient satisfaction were used to analyze clinical effectiveness.

Results

At 24 mos. both groups showed significant improvement vs baseline NDI, neck and arm pain, neurologic success and SF36 scores. TDR patients demonstrated statistical superiority over ACDF patients based on overall success (81.4% vs 69.4%, posterior probability of superiority (PPS) = 99.3%) and NDI success (87.9% vs 79.2%, pps = 99.0%). Adverse event rates were lower for TDR vs ACDF (15.8% vs 20.7%). Subsequent index level surgeries were significantly lower for TDR ACDF (2.4% vs 8.0%). Range of motion in the TDR group averaged 6.92° and 6.85° at superior and inferior levels respectively. Overall patient satisfaction was higher for TDR (94.5%) vs ACDF (89.3%).

Conclusion