Skip to:

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

Michael S. Hisey, MD,1 Jack E. Zigler, MD,2 Robert Jackson, MD,3 Pierce D. Nunley, MD,4 Hyun W. Bae, MD,5 Kee D. Kim, MD,6 Donna D. Ohnmeiss, Dr.Med.7

1Texas Back Institute, Denton, Texas, 2Texas Back Institute, Plano, Texas, 3Saddleback Memorial Medical Center, Laguna Hills, California, 4Spine Institute of Louisiana, Shreveport, Louisiana, 5Cedars Sinai Spine Center, Los Angeles, California, 6Department of Neurological Surgery, University of California, Davis, Sacramento, California, 7Texas Back Institute Research Foundation, Plano, Texas

Abstract

Introduction

There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up.

Methods

This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. 

Results

The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. 

Conclusions 

Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease.

Clinical Relevance

This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients.

Level of Evidence

This is a Level I study.

keywords: 
total disc replacement, Cervical Spine, anterior cervical fusion, degenerative disc disease, Mobi-C® Cervical Disc Prosthesis, cervical arthroplasty, artificial disc, randomized trial, clinical outcome
Volume 10 Article 10
doi: 
10.14444/3010