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

Abstract

IntroductionThere 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.

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up

“…21 The purpose of this study is to expand on results from the Mobi-C © Cervical Disc FDA IDE clinical trial with 7-year data. Previously reported 2- 13,22 , 4- 14,23 , and 5-year 24,25 follow-up results from this randomized clinical trial have shown equivalent or better performance of TDR compared to ACDF at both one and two levels of treatment. Here, we present 7-year results from the one and two level arms for a comprehensive, long-term evaluation of TDR with Mobi-C © .…”

“…13,15,24,25 The study protocol did not specify the indications for reoperation in either treatment group. The decision for subsequent surgical intervention was determined solely by the treating surgeon and the patient's personal decision to proceed.…”

Thirty-day readmission and reoperation rates after single-level anterior cervical discectomy and fusion versus those after cervical disc replacement

“…1,3,5,6,10,24 In the past decade, a growing interest in CDR as an alternative to ACDF in multiple long-term studies has revealed outcomes that are similar to or slightly better than those for ACDF. [11][12][13][14]16,17,19,20,23,25,31 However, there are limited data regarding 30-day readmission and reoperation rates among those who have undergone 1 of these 2 procedures; the main objective of this investigation was to obtain such data. In this study, we found that patients who underwent ACDF were more likely to be readmitted within 30 days than were patients who underwent CDR.…”

“…11-14, 16, 17, 19,20,23,31 Furthermore, rates of reoperation within 24-60 months have been found to be higher in patients who undergo ACDF, but according to a 7-year follow-up study by Gornet et al, 13 this rate decreases as time progresses. 16,17,23 However, there are limited data on the short-term outcome of ACDF versus CDR, particularly in terms of early reoperation and readmission rates. Thus, the purpose of this study was to compare 30-day readmission and reoperation rates between patients who underwent single-level ACDF and those who underwent CDR.…”

Editorial on “Long-term clinical outcomes of cervical disc arthroplasty: a prospective, randomized, controlled trial” by Sasso et al.

“…Some intermediate follow-up has also echoed similar benefits for CDA, while other studies have suggested convergence of clinical results, with maintained advantage in terms of range of motion and reoperation for CDA (7)(8)(9)(10)(11)(12). Indeed, larger registry studies, application of this technology outside of the U.S., and investigations of Worker's Compensation patients have made these conclusions even more generalizable (13)(14)(15).…”