Multi-center, Prospective, Randomized, Controlled Investigational Device Exemption Clinical Trial Comparing Mobi-C Cervical Artificial Disc to Anterior Discectomy and Fusion in the Treatment of Symptomatic Degenerative Disc Disease in the Cervical Spine

Abstract

BackgroundAnterior cervical discectomy and fusion (ACDF) is the gold standard for treating symptomatic cervical disc degeneration. Cervical total disc replacements (TDRs) have emerged as an alternative for some patients. The purpose of this study was to evaluate the safety and effectiveness of a new TDR device compared with ACDF for treating single-level cervical disc degeneration.MethodsThis was a prospective, randomized, controlled, multicenter Food and Drug Administration (FDA) regulated Investigational Device Exemption (IDE) study. A total of 245 patients were treated (164 TDR: 81 ACDF). The primary outcome measure was overall success based on improvement in Neck Disability Index (NDI), no subsequent surgical interventions, and no adverse events (AEs) classified as major complications.Secondary outcome measures included SF-12, visual analog scale (VAS) assessing neck and arm pain, patient satisfaction, radiographic range of motion, and adjacent level degeneration. Patients were evaluated preoperatively and postoperatively at 6 weeks, 3, 6, 12, 18, and 24 months. The hypothesis was that the TDR success rate was non-inferior to ACDF at 24 months.ResultsOverall success rates were 73.6% for TDR and 65.3% for ACDF, confirming non-inferiority (p < 0.0025). TDR demonstrated earlier improvements with significant differences in NDI scores at 6 weeks and 3 months, and VAS neck pain and SF-12 PCS scores at 6 weeks (p<0.05). Operative level range of motion in the TDR group was maintained throughout follow-up. Radiographic evidence of inferior adjacent segment degeneration was significantly greater with ACDF at 12 and 24 months (p < 0.05). AE rates were similar.ConclusionsMobi-C TDR is a safe and effective treatment for single-level disc degeneration, producing outcomes similar to ACDF with less adjacent segment degeneration. Level of Evidence: Level I.Clinical relevance: This study adds to the literature supporting cervical TDR as a viable option to ACDF in appropriately selected patients with disc degeneration.

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 © .…”

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

“…The study design, including patient selection criteria, randomization and surgical procedures, has previously been published in detail. 5 …”

“…[1][2][3][4][5][6][7][8] These studies have consistently found TDR to produce outcomes similar or superior to ACDF. There are a few studies with extended follow-up to five or more years.…”

“…1,5 However, some authors have reported no significant difference in ASD. 16 More randomized studies with long-term follow-up should be helpful in further evaluating cervical TDR.…”

Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up

“…7,18 The patient population included a total of 260 1-level and 339 2-level subjects randomized (2:1) to receive either TDR or ACDF treatment at 1 of 24 investigational sites. These 1-and 2-level results include 5 years of patient follow-up data.…”