单节段Mobi-C颈椎全椎间盘置换术与颈椎前路椎间盘切除融合术的前瞻性随机对照研究：5年随访结果

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

作者信息

Hisey Michael S, Zigler Jack E, Jackson Robert, Nunley Pierce D, Bae Hyun W, Kim Kee D, Ohnmeiss Donna D

机构信息

Texas Back Institute, Denton, Texas.

Texas Back Institute, Plano, Texas.

出版信息

Int J Spine Surg. 2016 Feb 26;10:10. doi: 10.14444/3010. eCollection 2016.

DOI:10.14444/3010

PMID:27162712

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4852596/

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.

摘要

引言

颈椎全椎间盘置换术（TDR）作为颈椎前路椎间盘切除融合术（ACDF）的替代方法，其作用正受到越来越多的关注。多项至少随访2年的前瞻性随机研究表明，在治疗单节段有症状的退行性椎间盘疾病时，TDR至少与ACDF一样安全有效。本研究的目的是比较使用Mobi-C®进行颈椎TDR与ACDF在5年随访时的结果。

方法

本前瞻性、随机、对照试验作为一项食品药品监督管理局监管的研究性器械豁免试验，在23个中心进行，245例患者随机分组（2:1），分别接受使用Mobi-C®颈椎间盘假体的TDR或使用前路钢板和同种异体骨的ACDF。结果评估包括综合总体成功评分、颈部功能障碍指数（NDI）、评估颈部和手臂疼痛的视觉模拟量表（VAS）、简短健康调查12项量表（SF-12）、患者满意度、主要并发症、后续手术、节段活动度以及相邻节段退变。

结果

TDR组60个月的随访率为85.5%，ACDF组为78.9%。TDR组的综合总体成功率为61.9%，ACDF组为52.2%，显示出统计学上的非劣效性。两组之间NDI、VAS颈部和手臂疼痛评分以及SF-12评分的改善相似，且从早期随访到60个月一直保持。TDR和ACDF在不良事件或主要并发症方面无显著差异。TDR在60个月内维持了活动度。TDR患者与器械相关的后续手术（TDR：3.0%，ACDF：11.1%，p<0.02）以及上位相邻节段退变（TDR：37.1%，ACDF：54.7%，p<0.03）明显更低。