中国组织工程研究

中国组织工程研究 ›› 2022, Vol. 26 ›› Issue (3): 397-402.doi: 10.12307/2022.065

• 脊柱植入物 spinal implant • 上一篇    下一篇

Mobi-C人工间盘联合ROI-C自稳性融合器与单纯ROI-C自稳性融合器治疗双节段颈椎病的中期疗效随访

张  琦，熊  洋，俞  兴，杨永栋，宋佳伟，仇子叶，马昱堃，姜国正，冯宁宁，王舒阳   

  1. 北京中医药大学东直门医院，北京市   100700
  • 收稿日期:2021-02-08 修回日期:2021-02-10 接受日期:2021-03-24 出版日期:2022-01-28 发布日期:2021-10-27
  • 通讯作者: 俞兴，博士生导师，主任医师，教授，北京中医药大学东直门医院骨科，北京市 100700
  • 作者简介:张琦，男，1997年生，宁夏回族自治区固原市人，北京中医药大学第一临床医院在读硕士，主要从事脊柱外科方面的研究。 熊洋，男，1988 年生，湖北省咸丰县人，北京中医药大学第一临床医院毕业，博士。
  • 基金资助:
    潍坊奥精仿生骨多中心临床研究项目，项目负责人：俞兴，项目名称：仿生矿化胶原人工骨在脊柱疾病及骨折治疗中的疗效观察

Mobi-C combined with ROI-C fusion cage versus ROI-C fusion cage alone for the treatment of two-level cervical spondylosis: midterm efficacy follow-up

Zhang Qi, Xiong Yang, Yu Xing, Yang Yongdong, Song Jiawei, Qiu Ziye, Ma Yukun, Jiang Guozheng, Feng Ningning, Wang Shuyang   

  1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2021-02-08 Revised:2021-02-10 Accepted:2021-03-24 Online:2022-01-28 Published:2021-10-27
  • Contact: Yu Xing, Doctoral supervisor, Chief physician, Professor, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • About author:Zhang Qi, Master candidate, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China Xiong Yang, MD, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China
  • Supported by:
    the Weifang Aojing Biomimetic Bone Multi-Center Clinical Research Project (to YX)

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摘要：

文题释义：
Mobi-C人工间盘：法国LDR公司产品，由上终板、下终板以及中间的内衬组成。其终板材料为锻造钴铬钼合金，外表面带有内(纯钛)、外(羟基磷灰石)两层涂层；内衬材料为超高分子量聚乙烯。其结构允许颈椎置换节段各向自如的可控制的运动，很好地保持了颈椎的生理曲度，减缓临近节段代偿性退变的速度。且其操作简单、手术安全性高。
ROI-C自稳性融合器：法国LDR公司产品，由1个聚醚醚酮材料的融合器及2枚弧形钛质楔片组成。此类融合器前高后低的形态，利于融合器与植骨床的充分结合，预弯嵌片两侧所特有的“倒刺”样自锁防退出装置可防止植入的融合器移动，可获取即刻稳定性，且吞咽困难发生率低，融合率高，创伤相对较小。

背景：早期有文献报道了部分人工间盘与融合假体联合的颈椎前路杂合手术(Hybrid手术)可获得满意的初中期临床结果，但对于不同的假体，其应用与临床疗效仍不清楚。
目的：比较Mobi-C人工间盘联合ROI-C椎间融合器与单纯ROI-C治疗双节段颈椎病的中期的临床疗效与影像学结果。
方法：选择至少完成4年有效随访的连续双节段病变颈椎病患者91例，均为2015年3月至2016年5月东直门医院骨伤三科收治，其中48例行颈椎前路Hybrid手术(Hybrid组)，43例行颈椎前路椎间盘切除减压融合术(ACDF组)。比较两组以下指标：临床结果包括术前、术后2周及末次随访时颈痛及上肢痛目测类比评分、改良的日本骨科协会评分、颈椎功能障碍指数及患者满意度；影像学测量包括术前、术后1个月及末次随访时C2-C7整体活动度、Mobi-C置入节段活动度、手术相邻上下节段活动度、手术节段曲度、ROI-C自稳性融合器置入节段融合率及下沉率。
结果与结论：①临床结果：末次随访时，两组的各项评分均较术前有显著改善(P < 0.05)，但两组间比较无显著差异(P > 0.05)；②影像学测量：末次随访时，Hybrid组的C2-C7整体活动度显著大于ACDF组[(40.84±15.19)° vs. (30.78±12.10)°，P < 0.05]；两组的手术节段曲度较术前均有所改善(P < 0.05)，但两组间无显著差异(P > 0.05)；相邻节段活动度两组间无显著差异(P > 0.05)；Hybrid组与ACDF组ROI-C自稳性融合器置入节段下沉率分别为26.09%和36.00%，两组间比较无显著差异(P > 0.05)。③结论：Mobi-C联合ROI-C治疗连续双节段颈椎病是一种安全有效的方法，其中期临床疗效不劣于前路椎间盘切除减压融合术，对于保留颈椎活动具备一定优势；骨吸收可能是ROI-C自稳性融合器植骨融合过程中早期的一个固有过程。

https://orcid.org/0000-0003-3127-7312 (张琦) 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 颈椎前路杂合手术, 颈椎前路椎间盘切除减压融合术, Mobi-C人工间盘, ROI-C自稳性融合器, 颈椎病, 双节段

Abstract: BACKGROUND: Previous studies have reported that anterior cervical hybrid surgery (Hybrid surgery) combined with partial artificial discs and fusion prostheses can obtain satisfactory early and mid-term clinical results, but for different prostheses, its application and clinical efficacy are still unclear.  
OBJECTIVE: To compare the clinical and radiological outcomes of treating two-level cervical spondylosis using Mobi-C combined with ROI-C in a hybrid surgery with anterior cervical discectomy and fusion and ROI-C alone.
METHODS:  Ninety-one patients with contiguous two-level cervical degenerative disc diseases, who were treated at Third Department of Orthopedics, Dongzhimen Hospital from March 2015 to May 2016 and received at least 4 years of effective follow-up, were included in this study. Among them, 48 cases underwent anterior cervical hybrid surgery as hybrid group; and 43 cases underwent anterior cervical discectomy and fusion as anterior cervical discectomy and fusion group. The following indicators were compared between the two groups. Clinical outcomes included visual analogue scales score for neck and upper limb pain, modified Japanese orthopaedic association, Neck disability index, patient satisfaction at preoperatively, 2 weeks postoperatively and the last follow-up. Radiological outcomes included C2-C7 range of motion, Mobi-C index level range of motion, range of motion at superior adjacent level, range of motion at inferior adjacent level, curvature of the operated levels, subsidence rate and fusion rate at ROI-C index levels preoperatively, 1 month postoperatively and the last follow-up.  
RESULTS AND CONCLUSION: (1) Clinical outcomes: At the last follow-up, scores of the two groups were significantly improved compared with preoperatively (P < 0.05), but the differences between groups were not significant (P > 0.05). (2) Radiological outcomes: At the last follow-up, the C2-C7 global range of motion in the hybrid group was significantly larger than that in the anterior cervical discectomy and fusion group [(40.84±15.19)° vs. (30.78±12.10)°, P < 0.05]. The curvature of the operated levels in both groups was improved significantly after surgery (P < 0.05), but there was no significant difference between the two groups (P > 0.05). There was no significant difference in range of motion of adjacent segments between the two groups (P > 0.05). The subsidence rates of ROI-C fusion were 26.09% and 36.00% in the hybrid group and anterior cervical discectomy and fusion group, respectively; and no significant difference was found between the two groups (P > 0.05). (3) It is indicated that Mobi-C combined with ROI-C is a safe and effective method for the treatment of contiguous double-level cervical spondylosis. It is not inferior to that of anterior cervical discectomy and fusion in the middle-stage clinical treatment, and it has certain advantages for retaining cervical movement. Bone resorption may be an integral component in the early stage of bony fusion in the ROI-C cage index level.

Key words: anterior cervical hybrid surgery, anterior cervical discectomy and fusion, Mobi-C artificial disc, ROI-C fusion cage, cervical spondylosis, double-level

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