中国组织工程研究

中国组织工程研究 ›› 2022, Vol. 26 ›› Issue (6): 908-913.doi: 10.12307/2022.175

• 脊柱植入物Spinal implants • 上一篇    下一篇

Isobar EVO非融合动态固定治疗腰椎融合术后邻椎病的中期疗效

宋佳伟，杨永栋，俞  兴，杨济洲，王逢贤，曲  弋，毕连涌   

  1. 北京中医药大学东直门医院骨科，北京市   100700
  • 收稿日期:2021-04-30 修回日期:2021-05-11 接受日期:2021-06-15 出版日期:2022-02-28 发布日期:2021-12-07
  • 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:宋佳伟，男，1994年生，陕西省西安市人，北京中医药大学第一临床医学院在读硕士，主要从事脊柱脊髓疾病的临床和基础研究。 杨永栋，男，1988年生，青海省西宁市人，蒙古族，博士，副研究员，主要从事脊柱脊髓疾病的临床和基础研究。
  • 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

Mid-term effect of Isobar EVO non-fusion dynamic fixation in the treatment of adjacent segment disease after lumbar fusion

Song Jiawei, Yang Yongdong, Yu Xing, Yang Jizhou, Wang Fengxian, Qu Yi, Bi Lianyong   

  1. Department of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2021-04-30 Revised:2021-05-11 Accepted:2021-06-15 Online:2022-02-28 Published:2021-12-07
  • Contact: Yu Xing, Doctoral supervisor, Chief physician, Professor, Department of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • About author:Song Jiawei, Master candidate, Department of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China Yang Yongdong, MD, Associate researcher, Department of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China Song Jiawei and Yang Yongdong contributed equally to this article.
  • Supported by:
    the Weifang Aojing Biomimetic Bone Multi-center Clinical Research Project (to YX)

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摘要：

文题释义：
Isobar EVO：Isobar EVO半刚性杆系统是法国Scient’x公司第二代半刚性的固定系统，与前一代Isobar TTL相比，微动关节轮廓减小25%，前屈角度增加50%，且明显增加了动态固定节段的活动度，使其更接近腰椎正常的活动度和生物力学特点，以更有效地保护邻近节段，减少应力遮挡，降低螺钉松动与断裂的风险，保护植入物。
Topping-off：“Topping-off”技术是一种新的概念，将坚强的固定融合和动态固定装置组合固定治疗，防止或减缓邻近腰椎节段的退变。该技术既能够坚强固定需要融合的节段使椎体间融合顺利进行，又可以通过卸载相邻间盘内压力、允许其有接近正常的运动范围，提供对相邻节段的支持和保护，创造一个良好的环境，从而避免或减缓融合后邻近节段的退变。

背景：腰椎融合术后邻椎病的治疗是脊柱外科的研究热点，传统延长融合节段的手术有可能加速邻椎病的再次出现。以椎弓根螺钉为基础的非融合技术在治疗腰椎退行性疾病和预防邻近节段退变中表现出良好的中短期疗效，但采用非融合技术治疗腰椎融合术后邻椎病的临床疗效亟待研究。
目的：评估Isobar EVO非融合动态固定治疗腰椎融合术后邻椎病的效果。
方法：选择2013年7月至2017年12月于东直门医院因保守治疗无效后再次手术的邻椎病患者，纳入了其中15例接受Isobar EVO 原位非融合动态稳定治疗的患者，并回顾了病历、手术报告和X射线成像研究。比较手术前后的临床结果(包括腰痛和下肢痛目测类比评分、腰椎功能障碍指数、SF-36量表生理健康评分)和影像学测量指标(包括手术节段及上位邻近节段活动度、手术节段前凸角和腰椎前凸角、手术节段及上位邻近节段平均间隙高度指数)。
结果与结论：15例患者完成了至少3年的随访。①临床结果：末次随访时各项评分较术前有显著改善(P < 0.05)，但随访各时段之间比较无显著差异(P > 0.05)。②影像学测量指标：末次随访时，手术节段活动度较术前明显减少[(3.16±0.45)° vs. (6.32±1.81)°，P < 0.05]，上位邻近节段活动度较术前明显增加[(5.51±1.22)° vs.  (4.87±1.47 )°，P < 0.05]，腰椎前凸角较术前明显增加[(30.95±8.96)°vs. (27.12±9.67)°，P < 0.05 ]，手术节段前凸角较术前明显增加[(11.32±4.86)° vs.  (10.14±6.44)°，P < 0.05]，手术节段平均间隙高度指数较术前明显增大(33.23±3.83 vs. 32.79±4.06，P < 0.05)，但上位邻近节段平均间隙高度指数较术前差异无统计学意义(P > 0.05)；以上指标在术后随访各时段之间相比差异均无统计学意义(P > 0.05)。所有病例在随访周期内未见内置物松动，未再次发生邻椎病。③结论：Isobar EVO 非融合动态固定是治疗邻椎病的有效方式，临床效果明显。术后3年以上随访结果显示该术式可在一定程度上预防再手术后邻椎病的发生，长期效果有待于进一步随访的结果和更高级别循证医学证据的支持。

https://orcid.org/0000-0001-7559-7321 (宋佳伟)

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: 邻椎病, 翻修手术, 非融合手术, 动态稳定, Isobar EVO, 腰椎

Abstract: BACKGROUND: The treatment of adjacent spondylopathy after lumbar fusion is a research hotspot in spine surgery. Traditional surgery to extend the fusion segment may accelerate the reappearance of adjacent segment disease. The non-fusion pedicle screw system based on pedicle screws has shown excellent short- and mid-term results in the treatment of lumbar degenerative diseases and the prevention of adjacent segment degeneration. However, reports on the use of non-fusion technology to treat adjacent segment disease after lumbar fusion need to be studied urgently.  
OBJECTIVE: To assess the postoperative outcome of non-fusion dynamic stabilization in situ with the Isobar EVO System for adjacent segment disease.
METHODS:  Patients with adjacent segment disease who were re-operated at Dongzhimen Hospital from July 2013 to December 2017 due to ineffective conservative treatment were selected. Fifteen patients with adjacent segment disease who received Isobar EVO in situ non-fusion dynamic stabilization treatment were enrolled. Medical records, surgical reports, and X-ray imaging studies were reviewed. The following two groups of indicators were compared before and after operation: low back pain visual analogue scale score and lower limb pain visual analogue scale score, Oswestry Disability Index, SF-36 scale physical health score, range of motion of the operative segment, the motion of the upper adjacent segment, the lordotic angle of the operative segment and the angle of lumbar spine, the disc of height index at surgical segment, and the disc of height index at superior segment.  
RESULTS AND CONCLUSION: Fifteen patients completed at least 3 years of follow-up. (1) Clinical results: At the last follow-up, the scores were significantly improved compared with those before the operation (P < 0.05), but there was no significant difference between different periods of the follow-up (P > 0.05). (2) Imaging measurement: At the last follow-up, mean range of motion of the segment was significantly reduced compared with that before the operation [(3.16±0.45)° vs. (6.32±1.81)°, P < 0.05]; the average motion range of the superior segment was significantly increased compared with that before the operation [(5.51±1.22)° vs. (4.87±1.47)°, P < 0.05]. The lumbar lordosis angle was significantly increased compared with that before the operation [(30.95±8.96)°vs. (27.12±9.67)° , P < 0.05 ]; the lordosis angle of the operation segment was significantly increased than that before the operation [(11.32±4.86)° vs. (10.14±6.44)°, P < 0.05]. Disc of height index at surgical segment was significantly higher than that before the operation (33.23±3.83 vs. 32.79±4.06, P < 0.05). However, disc of height index at superior segment was not statistically different from preoperatively (P > 0.05). There was no statistically significant difference in above indexes between each period of follow-up after operation (P > 0.05). In all cases, there was no loosening of the internal body during the follow-up period, and no adjacent segment disease occurred again. (3) It is concluded that Isobar EVO non-fusion dynamic fixation is an effective way to treat adjacent segment disease, and the clinical effect is obvious. The follow-up results for more than 3 years after surgery show that this operation can prevent the occurrence of adjacent segment disease after reoperation to a certain extent. The long-term effect needs to be supported by the results of further follow-up and higher-level evidence-based medicine.

Key words: adjacent segment disease, reoperation, non-fusion, dynamic stabilization, Isobar EVO, lumbar vertebrae

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