中国组织工程研究 ›› 2023, Vol. 27 ›› Issue (9): 1434-1440.doi: 10.12307/2023.263

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    下一篇

3D打印多孔钛合金椎间融合器在颈椎前路椎间盘切除植骨融合中应用效果与安全性的Meta分析

王彦金1,2,周英杰2,柴旭斌2,禚汉杰2   

  1. 1河南中医药大学,河南省郑州市   450046;2河南省洛阳正骨医院(河南省骨科医院),河南省洛阳市   471002
  • 收稿日期:2022-03-24 接受日期:2022-05-13 出版日期:2023-03-28 发布日期:2022-07-02
  • 通讯作者: 周英杰,硕士研究生导师,主任医师,河南省洛阳正骨医院(河南省骨科医院),河南省洛阳市 471002
  • 作者简介:王彦金,男,1997年生,河南省南阳市人,蒙古族,河南中医药大学在读硕士,主要从事中医药防治脊柱相关疾病的研究。
  • 基金资助:
    河南省科技攻关计划项目(182102310678),项目负责人:周英杰

Meta-analysis of the efficacy and safety of 3D printed porous titanium alloy fusion cage in anterior cervical discectomy and fusion

Wang Yanjin1,2, Zhou Yingjie2, Chai Xubin2, Zhuo Hanjie2   

  1. 1Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; 2Luoyang Orthopedic Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Luoyang 471002, Henan Province, China
  • Received:2022-03-24 Accepted:2022-05-13 Online:2023-03-28 Published:2022-07-02
  • Contact: Zhou Yingjie, Master’s supervisor, Chief physician, Luoyang Orthopedic Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Luoyang 471002, Henan Province, China
  • About author:Wang Yanjin, Master candidate, Henan University of Chinese Medicine, Zhengzhou 450046, Henan Province, China; Luoyang Orthopedic Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Luoyang 471002, Henan Province, China
  • Supported by:
    Key Science and Technology Project of Henan Province, No. 182102310678 (to ZYJ)

摘要:

文题释义:
3D打印椎间融合器:通过全椎体的CT螺旋扫描、三维成像建模,以钛合金为原材料采用电子熔炉技术在真空环境中打印出形态更加符合患者解剖的植入物。在具有良好生物相容性的同时,多孔结构能够有效避免应力遮挡效应,进而促进骨整合。
C2-7Cobb角:颈椎第2椎体上终板与第7椎体下终板垂线之间的夹角。

目的:系统评价3D打印椎间融合器在颈椎前路椎间盘切除植骨融合术中的临床疗效与安全性。
方法:通过检索PubMed、Embase、The Cochrane Library、CBM、CNKI、万方和维普数据库,收集各数据库建库至2022年4月有关颈椎前路椎间盘切除植骨融合术中置入3D打印椎间融合器(3D Cage)的临床对照试验文献,由2名独立研究者根据纳入、排除标准进行文献筛选、资料提取、质量评价,使用RevMan 5.3软件对结局指标进行Meta分析。
结果:①共纳入11篇相关文献,其中2篇中等偏倚风险的随机对照试验文献,9篇高质量回顾性研究文献;共涉及患者691例,试验组(3D Cage置入)338例,对照组(其他植入物置入)353例;②Meta分析结果显示:两组在椎间融合率(RR=1.03,95%CI:0.98-1.07,P=0.23)方面比较无明显差异;在手术时间(MD=-11.84,95%CI:-17.12至-6.57,P < 0.000 1)、术中出血量(MD=-10.60,95%CI:-16.86至-4.33,P=0.000 9)、并发症(RR=0.55,95%CI:0.35-0.88,P=0.01)、C2-7Cobb角(MD=4.14,95%CI:3.42-4.85,P < 0.000 01)、椎间隙高度(MD=0.48,95%CI:0.25-0.70,P < 0.000 1)以及亚组分析下的颈椎JOA评分(SMD=0.55,95%CI:0.29-0.82,P < 0.000 1;SMD=1.09,95%CI:0.73-1.46,P < 0.000 01)
方面试验组优于对照组。
结论:3D打印椎间融合器的椎间融合率不劣于其他植入物;3D打印椎间融合器能够缩短手术时间、减少术中出血、降低并发症发生;对于颈椎矢状位平衡以及神经功能恢复具有较好的促进作用。

https://orcid.org/0000-0003-2230-8607 (王彦金) 

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: 3D打印, 钛合金, 椎间融合器, 颈椎病, 颈椎间盘切除, Meta分析

Abstract: OBJECTIVE: To systematically evaluate the clinical efficacy and safety of 3D printed cages in anterior cervical discectomy and fusion.
METHODS:  PubMed, Embase, The Cochrane Library, CBM, CNKI, Wanfang, and VIP databases were searched to collect the clinical controlled trial articles on 3D printed fusion cage (3D Cage) placed in anterior cervical discectomy and fusion surgery from database establishment to April 2022. Two independent investigators performed literature screening, data extraction and quality evaluation according to the inclusion and exclusion criteria. Meta-analysis was performed on the outcome measures using RevMan 5.3 software.  
RESULTS: (1) A total of 11 relevant articles were included, containing 2 articles of randomized controlled trials with moderate risk of bias and 9 articles of high-quality retrospective study. A total of 691 patients were involved, 338 cases in the test group (3D cage implantation) and 353 cases in the control group (other implant implantation). (2) Meta-analysis results showed that there was no significant difference in the fusion rate (RR=1.03, 95%CI: 0.98 to 1.07, P=0.23) between the two groups. The operation time (MD=-11.84, 95%CI: -17.12 to -6.57, P < 0.000 1), intraoperative blood loss (MD=-10.60, 95%CI: -16.86 to -4.33, P=0.000 9), complications (RR=0.55, 95%CI: 0.35 to 0.88, P=0.01), C2-7 Cobb angle (MD=4.14, 95%CI: 3.42 to 4.85, P < 0.000 01), intervertebral space height (MD=0.48, 95%CI: 0.25 to 0.70, P < 0.000 01) and cervical JOA score under analysis (SMD=0.55, 95%CI: 0.29 to 0.82, P < 0.000 1; SMD = 1.09, 95%CI: 0.73 to 1.46, P < 0.000 01) were superior in the test group to those in the control group.
CONCLUSION: The fusion rate of 3D Cage was not inferior to other implants. 3D Cage could shorten operation time, reduce intraoperative blood loss and reduce the occurrence of complications; it could promote the sagittal balance of cervical vertebra and the recovery of neurological function.

Key words: 3D printing, titanium alloy, intervertebral fusion cage, cervical spondylosis, cervical discectomy, meta-analysis

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