中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (21): 3305-3312.doi: 10.3969/j.issn.2095-4344.3866

• 人工假体 artificial prosthesis • 上一篇    下一篇

计算机导航辅助与传统一期双侧全膝关节置换的比较

郑  恺，李荣群，孙厚义，张韦成，李  宁，周  军，朱  锋，王熠军，徐耀增   

  1. 苏州大学附属第一医院骨科，江苏省苏州市   215006
  • 收稿日期:2020-08-11 修回日期:2020-08-12 接受日期:2020-10-16 出版日期:2021-07-28 发布日期:2021-01-23
  • 通讯作者: 徐耀增，主任医师，教授，博士生导师，苏州大学附属第一医院骨科，江苏省苏州市 215006
  • 作者简介:郑恺，男，1995年生，福建省福鼎市人，汉族，苏州大学附属第一医院在读硕士，主要从事骨与关节方面的研究。

Computer-navigated versus conventional one-stage bilateral total knee arthroplasty

Zheng Kai, Li Rongqun, Sun Houyi, Zhang Weicheng, Li Ning, Zhou Jun, Zhu Feng, Wang Yijun, Xu Yaozeng   

  1. Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China
  • Received:2020-08-11 Revised:2020-08-12 Accepted:2020-10-16 Online:2021-07-28 Published:2021-01-23
  • Contact: Xu Yaozeng, Chief physician, Professor, Doctoral supervisor, Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China
  • About author:Zheng Kai, Master candidate, Department of Orthopedics, the First Affiliated Hospital of Soochow University, Suzhou 215006, Jiangsu Province, China

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摘要：

文题释义：
计算机导航辅助下全膝关节置换：将解剖标志与运动学结合，通过红外信号与导航主机交互，在导航实时数字化显示下，精确指导术中截骨、软组织平衡及假体安装，恢复良好的下肢力线，达到力线与软组织平衡的有机结合，提高临床疗效。
传统全膝关节置换：常规正中切口显露膝关节，采取股骨侧髓内定位、胫骨侧髓外定位的方式截骨，检查屈伸间隙与软组织平衡，试模测试膝关节屈伸活动度、稳定性、间隙平衡及髌骨轨迹，满意后安装假体。

背景：全膝关节置换后假体失效与假体置入位置及下肢对线不良、软组织失衡等因素相关，而传统全膝关节置换因其过于依赖术者经验和目测，难以实现操作的高精确性、可重复性和个性化治疗。
目的：探讨在一期双侧术式下，对比传统与计算机导航辅助下全膝关节置换的早期临床疗效。
方法：前瞻性纳入2019年6至12月在苏州大学附属第一医院骨科行一期双侧全膝关节置换治疗的连续21例(42膝)膝关节炎患者，利用电脑随机数字表随机分配一侧患膝行计算机导航辅助下全膝关节置换，对侧患膝行传统全膝关节置换。比较两侧全膝关节置换手术时间、切口长度、引流量；比较两侧术后下肢机械轴髋-膝-踝角α、目标力线偏倚程度、股骨远端机械轴外侧角β、股骨侧假体矢状面角δ、胫骨近端内侧角γ、胫骨后倾角ε、股骨-髌骨角Q、股骨切迹；比较两侧术后3，14 d及1，3，6个月的美国特种外科医院膝关节评分、西安大略和麦克马斯特大学骨关节炎指数、术后6个月关节遗忘指数(FJS-12)、患者满意度和并发症。该临床试验已在中国临床试验注册中心登记，注册号为ChiCTR2000033499。
结果与结论：①导航侧的手术时间为(88.95±15.45) min，长于传统侧(78.25±13.83) min(P < 0.05)；导航侧切口长度为(15.08±0.86) cm，长于传统侧(13.44±0.86) cm(P < 0.05)；②两组术后均能获得良好的假体位置，但是导航侧较传统侧术后目标力线偏倚更小(P < 0.05)；对于术前下肢力线畸形大于15°患者，导航侧较传统侧能够获得更准确的下肢力线(P < 0.05)；③导航侧术后3，6个月的美国特种外科医院评分高于传统侧(P < 0.05)；其余随访时间两组美国特种外科医院评分、西安大略和麦克马斯特大学骨关节炎指数、膝关节遗忘指数相比差异均无显著性意义(P > 0.05)；④结果表明与传统全膝关节置换相比，计算机导航辅助下全膝关节置换能够获得更精确的下肢目标力线，特别是对于术前下肢畸形严重的患者，并展现出一定的早期功能优势；但导航全膝关节置换的手术时间和切口长度相对延长。

关键词: 计算机导航, 膝, 关节置换, 一期双侧, 骨关节炎, 下肢力线

Abstract: BACKGROUND: Failure of total knee arthroplasty is mainly related to the poor prosthesis position, bad lower limbs alignment and imbalanced soft tissue. However, conventional total knee arthroplasty is difficult to achieve high accuracy, repeatability and personalized operation, because it relies too much on the experience and visual inspection of the surgeon. 
OBJECTIVE: To explore the early clinical efficacy between computer-navigated and conventional total knee arthroplasties under one-stage bilateral surgery.  
METHODS: Totally 21 patients (42 knees) with knee arthritis, who were treated with one-stage bilateral total knee arthroplasty in Department of Orthopedics, the First Affiliated Hospital of Soochow University  from June to December 2019, were prospectively enrolled in this study. The patients randomly underwent computer-navigated total knee arthroplasty for one knee and conventional total knee arthroplasty for the contralateral knee. The duration of operation, length of incision, and drainage volume were compared between the two sides. Lower limb alignment hip-knee-ankle angle α, deviation of goal alignment, mechanical lateral distal femoral angle β, sagittal femoral component angle δ, medial proximal tibial angle γ, tibial posterior slope angle ε, femoral-patella angle Q, and femoral notching were compared between the two sides after operation. Hospital for Special Surgery score, Western Ontario and McMaster Universities Osteoarthritis Index score at 3, 14 days, 1, 3, and 6 months, Forgotten Joint Score at 6 months, patients’ satisfaction, and complications were compared between the two sides. The clinical trial was registered in Chinese Clinical Trial Registry with the registration number of ChiCTR2000033499. 
RESULTS AND CONCLUSION: (1) The duration of operation in navigation group (88.95±15.45) minutes was longer compared with conventional group (78.25±13.83) minutes (P < 0.05). The incision length in the navigation group (15.08±0.86) cm was longer than that in the conventional group (13.44±0.86) cm (P < 0.05). (2) Both groups obtained good results of prosthetic position, while the navigation group achieved less deviation of goal alignment compared with conventional group (P < 0.05). In patients with a preoperative mechanical axis deviation of >15°, the reconstructed alignment was more precise in navigation group (P < 0.05). (3) The Hospital for Special Surgery score at 3 and 6 months was higher in the navigation group compared with the conventional group (P < 0.05). There was no statistically significant difference in Hospital for Special Surgery score, Western Ontario and McMaster Universities Osteoarthritis Index score, and Forgotten Joint Score between the two groups during the rest follow-up (P > 0.05). (4) The results confirmed that computer-navigated total knee arthroplasty obtained more accurate goal alignment compared with the conventional total knee arthroplasty, especially for those who had severe lower limb deformities before surgery, and showed certain early functional advantages. However, the duration of operation and length of incision were prolonged in computer-navigated total knee arthroplasty.

Key words: computer navigation, knee, arthroplasty, one-stage bilateral, osteoarthritis, lower limb alignment

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