中国组织工程研究

中国组织工程研究 ›› 2023, Vol. 27 ›› Issue (27): 4324-4331.doi: 10.12307/2023.605

• 人工假体 artificial prosthesis • 上一篇    下一篇

基于术前规划导航系统辅助全髋关节置换：一项随机对照临床研究

郭  峰1，张志峰2，孙智文1，吕  欣1，朴俊杰1，王  帝1，牛  爽1，陈晓伟1，张一波1   

  1. 1赤峰市医院(内蒙古医科大学赤峰临床医学院)，内蒙古自治区赤峰市   024000；2内蒙古医科大学第二附属医院，内蒙古自治区呼和浩特市   010000
  • 收稿日期:2021-11-15 接受日期:2022-07-09 出版日期:2023-09-28 发布日期:2022-11-07
  • 作者简介:郭峰，男，1981年生，内蒙古自治区呼和浩特市人，汉族，2006年内蒙古医学院毕业，副主任医师，主要从事关节外科的临床研究。 张志峰，男，1980年生，内蒙古自治区赤峰市人，蒙古族，2011年内蒙古医科大学毕业，硕士，副主任医师，主要从事关节外科的基础与临床研究。
  • 基金资助:
    内蒙古自治区自然科学基金项目(2020MS08144)，项目负责人：张志峰

Preoperative planning-based navigation system-assisted total hip arthroplasty: a randomized controlled clinical study

Guo Feng1, Zhang Zhifeng2, Sun Zhiwen1, Lyu Xin1, Piao Junjie1, Wang Di1, Niu Shuang1, Chen Xiaowei1, Zhang Yibo1   

  1. 1Chifeng Municipal Hospital (Chifeng Clinical Medical College of Inner Mongolia Medical University), Chifeng 024000, Inner Mongolia Autonomous Region, China; 2Second Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, Inner Mongolia Autonomous Region, China
  • Received:2021-11-15 Accepted:2022-07-09 Online:2023-09-28 Published:2022-11-07
  • About author:Guo Feng, Associate chief physician, Chifeng Municipal Hospital (Chifeng Clinical Medical College of Inner Mongolia Medical University), Chifeng 024000, Inner Mongolia Autonomous Region, China Zhang Zhifeng, Master, Associate chief physician, Second Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, Inner Mongolia Autonomous Region, China
  • Supported by:
    Natural Science Foundation of Inner Mongolia Autonomous Region, No. 2020MS08144 (to ZZF) 

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摘要：


文题释义：

手术导航系统：是将患者术前或术中影像数据和手术床上患者的解剖结构准确对应，术中跟踪手术器械并将手术器械的位置在患者影像上以虚拟探针的形式实时更新显示，使医生对手术器械相对患者解剖结构的位置一目了然，使外科手术更快速、更精确、更安全。

背景：全髋关节置换是治疗晚期髋关节骨性关节炎、类风湿性关节炎、股骨头缺血性坏死、强直性脊柱炎髋关节病变、高龄股骨颈骨折所致的疼痛、强直以及功能缺失的有效方法，全髋关节置换后髋臼假体的寿命主要取决于髋臼杯的准确安放，为此拟应用术前规划的导航系统辅助全髋关节置换术。
目的：评估国产基于术前规划的导航系统在全髋关节置换术中实现植入髋臼最佳安装精度的有效性，并阐明该导航系统的临床实用性。
方法：采用中央随机化系统分配受试者入组，减少选择偏倚，受试者按照1∶1的比例随机分组，分别为导航组(20例)，常规技术组(23例)，导航组1例患者失访，全髋关节置换均采用侧卧位，后外侧入路，导航组术中利用基于术前规划的导航系统辅助髋臼杯的植入，常规技术组采用常规手术器械引导植入髋臼杯。术后1个月(±7 d)通过CT确定髋臼位置，测量并记录外展角和前倾角，进行Harris评分、WOMAC评分和SF-36评分。
结果与结论：①使用基于术前规划导航系统辅助放置的髋臼假体平均外展角为(41.82±5.26)˚，常规手术技术放置的髋臼假体平均外展角为(43.69±5.83)˚，差异无显著性意义(P=0.29)；使用基于术前规划导航系统辅助放置的髋臼假体平均前倾角为(18.95±5.24)˚，常规手术技术放置的髋臼假体平均前倾角为(21.73±6.50)˚，差异无显著性意义(P=0.14)；②基于术前规划导航系统辅助放置的髋臼假体94.7%在Lewinnek安全区内，常规技术组放置的髋臼假体60.9%在Lewinnek安全区内(χ²=4.844，P=0.028)；基于术前规划导航系统辅助放置的髋臼假体73.7%在Callanan安全区内，常规技术组放置的髋臼假体34.8%在Callanan安全区内(χ²=6.313，P=0.012)，导航组的准确性明显优于常规技术组；③两组全髋关节置换术中出血量比较无显著性意义，导航组的手术时间明显延长，两组置换后Harris评分、WOMAC评分和SF-36评分较置换前均有明显改善(P < 0.05)；④结果表明，基于术前规划导航系统辅助全髋关节置换和常规全髋关节置换均可以显著改善患者的功能评分，并且基于术前规划导航系统可提高髋臼安放在安全区域内的定位精度，但是导航组手术时间更长。
https://orcid.org/0000-0002-9226-9538 (郭峰) 
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: 髋关节, 关节置换, 导航, 髋臼, 前倾角, 外展角

Abstract: BACKGROUND: Total hip arthroplasty is an effective treatment for advanced osteoarthritis of the hip, rheumatoid arthritis, ischemic necrosis of the femoral head, ankylosing spondylitis of the hip, pain, ankylosis and functional deficits due to fractures of the femoral neck in advanced age. The longevity of the acetabular prosthesis after total hip arthroplasty depends primarily on the accurate placement of the acetabular cup. A preoperatively planned navigation system was applied to assist total hip arthroplasty.  
OBJECTIVE: To evaluate the effectiveness of a preoperative planning-based navigation system for achieving optimal mounting accuracy of implanted acetabulars in total hip arthroplasty and to elucidate the clinical utility of this navigation system.
METHODS: A centralized randomization system was used to assign subjects to the group to reduce selection bias. Subjects were randomized in a 1:1 ratio to the navigation group (20 cases) and the conventional technique group (23 cases), with one patient lost to follow-up in the navigation group. Total hip arthroplasty was performed in the lateral decubitus position with a posterolateral approach. The navigational group used a preoperative planning-based navigation system to assist in the implantation of the acetabular cup, and the conventional technique group used conventional surgical instruments to guide the implantation of the acetabular cup. The acetabular position was determined by CT at 1 month (±7 days) postoperatively and the abduction and anteversion angles were measured and recorded; the Harris score, WOMAC score and SF-36 score were performed.  
RESULTS AND CONCLUSION: (1) The mean abduction angle of the acetabular prosthesis placed using preoperative planning-based navigation system was (41.82±5.26)˚ and the mean abduction angle of the acetabular prosthesis placed using conventional surgical techniques was (43.69±5.83)˚, with no significant difference (P=0.29). The mean anteversion angle of the acetabular prosthesis placed using preoperative planning-based navigation system was (18.95±5.24)˚ and the angle was (21.73±6.50)˚ for acetabular prostheses placed with conventional surgical techniques, with no significant difference (P=0.14). (2) 94.7% of acetabular prostheses placed with the aid of preoperative planning-based navigation system were placed within the Lewinnek safety zone, and 60.9% of acetabular prostheses placed in the conventional technique group were placed within the Lewinnek safety zone (χ²=4.844, P=0.028); 73.7% of acetabular prostheses placed with the aid of preoperative planning-based navigation system were placed within the Callanan safety zone, while 34.8% of acetabular prostheses placed in the conventional technique group were placed within the Callanan safety zone (χ²=6.313, P=0.012), and the accuracy of the navigation group was significantly better than that of the conventional technique group. (3) The intraoperative bleeding of total hip arthroplasty was not significant in the two groups, and the operating time was significantly longer in the navigation group. The Harris score, WOMAC score and SF-36 score improved significantly in both groups after arthroplasty compared with those before arthroplasty (P < 0.05). (4) These results concluded that both preoperative planning-based navigation system-assisted total hip arthroplasty and conventional total hip arthroplasty significantly improved patients' functional scores, and the preoperative planning-based navigation system improved the positioning accuracy of the acetabular arthroplasty in a safe area, but the navigation group took longer to operate.

Key words: hip joint, joint arthroplasty, navigation, acetabular, anteversion angle, abduction angle 

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