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HURWA机器人辅助全膝关节置换术可改善假体位置和对线——一项前瞻性随机多中心研究。

HURWA robotic-assisted total knee arthroplasty improves component positioning and alignment - A prospective randomized and multicenter study.

作者信息

Li Zheng, Chen Xin, Wang Xiaoquan, Zhang Bo, Wang Wei, Fan Yu, Yan Jun, Zhang Xiaofeng, Zhao Yu, Lin Yuan, Liu Jun, Lin Jin

机构信息

Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Department of Joint Surgery, Tianjin Hospital, Tianjin, 300211, PR China.

出版信息

J Orthop Translat. 2022 Feb 16;33:31-40. doi: 10.1016/j.jot.2021.12.004. eCollection 2022 Mar.

Abstract

BACKGROUND

The objective of this study was to compare the radiologic and clinical outcomes of HURWA robotic-assisted total knee arthroplasty (TKA) to those of conventional TKA.

METHODS

A total of 150 patients were randomized into two groups - 73 and 77 patients underwent robotic-assisted TKA and conventional TKA, respectively. Preoperative and postoperative Western Ontario McMaster University Osteoarthritis Index (WOMAC) score, Hospital for Special Surgery (HSS) score, 36-item Short Form Health Survey (SF-36) score, Knee Society Score (KSS) and range of motion (ROM) were obtained and compared between these two groups. The preoperative and postoperative hip-knee-ankle (HKA) angle and the rate of HKA≤3° in the two groups were also compared.

RESULTS

The postoperative mean HKA angle was 1.801° ​± ​1.608° of varus for the robotic-assisted TKA group and 3.017° ​± ​2.735° of varus for the conventional TKA group; these values were significantly different. The alignment rate for mechanical axis lower than 3° in the robotic-assisted TKA group and the conventional TKA group were 81.2% and 63.5%, respectively. Patients undergone robotic-assisted TKA or conventional TKA had similarly improved knee flexion and functional recovery reflected by WOMAC score, HSS score, SF-36 score and KSS.

CONCLUSION

HURWA robotic-assisted TKA is a safe and effective, resulting in better alignment for mechanical axis than conventional TKA. The improvement in knee flexion and functional recovery after HURWA robotic-assisted TKA were similar to those after conventional TKA. However, longer follow-up is needed to determine whether the improved alignment of mechanical axis will produce better long-term clinical outcomes.

THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE

Recently, the robotic-assisted TKA system has been introduced to clinical practice for TKA. Several robotic-assisted TKA systems, including CASPAR, Tsolution, ROSA, ROBODOC and Mako, have been implemented into clinical application.However, the clinical application of these robotic systems was limited due to their technical complexity, insufficient versatility and increased operative time. Until now, there are still no robotic-assisted TKA systems approved by the National Medical Products Administration of China. Therefore, more robotic-assisted TKA systems need to be designed and improved, particularly in China. Through our randomized, multicenter, single blind and parallel controlled trial, we showed that HURWA robot-assisted TKA system is a safe and effective system for TKA, which had improved knee flexion.

摘要

背景

本研究的目的是比较HURWA机器人辅助全膝关节置换术(TKA)与传统TKA的影像学和临床结果。

方法

总共150例患者被随机分为两组,分别有73例和77例患者接受了机器人辅助TKA和传统TKA。获取两组患者术前和术后的西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、特种外科医院(HSS)评分、36项简明健康调查问卷(SF-36)评分、膝关节协会评分(KSS)以及活动范围(ROM),并进行比较。还比较了两组患者术前和术后的髋-膝-踝(HKA)角以及HKA≤3°的比例。

结果

机器人辅助TKA组术后平均HKA角为内翻1.801°±1.608°,传统TKA组为内翻3.017°±2.735°;这些值有显著差异。机器人辅助TKA组和传统TKA组机械轴对线率低于3°的分别为81.2%和63.5%。接受机器人辅助TKA或传统TKA的患者,通过WOMAC评分、HSS评分、SF-36评分和KSS反映出膝关节屈曲和功能恢复情况相似。

结论

HURWA机器人辅助TKA是安全有效的,与传统TKA相比,其机械轴对线更好。HURWA机器人辅助TKA术后膝关节屈曲和功能恢复的改善与传统TKA相似。然而,需要更长时间的随访来确定机械轴对线的改善是否会产生更好的长期临床结果。

本文的转化潜力

近年来,机器人辅助TKA系统已被引入TKA的临床实践。包括CASPAR、Tsolution、ROSA、ROBODOC和Mako在内的几种机器人辅助TKA系统已应用于临床。然而,这些机器人系统的临床应用由于技术复杂性、通用性不足和手术时间增加而受到限制。到目前为止,中国国家药品监督管理局仍未批准任何机器人辅助TKA系统。因此,需要设计和改进更多的机器人辅助TKA系统,尤其是在中国。通过我们的随机、多中心、单盲和平行对照试验,我们表明HURWA机器人辅助TKA系统是一种安全有效的TKA系统,可改善膝关节屈曲。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/606d/8857449/de8fadcf279d/gr1.jpg

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