国产机器人辅助与传统人工全膝关节置换术早期临床效果的比较:随机对照试验Meta分析

Comparison of early clinical outcomes between domestic robot-assisted total knee arthroplasty and traditional surgery:Meta analysis of randomized controlled trials

目的比较国产机器人辅助全膝关节置换术(RA-TKA)与传统人工全膝关节置换术(CM-TKA)治疗原发性膝关节骨关节炎患者的早期临床疗效。方法检索2015年1月至2023年4月期间Embase、Pubmed、Web of Science数据库、中国知网和万方数据库,查找比较RA-TKA和CM-TKA疗效的临床对照研究。根据标准进行文献筛选、质量评价及数据提取后,应用Revman 5.3软件对文献数据进行Meta分析,比较RA-TKA组和CM-TKA组患者的手术时间、术中出血量、髋-膝-踝角(HKA)、HKA偏倚值、冠状面股骨组件角(FFC)、冠状面胫骨组件角(FTC)、矢状面股骨组件角(LFC)、胫骨外侧组件角(LTC)、美国膝关节协会评分法(KSS)评分、疼痛视觉模拟评分法(VAS)评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、膝关节活动度、美国特种外科医院(HSS)膝关节评分、住院时间及并发症发生率等。结果共纳入8项研究449例患者,RA-TKA组221例,CM-TKA组228例。Meta分析结果显示:RA-TKA组患者的手术时间显著长于CM-TKA组患者(MD=18.41,95%CI:11.28~25.23,P<0.001),HKA(MD=0.41,95%CI:0.06~0.76,P=0.020)、HKA偏倚值(MD=-0.92,95%CI:-1.25~-0.60,P<0.001)、FTC(MD=0.38,95%CI:0.08~0.67,P=0.010)、LTC(MD=1.71,95%CI:0.94~2.48,P<0.001)及膝关节活动度(MD=-2.23,95%CI:-4.18~-0.27,P=0.030)显著优于CM-TKA组患者,差异均有统计学意义;而两组患者的术中出血量、FFC、LFC、KSS评分、疼痛VAS评分、WOMAC评分、HSS膝关节评分、住院时间及并发症发生率等比较差异均无统计学意义(P>0.05)。结论在TKA中使用国产机器人辅助系统可明显提高假体固定精度,更好地重建下肢力线,并有促进膝关节功能恢复的潜在优势。

Objective To compare the early clinical outcomes between domestic robot-assisted total knee arthroplasty(RA-TKA)and conventional manual total knee arthroplasty(CM-TKA)for patients with primary knee osteoarthritis.Methods Embase,Pubmed,Web of Science,Zhi.com and Wanfang databases from January 2015 to April 2023 were searched for clinical controlled trials(RCTs)comparing the clinical outcomes between RA-TKA and CM-TKA.After literature screening,quality evaluation and data extraction according to the criteria required,Revman 5.3 software was applied to perform a Meta-analysis of the literature data.The operation time,intraoperative bleeding,hip-knee-ankle angle(HKA),HKA bias value,frontal femoral component(FFC),frontal tibia component(FTC),lateral femoral component(LFC),lateral tibia component(LTC),Knee Society Score(KSS),visual analogue scale(VAS),Western Ontario and McMaster University Osteoarthritis Index(WOMAC),knee mobility,Hospital for Specialty Surgery(HSS)knee score,length of hospital stay,and rate of complications were compared between the RA-TKA and CM-TKA patients.Results Eight RCTs and 449 patients were included,with 221 patients in the RA-TKA group and 228 ones in the CM-TKA group.The Meta-analysis showed that the RA-TKA group had significantly longer operation time(MD=18.41,95%CI:11.28 to 25.23,P<0.001),significantly better HKA(MD=0.41,95%CI:0.06 to 0.76,P=0.020),significantly better HKA bias value(MD=-0.92,95%CI:-1.25 to-0.60,P<0.001),significantly better FTC(MD=0.38,95%CI:0.08 to 0.67,P=0.010),significantly better LTC(MD=1.71,95%CI:0.94 to 2.48,P<0.001),and significantly better knee mobility(MD=-2.23,95%CI:-4.18~-0.27,P=0.030)than the CM-TKA group.However,the differences were not statistically significant between the 2 groups in the intraoperative bleeding,FFC,LFC,KSS,VAS,WOMAC,HSS,length of hospital stay,or rate of complications(P>0.05).Conclusion Use of a domestic robot to assist conventional manual TKA can significantly improve the accuracy of prosthesis fixation and reconstruct the alignment of lower limb better,showing potential advantages in promoting functional recovery of the knee for the patients.