国产机器人辅助全膝关节置换术的精准性:一项多中心随机对照临床研究  

Accuracy of total knee arthroplasty assisted by a kind of homemade robot:a multicenter randomized controlled trial

作　　者：邵宏翊[1] 吴立东[2] 曹光磊[3] 李征[3] 杨德金[1] 周一新[1] SHAO Hongyi;WU Lidong;CAO Guanglei;LI Zheng;YANG Dejin;ZHOU Yixin(Department of Orthopaedic Surgery,Beijing Jishuitan Hospital,Fourth Clinical College of Peking University,Beijing 100035;Department of Orthopaedics,Second Affiliated Hospital,School of Medicine,Zhejiang University,Hangzhou 310000;Department of Orthopaedics,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]北京积水潭医院、北京大学第四临床医学院矫形骨科,北京100035 [2]浙江大学医学院附属第二医院骨科,杭州310000 [3]首都医科大学宣武医院骨科,北京100053

出　　处：《中华骨与关节外科杂志》2023年第4期310-316,共7页Chinese Journal of Bone and Joint Surgery

基　　金：北京市自然科学基金-海淀原始创新联合基金资助(L202051);北京市自然科学基金海淀重点研究专题(L212008)。

摘　　要：目的:评价一种国产骨科手术机器人(TiRobot Recon)辅助实施全膝关节置换术(TKA)手术操作的精准性。方法:采用多中心前瞻性随机对照研究,纳入2021年1月至2022年1月116例拟行TKA的患者,平均年龄(69.8±6.2)岁,其中男30例,女86例,按照1∶1比例随机分为机器人手术组(58例)和传统手术组(58例)。两组患者的术后髋膝踝角(HKA角)作为主要评价指标,次要评价指标包括假体冠状面股骨角(α角)、胫骨角(β角),矢状面股骨角(γ角)、胫骨角(δ角),横断面股骨旋转角(ρ角)。结果:机器人手术组患者术后HKA角相较于目标HKA角偏离率,股骨与胫骨假体组件位置α角、β角、γ角、δ角和ρ角相较于目标值偏离率均比传统手术组低,且差异有统计学意义(P<0.001)。两组患者术中和术后均未发生严重并发症。结论:国产手术机器人系统辅助TKA相较于传统TKA可以提高膝关节下肢力线及假体位置的精准度。Objective:To evaluate the operation accuracy of total knee arthroplasty assisted by a kind of homemade robot(TiRobot Recon).Methods:This was a multicenter prospective randomized controlled study.From January 2021 to January 2022,116 patients who would undergo total knee arthroplasty were randomly divided into robotic group and traditional operation group according to the ratio of 1∶1.Among them,the average age was(69.8±6.2)years with 30 male patients and 86 female patients.The primary outcome of this study was hip-knee-ankle angle(HKA angle)compared between the two groups,while secondary outcomes included femoral component(αangle)and tibial component angle(βangle)in coronal position,femoral component(γangle)and tibial component angle(δangle)in sagittal position and transverse femoral component rotation angle(ρangle).Results:The deviation rate of the HKA,and the position of femoral and tibial components(αangle,βangle,γangle,δangle andρangle)relative to the target in the robot group were lower than traditional operation group postoperatively(P<0.001).There were no serious complications in the two groups.Conclusions:The robotic system can improve the accuracy of lower limb alignment and prosthesis position compared with traditional surgery.

关 键 词：骨关节炎 全膝关节置换术 机器人 下肢力线 

分 类 号：R687.4[医药卫生—骨科学]