国产机器人辅助人工全膝关节置换术近期疗效的前瞻性随机对照研究

A prospective randomized controlled trial on the short-term effectiveness of domestic robot-assisted total knee arthroplasty

目的通过前瞻性随机对照研究,探讨国产机器人辅助人工全膝关节置换术(robot-assisted total knee arthroplasty,RATKA)的近期疗效。方法以2020年10月—12月拟接受初次单侧TKA的患者作为研究对象,根据随机数字表法分为传统TKA组和RTKA组[术中应用骨圣元化全膝关节置换手术辅助系统(YUANHUA-TKA)]。共63例患者符合选择标准纳入研究,其中3例主动退出试验,最终纳入60例进行分析;其中RATKA组28例,传统TKA组32例。两组患者性别、年龄、身体质量指数、美国麻醉医师协会(ASA)分级、骨关节炎病程、手术侧别以及术前膝关节疼痛视觉模拟评分(VAS)静息及运动评分、关节活动度(range of motion,ROM)、膝关节学会评分系统(KSS)评分、美国西部Ontario与McMaster大学骨关节炎指数(WOMAC)疼痛、僵硬、功能评分及髋-膝-踝角(hip-knee-ankle angle,HKA)偏移等一般资料比较,差异均无统计学意义(P>0.05),具有可比性。记录两组手术时间、术中出血量;采用膝关节VAS静息及运动评分、ROM、KSS评分以及WOMAC疼痛、僵硬、功能评分,评价膝关节功能及疼痛情况;术后3个月行步态分析(屈伸角)。摄膝关节正侧位以及站立位双下肢全长X线片,测算HKA偏移程度及胫骨平台后倾角(lateral tibia component,LTC)、冠状面股骨组件角(frontal femoral component,FFC)、冠状面胫骨组件角(frontal tibia component,FTC)、矢状面股骨组件角(lateral femoral component,LFC),评价下肢力线及假体位置。结果两组手术均顺利完成;术后切口均Ⅰ期愈合,无手术相关并发症发生。RATKA组手术时间较传统TKA组延长(t=12.253,P=0.001),术中出血量组间差异无统计学意义(t=3.382,P=0.071)。两组患者均获随访3个月。术后3个月,两组膝关节VAS静息及运动评分、ROM、KSS评分以及WOMAC疼痛、僵硬、功能评分均较术前改善,差异有统计学意义(P<0.05);上述指标手术前后差值组间比较,差异均无统计学意义(P>0.05)。步态分析显示RATKA组患者屈伸角较传统TKA组增大(t=9.469,P=0.003)。术后3个月X线片复查示两组假体均位置良好,无假体松动、下沉等不良事件。两组HKA偏移手术前后比较差异均有统计学意义(P<0.05),HKA偏移手术前后差值组间比较差异无统计学意义(t=1.254,P=0.267)。两组FFC、FTC、LFC差异均无统计学意义(P>0.05);RATKA组LTC小于传统TKA组(t=17.819,P=0.000),更接近理想值。结论采用国产机器人行RATKA能提高截骨、假体安放位置以及下肢力线精准度,获得较好近期疗效,远期疗效有待进一步观察。

Objective To explore the short-term effectiveness of domestic robot-assisted total knee arthroplasty(RATKA) conducted by a prospective randomized controlled trial. Methods Patients who were scheduled for primary unilateral TKA between October 2020 and December 2020 were eligible in this randomized controlled trial. According to the random number table method, they were allocated to the traditional TKA group and the RATKA group [application of the Yuanhua robotic-assisted TKA(YUANHUA-TKA) system during operation]. A total of 63 patients met the selection criteria were enrolled in the study, of which 3 cases voluntarily withdrew from the trial. And finally 60 cases were enrolled for analysis;of which 28 cases were in the RATKA group and 32 cases were in the traditional TKA group. There was no significant difference in gender, age, body mass index, American Society of Anesthesiologists(ASA) classification,duration of osteoarthritis, surgical side, and preoperative knee visual analogue scale(VAS) resting and motion scores, joint range of motion(ROM), Knee Society Score(KSS), Western Ontario and McMaster University Osteoarthritis Index(WOMAC) pain, stiffness, and function scores, hip-knee-ankle angle(HKA) deviation(P>0.05). The operation time and intraoperative blood loss of the two groups were recorded. Knee joint VAS resting and motion scores, ROM, KSS scores,and WOMAC pain, stiffness, and function scores were used to evaluate the knee joint function and pain. Gait analysis(flexion and extension angle) was conducted at 3 months after operation. The full length X-ray films of lower limbs and anteroposterior and lateral X-ray films of knee joint were taken. The HKA deviation, lateral tibia component(LTC),frontal femoral component(FFC), frontal tibia component(FTC), and lateral femoral component(LFC) measured on the X-ray films were used to evaluat the lower limb alignment and prosthesis position. Results The operations of the two groups completed successfully;the incisions healed by first intention after operation, and no complications related to the operation occurred. The operation time of the RATKA group was significantly longer than that of the traditional TKA group(t=12.253, P=0.001), and there was no significant difference in intraoperative blood loss between the two groups(t=3.382, P=0.071). All patients were followed up 3 months. At 3 months after operation, the knee joint VAS resting and motion scores, ROM, KSS scores, and WOMAC pain, stiffness, and function scores improved significantly when compared with preoperatively in the two groups(P<0.05);there was no significant difference of pre-and post-operative indicators between the two groups(P>0.05). The gait analysis showed that the flexion and extension angle in the RATKA group was significantly bigger than that in the traditional TKA group(t=9.469, P=0.003). X-ray films reexamination at 3 months after operation showed that the prostheses in the two groups were in good positions, and there was no adverse events such as prosthesis loosening or sinking. There were significant differences in the HKA deviation between pre-and post-operation in the two groups(P<0.05), but the difference of pre-and post-operative HKA deviation between the two groups was not significant(t=1.254, P=0.267). There was no significant difference in FFC, FTC, and LFC between the two groups(P>0.05);the LTC was significantly smaller in the RATKA group than in the traditional TKA group(t=17.819,P=0.000), which was closer to the ideal value. Conclusion YUANHUA-TKA system can improve the accuracy of osteotomy and the prosthesis placement as well as the lower limb alignment. Its short-term effectiveness can be promised,but long-term effectiveness needs to be further studied.