【摘要】 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)治疗膝骨关节炎的早期疗效。方法 以2021年8月至2022年1月拟接受初次单侧全膝关节置换术(total knee arthroplasty, TKA)的18例患者作为研究对象，根据随机数字表法分为传统TKA组和RATKA组，每组9例患者。传统TKA组男3例，女6例；平均年龄(70.00±10.63)岁。RATKA组男3例，女6例；平均年龄(68.22±6.12)岁。记录两组手术时间、术中出血量、术后住院天数、术后血红蛋白(hemoglobin, HB)及红细胞比容(hematocrit, HCT);采用活动度(range of motion, ROM)、膝关节学会评分系统(knee society score, KSS)评分以及西安大略和麦克马斯特大学(the Western Ontario and McMaster Universities, WOMAC)关节炎指数疼痛、僵硬、功能评分，评估膝关节功能及疼痛情况；拍摄双下肢全长正位及单侧膝关节侧位X线片，测算髋-膝-踝角(hip-knee-ankle angle, HKA)偏移程度及股骨远端外侧角(lateral distal femoral angle, LDFA)、胫骨近端内侧角(medial proximal tibial angle, MPTA)、关节汇聚角(joint lineconvergence angle, JLCA)等，评价下肢力线及假体植入位置。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(P=0.002),两组患者术中出血量、术后引流量、术后HB及HCT减少量等组间比较，差异均无统计学意义(P>0.05)。术后5个月随访，两组膝关节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)。RATKA组术后HKA偏移明显优于传统TKA组，差异有统计学意义(P<0.05)。两组术后LDFA及MPTA比较，差异均无统计学意义(P>0.05);RATKA组JLCA小于传统TKA组(P<0.05),更接近理想值。结论 采用国产机器人行RATKA能提高假体安放位置以及下肢力线精准度，获得较好早期疗效，远期疗效有待进一步观察。更多还原

【Abstract】 Objective To investigate the early effect of domestic robot-assisted total knee arthroplasty(RATKA)for knee osteoarthritis by a prospective randomized controlled trial.Methods The clinical data of 18 patients who underwent total knee arthroplasty(TKA) from August 2021 to January 2022 were collected.They were divided into traditional TKA group and RATKA group by random number table method,with 9 patients in each group.There were3 males and 6 females in the traditional TKA group,with an average age of(70.00±10.63) years.And there were 3 males and 6 females in RATKA group,with an average age of(68.22±6.12) years.Operation time,intraoperative blood loss,postoperative days in hospital,postoperative hemoglobin(HB) and hematocrit(HCT) of the two groups were recorded.ROM,KSS score and WOMAC pain,stiffness,and functional scores were used to evaluate knee function and pain.X-rays of both lower limbs were taken to measure the degree of bias of HKA,lateral distal femoral angle(LDFA),medial proximal tibial angle(MPTA) and joint line convergence angle(JLCA),expecting to evaluate the lower limb alignment and implant position of prosthesis.Results The operations in both groups were successfully completed.All the incisions healed at stage I and no operative complications occurred.The operation time of the RATKA group was longer than that of the traditional TKA group(P=0.002),and there were no significant difference in intraoperative blood loss,postoperative drainage volume,postoperative HB and HCT reduction between the two groups(P>0.05).After 5 months of follow-up,ROM and KSS scores of knee joint as well as WOMAC pain,stiffness,and functional scores were better in both groups compared with those before surgery.The differences were statistically significant(P<0.05),but there were no significant difference in the difference of the above indexes between the two groups(P>0.05).The postoperative degree of bias of hip-knee-ankle angle of the RATKA group was significantly better than that of the traditional TKA group,with statistically significant difference(P <0.05).There was no significant difference in postoperative LDFA and MPTA between the two groups(P>0.05).JLCA in RATKA group was lower than that in traditional TKA group(P<0.05) and it was closer to the ideal value in RATKA group.Conclusion TKA performed by domestic robot can improve the precision of placement of the prosthesis and the lower limb alignment,and achieve good short-term effectiveness.The long-term effectiveness remains to be further observed.更多还原