Medical School of Chinese PLA, Beijing, China.
Department of Orthopeadics, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.
Orthop Surg. 2022 Sep;14(9):1972-1980. doi: 10.1111/os.13323. Epub 2022 Jul 18.
Robot-assisted surgery has been promoted worldwide in recent years. The development of a domestic orthopaedic robot and its clinical application are therefore of great significance. This study aimed to compare the early clinical and radiographic outcomes of domestic robot-assisted total knee arthroplasty (RA-TKA) with conventional manual total knee arthroplasty (CM-TKA).
A total of 77 patients who underwent primary single-sided TKA from June to December 2020 were prospectively enrolled; resulting in the inclusion of 72 patients. The patients were randomly divided into the RA-TKA group (37 cases, with TKA being assisted by the Yuanhua Orthopaedic Robotic System) and the CM-TKA group (35 cases, with TKA being performed using conventional tools). Knee function was evaluated by the knee range of motion (ROM), the American Knee Society Score (KSS), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Postoperative radiographic results were evaluated by full-length weight-bearing X-rays of the lower limb and anteroposterior and lateral X-rays of the knee were obtained preoperatively and at 90 days postoperative. The operative duration, blood loss, postoperative knee function, radiographic outcomes, and incidence of complications were compared by Student's t-test, Mann-Whitney U test, or chi-square test. Serum levels of inflammatory markers before the operation and 1, 3, and 30 days after the operation were recorded and compared between the two groups.
The operation was significantly longer in the RA-TKA group than in the CM-TKA group (154.3 vs 115.2 min, p < 0.001). There was no significant difference in blood loss (933 vs 863 ml, p = 0.519) between the two groups. The knee ROM, KSS, and WOMAC were significantly improved in both groups 90 days after the operation compared with before the operation (p < 0.05), but there were no significant differences between the two groups (p > 0.05). The incidence of postoperative deep vein thrombosis was not statistically different between the two groups. In the radiographic findings at 90 days postoperatively we found the frequency of lateral tibial component (LTC) angle outliers was significantly lower in the RA-TKA group (3.0% vs 29.4%, p = 0.003). The neutrophil-to-lymphocyte ratio (NLR) was significantly lower in the RA-TKA group than in the CM-TKA group on day 1 after surgery (9.9 vs 12.7, p = 0.024).
RA-TKA requires more time than CM-TKA, which may be related to the learning curve and intraoperative registration. The short-term postoperative knee functional outcomes had no differences between the two groups, and RA-TKA improved the accuracy of tibial component alignment. Further follow-up studies are required to investigate the long-term outcomes.
近年来,机器人辅助手术在全球范围内得到了推广。因此,开发国产骨科机器人并将其临床应用具有重要意义。本研究旨在比较国产机器人辅助全膝关节置换术(RA-TKA)与传统手工全膝关节置换术(CM-TKA)的早期临床和影像学结果。
前瞻性纳入 2020 年 6 月至 12 月行初次单侧 TKA 的 77 例患者,最终纳入 72 例患者。将患者随机分为 RA-TKA 组(37 例,采用元化骨科机器人系统辅助 TKA)和 CM-TKA 组(35 例,采用传统工具行 TKA)。采用膝关节活动度(ROM)、美国膝关节协会评分(KSS)和西部安大略省和麦克马斯特大学骨关节炎指数(WOMAC)评估膝关节功能。术后通过下肢全长负重位 X 线片和膝关节正侧位 X 线片评估术后影像学结果,术前和术后 90 天分别进行评估。采用 Student's t 检验、Mann-Whitney U 检验或卡方检验比较手术时间、失血量、术后膝关节功能、影像学结果和并发症发生率。记录并比较两组患者术前及术后 1、3、30 d 时的血清炎症标志物水平。
RA-TKA 组的手术时间明显长于 CM-TKA 组(154.3 比 115.2 min,p<0.001)。两组间失血量差异无统计学意义(933 比 863 ml,p=0.519)。两组患者术后 90 d 的膝关节 ROM、KSS 和 WOMAC 评分均明显高于术前(p<0.05),但两组间差异无统计学意义(p>0.05)。两组术后深静脉血栓形成发生率无统计学差异。术后 90 d 的影像学结果显示,RA-TKA 组外侧胫骨组件(LTC)角度异常的发生率明显低于 CM-TKA 组(3.0%比 29.4%,p=0.003)。术后第 1 天,RA-TKA 组的中性粒细胞与淋巴细胞比值(NLR)明显低于 CM-TKA 组(9.9 比 12.7,p=0.024)。
RA-TKA 比 CM-TKA 所需时间更长,这可能与学习曲线和术中注册有关。两组患者术后短期膝关节功能无差异,RA-TKA 改善了胫骨组件对线的准确性。需要进一步的随访研究来探讨其长期结果。