机器人辅助与传统全膝关节置换术的早期放射学和临床结果：一项多中心随机对照试验。
Early Radiographic and Clinical Outcomes of Robotic-arm-assisted versus Conventional Total Knee Arthroplasty: A Multicenter Randomized Controlled Trial.
机构信息
Peking University Third Hospital, Department of Orthopaedics/Engineering Research Center of Bone and Joint Precision Medicine, Ministry of Education/Beijing Key Laboratory of Spinal Disease Research, Beijing, China.
The First Affiliated Hospital of Shandong First Medical University/Shandong Provincial Qianfoshan Hospital, Jinan, China.
出版信息
Orthop Surg. 2024 Nov;16(11):2732-2740. doi: 10.1111/os.14196. Epub 2024 Aug 12.
OBJECTIVE
A robotic system was recently introduced to improve prosthetic alignment during total knee arthroplasty (TKA). The purpose of this multicenter, prospective, randomized controlled trial (RCT) was to determine whether robotic-arm-assisted TKA improves clinical and radiological outcomes when compared to conventional TKA.
METHODS
One hundred and thirty patients who underwent primary TKA were enrolled in this prospective, randomized controlled trial, which was conducted at three hospitals. Five patients were lost to follow-up 6 weeks after surgery. Therefore, 125 participants (63 in the intervention group and 62 in the control group) remained in the final analysis. The primary outcome was the rate at which the mechanical axis of the femur deviated by less than 3° from the mechanical axis of the tibia. This was evaluated by full-length weight-bearing X-rays of the lower limb 6 weeks postoperatively. Secondary outcomes included operation times, 6-week postoperative functional outcomes evaluated by the American Knee Society score (KSS) and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), short form-36 (SF-36) health survey results, and the occurrence of adverse events (AEs) and serious adverse events (SAEs).
RESULTS
At 6 weeks postoperatively, we found that the rate of radiographic inliers was significantly higher in the intervention group (78.7% vs 51.6%; p = 0.00; 95% confidence interval, 10.9% to 43.2%). The operation was significantly longer in the intervention group than in the control group (119.5 vs 85.0 min; p = 0.00). There were no significant differences in the 6-week postoperative functional outcomes, SF-36, AEs, and SAEs between the two groups. There were no AEs or SAEs that were determined to be "positively related" to the robotic system.
CONCLUSION
Robotic-arm-assisted TKA is safe and effective, as demonstrated in this trial.
目的
最近引入了一种机器人系统，以改善全膝关节置换术（TKA）中的假肢对线。本多中心、前瞻性、随机对照试验（RCT）的目的是确定与传统 TKA 相比，机器人辅助 TKA 是否能改善临床和影像学结果。
方法
本前瞻性随机对照试验纳入了 130 例接受初次 TKA 的患者，试验在三家医院进行。术后 6 周有 5 例患者失访。因此，最终分析纳入了 125 名参与者（干预组 63 例，对照组 62 例）。主要结局是股骨机械轴与胫骨机械轴的偏差小于 3°的比例。术后 6 周通过下肢全长负重 X 线片评估。次要结局包括手术时间、术后 6 周采用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）评估的功能结局、短表 36（SF-36）健康调查结果，以及不良事件（AE）和严重不良事件（SAE）的发生情况。
结果
术后 6 周，我们发现干预组的影像学内固定率显著更高（78.7%比 51.6%；p=0.00；95%置信区间，10.9%至 43.2%）。干预组的手术时间明显长于对照组（119.5 比 85.0 分钟；p=0.00）。两组术后 6 周的功能结局、SF-36、AE 和 SAE 均无显著差异。两组均无被确定为“与机器人系统呈正相关”的 AE 或 SAE。
结论
本试验证明，机器人辅助 TKA 安全且有效。
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