全膝关节置换术中主动机器人的安全有效应用：一项多中心研究的早期结果
Safe and effective use of active robotics for TKA: Early results of a multicenter study.
作者信息
Stulberg Bernard N, Zadzilka Jayson D, Kreuzer Stefan, Kissin Yair D, Liebelt Ralph, Long William J, Campanelli Valentina
机构信息
St. Vincent Charity Medical Center, Cleveland, OH, USA.
Houston Methodist West Hospital, Houston, TX, USA.
出版信息
J Orthop. 2021 Jul 23;26:119-125. doi: 10.1016/j.jor.2021.07.001. eCollection 2021 Jul-Aug.
Abstract
BACKGROUND
A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population.
METHODS
A multicenter clinical trial was conducted, following 115 patients for at least 6-months. A pre-defined list of robot-related adverse events was used to evaluate safety. Efficacy was assessed radiographically comparing planned versus achieved coronal limb alignment.
RESULTS
No pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases.
CONCLUSION
Active robotics for TKA is safe and effective as demonstrated in this trial.
摘要
背景
一种用于全膝关节置换术（TKA）的新型主动机器人系统可对骨表面进行自动铣削。研究目的是评估该系统在美国人群中的安全性和有效性。
方法
进行了一项多中心临床试验，对115名患者进行了至少6个月的随访。使用预先定义的与机器人相关的不良事件列表来评估安全性。通过影像学比较计划的与实际实现的冠状位肢体对线来评估疗效。
结果
未发生预先定义的不良事件，11.2%的病例术后肢体对线与计划相差超过±3°。
结论
本试验表明，用于TKA的主动机器人技术是安全有效的。
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