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首页> 外文OA文献 >A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty
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A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty

机译：一个预期的双盲随机控制试验比较机器人臂辅助功能上对齐的全膝关节形成术与机器人臂辅助的机械排列的总膝关节置换术

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Abstract Background Total knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients. Methods and analysis This prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK. Discussion This is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications. Registration Clinical Trials.gov, NCT04092153. Registered on 17 September 2019.
机译：抽象背景全膝关节置换术（TKA）与机械对准（MA）旨在在所有患者中实现中性肢体对齐，而TKA具有功能对准（FA）的目的是通过操纵骨切除和精细来恢复原生，患者特异性解剖学和膝关节运动学 - 贯穿植入物定位。本研究的目的是通过比较MA TKA与FA TKA的患者满意度，功能结果，植入物生存，并发症和成本效益来确定TKA中的最佳取向技术。机器人技术将用于在所有研究患者中执行具有高含量精度的计划植入物定位和肢体对齐。方法和分析该前瞻性双盲随机对照试验将包括100名患有症状膝关节骨关节炎患者接受初级机器人臂辅助TKA。在知情同意之后，使用在线随机数发生器的比例，患者将以1：1的比例随机化为MA TKA（对照组）或FA TKA（调查组）。盲目的观察者将在手术后定期检查患者，以记录与术后康复，临床进展，功能性结果，植入物定位和肢体对准，步态，植入稳定性，成本效益和并发症有关的预定义的研究结果。与MA TKA相比，优势研究设计将用于评估FA TKA是否提供卓越的结果。主要和次要目标将用于量化和吸引两组治疗疗效差异的推断。将进行有意治疗和每协定人口分析。将采用以下统计方法来分析数据：描述性统计，独立T测试，配对T测试，方差分析，Fisher精确测试，Chi-Square测试和图形显示。从英国伦敦苏里研究伦理委员会获得道德批准。该研究由英国伦敦大学学院赞助。讨论这是描述使用机器人技术实现FA TKA的第一项研究，以及唯一现有的临床试验比较机器人MA TKA与机器人FA TKA。该研究的结果将改善对TKA中最佳取向技术的理解，以实现高患者满意度，改善功能性结果，提高植入物生存，提高成本效益和降低并发症。注册临床试验.GOV，NCT04092153。 2019年9月17日注册。

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