Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.
Warwick Orthopaedics Specialist Training Programme, University Hospitals Coventry & Warwickshire, Coventry, UK.
Bone Joint J. 2024 Feb 1;106-B(2):114-120. doi: 10.1302/0301-620X.106B2.BJJ-2023-0711.R1.
Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.
全髋关节和膝关节置换术(THA、TKA)是非常成功的手术;然而,两者的结果都存在差异,导致一些患者对结果不满意。外科医生正在转向机器人辅助手术等技术,试图改善结果。需要进行强有力的研究,以确定这些创新是否真正使患者受益。机器人关节置换术的临床和成本效益随机对照试验(RACER)试验是多中心、患者盲法随机对照试验。患者患有原发性髋或膝关节骨关节炎。手术是 Mako 辅助 THA 或 TKA,对照组则采用常规器械进行手术。主要临床结果是 12 个月时的遗忘关节评分,并且进行了内置的成本效益分析。次要结果包括早期疼痛、组件的对准以及中至长期结果。本注释概述了评估这些技术的必要性,并讨论了进行此类试验时的设计和挑战,包括手术工作流程、分离手术效果、盲法和评估学习曲线。最后,讨论了机器人手术的未来,包括同时引入和评估此类技术的必要性。