Total knee arthroplasty is a common surgery for end-stage knee osteoarthritis. Partial knee arthroplasty is also a treatment option for patients with arthritis present in only one or two knee compartments. Partial knee arthroplasty can preserve the natural knee biomechanics, but these replacements may not last as long as total knee replacements. Robotic-assisted orthopedic techniques can help facilitate partial knee replacements, increasing accuracy and precision. This trial will investigate the feasibility and assess clinical outcomes for a larger definitive trial. This is a protocol for an ongoing parallel randomized pilot trial of 64 patients with uni- or bicompartmental knee arthritis. Patients are randomized to either receive robot-assisted partial knee arthroplasty or manual total knee arthroplasty. The primary outcome of this pilot is investigating the feasibility of a larger trial. Secondary (clinical) outcomes include joint awareness, return to activities, knee function, patient global impression of change, persistent post-surgical pain, re-operations, resource utilization and cost-effectiveness, health-related quality of life, radiographic alignment, knee kinematics during walking gait, and complications up to 24 months post-surgery. The RoboKnees pilot study is the first step in determining the outcome of robot-assisted partial knee replacements. Conclusions from this study will be used to design future large-scale trials. This study will inform surgeons about the potential benefits of robot-assisted partial knee replacements. This study was prospectively registered on clinicaltrials.gov (identifier: NCT04378049) on 4 May 2020, before the first patient was randomized.

中文翻译：

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机器人辅助部分膝关节置换术与标准全膝关节置换术 (RoboKnees)：试点随机对照试验方案

全膝关节置换术是治疗终末期膝骨关节炎的常见手术。对于仅存在一个或两个膝关节室的关节炎患者，部分膝关节置换术也是一种治疗选择。部分膝关节置换术可以保留自然的膝关节生物力学，但这些置换术的持续时间可能不如全膝关节置换术。机器人辅助矫形技术可以帮助促进部分膝关节置换术，提高准确性和精确度。该试验将调查可行性并评估更大规模的最终试验的临床结果。这是一项针对 64 名单室或双室膝关节炎患者正在进行的平行随机试点试验的方案。患者被随机分配接受机器人辅助部分膝关节置换术或手动全膝关节置换术。该试点的主要成果是调查更大规模试验的可行性。次要（临床）结果包括关节意识、恢复活动、膝关节功能、患者对变化的总体印象、持续的术后疼痛、再次手术、资源利用和成本效益、与健康相关的生活质量、放射线对准、膝关节步行步态的运动学以及术后 24 个月的并发症。RoboKnees 试点研究是确定机器人辅助部分膝关节置换术结果的第一步。这项研究的结论将用于设计未来的大规模试验。这项研究将使外科医生了解机器人辅助部分膝关节置换术的潜在好处。该研究于 2020 年 5 月 4 日（第一名患者被随机分组​​之前）在 ClinicalTrials.gov 上前瞻性注册（标识符：NCT04378049）。