Hautala Joni, Koriseva Laura, Reito Aleksi, Mattila Ville, Eskelinen Antti
Faculty of Medicine, Tampere University, Tampere, Finland
Coxa Hospital Ltd, Tampere, Finland.
BMJ Open. 2025 May 15;15(5):e091956. doi: 10.1136/bmjopen-2024-091956.
This protocol assesses the effect of a wearable activity tracker-assisted physiotherapeutic intervention on postoperative outcomes in patients undergoing total knee replacement (TKR) surgery. Despite advancements in TKR technology, patient dissatisfaction remains a concern, with adherence to physical activity guidelines being particularly poor among those with knee osteoarthritis. The primary aim of this trial is to evaluate the effectiveness of a smart ring-assisted physiotherapeutic intervention in improving outcomes, as measured by the Oxford Knee Score (OKS), 12 months after a TKR.
We are conducting this randomised controlled trial at Coxa Hospital for Joint Replacement in Finland, where participants are randomly assigned to either an intervention with smart ring-supported physiotherapeutic intervention or a usual care control group in a 1:1 ratio in patients undergoing TKR surgery. The primary outcome measure is the OKS at 12 months after surgery. Secondary outcomes encompass OKS variance, poor postoperative outcome (defined as ≤7 points change on the OKS), quality of life questionnaire EuroQol 5-Dimensions 5-Levels(EQ-5D-5L), knee range of motion, pain scores, patient satisfaction and healthcare resource utilisation. The study population comprises patients aged 18-70 undergoing unilateral primary TKR for knee osteoarthritis. Statistical analysis involves logistic regression and linear mixed models to assess group differences in outcomes over time, with adjustments for relevant covariates.
The trial was approved by the Tampere University Hospital Ethical Committee (R22078) and participants are required to provide written informed consent. Procedures in conducting the trial are aligned with the principles of Good Scientific Practice outlined by the Finnish Advisory Board on Research Integrity. The results of this trial will be disseminated as a series of articles published in a peer-reviewed medical journal.
NCT05599776.
本方案评估可穿戴活动追踪器辅助的物理治疗干预对全膝关节置换术（TKR）患者术后结局的影响。尽管TKR技术取得了进步，但患者满意度仍然是一个问题，尤其是膝骨关节炎患者对体育活动指南的依从性特别差。本试验的主要目的是评估智能指环辅助的物理治疗干预在改善TKR术后12个月结局方面的有效性，结局通过牛津膝关节评分（OKS）来衡量。
我们正在芬兰科克萨关节置换医院进行这项随机对照试验，在接受TKR手术的患者中，参与者以1:1的比例随机分配到接受智能指环支持的物理治疗干预组或常规护理对照组。主要结局指标是术后12个月的OKS。次要结局包括OKS差异、术后不良结局（定义为OKS变化≤7分）、生活质量问卷欧洲五维五水平量表（EQ-5D-5L）、膝关节活动范围、疼痛评分、患者满意度和医疗资源利用情况。研究人群包括年龄在18至70岁之间、因膝骨关节炎接受单侧初次TKR的患者。统计分析采用逻辑回归和线性混合模型来评估不同时间结局的组间差异，并对相关协变量进行调整。
该试验已获得坦佩雷大学医院伦理委员会（R22078）的批准，参与者需要提供书面知情同意书。进行该试验的程序符合芬兰研究诚信咨询委员会概述的良好科学实践原则。本试验的结果将作为一系列文章发表在同行评审的医学杂志上。
NCT05599776。
