Department of Knee Joint Surgery, Honghui Hospital, Xi'an Jiaotong University, No. 555 E. Youyi Rd, Xi'an, Shaanxi, China.
Department of Health Statistics, Faculty of Preventive Medicine, The Air Force Military Medical University, No.169 W. Changle Rd, Xi'an, Shaanxi, China.
J Orthop Surg Res. 2023 Jun 27;18(1):461. doi: 10.1186/s13018-023-03898-z.
Total knee arthroplasty (TKA) is a surgical procedure primarily used to treat patients with end-stage knee osteoarthritis (KOA). Postoperative physical exercise is a critical part of the overall treatment of KOA and can bring significant benefits to the patients' recovery. Wearable devices can monitor patients' exercise data and upload it to the physician's workstation. This allows the rehabilitation physician to make timely adjustments based on the patients' movement feedback, and the surgeon can be informed of the patients' functional status. Overall, this study aims to evaluate the effectiveness of using wearable monitoring devices for rehabilitation exercise after TKA, with a focus on cost, time savings, and patient outcomes.
METHOD/DESIGN: This is a single-center, single-blinded, parallel randomized controlled trial conducted at Xi'an Honghui Hospital, a regional orthopedic medical center. Eligible patients will be recruited to participate in the study, and baseline data collection and clinical assessments will be conducted at the time of admission. Using the principle of random allocation, recruited patients will be divided into either the experimental or control group. Both groups will undergo a standard, widely promoted rehabilitation program. The patients in the experimental group will wear equipment to detect and track mobility in the lower limbs. All patients will return to the outpatient clinic for follow-up assessments at 2 weeks, 12 weeks, and 24 weeks after discharge, where outcome indicators will be measured. The primary outcome will be the cost and time after discharge, while secondary outcomes will include the 6-min walk test (6MWT), range of motion (ROM), visual analog scale (VAS), American Knee Society Score (KSS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
We should encourage the adoption of novel, easy-to-use, supervised devices if they prove to be beneficial for patients in terms of cost, time, and effectiveness after TKA. This type of device is particularly important for people in remote rural areas, those with limited financial resources, and those who are reluctant to return to hospitals for follow-up care. Trial registration Chinese Clinical Trial Registry ChiCTR2300068418. Registered on 17 February 2023.
全膝关节置换术（TKA）主要用于治疗终末期膝骨关节炎（KOA）患者。术后物理锻炼是 KOA 整体治疗的关键部分，可以为患者的康复带来显著益处。可穿戴设备可以监测患者的运动数据并将其上传到医生的工作站。这使康复医师能够根据患者的运动反馈及时进行调整，同时也可以让外科医生了解患者的功能状态。总的来说，本研究旨在评估使用可穿戴监测设备对 TKA 后康复运动的效果，重点关注成本、时间节省和患者结局。
方法/设计：这是一项在西安红会医院（一家地区性骨科医疗中心）进行的单中心、单盲、平行随机对照试验。将招募符合条件的患者参加研究，并在入院时进行基线数据收集和临床评估。通过随机分配原则，将招募的患者分为实验组和对照组。两组都将接受标准的、广泛推广的康复方案。实验组的患者将佩戴设备来检测和跟踪下肢的活动度。所有患者将在出院后 2 周、12 周和 24 周返回门诊进行随访评估，测量结局指标。主要结局将是出院后的成本和时间，次要结局将包括 6 分钟步行试验（6MWT）、关节活动度（ROM）、视觉模拟量表（VAS）、美国膝关节协会评分（KSS）、西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）。
如果新型、易用、有监督的设备在 TKA 后在成本、时间和效果方面对患者有益，我们应该鼓励采用。这种设备对于偏远农村地区的人、经济资源有限的人和不愿意回医院进行随访的人特别重要。
中国临床试验注册中心 ChiCTR2300068418。注册于 2023 年 2 月 17 日。
