Institute of Bone and Joint Research, The University of Sydney, Sydney, New South Wales, Australia
Department of Rheumatology, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2021 Jan 17;11(1):e041328. doi: 10.1136/bmjopen-2020-041328.
Postsurgical rehabilitation is critical for optimal recovery in people undergoing orthopaedic surgery. Currently, knee and lumbar spine postsurgical care is not standardised, economically sustainable, nor based on quality evidence, contributing to substantial clinical variation, poor outcomes and increasing healthcare costs. This protocol describes the design of a randomised controlled trial aiming to evaluate the effectiveness and cost-effectiveness of a postsurgical clinical pathway augmented by disruptive technology and compared with standardised rehabilitation alone, in decreasing pain and improving function after total knee replacement (TKR) or lumbar laminectomy (with or without fusion).
An assessor-blinded, parallel group, randomised controlled trial will be conducted to recruit 204 consenting participants (102 per arm) of whom 50% are undergoing TKR and 50% lumbar surgery. The intervention group will receive a 6-month technology-enabled rehabilitation package in addition to usual postsurgical care. The package includes (1) an exercise program delivered via the Physitrack app on the iPad, (2) a health-coaching program delivered via video calls and motivational messages, (3) use of physical activity tracker with goal setting and motivational reminders (Fitbit). For those undergoing TKR, the intervention will also include knee joint range of motion self-monitoring via the Goniometer app. The control group will receive usual postsurgical care. Participants will be followed up at 3, 6 and 12 months from the enrolment date. The primary outcome is pain measured with the Numerical Rating Scale at 3 months. Secondary outcomes include pain-related disability, quality of life, computer self-efficacy, physical activity participation and sedentary behaviour. Data analysis will be blinded and by intention-to-treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life-year gained.
This protocol is approved by the human research ethics committee of the University of Sydney. Dissemination will occur through lay summary, infographics, conferences and journal publications.
ACTRN12618001448235.
骨科手术后的康复对于患者的最佳恢复至关重要。目前，膝关节和腰椎手术后的护理既没有标准化，也没有经济可持续性，更没有基于高质量证据，这导致了大量的临床差异、不良结果和医疗保健成本的增加。本方案描述了一项随机对照试验的设计，旨在评估通过破坏性技术增强的术后临床路径与单独标准化康复相比，在减少全膝关节置换术（TKR）或腰椎减压术（伴或不伴融合）后疼痛和改善功能方面的有效性和成本效益。
一项评估者盲法、平行组、随机对照试验将招募 204 名同意的参与者（每组 102 名），其中 50%接受 TKR，50%接受腰椎手术。干预组将在接受常规术后护理的基础上，接受为期 6 个月的技术增强型康复方案。该方案包括：（1）通过 iPad 上的 Physitrack 应用程序提供的锻炼计划；（2）通过视频通话和激励信息提供的健康指导计划；（3）使用具有目标设定和激励提醒功能的身体活动追踪器（Fitbit）。对于接受 TKR 的患者，干预还将包括通过 Goniometer 应用程序进行膝关节活动范围的自我监测。对照组将接受常规术后护理。参与者将从入组日期起，在 3、6 和 12 个月进行随访。主要结局是 3 个月时用数字评分量表测量的疼痛。次要结局包括疼痛相关残疾、生活质量、计算机自我效能、身体活动参与度和久坐行为。数据分析将采用盲法和意向治疗。基于试验的成本效益分析将确定每获得一个质量调整生命年的增量成本。
本方案已获得悉尼大学人类研究伦理委员会的批准。传播将通过通俗易懂的摘要、信息图、会议和期刊出版物进行。
ACTRN12618001448235。
