Evaluation Of Robotic-Assisted Versus Conventional Total Knee Arthroplasty Within A Virtual Peri-Operative Comprehensive Care Program: A Protocol For A Randomized Controlled Trial Assessing Knee-related Pain and Functional Limitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Oxford Knee Score (OKS), a composite patient-reported outcome measure of knee-related pain and functional limitation.
研究概览
简要总结
The goal of this clinical trial is to learn whether robotic-assisted total knee replacement improves recovery compared with conventional total knee replacement in adults with knee osteoarthritis when both groups follow the same structured home-based rehabilitation program. Robotic-assisted and conventional (non-robotic) total knee replacement are both widely used as part of routine clinical care. This study will compare recovery during the first six weeks after surgery.
The main questions the study aims to answer are:
- Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement?
- Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' experience of rehabilitation?
- Are there any differences in recovery, length of hospital stay, or safety between the two surgical approaches?
Researchers will compare robotic-assisted total knee replacement with conventional total knee replacement. Both groups will complete the same rehabilitation program before and after surgery so that any differences in recovery are more likely to be related to the type of surgery rather than differences in rehabilitation.
Participants will:
- Be randomly assigned (by chance, similar to flipping a coin) to receive either robotic-assisted or conventional total knee replacement surgery.
- Complete a structured rehabilitation program that includes education and exercises during the four weeks before surgery and a home-based exercise program for six weeks after surgery.
- Use a study-provided seated exercise bike, receive support from a physiotherapist through telehealth appointments, secure messaging, and home visits where required, and use a digital application to guide the rehabilitation program and record exercise completion and symptoms.
- Complete questionnaires about knee pain, knee function, general health, quality of life, and satisfaction with the rehabilitation program.
- Attend study assessments before surgery, immediately before surgery after completing the pre-surgery program, and about six weeks after surgery. These assessments include simple physical activities such as standing up from a chair, walking, cycling, and measuring leg strength.
- Allow information about their surgery and hospital stay, such as the duration of surgery and the number of nights spent in hospital, to be recorded for the study.
The results of this study will help researchers understand whether robotic-assisted total knee replacement provides additional benefits over conventional total knee replacement when both are combined with the same structured home-based rehabilitation program. The findings may help patients, healthcare professionals, and health services make informed decisions about the use of robotic-assisted knee replacement surgery.
详细描述
Total knee replacement, also known as total knee arthroplasty (TKA) is an effective treatment for people with end-stage knee osteoarthritis who continue to experience pain and functional limitation despite non-surgical management. Advances in enhanced recovery pathways have shortened hospital stays, with much of the recovery process now occurring at home during the first few weeks after surgery. As a result, both surgical technique and postoperative rehabilitation may influence early recovery.
Robotic-assisted TKA has been introduced to improve the precision and consistency of implant positioning and alignment. Although robotic systems have demonstrated improvements in surgical accuracy compared with conventional techniques, evidence that these technical advantages translate into clinically meaningful improvements in early patient outcomes remains inconsistent. Previous comparative studies have varied substantially in peri-operative care pathways, rehabilitation protocols, outcome assessment, and follow-up, making it difficult to determine whether differences in recovery are attributable to the surgical technique itself or to differences in postoperative management.
This trial has been designed to evaluate robotic-assisted and conventional TKA within an identical, structured peri-operative rehabilitation pathway. By standardising rehabilitation, participant education, postoperative support, and follow-up across both treatment groups, the study aims to minimise variation in postoperative care and provide a clearer assessment of whether robotic assistance offers additional benefit beyond conventional surgical techniques.
The study also reflects contemporary models of arthroplasty care that increasingly incorporate virtual rehabilitation, telehealth, remote monitoring, and home-based exercise. Evaluating surgical techniques within a standardised virtual care programme provides evidence that is directly relevant to current clinical practice, where much of early recovery occurs outside the hospital setting.
This study is a prospective, single-centre, parallel-group randomised controlled trial conducted at St John of God Murdoch Hospital in Western Australia. Approximately 60 adults undergoing primary TKA for radiographically confirmed knee osteoarthritis will be randomly allocated in a 1:1 ratio to receive either robotic-assisted or conventional surgery performed as part of routine clinical care by experienced orthopaedic surgeons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to treatment allocation. Blinding of participants will be supported through standardized peri-operative communication and delivery of an identical hybrid virtually-assisted comprehensive peri-operative care program in both groups. Participants will not be informed of their surgical allocation and will be reminded not to disclose details of their procedure during outcome assessments. Data analysts will also remain blinded through the use of masked group labels until completion of the primary analysis. Operating surgeons and clinical care providers cannot be blinded because of the nature of the surgical interventions and routine peri-operative care.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 years or older.
- •Knee osteoarthritis confirmed by clinical assessment and imaging (e.g., X-ray or MRI) requiring primary total knee replacement surgery.
- •Scheduled to undergo primary total knee arthroplasty with one of the participating surgeons at St John of God Murdoch Hospital.
- •Able to understand the study requirements and provide written informed consent.
- •Physically able to participate in the home-based exercise and stationary cycling rehabilitation program.
排除标准
- •Unable to understand English sufficiently to provide informed consent, complete study questionnaires, or safely follow the rehabilitation program.
- •Previous major surgery on the leg undergoing knee replacement (for example, revision knee replacement or high tibial osteotomy).
- •Osteoarthritis caused by another medical condition (for example, inflammatory arthritis, previous joint infection, gout, fracture involving the joint, congenital abnormality, or haemochromatosis).
- •Chronic pain unrelated to the knee being replaced that could affect study assessments.
- •Unstable heart or lung conditions that make exercise-based rehabilitation unsafe.
- •Body weight greater than 120 kg.
- •Physical conditions that prevent safe participation in the cycling-based rehabilitation program or completion of the study assessments.
结局指标
主要结局
Oxford Knee Score (OKS), a composite patient-reported outcome measure of knee-related pain and functional limitation.
时间窗: Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Oxford Knee Score questionnaire (validated 12-item patient-reported outcome measure assessing knee-related pain and functional limitation, combined into a single score ranging from 0 to 48, with higher scores indicating better knee-related health status).
次要结局
- Adherence to the virtual comprehensive care program(Continuously throughout the peri-operative program via the digital platform and summarised weekly (pre-operative weeks 1-4 and post-operative weeks 1-6), with a final cumulative adherence value at 6 weeks post-surgery.)
- Program completion of the virtual comprehensive care program(Assessed at completion of the peri-operative program (6 weeks post-surgery).)
- Tourniquet time(During the total knee arthroplasty procedure.)
- Hospital length of stay(From hospital admission until hospital discharge, assessed up to 30 days.)
- KOOS-JR (Knee Injury and Osteoarthritis Outcome Score - Joint Replacement), a composite patient-reported outcome measure of knee-related symptoms and functional limitation reflecting overall knee-related health status.(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Health-related quality of life(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Knee pain intensity(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Thigh circumference of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Calf circumference of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Active knee flexion end-range angle of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Active knee extension end-range angle of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Passive knee extension end-range angle of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Walking speed(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Step length symmetry during walking(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Peak knee flexion angle during swing phase of walking.(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Double support time during walking(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Sit-to-stand performance(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Sit-to-stand loading symmetry(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Sit-to-stand knee extensor moment(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Isometric knee flexion strength of the operated limb.(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Isometric knee extension strength of the operated limb(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Operated limb muscle power (peak power output, Watts)(Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.)
- Patient satisfaction with care(6 weeks post-surgery.)
研究者
Mark Hurworth
Mr Mark Hurworth, MBChB FRACS FA(Orth)A, Orthopaedic Surgeon
Orthoworth Pty Ltd