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:
1. Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement? 2. Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' experience of rehabilitation? 3. 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.
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.
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.
Parallel
Robotic-assisted Total Knee Arthroplasty
Procedure/SurgeryPrimary total knee arthroplasty performed using an approved robotic-assisted surgical system by an experienced orthopaedic surgeon. Robotic assistance is used for pre-operative planning and/or intra-operative execution of bone resections and component positioning in accordance with the manufacturer's instructions for use and the surgeon's standard clinical practice.
Conventional Total Knee Arthroplasty
Procedure/SurgeryPrimary total knee arthroplasty performed using conventional manual instrumentation without robotic assistance by an experienced orthopaedic surgeon. Surgical technique follows standard clinical practice.
Hybrid Virtually-Assisted Peri-operative Rehabilitation Program
BehavioralA standardized hybrid virtually-assisted comprehensive peri-operative care program delivered before and after surgery. The program comprises a 4-week pre-operative preparation phase followed by a 6-week post-operative rehabilitation phase. It includes patient education, home-based cycling and non-cycling exercises, telehealth consultations, tele-messaging support, remote monitoring, limited in-person physiotherapy services, and symptom-contingent, rule-based exercise progression. The program is delivered identically to both study groups using standardized, protocol-defined procedures.
Oxford Knee Score (OKS), a composite patient-reported outcome measure of knee-related pain and functional limitation.
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).
Adherence to the virtual comprehensive care program
Adherence will be defined as the proportion of prescribed exercise sessions completed over the intervention period, based on session completion logs recorded in the digital rehabilitation platform and study-specific database. Additional data captured by the platform, including cycling metrics (e.g., cadence and power output) and participant-reported pain and perceived exertion, will be used to support physiotherapist monitoring and exercise progression but are not included in the calculation of adherence.
Program completion of the virtual comprehensive care program
Program completion will be determined from records within the digital rehabilitation platform and study-specific database, defined as participation through the full intervention period (4-week pre-operative and 6-week post-operative phases), as documented by session completion logs and physiotherapist records.
Tourniquet time
Provided by the operating surgeon and recorded in the study database using the participant's study identification code.
Hospital length of stay
Hospital length of stay, measured in days from hospital admission to hospital discharge for the index admission for total knee arthroplasty, provided by the operating surgeon and recorded in the study database.
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Mark Hurworth
Lead sponsor
Orthoworth Pty Ltd
Sponsor institution
Curtin University
Collaborator
Johnson & Johnson Medical Companies
Collaborator
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