Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
R-TKR VCare
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
3 other identifiers
interventional
60
0 countries
N/A
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 21, 2026
July 1, 2026
2.4 years
July 6, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Secondary Outcomes (23)
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.
- +18 more secondary outcomes
Study Arms (2)
Robotic-assisted Total Knee Arthroplasty
EXPERIMENTALParticipants undergo robotic-assisted primary total knee arthroplasty and receive a standardized hybrid virtually-assisted comprehensive peri-operative care program comprising a 4-week pre-operative preparation phase and a 6-week post-operative rehabilitation phase, including patient education, home-based exercise, telehealth support, tele-messaging, remote monitoring, and limited in-person physiotherapy services.
Conventional Total Knee Arthroplasty
ACTIVE COMPARATORParticipants undergo conventional (non-robotic) primary total knee arthroplasty and receive the same standardized hybrid virtually-assisted comprehensive peri-operative care program comprising a 4-week pre-operative preparation phase and a 6-week post-operative rehabilitation phase, including patient education, home-based exercise, telehealth support, tele-messaging, remote monitoring, and limited in-person physiotherapy services.
Interventions
Primary total knee arthroplasty performed using conventional manual instrumentation without robotic assistance by an experienced orthopaedic surgeon. Surgical technique follows standard clinical practice.
A 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.
Primary 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mark Hurworthlead
- Curtin Universitycollaborator
- Johnson & Johnson Medical Companiescollaborator
Related Publications (3)
Hurworth M, Evans JM, Gibbons R, Mackie KE, Edmondston SJ. Cycle Sprint Test for the Evaluation of Lower Limb Muscle Power After Total Knee Arthroplasty: A Proof-of-Concept Study. Arthroplast Today. 2021 Jun 15;9:118-121. doi: 10.1016/j.artd.2021.05.007. eCollection 2021 Jun.
PMID: 34189216BACKGROUNDHurworth M, Trigg C, Haywood Z, Edmondston SJ. Feasibility and Patient Acceptability of a Cycling-based Telerehabilitation Program Following Primary Total Knee Arthroplasty. Journal of Orthopaedic Reports. 2026 Mar 18:100967. doi:10.1016/j.jorep.2026.100967
BACKGROUNDEdmondston, S.J, Gibbons, R, Mackie, K.E., Haywood, Z., Hince, D., Hurworth M. Reliability of a Cycle Sprint Test to Measure Lower Limb Muscle Power. Physical Medicine and Rehabilitation - International. 2021 8(4):1189. doi:10.26420/physmedrehabilint.2021.1189
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Hurworth, MBChB FRACS FA(Orth)A
Murdoch Orthopaedic Clinic, St John of God Medical Centre, 10/100 Murdoch Drive, Murdoch 6150 WA, Australia
- STUDY DIRECTOR
Novak S. J. Elliott, MBiomedE PhD
Curtin School of Allied Health, Curtin University, Kent Street, Bentley WA 6102, Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Mr Mark Hurworth, MBChB FRACS FA(Orth)A, Orthopaedic Surgeon
Study Record Dates
First Submitted
July 6, 2026
First Posted
July 21, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Beginning after publication of the primary trial results, with no specified end date. Requests will be considered after study completion and publication, subject to ethics approval, institutional data governance requirements, participant consent, applicable regulations, and execution of any required data access agreement.
- Access Criteria
- Access may be granted to researchers for secondary analyses, data verification, meta-research, systematic reviews, meta-analyses, studies exploring new research questions, or studies testing whether findings can be repeated or confirmed. Requests must include a scientifically sound proposal or protocol and will be reviewed case-by-case by the study team, trial custodian, sponsor, or relevant data sharing committee. Access is subject to ethics approval where required, institutional governance approval, and execution of a data access agreement specifying permitted uses, data security requirements, and restrictions on re-identification.
De-identified individual participant data underlying the primary and secondary trial analyses may be shared following publication of the primary trial results. This may include de-identified outcomes data, primary outcome data, safety data, and other trial data generated and/or analysed under this protocol. Baseline or pilot data external to this protocol will not be shared. No identifiable participant information will be shared. Data sharing will occur only where consistent with participant consent, ethics approval, institutional data governance requirements, applicable regulations, and any required data access agreement.