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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: Robotic-assisted Total Knee Arthroplasty; Behavioral: Hybrid Virtually-Assisted Peri-operative Rehabilitation Program; Procedure: Conventional Total Knee Arthroplasty

Detailed Description

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.

Participants, outcome assessors, and data analysts will remain blinded to treatment allocation wherever feasible. Because the operating surgeon must perform the allocated procedure, surgeons cannot be blinded. The study focuses on the first six weeks after surgery, corresponding to completion of the structured early rehabilitation programme and the period during which most patients experience the greatest improvements in pain, mobility, and physical function. Analyses will follow the intention-to-treat principle.

Participants allocated to either treatment group will undergo the same clinical pathway before and after surgery. Both robotic-assisted and conventional TKA are established procedures routinely used in contemporary orthopaedic practice.

Following surgery, all participants will complete the same six-week virtual comprehensive care programme, incorporating pre-operative preparation, structured home-based rehabilitation, physiotherapist supervision, telehealth consultations, digital messaging, remote monitoring, and exercise progression. The rehabilitation programme has been standardised to ensure that postoperative management is equivalent for both treatment groups, allowing any observed differences in recovery to be interpreted in the context of the surgical technique rather than differences in rehabilitation.

Recovery will be evaluated using a combination of patient-reported questionnaires, clinical assessments, physical performance tests, and biomechanical measures collected at predefined time points before and after surgery. These assessments are designed to provide a comprehensive evaluation of early recovery by examining symptoms, physical function, strength, walking performance, movement quality during functional tasks, rehabilitation engagement, and patient experience.

By combining conventional clinical outcome measures with objective biomechanical assessment, the study aims to provide a detailed understanding of how recovery progresses during the early postoperative period and whether differences between surgical techniques are reflected in both patient-reported outcomes and physical performance.

This trial addresses an important evidence gap by evaluating robotic-assisted and conventional TKA within an identical, contemporary rehabilitation programme. By reducing variation in postoperative care, the study is designed to isolate the contribution of surgical technique to early recovery.

The findings will improve understanding of the comparative effectiveness of robotic-assisted and conventional TKA during the first six weeks after surgery and may assist patients, clinicians, and health services when making decisions regarding surgical technology and peri-operative care pathways. More broadly, the study will contribute evidence regarding the integration of surgical innovation with structured, digitally supported rehabilitation programmes and may inform future models of patient-centred arthroplasty care.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Novak S. J. Elliott, MBiomedE PhD; Phone Number: 61 + 892669266; Email: n.s.j.elliott@curtin.edu.au
• Study Contact Backup: Name: Mark Hurworth, MBChB FRACS FA(Orth)A; Phone Number: 61 + 863326341; Email: mark@orthowork.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic-assisted Total Knee Arthroplasty; Participants 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.	Procedure: Robotic-assisted Total Knee Arthroplasty; 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.; Behavioral: Hybrid Virtually-Assisted Peri-operative Rehabilitation Program; 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.; Other Names: Home-based Rehabilitation Program; Virtual Comprehensive Care Program; Virtual Peri-operative Comprehensive Care Program
Active Comparator: Conventional Total Knee Arthroplasty; Participants 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.	Behavioral: Hybrid Virtually-Assisted Peri-operative Rehabilitation Program; 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.; Other Names: Home-based Rehabilitation Program; Virtual Comprehensive Care Program; Virtual Peri-operative Comprehensive Care Program; Procedure: Conventional Total Knee Arthroplasty; Primary total knee arthroplasty performed using conventional manual instrumentation without robotic assistance by an experienced orthopaedic surgeon. Surgical technique follows standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Assessed at completion of the peri-operative program (6 weeks post-surgery).
Tourniquet time	Provided by the operating surgeon and recorded in the study database using the participant's study identification code.	During the total knee arthroplasty procedure.
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.	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.	KOOS-JR questionnaire (validated patient-reported outcome measure assessing knee-related symptoms and functional limitation, combined into a single score ranging from 0 to 100, 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.
Health-related quality of life	EQ-5D-5L questionnaire (validated generic, preference-based measure of health-related quality of life generating a utility index score anchored at 0 [death] and 1 [full health]).	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Knee pain intensity	Patient-reported pain intensity of the operated knee measured using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst pain imaginable.	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	Thigh circumference of the operated limb measured using a non-elastic anthropometric tape measure at a standardised distance (10 cm proximal to the superior pole of the patella), with the participant in supine and the knee extended.	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	Calf circumference of the operated limb measured using a non-elastic anthropometric tape measure at the point of maximal calf girth, with the participant in prone and the measurement location standardised relative to the fibular head.	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	Maximum active knee flexion angle of the operated limb with the participant in supine performing a heel slide, measured using a goniometer.	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	Maximum active knee extension angle of the operated limb with the participant in supine and the heel supported to allow full knee straightening, measured using a goniometer.	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	Maximum passive knee extension angle of the operated limb with the participant in supine and the heel supported to allow full knee straightening, measured using a goniometer with gentle examiner-applied overpressure.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Walking speed	10 metre walk test (10MWT), recorded as time to traverse the central 10 m at maximal walking speed using a standardised acceleration and deceleration protocol.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Step length symmetry during walking	Gait symmetry derived from wearable inertial measurement units during a 10-metre walk test, quantified as the mean symmetry ratio of step length between the operated limb and contralateral limb across all gait cycles of the walk test, with a value of 1 indicating perfect symmetry.	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.	Sagittal plane knee joint kinematics derived from wearable inertial measurement units during a 10-metre walk test, quantified as peak knee flexion angle of the operated knee during the swing phase. Peak knee flexion values are averaged across all steps recorded during the walk test.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Double support time during walking	Temporal gait characteristics derived from wearable inertial measurement units during a 10-metre walk test, quantified as double support time expressed as a percentage of the gait cycle. Double support time values are averaged across all gait cycles recorded during the walk test.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Sit-to-stand performance	Five Times Sit-to-Stand Test (5xSTS), recorded as the time (seconds) taken to complete five sit-to-stand repetitions from a standard chair as quickly as possible without use of the upper limbs.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Sit-to-stand loading symmetry	Measured during the Five Times Sit-to-Stand test using dual force plates, quantified as the mean symmetry ratio of peak vertical ground reaction force between the operated and non-operated limbs across the five sit-to-stand repetitions, with a value of 1 indicating perfect 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	Measured during the Five Times Sit-to-Stand test using dual force plates and wearable inertial measurement units, quantified as the peak sagittal-plane knee extension moment of the operated limb during the rising phase, averaged across the five repetitions.	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.	Maximum isometric knee flexion torque of the operated limb measured using a fixed force frame.	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	Maximum isometric knee extension torque of the operated limb measured using a fixed force frame.	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)	Operated limb muscle power will be measured using a standardised cycle ergometer sprint test. Participants perform three 10-second maximal seated sprint efforts on a stationary cycle, with 1-minute recovery between efforts. Power output (Watts) is recorded using a dual-sided crank-based power meter, enabling separate measurement of left and right limb power. Peak power output is defined as the highest power value (Watts) recorded for the operated limb across the three sprint efforts.	Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.
Patient satisfaction with care	Patient satisfaction measured using the Net Promoter Score (NPS) questionnaire (0-10 scale, summarised as Net Promoter Score).	6 weeks post-surgery.

Collaborators and Investigators

• Sponsor: Mark Hurworth
• Collaborators: Curtin University; Johnson & Johnson Medical Companies
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• Hurworth 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
• Edmondston, 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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; Recovery of Function; Arthroplasty, Replacement, Knee; Home-Based Rehabilitation; Robotic-Assisted Total Knee Arthroplasty; Inertial Measurement Units; Force Plates
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: DPS-JMP-2023-044 (Other Grant/Funding Number: Johnson & Johnson Medical Pty Ltd); ACTRN12626000457347p (Registry Identifier: ANZCTR); U1111-1336-7936 (Registry Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No