Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation

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.

• Adherence to the virtual comprehensive care program [Time frame: 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 [Time frame: Assessed at completion of the peri-operative program (6 weeks post-surgery).]
• Tourniquet time [Time frame: During the total knee arthroplasty procedure.]
• Hospital length of stay [Time frame: 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. [Time frame: Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.]
• Health-related quality of life [Time frame: Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.]
• Knee pain intensity [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline (4 weeks pre-operative), pre-surgery (after completion of the pre-operative program), and 6 weeks post-surgery.]