None listed
Conditions
Brief summary
This study will investigate whether robotic-assisted total knee replacement surgery leads to better recovery than conventional knee replacement surgery for people with knee osteoarthritis. Adults scheduled for total knee replacement will be randomly assigned to receive either robotic-assisted surgery or conventional surgery. All participants will complete the same home-based hybrid virtually-assisted rehabilitation program that begins four weeks before surgery and continues for six weeks after surgery, with support from physiotherapists through telehealth and limited in-person care. Recovery will be assessed using questionnaires about knee pain and function, including the Oxford Knee Score, as well as physical performance tests and hospital outcomes during the first six weeks after surgery. The results will help determine whether robotic-assisted knee replacement provides improved recovery compared with conventional surgery when both are combined with the same standardised rehabilitation program.
Interventions
Robotic-assisted total knee arthroplasty (RTKA) Participants will undergo robotic-assisted total knee arthroplasty performed by an experienced orthopaedic surgeon using the VELYS™ Robotic-Assisted Solution (DePuy Synthes / Johnson & Johnson MedTech). - Duration of surgery: Typically up to approximately 120 minutes, depending on clinical complexity. - Use of robotic assistance: The system is used for pre-operative planning and intra-operative guidance of bone resections and implant positioning in accordance with manufacturer guidelines and standard surgical practice. - Monitoring of intervention fidelity: Surgical details, including procedure type (robotic-assisted), tourniquet time, and intra-operative variables, will be documented in standardised operative reports by the treating surgeon. No additional adherence monitoring is required for the surgical intervention. Pre-operative virtual comprehensive care program (4 weeks) Exercise program: Participants complete a structured home-based exercise program delivered via a digital application. - Frequency and duration: - 2–3 sessions per day, - Each session approximately 5–15 minutes, - 7 days per week. - Exercise components include: - Cycling-based interval exercise using an upright stationary cycle (varying resistance and intensity) - Knee range-of-motion exercises (e.g., knee flexion stretch) - Strengthening exercises (e.g., straight leg raise, resisted knee extension, resisted hip extension, heel raises) - Functional exercises (e.g., mini squats, sit-to-stand, isometric wall sit) Exercises are progressed using symptom-based criteria (pain and perceived exertion). Education component: Participants receive structured education during the pre-operative phase, including: - Understanding the surgical procedure and expected recovery - Pain management strategies - Safe exercise participation and progression - Use of the stationary cycle and digital platform - Expectations for post-operative rehabilitation and activity Delivery format: - Physiotherapist-led in-person onboarding session - Supplemented by digital app-based guidance, written materials, and in-app prompts Telehealth and support: - Initial in-person onboarding session (equipment setup and education) - Ongoing remote monitoring and tele-messaging support during business hours (weekdays) - Telehealth consultations are provided as required, based on participant symptoms, adherence, or clinician judgement Adherence monitoring Adherence is monitored using a digital rehabilitation platform, including: - Automatic capture of cycling data (frequency, duration, cadence, power output) - App-based logging of exercise completion - Participant-reported pain and perceived exertion after sessions - Physiotherapist review of adherence and progression via a cloud-based system Post-operative rehabilitation program (6 weeks) Exercise program The post-operative program continues the same structured approach as the pre-operative phase, with progression based on recovery status. - Frequency and duration: - 3 sessions per day, - Each session approximately 8–16 minutes, - 7 days per week - Exercise components include: - Cycling-based rehabilitation (initially partial revolutions/rocking ? progressing to full cycling) - Knee range-of-motion exercises - Strengthening exercises - Functional and mobility exercises (e.g., sit-to-stand, gait-related tasks) The exercise program is largely consistent with the pre-operative program, with early emphasis on: - regaining knee range of motion - gradual return to functional tasks Education component: The post-operative education component follows the same delivery model as the pre-operative phase (physiotherapist-led guidance supplemented by app-based materials and in-app prompts), with content adapted to the recovery phase. Education topics are similar to those provided pre-operatively, with greater emphasis on: - Pain and swelling management during recovery - Safe progression of exercises following surgery - Use of the stationary cycle in rehabilitation - Return to daily activities and functional tasks - Recognition of adverse symptoms and when to seek clinical review Education is reinforced through telehealth interactions and tele-messaging and is individualised according to participant recovery status. Telehealth and support: - Ongoing remote monitoring and tele-messaging support (weekdays) - Telehealth consultations provided as clinically indicated based on symptoms and recovery - Physiotherapist oversight throughout the rehabilitation period Adherence monitoring: Same as pre-operative phase: - Digital platform monitoring of cycling and exercise completion - Pain and exertion tracking - Physiotherapist review of adherence and progression decisions - All deviations and modifications recorded within the system
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adults aged 40 years or older. 2. Radiographically confirmed knee osteoarthritis requiring primary total knee arthroplasty. 3. Scheduled to undergo primary total knee arthroplasty at St John of God Murdoch Hospital, Western Australia. 4. Able to provide informed consent. 5. Able and willing to participate in a home-based virtual rehabilitation program delivered via telehealth.
Exclusion criteria
1. Secondary osteoarthritis of the knee (e.g., inflammatory arthritis or post-traumatic osteoarthritis). 2. Previous major surgery of the operative lower limb that may affect functional outcomes following total knee arthroplasty. 3. Unstable or serious medical conditions that would make participation unsafe or interfere with peri-operative rehabilitation. 4. Inability to safely participate in cycling-based rehabilitation or complete the home-based exercise program. 5. Body weight greater than 120 kg.