[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648083":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":48,"locations":26,"responsibleParty":56,"collaborators":60,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":26},{"fullName":5,"class":6},"Orthoworth Pty Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic-assisted Total Knee Arthroplasty","EXPERIMENTAL","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.",[13,14],"Procedure: Robotic-assisted Total Knee Arthroplasty","Behavioral: Hybrid Virtually-Assisted Peri-operative Rehabilitation Program",{"label":16,"type":17,"description":18,"interventionNames":19},"Conventional Total Knee Arthroplasty","ACTIVE_COMPARATOR","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.",[20,14],"Procedure: Conventional Total Knee Arthroplasty",[22,27,30],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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\u002For 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.",[9],null,{"type":23,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"Primary total knee arthroplasty performed using conventional manual instrumentation without robotic assistance by an experienced orthopaedic surgeon. Surgical technique follows standard clinical practice.",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"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.",[16,9],[36,37,38],"Virtual Comprehensive Care Program","Virtual Peri-operative Comprehensive Care Program","Home-based Rehabilitation Program",[40,44],{"name":41,"affiliation":42,"role":43},"Mark Hurworth, MBChB FRACS FA(Orth)A","Murdoch Orthopaedic Clinic, St John of God Medical Centre, 10\u002F100 Murdoch Drive, Murdoch 6150 WA, Australia","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":47},"Novak S. J. Elliott, MBiomedE PhD","Curtin School of Allied Health, Curtin University, Kent Street, Bentley WA 6102, Australia","STUDY_DIRECTOR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":26,"email":52},"CONTACT","61 + 892669266","n.s.j.elliott@curtin.edu.au",{"name":41,"role":50,"phone":54,"phoneExt":26,"email":55},"61 + 863326341","mark@orthowork.com.au",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Mark Hurworth","Mr Mark Hurworth, MBChB FRACS FA(Orth)A, Orthopaedic Surgeon",[61,64],{"name":62,"class":63},"Curtin University","OTHER",{"name":65,"class":6},"Johnson & Johnson Medical Companies","100648083","robotic-assisted-versus-conventional-total-knee-arthroplasty-with-virtual-home-based-rehabilitation-100648083",false,"NCT07716267","Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation","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","R-TKR VCare","Inclusion Criteria:\n\n* Adults aged 40 years or older.\n* Knee osteoarthritis confirmed by clinical assessment and imaging (e.g., X-ray or MRI) requiring primary total knee replacement surgery.\n* Scheduled to undergo primary total knee arthroplasty with one of the participating surgeons at St John of God Murdoch Hospital.\n* Able to understand the study requirements and provide written informed consent.\n* Physically able to participate in the home-based exercise and stationary cycling rehabilitation program.\n\nExclusion Criteria:\n\n* Unable to understand English sufficiently to provide informed consent, complete study questionnaires, or safely follow the rehabilitation program.\n* Previous major surgery on the leg undergoing knee replacement (for example, revision knee replacement or high tibial osteotomy).\n* Osteoarthritis caused by another medical condition (for example, inflammatory arthritis, previous joint infection, gout, fracture involving the joint, congenital abnormality, or haemochromatosis).\n* Chronic pain unrelated to the knee being replaced that could affect study assessments.\n* Unstable heart or lung conditions that make exercise-based rehabilitation unsafe.\n* Body weight greater than 120 kg.\n* Physical conditions that prevent safe participation in the cycling-based rehabilitation program or completion of the study assessments.","ALL","40 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.\n\nThe main questions the study aims to answer are:\n\n1. Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement?\n2. Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' experience of rehabilitation?\n3. Are there any differences in recovery, length of hospital stay, or safety between the two surgical approaches?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned (by chance, similar to flipping a coin) to receive either robotic-assisted or conventional total knee replacement surgery.\n* 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.\n* 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.\n* Complete questionnaires about knee pain, knee function, general health, quality of life, and satisfaction with the rehabilitation program.\n* 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.\n* 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.\n\nThe 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.",[84],"Osteoarthritis, Knee",[86,87,88,89,90,91,92],"Arthroplasty, Replacement, Knee","Robotic-Assisted Total Knee Arthroplasty","Home-Based Rehabilitation","Telerehabilitation","Recovery of Function","Inertial Measurement Units","Force Plates","NOT_YET_RECRUITING","2026-07-16",{"date":96,"type":97},"2026-07-21","ACTUAL",{"date":99,"type":78},"2026-07",{"date":101,"type":78},"2028-12",{"name":58,"class":6}]