protocolSection identificationModule nctId: NCT06305065, orgStudyIdInfo id: 2024.089, briefTitle: Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments., conditionsModule conditions: Knee Osteoarthritis, conditions: Total Knee Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Subjects will be randomly assigned to the KUNWU navigational or CORI Surgical System or conventional manual instrumentation groups according to a balanced randomization procedure using a 1:1:1 allocation ratio. To ensure balanced group assignment, a block randomization schedule will be generated. All subjects who sign the ICF and meet all inclusion and exclusion criteria will be randomized in a 1:1:1 randomization allocation ratio. The block size should be sufficiently small to allow approximately equal allocation of subjects in each group should the study be terminated prematurely whilst also being large enough so as the next treatment cannot be guessed. The study is non-blinded., enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: KUNWU Navigation TKA procedure, interventions name: CORI Surgical System TKA procedure, interventions name: Conventional TKA procedure, outcomesModule primaryOutcomes measure: Post-operative leg alignment - Hip-knee-ankle axis (HKA axis), secondaryOutcomes measure: Lateral View, secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral coronal alignment (FCA), secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral sagittal alignment (FSA), secondaryOutcomes measure: Standard Radiographic Evaluation - Femoral component rotation (FCR), secondaryOutcomes measure: Standard Radiographic Evaluation - Tibial coronal alignment (TCA), secondaryOutcomes measure: Standard Radiographic Evaluation - Tibial slope, secondaryOutcomes measure: Standard Radiographic Evaluation - Joint line distance, secondaryOutcomes measure: Knee Society Score (KSS), secondaryOutcomes measure: Oxford Knee Score (OKS), secondaryOutcomes measure: HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L, secondaryOutcomes measure: Forgotten Joint Score (FJS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Chinese University of Hong Kong, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False