protocolSection identificationModule nctId: NCT06389435, orgStudyIdInfo id: 2024DS, secondaryIdInfos id: Knee, type: OTHER, domain: Danderyds sjukhus, briefTitle: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques, acronym: ROCKETS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Stockholm South General Hospital, descriptionModule briefSummary: Rationale for conducting the study:The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.Study design:Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.Study population:Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.Number of patients:400Inclusion criteria:Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.Exclusion criteria:Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.Primary outcome variables:The Forgotten Joint Score (FJS) at 2 years after surgery, conditionsModule conditions: Knee Arthroplasty, Total, conditions: Robotic-assisted, conditions: Osteoarthritis of the Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Patients will be randomized to undergo TKR or RTKR, outcomesModule primaryOutcomes measure: The Forgotten Joint Score (FJS), secondaryOutcomes measure: KOOS, secondaryOutcomes measure: ADLS knee instability, secondaryOutcomes measure: The Forgotten Joint Score (FJS), secondaryOutcomes measure: EQ-5D, secondaryOutcomes measure: Knee alignment, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Danderyds Sjukhus, status: RECRUITING, city: Stockholm, zip: 18288, country: Sweden, contacts name: Olof Skoldenberg, Md, PhD, role: CONTACT, phone: 800-555-5555, email: olof.skoldenberg@ki.se, contacts name: Olof Skoldenberg, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Karl Erikson, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False