[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633938":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":42,"overallOfficials":13,"centralContacts":13,"locations":54,"responsibleParty":74,"collaborators":13,"id":77,"slug":13,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":13,"enrollmentInfo":86,"targetDuration":13,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":56,"whyStopped":13,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Forgotten Joint Score (FJS)","Forgotten Joint Score (FJS) The Forgotten Joint Score (FJS) is a patient-reported outcome measure assessing joint awareness in daily life following total knee arthroplasty. The score ranges from 0 to 100, with higher scores indicating better outcomes (less joint awareness).","Pre-operative, 6 weeks, 6 months, and 2 years post-operatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Participants receive either kinematic or functional alignment based on the operating surgeon as part of routine clinical care. Within each alignment group, participants are randomized to receive one of two implant insert types (medial stabilised or cruciate retaining) using a REDCap-based allocation process.","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective interventional study evaluating outcomes in patients undergoing robotic-assisted total knee arthroplasty using the VELYS system. The study includes patients treated using either kinematic alignment or functional alignment techniques, which are determined by the operating surgeon based on clinical practice and are not randomized as part of the study protocol.\n\nWithin each alignment group, participants are randomized to receive one of two implant insert types: medial stabilised (MS) or cruciate retaining (CR). Randomisation is performed using a REDCap-based allocation system.\n\nThe primary objective of the study is to assess patient-reported outcomes following surgery. Secondary outcomes may include clinical and functional measures collected at predefined time points, including pre-operative and post-operative follow-up visits.\n\nThis study reflects real-world clinical practice while incorporating a randomized component for implant selection. The design allows for evaluation of both implant-related outcomes and comparisons across different alignment techniques, while maintaining clarity regarding which aspects of the intervention are randomized.",[23,29,34,38],{"label":24,"type":25,"description":26,"interventionNames":27},"Kinematic Alignment + Medial Stabilized Insert","EXPERIMENTAL","Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.",[28],"Device: Medial Stabilized Insert",{"label":30,"type":25,"description":31,"interventionNames":32},"Kinematic Alignment + Cruciate Retaining Insert","Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty",[33],"Device: Cruciate Retaining Insert",{"label":35,"type":25,"description":36,"interventionNames":37},"Functional Alignment + Medial Stabilized Insert","Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.",[28],{"label":39,"type":25,"description":40,"interventionNames":41},"Functional Alignment + Cruciate Retaining Insert","Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty",[33],[43,50],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DEVICE","Medial Stabilized Insert","A medial stabilised polyethylene insert used in robotic-assisted total knee arthroplasty to provide enhanced stability during knee motion.",[35,24],[49],"MS insert",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":13},"Cruciate Retaining Insert","A cruciate retaining polyethylene insert used in robotic-assisted total knee arthroplasty that preserves the posterior cruciate ligament.",[39,30],[55],{"facility":5,"status":56,"city":57,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Singapore","SG",{"type":60,"coordinates":61},"Point",[62,63],103.85007,1.28967,{"lat":63,"lon":62},[66,71],{"name":67,"role":68,"phone":69,"phoneExt":13,"email":70},"Clinical Research Coordinator","CONTACT","+6563266400","shameemah.mohamed.fouze@sgh.com.sg",{"name":72,"role":73,"phone":13,"phoneExt":13,"email":13},"Lincoln Ming Han Liow, MBBS","PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Lincoln Liow Ming Han","A\u002FProf Dr Lincoln Liow","100633938",false,"NCT07533188","Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types","A Prospective Randomized Controlled Trial Comparing Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty Using the VELYS System","VELYS RCT","\\*Inclusion Criteria:\\*\n\n* Patients undergoing robotic-assisted total knee arthroplasty using the VELYS system\n* Diagnosis of knee osteoarthritis requiring surgical intervention\n* Able to provide informed consent\n* Willing to complete patient-reported outcome measures\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Patients undergoing revision knee arthroplasty\n* Presence of active infection\n* Inability to comply with follow-up assessments\n* Severe co-morbidities that may affect surgical outcomes or participation in the study","ALL","18 Years",{"count":87,"type":88},240,"ESTIMATED","INTERVENTIONAL",[91],"NA","This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.",[94,95],"Knee Osteoarthritis","Degenerative Joint Disease of the Knee",[97,98,99,100,45,51,101,102],"Robotic-Assisted Total Knee Arthroplasty","VELYS System","Kinematic Alignment","functional Alignment","Patient-Reported Outcomes","Total Knee Replacement","2026-04-16",{"date":105,"type":106},"2026-04-21","ACTUAL",{"date":108,"type":106},"2025-10-14",{"date":110,"type":88},"2027-10-14",{"name":5,"class":6},1]