[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593245":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":24,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Diakonhjemmet Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","Patients randomly allocated to standard follow-up will be summoned for a hospital visit with a physiotherapist at 8 weeks and 12 months post-surgery. The physiotherapist will conduct an assessment in line with regular clinical practice. If the patient is experiencing lack of improvement or adverse events, an orthopedic surgeon may be consulted. The patients will also answer patient-reported outcomes at 8 weeks and 6- and 12 months post-surgery, however, these answers will not be monitored.",[13],"Other: Usual Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Remote monitoring","EXPERIMENTAL","Patients randomly allocated to the remote monitoring group will answer patient-reported outcome at 1, 2, 3, 6 and 12 months. They will be provided with a brief introduction from the study personnel on how to answer questions remotely through the Youwell\u002FDignio platform. Patients will get an SMS notification on their mobile phone with a link to the questionnaire. They will have to log in with BankID to access the questionnaire. A physiotherapist will monitor the answers and will contact the patient if an unexpected deterioration or adverse events are detected.",[19],"Other: Remote monitoring",[21,25],{"type":6,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"The remote monitoring group will be more closely followed than the control group in order to detect any deterioration over time. This group will not be scheduled for a face-to-face consultation unless it is deemed necessary by a physiotherapist or if the patient contacts the hospital themselves.",[15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Usual Care","The control group will follow usual care with face-to-face consultation with a physiotherapist at 2 and 12 months. They will also anwer questionnaires at 2, 6 and 12 months, but these will not be monitored.",[9],[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Anne Therese Tveter, PhD","CONTACT","+47 91115550","a.t.tveter@medisin.uio.no",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Oslo","Please Select","0370","Norway","NO",{"type":44,"coordinates":45},"Point",[46,47],10.74609,59.91273,{"lat":47,"lon":46},[50,51],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},{"name":31,"role":52,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Anne Therese Tveter","Professor","100593245","remote-monitoring-after-knee-replacement-surgery-100593245",false,"NCT07003932","Remote Monitoring After Knee Replacement Surgery","OA-AID TKR","Inclusion Criteria:\n\n* Men and women, 50 years of age or older\n* Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis\n\nExclusion Criteria:\n\n* Revision of previous knee replacement surgery\n* Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)\n* Congitive dysfunction\n* Knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)\n* Unable to understand Norwegian\n* Low digital competency\u002F cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)\n* Deemed inappropriate for remote monitoring by orthopedic surgeon","ALL","50 Years",{"count":66,"type":67},140,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to evaluate the effect, cost-effectiveness, safety and satisfaction with replacing standardized, pre-scheduled face-to-face visits with remote monitoring and video consultations or face-to-face consultations only when needed after knee replacement surgery due to knee osteoarthritis.\n\nThe primary outcome is the probability of being a OMERACT-OARSI responder at 6 months post-surgery. This is a composite index where participants are classified as a responder or non-responder based on improvement in pain, function and\u002For disease activity. Health-related quality of life and healthcare costs will be used to determine cost-effectiveness. Patient-reported adverse events and statisfaction will be used to determine safety and satisfaction.\n\nPatients will be recruited from Diakonhjemmet Hospital. Patients undergoing knee replacement surgery will be randomly allocated to a control group who are summoned for a face-to-face consultation at Diakonhjemmet Hospital at 2 and 12 months, or a remote monitoring group who will not be scheduled for hospital visits but will answer patient-reported outcomes throught a web-application at 1, 2, 3, 6 and 12 months post-surgery and only be scheduled for hospital visits when needed.\n\nAn additional study with follow-up after 5 and 10 years will be conducted.",[73,74],"Knee Arthroplasty, Total","Knee Replacement Arthroplasty",[76,77,78],"knee arthroplasty","remote follow-up","non-inferiority","2026-05-17",{"date":81,"type":82},"2026-05-19","ACTUAL",{"date":84,"type":82},"2025-06-04",{"date":86,"type":67},"2035-12-31",{"name":5,"class":6},1]