[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580631":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":156,"collaborators":159,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":164,"sex":170,"minAge":171,"maxAge":18,"enrollmentInfo":172,"targetDuration":18,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: AtMoves Knee System group","EXPERIMENTAL","The intervention group will undergo a CT-scan using the AtMoves Knee System. They are allowed to undergo the diagnostic pathway determined by their treating orthopedic surgeon.",[13],"Device: AtMoves Knee System",{"label":15,"type":16,"description":17,"interventionNames":18},"Control: usual care\u002Fdiagnostics","NO_INTERVENTION","The control group is not allowed to undergo a CT-scan using the AtMoves Knee System. They will undergo the diagnostic pathway determined by their treating orthopedic surgeon.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","AtMoves Knee System","The AtMoves Knee Stystem is a loading device that is able to exert force in varus and valgus. when these forces are applied during a CT-scan micromotions of the tibial component of the total knee prosthesis can be detected.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Milo J.K. Mokkenstorm, MD","CONTACT","+31205662172","digitalknee@amsterdamumc.nl",[32,51,65,80,114,129,142],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"St. Maartenskliniek","NOT_YET_RECRUITING","Nijmegen","Gelderland","6574 NA","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],5.85278,51.8425,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Petra Heesterbeek","+3124 365 9911","p.heesterbeek@maartenskliniek.nl",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Zuyderland Ziekenhuis","Heerlen","Limburg","6419 PC",{"type":41,"coordinates":57},[58,59],5.98154,50.88365,{"lat":59,"lon":58},[62],{"name":18,"role":28,"phone":63,"phoneExt":18,"email":64},"+3188 459 7777","info@zuyderland.nl",{"facility":66,"status":34,"city":67,"state":68,"zip":69,"country":38,"countryCode":39,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Amphia ziekenhuis","Breda","North Brabant","4818CK",{"type":41,"coordinates":71},[72,73],4.77596,51.58656,{"lat":73,"lon":72},[76],{"name":77,"role":28,"phone":78,"phoneExt":18,"email":79},"I Koenraadt-Van Oost","+3176 595 5000","ivanoost@amphia.nl",{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":38,"countryCode":39,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Amsterdam UMC","RECRUITING","Amsterdam","North Holland","1105AZ",{"type":41,"coordinates":87},[88,89],4.88969,52.37403,{"lat":89,"lon":88},[92,94,98,100,102,104,106,108,110,112],{"name":27,"role":28,"phone":93,"phoneExt":18,"email":30},"+3120-5662172",{"name":95,"role":28,"phone":96,"phoneExt":18,"email":97},"Leendert Blankevoort, PhD","+31 20 56 66980","L.Blankevoort@amsterdamumc.nl",{"name":95,"role":99,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":27,"role":101,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":103,"role":101,"phone":18,"phoneExt":18,"email":18},"Chiel Klein, Bsc",{"name":105,"role":101,"phone":18,"phoneExt":18,"email":18},"Arthur Kievit, MD",{"name":107,"role":101,"phone":18,"phoneExt":18,"email":18},"Matthias Schafroth, MD, PhD",{"name":109,"role":101,"phone":18,"phoneExt":18,"email":18},"Geert Streekstra, PhD",{"name":111,"role":101,"phone":18,"phoneExt":18,"email":18},"Iwan Dobbe, PhD",{"name":113,"role":101,"phone":18,"phoneExt":18,"email":18},"George S Buijs, MD",{"facility":115,"status":34,"city":116,"state":117,"zip":118,"country":38,"countryCode":39,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"OCON","Hengelo","Overijsel","7555 DL",{"type":41,"coordinates":120},[121,122],6.79306,52.26583,{"lat":122,"lon":121},[125],{"name":126,"role":28,"phone":127,"phoneExt":18,"email":128},"Max Havinga","+3188 708 3370","f.wagenaar@ocon.nl",{"facility":130,"status":34,"city":131,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"NoordWest Ziekenhuisgroep","Alkmaar",{"type":41,"coordinates":133},[134,135],4.74861,52.63167,{"lat":135,"lon":134},[138],{"name":139,"role":28,"phone":140,"phoneExt":18,"email":141},"George Buijs, MD","+3172 548 4444","g.buijs@nwz.nl",{"facility":143,"status":34,"city":144,"state":18,"zip":145,"country":38,"countryCode":39,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Elisabeth-TweeSteden Ziekenhuis","Tilburg","5022 GC",{"type":41,"coordinates":147},[148,149],5.0913,51.55551,{"lat":149,"lon":148},[152],{"name":153,"role":28,"phone":154,"phoneExt":18,"email":155},"Lennard van den Boom","+3113 221 0000","info@etz.nl",{"type":99,"investigatorFullName":157,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Leendert Blankevoort","Associate professor",[160],{"name":161,"class":6},"Sint Maartenskliniek","100580631","digital-knee-study-adequately-diagnosing-total-knee-arthroplasty-loosening-by-evaluating-the-atmoves-knee-system-in-a-routine-clinical-setting-100580631",false,"NCT06839807","DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting","Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting","DigitalKnee","Inclusion Criteria:\n\n* Age 18 years or older.\n* Subjects must have underwent either unilateral or bilateral TKA surgery.\n* Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon\n* The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.\n* The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.\n* Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.\n\nExclusion Criteria:\n\n* A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)\n* Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.\n* Posttraumatic or congenital deformation of the leg for which the loading device does not fit.\n* Pregnancy or suspected pregnancy.\n* Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.","ALL","18 Years",{"count":173,"type":174},124,"ESTIMATED","INTERVENTIONAL",[177],"NA","The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is:\n\nDoes the use of the AtMoves Knee System reduce the percentage of failed outcomes? A \"failed outcome\" is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months.\n\nResearchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of \"failed outcomes\" between these groups.\n\nDuring the one-year follow-up, participants in both groups will be asked to fill out questionnaires.",[180,181,182,183,184],"Aseptic Loosening","Aseptic Loosening of Prosthetic Joint","Aseptic Loosening of Orthopaedic Hardware","Knee Arthroplasty, Total","Total Knee Arthroplasty (Replacement)",[186,187,188,189,190],"Aseptic loosening of total knee prosthesis","Aseptic loosening","Total knee arthroplasty","Aseptic loosening of prosthetic joint","Knee arthroplasty","2025-02-17",{"date":193,"type":194},"2025-02-21","ACTUAL",{"date":196,"type":174},"2025-02",{"date":198,"type":174},"2026-06",{"name":5,"class":6},7]