[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633115":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":36,"locations":42,"responsibleParty":61,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Imageless Robotic Navigation","ACTIVE_COMPARATOR",null,[13],"Procedure: Imageless Robotic-Assisted Total Knee Arthroplasty",{"label":15,"type":10,"description":11,"interventionNames":16},"Image-based Robotic Navigation",[17],"Procedure: Image-based Robotic-Assisted Total Knee Arthroplasty",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","Imageless Robotic-Assisted Total Knee Arthroplasty","Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Image-based Robotic-Assisted Total Knee Arthroplasty","Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation",[15],[29,32,34],{"name":30,"affiliation":5,"role":31},"Paweł Łęgosz, MD, Professor","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":31},"Łukasz Pulik, MD, PhD",{"name":35,"affiliation":5,"role":31},"Paweł Kasprzak, MD",[37],{"name":35,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","22 50 21 514","+48","pawel.kasprzak@wum.edu.pl",[43],{"facility":44,"status":11,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw","Warsaw","Mazovian","02-005","Poland","PL",{"type":51,"coordinates":52},"Point",[53,54],21.01178,52.22977,{"lat":54,"lon":53},[57,58,59,60],{"name":35,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":30,"role":31,"phone":11,"phoneExt":11,"email":11},{"name":33,"role":31,"phone":11,"phoneExt":11,"email":11},{"name":35,"role":31,"phone":11,"phoneExt":11,"email":11},{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100633115","imageless-navigation-versus-image-based-navigation-in-robotic-assisted-total-knee-arthroplasty-for-knee-osteoarthritis-100633115",false,"NCT07522489","Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis","Outcomes of Robotic-Assisted Total Knee Arthroplasty With Imageless Navigation Versus Image-Based Navigation: A Randomised, Single-Blinded, Non-Inferiority Trial","Inclusion Criteria:\n\n1. Symptomatic, radiologically confirmed advanced osteoarthritis of the knee.\n2. Patients referred for primary robotic-assisted total knee arthroplasty.\n3. Patients in whom a correctly performed radiograph with designated sensors has confirmed the possibility of performing robotic-assisted total knee arthroplasty with image-based navigation.\n4. Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits.\n\nExclusion Criteria:\n\n1. No informed consent for the surgery.\n2. No informed consent for taking part in the study.\n3. Pregnancy.\n4. Active infections.\n5. Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).","ALL","18 Years",{"count":73,"type":74},146,"ESTIMATED","INTERVENTIONAL",[77],"NA","The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis.\n\nThe main questions the study aims to answer are:\n\n1. Does imageless procedure provide functional results comparable to those of image-based navigation?\n2. Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis.\n\nParticipants will:\n\n1. Answer survey questions about knee pain and function before RA-TKA.\n2. Undergo RA-TKA with imageless navigation or image-based navigation.\n3. Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.",[80,81,82,83],"Osteoarthritis (OA) of the Knee","Knee Pain Arthritis","Total Knee Arthroplasty (TKA)","Robotic Assisted Arthroplasty",[85,86,87,88,89],"Knee Osteoarthritis","Robotic-Assisted Total Knee Arthroplasty","Patient Reported Outcome Measures","Imageless Navigation","Image-based Navigation","NOT_YET_RECRUITING","2026-04-07",{"date":93,"type":94},"2026-04-13","ACTUAL",{"date":96,"type":74},"2026-05",{"date":98,"type":74},"2029-01",{"name":5,"class":6},1]