[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569814":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with TKA",null,"Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[13],"Device: Total knee arthroplasty",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with THA","Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[18],"Device: Total Hip arthroplasty",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Total knee arthroplasty","Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Total Hip arthroplasty","Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Miguel Correa-Tapia","CONTACT","+41791522905","Miguel.CorreaTapia@zimmerbiomet.com",{"name":36,"role":32,"phone":37,"phoneExt":10,"email":38},"Linda Meijer","+31657933741","linda.meijer@zimmer.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Klinikum Weiden","RECRUITING","Weiden","Bavaria","92637","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],12.15613,49.67682,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":57,"phoneExt":10,"email":58},"Christian von Rüden","00490961 303-0","christian.vonrueden@kno.ag",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100569814","hi-fatigue-g-bone-cement-retrospective-study-100569814",false,"NCT06699134","Hi-Fatigue G Bone Cement Retrospective Study","Evaluation of Hi-Fatigue G Bone Cement With Gentamicin A Retrospective Data Collection","Inclusion Criteria:\n\n* Subject qualified for cemented TKA or THA with a Zimmer Biomet implant\n* Subject is willing and able to give written informed consent for retrospective data collection and undergo interim and final evaluation (X-Ray \\& Scores completion)\n* Subject \\> 18 years old\n\nExclusion Criteria:\n\n* Muscle wasting\n* Neuromuscular compromise in the affected limb\n* Known hypersensitivity to any of the cement constituents\n* Subjects with severe renal failure\n* Bilateral interventions\n* Subject is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, known alcohol or drug abuser, anticipated to be non-compliant)","ALL","18 Years",{"count":71,"type":72},90,"ESTIMATED","OBSERVATIONAL","The objective of this retrospective monocentric study is to collect survivorship and clinical data confirming safety, performance and clinical benefits for the Hi-Fatigue G Bone Cement.\n\nThe assessments will include:\n\n* Radiological analysis performed at different time points according to the standard of care of the hospital\n* Implant survivorship and safety based on removal of a study device\n* Patient reported outcome measures (PROMs)\n\nPrimary endpoint:\n\nAssessment of radiolucent lines around the components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).\n\nSecondary endpoints:\n\n* Evaluation of implant survivorship and safety by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n* Evaluation of PROMs\n* Obtain information regarding the cementing technique and handling of the cement, if available",[76],"Total Hip and Knee Arthroplasties",[78,79,80],"Bone Cement","Knee Arthroplasty","Hip Arthroplasty","2025-12-01",{"date":83,"type":84},"2025-12-02","ACTUAL",{"date":86,"type":84},"2024-11-19",{"date":88,"type":72},"2026-10",{"name":5,"class":6},1]