[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569814":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":27,"armGroups":28,"interventions":39,"overallOfficials":23,"centralContacts":49,"locations":59,"responsibleParty":79,"collaborators":23,"id":81,"slug":23,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":23,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":23,"enrollmentInfo":89,"targetDuration":23,"studyType":92,"phases":23,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":62,"whyStopped":23,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Zimmer Biomet","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Radiographic evaluation","Detection of radiolucent lines around the implant components (tibial, femoral, acetabular) at 5 years (in accordance with the hospital standard of care).","From enrollment to the 5 year post-op follow up.",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Survivorship","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.",{"measure":18,"description":19,"timeFrame":12},"Patient reported outcome measures (PROM)","Evaluation of PROMs, collected in accordance with the hospital standard of care.",{"measure":21,"description":22,"timeFrame":12},"Cement Information","Obtain information regarding the cementing technique and handling of the cement, if available",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","RETROSPECTIVE","Patients operated with primary total knee or hip replacement using Hi-Fatigue G Bone Cement, a Zimmer Biomet implant, and who meet the inclusion \u002F exclusion criteria for study participation.\n\nTwo consecutive groups of patients that underwent cemented TKA or THA according to the instructions for use of both the respective implant and of Hi-Fatigue G Bone Cement.",[29,34],{"label":30,"type":23,"description":31,"interventionNames":32},"Patients with TKA","Patients with primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[33],"Device: Total knee arthroplasty",{"label":35,"type":23,"description":36,"interventionNames":37},"Patients with THA","Patients with primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[38],"Device: Total Hip arthroplasty",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":23},"DEVICE","Total knee arthroplasty","Primary total knee replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[30],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":23},"Total Hip arthroplasty","Primary total hip replacement using Hi-Fatigue G Bone Cement and a Zimmer Biomet implant",[35],[50,55],{"name":51,"role":52,"phone":53,"phoneExt":23,"email":54},"Miguel Correa-Tapia","CONTACT","+41791522905","Miguel.CorreaTapia@zimmerbiomet.com",{"name":56,"role":52,"phone":57,"phoneExt":23,"email":58},"Linda Meijer","+31657933741","linda.meijer@zimmer.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Klinikum Weiden","RECRUITING","Weiden","Bavaria","92637","Germany","DE",{"type":69,"coordinates":70},"Point",[71,72],12.15613,49.67682,{"lat":72,"lon":71},[75],{"name":76,"role":52,"phone":77,"phoneExt":23,"email":78},"Christian von Rüden","00490961 303-0","christian.vonrueden@kno.ag",{"type":80,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","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":90,"type":91},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",[95],"Total Hip and Knee Arthroplasties",[97,98,99],"Bone Cement","Knee Arthroplasty","Hip Arthroplasty","2025-12-01",{"date":102,"type":103},"2025-12-02","ACTUAL",{"date":105,"type":103},"2024-11-19",{"date":107,"type":91},"2026-10",{"name":5,"class":6},1]