[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"total-hip-and-knee-arthroplasties\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:total-hip-and-knee-arthroplasties":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"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":19,"type":20},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",[24],"Total Hip and Knee Arthroplasties",[26,27,28],"Bone Cement","Knee Arthroplasty","Hip Arthroplasty","RECRUITING","2025-12-01",{"date":32,"type":33},"2025-12-02","ACTUAL",{"date":35,"type":33},"2024-11-19",{"date":37,"type":20},"2026-10",{"name":39,"class":40},"Zimmer Biomet","INDUSTRY"]