[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572787":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":71,"collaborators":25,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":25,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Aesculap AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IP coated hip arthroplasty implants","EXPERIMENTAL","Participants receive an infection prevention (IP) coated hip implant",[13],"Device: IP Plasmafit® Revision cup (and stem) system",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard hip arthroplasty implants","ACTIVE_COMPARATOR","Participants receive a standard (uncoated) hip implant",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","IP Plasmafit® Revision cup (and stem) system","Revision total hip arthroplasty (THA) due to periprosthetic joint infection",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Sebastian Meller, Dr.","Charite University, Berlin, Germany","PRINCIPAL_INVESTIGATOR",[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Lutz Dreyer, Dr.","CONTACT","+49 7461 95","0","hiprevision_study@bbraun.com",{"name":39,"role":34,"phone":40,"phoneExt":36,"email":37},"Britta Wachter, Dr.","+49 746195",[42,57],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","10117","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],13.41053,52.52437,{"lat":53,"lon":52},[56],{"name":28,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":58,"status":44,"city":59,"state":25,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP","Otwock","05-400","Poland","PL",{"type":50,"coordinates":64},[65,66],21.26129,52.10577,{"lat":66,"lon":65},[69],{"name":70,"role":34,"phone":25,"phoneExt":25,"email":25},"Jerzy Białecki, Prof. Dr.",{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100572787","ip-coated-revision-hip-implants-100572787",false,"NCT06737809","IP-coated Revision Hip Implants","HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses","HIPrevision","Inclusion Criteria:\n\n* Patients \\> 18 years\n* Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site\n* According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits\n* ASA physical status I - III\n* Patient's signed written informed consent is available\n\nExclusion Criteria:\n\n* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)\n* The investigational implant components (femoral and\u002For acetabular) are not suitable for the patient anatomy or bone defect\n* Patients who require plate osteosynthesis at the implantation site\n* Patients with an already implanted silver-coated device\n* Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy\n* Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy\n* Severe soft tissue defects that require local or free flap procedure\n* Periprosthetic joint infections with evidence of fungal infection\n* Antibiotic suppression therapy\n* BMI \\> 40 kg\u002Fm2\n* Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions\n* Known or patient reported hypersensitivity to silver or titanium\n* Patients held in a custodial setting\n* Patients in a relationship of dependence on the sponsor, the clinic or the investigator\n* Patients with contraindication for the investigational and comparator devices:\n* in case of secondary diseases influencing the function of the joint implant\n* in case of severe osteoporosis or osteomalacia\n* in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage\n* in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated","ALL","18 Years",{"count":84,"type":85},268,"ESTIMATED","INTERVENTIONAL",[88],"NA","The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.",[91],"Peri-Prosthetic Joint Infection",[93,94,95,96,97,98],"arthroplasty","replacement","hip","anti-infective agent","silver","periprosthetic joint infection","2026-01-09",{"date":101,"type":102},"2026-01-12","ACTUAL",{"date":104,"type":102},"2025-06-25",{"date":106,"type":85},"2028-06",{"name":5,"class":6},2]