[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488584":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":77,"collaborators":25,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":25,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective group","EXPERIMENTAL","50 patients prospectively included with early prosthesis reimplantation",[13],"Procedure: Early prosthesis reimplantation",{"label":15,"type":6,"description":16,"interventionNames":17},"Retrospective group","Last 50 patients with hip or knee prosthetic-joint infection managed with classical two-stage implant exchange",[18],"Other: Retrospective analysis of medical records",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Early prosthesis reimplantation","Early prosthesis reimplantation, within 16 to 30 days after implants removal",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Retrospective analysis of medical records","Analysis of 50 records of operated patients managed with classical two-stage implant exchange",[15],[31],{"name":32,"affiliation":33,"role":34},"Nathalie PANSU, MD","Infectious Diseases department, Montpellier university hospital","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+33467339510","n-pansu@chu-montpellier.fr",{"name":41,"role":37,"phone":38,"phoneExt":25,"email":42},"Vincent LE MOING, MD PhD","v-le_moing@chu-montpellier.fr",[44,62],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHU de Montpellier - Hôpital Saint-Eloi","RECRUITING","Montpellier","34090","France","FR",{"type":52,"coordinates":53},"Point",[54,55],3.87635,43.61093,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":61,"email":39},"Nathalie PANSU, PH","06 65 84 93 64","+ 33",{"facility":63,"status":46,"city":64,"state":25,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"CH de Sète - Hôpitaux du bassin de Thau","Sète","34200",{"type":52,"coordinates":67},[68,69],3.69278,43.4028,{"lat":69,"lon":68},[72],{"name":73,"role":37,"phone":74,"phoneExt":75,"email":76},"Flavien BOUCHET, Ph","06 50 65 30 94","+33","fbouchet@ch-bassindethau.fr",{"type":78,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100488584","short-interval-full-two-stage-implant-exchange-100488584",false,"NCT05642013","SHort Interval Full Two-stage Implant Exchange","SHIFT","Inclusion Criteria:\n\nProspective group:\n\n* Patient over 18 years old\n* Patient managed for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed \u002F Or biological ≥ 2 samples positive for the same microorganism \u002F And\u002F or 3000 leukocytes or \\> 80% of PNN on the synovial fluid \u002F Or histological: visible microorganism, \\> or = 5 PNN on 5 HPN\n* Patient with an indication for 2-stage surgery:\n\nA Impossibility of conservative treatment : infection occurring more than 4 weeks after prosthesis implantation, fistula, documented resistant germ, loosened prosthesis \u002F B Unsuitable 1-stage change: recurrence after 1-stage management, precarious bone capital, documented resistant microorganism, infection without prior microbiological documentation, fistula, surgeon's assessment in disfavor\n\n\\- Effective contraception during the research period for fertile women of childbearing age\n\nRetrospective group :\n\n* Patient managed before 31\u002F12\u002F2021 for a definite osteoarticular infection in a hip or knee prosthesis according to EBJIS definitions (2021) Clinical definition : fistula communicating with the prosthesis, prosthesis exposed Or biological ≥ 2 samples positive for the same microorganism And\u002F or 3000 leukocytes or \\> 80% of PNN on the synovial fluid Or histological: visible microorganism, \\> or = 5 PNN on 5 HPN\n* Patient managed by 2 \"long\" stage surgery with reimplantation time \\> 6 weeks with an evolutionary follow-up of at least 15 months after the end of antibiotics\n\nExclusion Criteria:\n\nProspective group :\n\n* Indication for conservative treatment, 1-stage or 2 long stage surgery\n* Reimplantation by another surgical approach requiring complete skin closure of the initial scar\n* Other surgeries scheduled within 30 days of removal\n* Participation in another interventional treatment study and\u002For in an exclusion period due to participation in another protocol\n* Subject not affiliated with a social security plan or beneficiary of such a plan\n* Failure to obtain written informed consent\n* Patient with a legal protection measure (guardianship, curatorship)\n* Patient under justice safeguard\n* Pregnant or breastfeeding woman\n\nRetrospective group :\n\n\\- Refusal to participate\n\nStudy exit criteria\n\n* Bacteriological samples positive for fungi\n* Infection not retained after analysis of samples (no sufficient clinical or biological criteria according to EBJIS definition)\n* Withdrawal of consent","ALL","18 Years",{"count":89,"type":90},100,"ESTIMATED","INTERVENTIONAL",[93],"NA","This study is a prospective bicentric feasibility study, which aims to evaluate the feasibility of a two-stage full implant exchange with early prosthesis reimplantation between 16 and 30 days after implants removal for hip or knee prosthetic joint infection.\n\nThis study concern 50 patients, prospectively included and compared to the last 50 patients with hip or knee PJI managed with classical two-stage implant exchange.\n\nThe duration of the study is 42 months.",[96],"Prosthetic-joint Infection",[98,99,100,101],"prosthetic joint infection","knee","hip","two-stage exchange","2024-08-02",{"date":104,"type":105},"2024-08-06","ACTUAL",{"date":107,"type":105},"2023-01-23",{"date":109,"type":90},"2027-07-23",{"name":5,"class":6},2]