[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588660":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":19,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":19,"overallStatus":62,"whyStopped":19,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":19},{"fullName":5,"class":6},"Istituto Clinico Humanitas","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"SURGERY","TOTAL KNEE REPLACEMENT SURGERY AND REVISION SURGERY OF INFECTED KNEE PROSTHESIS",[12],"Procedure: total knee replacement",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"PROCEDURE","total knee replacement","The Orthopedic Surgeon will remove the damaged cartilage and bone then implant the new metal and plastic knee to restore the alignment and function of your knee. The surgical procedure takes about 1-2 hours on average. While in case of infection, an antibiotic cement is inserted, which will be removed with the subsequent prosthetic implant surgery. Finally, prosthetic components can be more filling, depending on the amount of bone that is previously removed.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"TOMMASO BONANZINGA","Humanitas Research Hospital IRCCS, Rozzano-Milan","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"ROBERTA TALLARITA","CONTACT","0282247770","roberta.tallarita@humanitas.it",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"LILIA LILIA DE CAROLIS","0282245206","lilia.decarolis@humanitas.it",{"type":36,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[38],{"name":39,"class":6},"Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli","100588660","microbiota-as-early-diagnostic-and-predictive-factor-for-osteoarthritic-degeneration-and-microbial-contamination-100588660",false,"NCT06944288","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination","Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)","MILESTONE","Inclusion Criteria:\n\n* proven gut dysbiosis (increased Firmicutes\u002FBacteroidetes (F\u002FB) phyla ratio and increased permeability); age range 18-50 years old.\n* patients undergoing total knee replacement surgery\n* patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI\n\nExclusion Criteria:\n\n* musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases\n* any concurrent or previous diseases or conditions which might negatively affect the surgery\n* major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI \\> 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (\\\u003C 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (\\\u003C 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations","ALL","18 Years","50 Years",{"count":52,"type":53},170,"ESTIMATED","INTERVENTIONAL",[56],"NA","The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.\n\nIn particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.\n\nFinally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.\n\nThe patients will be included in the study under\n\n* objective 1\n* objective 2\n* objective 3",[59,60,61],"Knee Prosthesis","Knee Prosthesis Infection","Disbiosis","NOT_YET_RECRUITING","2025-04-22",{"date":65,"type":66},"2025-04-25","ACTUAL",{"date":68,"type":53},"2026-02-01",{"date":70,"type":53},"2026-05-30",{"name":5,"class":6}]