[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"periprosthetic-joint-infection-pji\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:periprosthetic-joint-infection-pji":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,69,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100639656","phase-2-periprosthetic-joint-infection-bubble-study-100639656",false,"NCT07599865","Periprosthetic Joint Infection Bubble Study","Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections","PJI","Inclusion Criteria:\n\n* Be at least 18 years of age\n* Be medically stable\n* If female of child-bearing potential, must have a negative pregnancy test\n* Be conscious and able to comply with study procedures\n* Have read and signed the IRB-approved Informed Consent form for participating in the study\n* For Cohort 1, be scheduled for one- or two-stage exchange arthroplasty revision surgery for PJI of the knee\n* For Cohort 2, be scheduled for DAIR revision surgery for PJI of the knee\n\nExclusion Criteria:\n\n* Females who are pregnant or nursing\n* Patients currently on chemotherapy requiring systemic treatment\n* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable\n* Patients with a history of anaphylactic allergy to perflutren or any other components of Definity\n* Patients with a history of failed one- or two-stage revision for infection\n* Patients for which placement of a surgical drain is contraindicated\n* Patients in protected classes (e.g., prisoners)","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50\u002F50 in the active and control groups). Subjects in the active group will receive a local bolus injection of antibiotics and ultrasound-active microbubbles within 24 hours of their revision surgery. The fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.",[27],"Periprosthetic Joint Infection (PJI)",[29,30],"Periprosthetic knee infection","ultrasound-triggered microbubble destruction","NOT_YET_RECRUITING","2026-05-14",{"date":34,"type":35},"2026-05-20","ACTUAL",{"date":37,"type":21},"2026-06",{"date":39,"type":21},"2030-06",{"name":41,"class":42},"Thomas Jefferson University","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100584466","phase-1-a-phase-12-study-to-evaluate-the-safety-pk-and-efficacy-of-tnp-2092-administered-via-ia-injection-in-pji-participants-100584466","NCT06889701","A Phase 1\u002F2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants","A Phase 1\u002F2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in Participants With Early or Acute Hematogenous PJI Requiring or Not Requiring DAIR After TKA, or Requiring Long-term Antibiotic Therapy","Inclusion Criteria:\n\n* Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requires or does not require DAIR therapy after TKA, or results of treatment for PJI (including PJI occurring after various joint replacements and revision surgeries) did not meet the clinical cure criteria and requiring long-term antibiotic suppression therapy as judged by investigators before enrollment.\n* Suspected or confirmed PJI was caused by a Gram-positive bacterial infection, including methicillin-resistant and ciprofloxacin-resistant Staphylococcus aureus and Staphylococcus epidermidis, as judged by the investigator.\n* Agree to be hospitalized for 2 weeks with local intra-articular injection.\n* 18 years of age or older (of either sex) at the time of signing the informed consent form (ICF).\n* The implanted prosthetic joint was well fixed.\n* No sinus tract that communicates with the prosthesis.\n* Body mass index (BMI) ≥ 18 kg\u002Fm\\^2 and ≤ 34 kg\u002Fm\\^2.\n* Agree to voluntarily use effective contraception from signing the ICF through 8 weeks after the last dose of investigational product (in case of premature withdrawal from the study) or through completion of the end-of-study visit. Male participants must refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n* History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.\n* Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed Gram-negative and\u002For fungal infection.\n* Definite systemic infection (sepsis).\n* Expected survival less than 1 years.\n* Female participant is pregnant, lactating, or has a positive screening\u002Fbaseline pregnancy test.\n* Surgical or medical conditions that, in the opinion of the investigator, could affect the participant's ability to participate in the study, or affect the administration of investigational product, or affect the interpretation of study results, including but not limited to active malignancy, metabolic disease, alcohol or drug abuse, or clinically significant laboratory abnormalities.\n* Presence of serious liver, blood, or immune system disorders as evidenced by the following:\n\n  1. Acute hepatitis of any cause within the past year.\n  2. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels \\> 2 times the upper limit of normal (ULN).\n  3. Presence of end-stage liver disease-related manifestations such as ascites or hepatic encephalopathy.\n  4. Current or anticipated neutropenia (ie, neutrophil count \\\u003C 0.5 x 10\\^9\u002FL).\n  5. Chemotherapy for cancer, radiation therapy, or potent noncorticosteroid immunosuppressants (eg, cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc) within the past 3 months or corticosteroids (≥ 40 mg prednisone\u002Fday) for more than 14 days within 30 days prior to randomization.\n* Positive AIDS antibody screening.\n* History or evidence of severe renal disease or creatinine clearance \\\u003C 30 mL\u002Fmin based on the Cockcroft-Gault formula.\n* Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.\n* Participants who, in the opinion of the investigator, were unable to comply with the protocol and study drug administration procedures or complete the clinical study.",{"count":52,"type":21},33,[54,24],"PHASE1","This is a Phase 1\u002F2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacements and revision surgeries).",[27],"RECRUITING","2026-03-04",{"date":60,"type":35},"2026-03-05",{"date":62,"type":35},"2025-04-03",{"date":64,"type":21},"2026-08",{"name":66,"class":67},"TenNor Therapeutics Inc.","INDUSTRY",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100620502","preop-biomarkers-as-outcome-predictors-in-2-stage-revision-surgery-for-pji-100620502","NCT07358455","Preop Biomarkers as Outcome Predictors in 2 Stage Revision Surgery for PJI","Identification of Pre-prosthetic Revision Markers Predictive of Outcome in Patients With Periprosthetic Infection","ARKO-PJI","Inclusion criteria\n\n* Age ≥ 18 years\n* Diagnosis of an orthopaedic periprosthetic joint infection (PJI)\n* Surgical treatment\n* Minimum follow-up of 12 months\n* Written informed consent to participate in the study\n\nExclusion criteria\n\n* Age \\\u003C 18 years\n* Patients undergoing prosthetic revision without evidence of periprosthetic joint infection\n* Treatment with antibiotic therapy alone (non-surgical management)\n* Follow-up \\\u003C 12 months\n* Incomplete dataset\n* Lack of informed consent to participate in the study",{"count":78,"type":21},200,"OBSERVATIONAL","With the progressive ageing of the population, a significant increase in the incidence of skeletal fractures-particularly of the proximal femur-as well as degenerative conditions such as osteoarthritis has been observed, for which joint arthroplasty represents the treatment of choice. However, this procedure is not free from complications; beyond technical and mechanical issues related to potential implant malpositioning, one of the most feared is periprosthetic joint infection (PJI), which poses a major challenge in terms of clinical management and prognostic impact. Therapeutic strategies for PJI range from debridement with retention of the implant and exchange of modular components (DAIR\u002FDAPRI) to complete implant removal with insertion of an articulating spacer, often followed by a subsequent reimplantation procedure. These approaches require prolonged antibiotic regimens, potentially exerting a negative effect on renal function, particularly in cases of extended exposure to nephrotoxic agents. Despite the clinical relevance of this issue, the current literature still provides limited evidence regarding the identification of inexpensive and readily available biomarkers capable of predicting treatment outcomes in PJI, especially in patients undergoing spacer implantation followed by reimplantation. Recent literature has increasingly explored the use of biomarkers such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic inflammation response index (SIRI), and others to characterize inflammatory and nutritional status, and to investigate possible associations between these markers and the outcomes of selected surgical procedures. The availability of predictive markers could optimize therapeutic management by reducing the risk of infection recurrence and improving postoperative risk stratification.",[27],"2026-01-22",{"date":84,"type":35},"2026-01-23",{"date":86,"type":21},"2026-01",{"date":88,"type":21},"2026-12",{"name":90,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":68},"100577897","molecular-biology-in-the-identification-of-pathogens-at-reimplantation-in-the-two-stage-treatment-of-periprosthetic-infections-100577897","NCT06804265","Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections","Molecular Biology (Multiplex PCR) in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections (PJI)","MOLPJI","Inclusion Criteria:\n\n* Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.\n* treatment of infection with two-stage protocol.\n* Obtaining informed consent\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Isolates obtained during explantation not included in MULTIPLEX PCR panel",{"count":20,"type":21},"The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.",[27],[103],"Multiplex PCR","2025-01-29",{"date":106,"type":35},"2025-02-03",{"date":108,"type":35},"2025-01-07",{"date":110,"type":21},"2028-04-30",{"name":112,"class":42},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]