[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639656":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":25,"enrollmentInfo":82,"targetDuration":25,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":93,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Cohort 1 Exchange anthroplasty","Will be enrolled and randomized into either the treatment or control group. The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain. The experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences.",[12],"Drug: Ultrasound-triggered microbubble destruction with antibiotics",{"label":14,"type":6,"description":10,"interventionNames":15},"Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Ultrasound-triggered microbubble destruction with antibiotics","A combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery. Ultrasound will be used to rupture the microbubbles to enhance antibiotic activity.",[9,14],[23,24],"antibiotics","ultrasound-triggered microbubble destruction",null,[27,49],{"facility":28,"status":25,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"University of Pittsburgh Medical Center (UPMC)","Pittsburgh","Pennsylvania","15213","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-79.99589,40.44062,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":25,"email":45},"Dana Farrell","CONTACT","412-641-3156","djf52@pitt.edu",{"name":47,"role":48,"phone":25,"phoneExt":25,"email":25},"Kenneth Urish, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":50,"status":25,"city":51,"state":52,"zip":53,"country":32,"countryCode":33,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":35,"coordinates":55},[56,57],-96.80667,32.78306,{"lat":57,"lon":56},[60,64],{"name":61,"role":43,"phone":62,"phoneExt":25,"email":63},"Jonathan Thompson","214-645-1620","jonathan.thompson@utsouthwestern.edu",{"name":65,"role":48,"phone":25,"phoneExt":25,"email":25},"Antonia Chen, MD",{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[69],{"name":70,"class":71},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","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":83,"type":84},100,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90],"Periprosthetic Joint Infection (PJI)",[92,24],"Periprosthetic knee infection","NOT_YET_RECRUITING","2026-05-14",{"date":96,"type":97},"2026-05-20","ACTUAL",{"date":99,"type":84},"2026-06",{"date":101,"type":84},"2030-06",{"name":5,"class":6},2]