Thomas Jefferson University
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 50/50 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.
Inclusion Criteria: * Be at least 18 years of age * Be medically stable * If female of child-bearing potential, must have a negative pregnancy test * Be conscious and able to comply with study procedures * Have read and signed the IRB-approved Informed Consent form for participating in the study * For Cohort 1, be scheduled for one- or two-stage exchange arthroplasty revision surgery for PJI of the knee * For Cohort 2, be scheduled for DAIR revision surgery for PJI of the knee Exclusion Criteria: * Females who are pregnant or nursing * Patients currently on chemotherapy requiring systemic i…
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.
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