NCT07599865PHASE2Recruiting
Periprosthetic Joint Infection Bubble Study
Thomas Jefferson University
Start Date
6/30/2026
Completion Date
6/1/2030
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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 infusion treatment
* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
* Patients with a history of anaphylactic allergy to perflutren or any other components of Definity
* Patients with a history of failed one- or two-stage revision for infection
* Patients for which placement of a surgical drain is contraindicated
* Patients in protected classes (e.g., prisoners)
Interventions
DRUG
Ultrasound-triggered microbubble destruction with antibiotics
Conditions
Periprosthetic Joint Infection (PJI)
Locations
Thomas Jefferson University/Rothman Institute
Philadelphia, Pennsylvania 19107
United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15213
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States