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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

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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