Periprosthetic Joint Infection Bubble Study

Recruiting now · Phase 2

Conditions studied: Periprosthetic Joint Infection (PJI)

In brief

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.

Key facts

Study ID: NCT07599865
Run by: Thomas Jefferson University
People needed: 100
Starts: 2026-06-30
Expected to finish: 2030-06-01
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Thomas Jefferson University/Rothman Institute — Philadelphia, Pennsylvania, United States (enrolling)
University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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