Periprosthetic Joint Infection Bubble Study
Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
- Periprosthetic Joint Infection (PJI)
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Thomas Jefferson University
- Enrolment target
- 100
- Started
- 13 August 2026
- Main results due
- 1 June 2029
- Study sites
- 3
- Registry updated
- 23 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(3)
Thomas Jefferson University/Rothman Institute
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Not yet recruiting
Showing 3 of 3 sites. 1 of the 3 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07599865. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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