NCT07599865RecruitingPhase 2
Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
Thomas Jefferson University5 sites in 1 country100 target enrollmentStarted: June 30, 2026Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Thomas Jefferson University
- Enrollment
- 100
- Locations
- 5
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (5)
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