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RECRUITING
NCT07599865
PHASE2

Periprosthetic Joint Infection Bubble Study

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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.

Official title: Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-06-30

Completion Date

2030-06-01

Last Updated

2026-07-31

Healthy Volunteers

No

Interventions

DRUG

Ultrasound-triggered microbubble destruction with antibiotics

A combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery. Ultrasound will be used to rupture the microbubbles to enhance antibiotic activity.

Locations (3)

Thomas Jefferson University/Rothman Institute

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States