Periprosthetic Joint Infection Bubble Study

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.

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Key information

Conditions

Periprosthetic Joint Infection (PJI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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)

Treatment and study plan

Ultrasound-triggered microbubble destruction with antibiotics

Drug

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.

Other names: antibiotics, ultrasound-triggered microbubble destruction

Primary outcomes

Re-Infection Rate

Time frame: 2 years

Rate of re-infection within 2 years post-intervention

Secondary outcomes

Time to Re-Infection

Time frame: 2 years

Time between initial intervention and presentation with re-infection
Bacterial Debris

Time frame: 72 hours

Measurement of bacterial debris present in would exudate from drains

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: PJI

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2030
First posted: May 20, 2026
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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