Periprosthetic Joint Infection Bubble Study

This study is testing a new way to treat infected knee replacements. If you have an infected knee replacement, you might be eligible. All participants will receive standard surgery for their infection. Half of the participants will also receive an injection of Definity microbubbles and antibiotics into the knee after surgery. Ultrasound will then be used to break up these microbubbles, which researchers hope will make the antibiotics work better. The main goal is to see if this extra treatment can reduce the rate of re-infection by at least 24% over two years. The study aims to enroll 100 people and is currently unclear on its recruitment status.

Study design
This is an interventional study with 100 planned participants. Participants will be randomly divided into two groups: one receiving standard care and the other receiving standard care plus the microbubble treatment.
What's involved
You will undergo revision surgery for your infected knee replacement. If in the active group, you will receive an injection of Definity microbubbles and antibiotics within 24 hours of surgery, followed by ultrasound treatment.
Compensation
Not stated in the trial record.
Follow-up
Your re-infection rate will be measured at 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07599865

Periprosthetic Joint Infection Bubble Study

Recruiting
PHASE2Ages 18+InterventionalTreatment
Thomas Jefferson University
~100 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Ultrasound-triggered microbubble destruction with antibiotics

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Re-Infection Rate
Measured over 2 years
Periprosthetic Joint Infection (PJI)

NCT07599865

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Thomas Jefferson University/Rothman Institute

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Not yet recruiting

  • UT Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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)
  • Re-Infection Rate2 years

    Rate of re-infection within 2 years post-intervention