Ultrasound-Triggered Microbubbles Plus Antibiotics for Knee Infections after Joint Replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In people with an infected knee replacement, participants are randomly assigned to receive the standard surgical treatment with or without an additional ultrasound-activated microbubble therapy and antibiotics within 24 hours of revision. The primary goal is to see if this combination reduces re-infection by at least 24% compared with standard care alone. The trial uses a Phase 2 design to evaluate safety and preliminary effectiveness. Participants must meet specific surgical and health criteria and come from several U.S. centers partnered with Thomas Jefferson University and NIAID.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• TNP-2092 injection for knee prosthetic joint infection

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• Biomarkers for Prosthetic Infection Detection using Nanopore Sequencing

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.