Periprosthetic Joint Infection Bubble Study (NCT07599865) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Periprosthetic Joint Infection Bubble Study
United States100 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.