Sound waves and bubbles take on stubborn joint infections
NCT ID NCT07599865
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study tests a new way to treat infected knee replacements. About 100 adults having surgery for an infected knee will be randomly assigned to receive either standard care or standard care plus an extra treatment. The extra treatment involves injecting antibiotics along with special microbubbles into the knee within 24 hours after surgery, then using ultrasound to activate the bubbles. The goal is to see if this approach can lower the chance of the infection coming back within two years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Thomas Jefferson University/Rothman Institute
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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UT Southwestern Medical Center
NOT_YET_RECRUITINGDallas, Texas, 75390, United States
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University of Pittsburgh Medical Center (UPMC)
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A dipstick test for joint infection? study puts cheap diagnostics to the test
- Blood markers may predict joint infection treatment success
- Which surgery best fights knee replacement infections? study digs into data
- New injection could fight stubborn joint infections after knee surgery