Periprosthetic Joint Infection Bubble Study
Recruiting
Phase 2
Interventional Study
Periprosthetic Joint Infection (PJI)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Thomas Jefferson University · Other
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About This Trial
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 f…
Trial Locations
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Eligibility Criteria
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
* …
Contacts
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