Periprosthetic Joint Infection Bubble Study
ConditionPeriprosthetic Joint Infection (PJI)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
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 fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ultrasound-triggered microbubble destruction with antibiotics
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Thomas Jefferson University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov