Periprosthetic Joint Infection Bubble Study
ConditionPeriprosthetic Joint Infection (PJI)
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-triggered microbubble destruction with antibiotics
DrugA combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery. Ultrasound will be used to rupture the microbubbles to enhance antibiotic activity.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Cohort 1 Exchange anthroplasty - experimental groupExperimental treatment 1 intervention
Group B: Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimentalExperimental treatment 1 intervention
Group C: Cohort 1 Exchange anthroplasty - control groupNo intervention 0 interventions
Group D: Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Re-Infection Rate
Rate of re-infection within 2 years post-intervention
Time frame
2 yearsSecondary outcomes
1
Time to Re-Infection
Time between initial intervention and presentation with re-infection
Time frame
2 years2
Bacterial Debris
Measurement of bacterial debris present in would exudate from drains
Time frame
72 hoursSponsors and contacts
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Thomas Jefferson University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov