Periprosthetic Joint Infection Bubble Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound-triggered microbubble destruction with antibiotics.
- Who it may be relevant to
- Registry conditions: Periprosthetic Joint Infection (PJI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
Overview
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.
Interventions
- Drug Ultrasound-triggered microbubble destruction with antibiotics
A 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.
Primary outcome measures
- Re-Infection Rate [Time frame: 2 years]
Secondary outcome measures (2)
- Time to Re-Infection [Time frame: 2 years]
- Bacterial Debris [Time frame: 72 hours]
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
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Thomas Jefferson University/Rothman Institute — Philadelphia
- University of Pittsburgh Medical Center (UPMC) — Pittsburgh
- UT Southwestern Medical Center — Dallas
Publications
- Zhao N, Curry D, Evans RE, Isguven S, Freeman T, Eisenbrey JR, Forsberg F, Gilbertie JM, Boorman S, Hilliard R, Dastgheyb SS, Machado P, Stanczak M, Harwood M, Chen AF, Parvizi J, Shapiro IM, Hickok NJ, Schaer TP. Microbubble cavitation restores Staphylococcus aureus antibiotic susceptibility in vitro and in a septic arthritis model. Commun Biol. 2023 Apr 17;6(1):425. doi: 10.1038/s42003-023-04752 PMID 37069337
Identifiers
NCT: NCT07599865 · 2025-0492 · 1R01AI187384-01