Periprosthetic Joint Infection Bubble Study

Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07599865

Acronym

PJI

Enrollment

100

Registered

2026-05-20

Start date

2026-06-30

Completion date

2030-06-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Joint Infection (PJI)

Keywords

Periprosthetic knee infection, ultrasound-triggered microbubble destruction

Brief summary

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

DRUGUltrasound-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

There are 2 cohorts based on the type of standard-of-care revision surgery a subject undergoes, DAIR or implant exchange. Within each cohort, there is a control arm and an experimental arm.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Re-Infection Rate	2 years	Rate of re-infection within 2 years post-intervention

Secondary

Measure	Time frame	Description
Time to Re-Infection	2 years	Time between initial intervention and presentation with re-infection
Bacterial Debris	72 hours	Measurement of bacterial debris present in would exudate from drains

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026