Periprosthetic Joint Infection Bubble Study (PJI)

Thomas Jefferson University

Status and phase: Enrolling; Phase 2

Conditions: Periprosthetic Joint Infection (PJI)

Treatments: Drug: Ultrasound-triggered microbubble destruction with antibiotics

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07599865

1R01AI187384-01 (U.S. NIH Grant/Contract)

2025-0492

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Cohort 1 Exchange anthroplasty - experimental group

Experimental group

Description:

The experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences.

Treatment:

Drug: Ultrasound-triggered microbubble destruction with antibiotics

Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimental

Experimental group

Description:

The experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences.

Treatment:

Drug: Ultrasound-triggered microbubble destruction with antibiotics

Cohort 1 Exchange anthroplasty - control group

No Intervention group

Description:

The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain.

Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - control

No Intervention group

Description:

The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain.