Recruiting
Phase 2

Ultrasound Microbubbles

Sponsor:

Thomas Jefferson University

Code:

NCT07599865

Conditions

Periprosthetic Joint Infection (PJI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ultrasound-triggered microbubble destruction with antibiotics

Study Details

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.

Conditions

Periprosthetic Joint Infection (PJI)

Study ID

NCT07599865

Start date

Jun 30, 2026

Status verified date

Jul, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 Exchange anthroplasty - experimental group

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.

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

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.

no intervention: Cohort 1 Exchange anthroplasty - control group

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.

no intervention: Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - control

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.

Interventions

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 measure

  • Re-Infection Rate [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Thomas Jefferson University/Rothman Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Edsel Mangubat, MBA, MSN, RN

267-386-5480Edsel.mangubat@jefferson.edu

Principal Investigator:

Lauren Delaney, PhD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Periprosthetic knee infection
  • ultrasound-triggered microbubble destruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-07-31.