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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI187384-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Exchange anthroplasty | Other | Will be enrolled and randomized into either the treatment or 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. 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. |
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| Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery | Other | Will be enrolled and randomized into either the treatment or 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. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-triggered microbubble destruction with antibiotics | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-Infection Rate | Rate of re-infection within 2 years post-intervention | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Re-Infection | Time between initial intervention and presentation with re-infection | 2 years |
| Bacterial Debris | Measurement of bacterial debris present in would exudate from drains |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37069337 | Background | 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-y. |
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De-identified data will be shared upon request
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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| 72 hours |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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