Periprosthetic Joint Infection Bubble Study (PJI)
14. maj 2026 opdateret af: Thomas Jefferson University
Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center (UPMC)
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Ledende efterforsker:
- Kenneth Urish, MD, PhD
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Kontakt:
- Dana Farrell
- Telefonnummer: 412-641-3156
- E-mail: djf52@pitt.edu
-
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern Medical Center
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Kontakt:
- Jonathan Thompson
- Telefonnummer: 214-645-1620
- E-mail: jonathan.thompson@utsouthwestern.edu
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Ledende efterforsker:
- Antonia Chen, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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 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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Cohort 1 Exchange anthroplasty
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.
|
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.
Andre navne:
|
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Andet: Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery
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.
|
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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Re-Infection Rate
Tidsramme: 2 years
|
Rate of re-infection within 2 years post-intervention
|
2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Re-Infection
Tidsramme: 2 years
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Time between initial intervention and presentation with re-infection
|
2 years
|
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Bacterial Debris
Tidsramme: 72 hours
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Measurement of bacterial debris present in would exudate from drains
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72 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. juni 2030
Datoer for studieregistrering
Først indsendt
14. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. maj 2026
Først opslået (Faktiske)
20. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-0492
- 1R01AI187384-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
De-identified data will be shared upon request
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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