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Periprosthetic Joint Infection Bubble Study

Study acronym: PJI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 1, 2028 → Jun 1, 2029
See other at-risk trials from Thomas Jefferson University

Record History

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  1. Primary completion pushed from Jun 1, 2028 to Jun 1, 2029 Show 4 more changesShow less
    • Start date changed from estimate of Jun 30, 2026 to Aug 13, 2026
    • Eligibility criteria expanded, about 14 words
    • Site details revised at 1 of 3 sites
    • Publications: details revised at 1 of 1 entry
  2. Recruitment openedv2 Show 6 more changesShow less
    • Trial arms changed: 2 → 4
    • Study sites: 2 to 3
    • Primary completion date: Jun 2028 to Jun 1, 2028
    • Study completion date: Jun 2030 to Jun 1, 2030
    • Start date: Jun 2026 to Jun 30, 2026
    • Eligibility criteria expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07599865
Lead Sponsor Thomas Jefferson University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Periprosthetic Joint Infection (PJI)
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov