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Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Study acronym: IOTAA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Dec 13, 2023 to Dec 3, 2024v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Trial Details
NCT Number NCT06384651
Lead Sponsor The Methodist Hospital Research Institute
Conditions Infections, Ankle Arthritis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov