Clinical Trial

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Study acronym: IOTAA
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-24.
Trial Details
NCT Number NCT06384651
Lead Sponsor The Methodist Hospital Research Institute
Conditions Infections, Ankle Arthritis
Enrollment 40 participants
Start Date 2024-12-03
Primary Completion 2027-04 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-24