drugset / Trial / NCT06384651

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

NCT06384651

Phase 4 Recruiting 40 enrolled The Methodist Hospital Research Institute
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-12-03
Primary completion
2027-04
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vancomycin Other / unclassified 15 mg/kg Intravenous
Comparator Vancomycin Other / unclassified 500 mg Intravenous