NCT06384651

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infections
• Ankle Arthritis

Interventions

Type	Name	Description
DRUG	Intraosseous Vancomycin Injection	* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * IO Injection will take place into the medial malleolus.
DRUG	Intravenous Vancomycin	• Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL normal saline (NS))

Timeline

• Start date: 2024-12-03
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2024-04-25
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study