Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

PHASE4RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 3, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

December 31, 2027

Conditions
InfectionsAnkle Arthritis
Interventions
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))

Trial Locations (1)

77030

RECRUITING

Houston Methodist Hospital, Houston

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER

NCT06384651 - Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty | Biotech Hunter | Biotech Hunter