Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Recruiting now · Phase 4

Conditions studied: Infections, Ankle Arthritis

In brief

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.

Key facts

Study ID

NCT06384651

Run by

The Methodist Hospital Research Institute

People needed

40

Starts

2024-12-03

Expected to finish

2027-12-01

Last updated by the study team

2025-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is undergoing total ankle arthroplasty.
• Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
• Age Range >18

You may not qualify if…

• Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
• BMI > 40.
• Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
• Inability to administer the IO infusion.
• Patient refusal to participate.
• Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.
• Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
• Vulnerable populations

Where it is running

• Houston Methodist Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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