NCT06384651PHASE4Recruiting
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
The Methodist Hospital Research Institute
Start Date
12/3/2024
Completion Date
12/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria
* 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
Exclusion Criteria
* 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
Interventions
DRUG
Intraosseous Vancomycin Injection
DRUG
Intravenous Vancomycin
Conditions
InfectionsAnkle Arthritis
Locations
Houston Methodist Hospital
Houston, Texas 77030
United States