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NCT06384651 | RECRUITING | Infections

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Sponsor:

The Methodist Hospital Research Institute

Information provided by (Responsible Party):

Jason S. Ahuero

Brief 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.

Condition or disease

Infections

Ankle Arthritis

Intervention/treatment

Intraosseous Vancomycin Injection

Intravenous Vancomycin

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : DOUBLE
Masking Description : single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.
Primary Purpose : TREATMENT
Official Title : Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Actual Study Start Date : 2023-12-13
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
    • Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

    Location Details

    NCT06384651

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Texas

    Houston Methodist Hospital

    Houston, Texas, United States, 77030