Intraosseous Vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Last updated: January 22, 2025
Sponsor: The Methodist Hospital Research Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Joint Injuries

Treatment

Intravenous Vancomycin

Intraosseous Vancomycin Injection

Clinical Study ID

NCT06384651
PRO00037789
  • Ages > 18
  • All Genders

Study 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

Inclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Intravenous Vancomycin
Phase: 4
Study Start date:
December 03, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.