Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intraosseous Vancomycin Injection
- Intravenous Vancomycin
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov