Actively Recruiting
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Led by The Methodist Hospital Research Institute · Updated on 2025-01-24
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is undergoing total ankle arthroplasty.
- Patient is able to give informed consent to participate in the study. LAR consents will not be utilized.
- Age 18 years or older.
You will not qualify if you...
- Previous lower extremity surgery that precludes safe participation as judged by the investigator.
- Body mass index (BMI) over 40.
- Allergy or medical contraindication to vancomycin, cefepime, ancef, or other standard pre-operative antibiotics.
- Inability to administer the intraosseous infusion.
- Patient refusal to participate.
- Uncontrolled diabetes mellitus type 1 or 2, defined as Hemoglobin A1C over 7.5.
- Immunocompromised or immunosuppressed status, including HIV, Hepatitis C, end stage renal disease, dialysis, transplant, recent chemo/radiation (within 6 months), or related medications.
- Vulnerable populations.
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Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Thomas C Sullivan, BS
CONTACT
B
Blesson Varghese, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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