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
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying two different methods of giving the antibiotic vancomycin during total ankle arthroplasty (TAA). They aim to compare the levels of vancomycin in bone, soft tissue, and blood samples between patients receiving the standard intravenous (IV) method and those receiving an intraosseous (IO) injection. The study also looks at infection rates 30 and 90 days after surgery to see if there is any difference between the two groups. Participants will receive either the usual IV antibiotics including vancomycin given about one hour before surgery, or an IO vancomycin injection administered directly into the medial malleolus bone during surgery after sterile preparation. The IV group will not get preoperative IV vancomycin, while the IO group receives 500 mg of vancomycin in normal saline through IO injection. Both groups get other standard antibiotics like ancef or cefepime. During the study, researchers will measure vancomycin concentrations in various tissue samples taken around the time of surgery, including bone and synovium samples. They will monitor patients for wound complications and infections up to 90 days after surgery. Participants will be randomly assigned to one of the two groups, and both patients and researchers will be blinded to the treatment. The total participation time includes surgery and follow-up visits for complication monitoring.
CONDITIONS
Brief 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.
- Age 18 years or older.
You will not qualify if you...
- Previous lower extremity surgery that precludes safe participation.
- Body mass index (BMI) greater than 40.
- Allergy or contraindication to vancomycin, cefepime, ancef, or other standard pre-operative antibiotics.
- Inability to receive intraosseous infusion.
- Patient refusal to participate.
- Uncontrolled Diabetes Mellitus type 1 or 2 with Hemoglobin A1C above 7.5.
- Immunocompromised or immunosuppressed conditions including HIV, Hepatitis C, end stage renal disease, dialysis, transplant, recent chemo/radiation, or immunosuppressive medications.
- Vulnerable populations.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Perioperative period
Participants receive either intraosseous or intravenous vancomycin during total ankle arthroplasty surgery.
1 surgical visit (in-person)
Duration - 90 days after the procedure
Participants are monitored for wound complications and infection rates after surgery.
Approximately 3 post-operative visits
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Thomas C Sullivan, BS
B
Blesson Varghese, BS
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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