Vancomycin Administration in Total Ankle Arthroplasty

This study is comparing two ways to give an antibiotic called vancomycin during total ankle replacement surgery. One group of patients will receive vancomycin through a standard IV (into a vein). The other group will receive vancomycin directly into the bone in the ankle (intraosseous injection). Researchers want to see if both methods deliver similar amounts of vancomycin to the bone, soft tissue, and throughout the body. They also want to compare infection rates 30 and 90 days after surgery between the two groups. You may be able to join if you are at least 18 years old and are having total ankle replacement surgery. The study is currently recruiting 40 participants.

Study design
This is an interventional study comparing two different ways to give antibiotics during surgery, involving 40 participants.
What's involved
You would receive vancomycin either intravenously or through an intraosseous injection during your total ankle replacement surgery. Tissue and blood samples will be taken during and immediately after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your post-operative complication rates (infection) will be compared at 30 and 90 days after surgery.

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NCT06384651

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Recruiting
PHASE4Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~40 participants
Updated 2025-01-24 on ClinicalTrials.gov
What's tested:Intraosseous Vancomycin InjectionIntravenous Vancomycin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systemic Sample Vancomycin Tissue Concentration - Start of Case
Measured over perioperatively
+4 more outcomes measured
Infections
Ankle Arthritis
1 sites across 1 states
Texas1
  • Jason S Ahuero, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

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Eligibility criteria

Inclusion

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

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
  • Systemic Sample Vancomycin Tissue Concentration - Start of Caseperioperatively
  • Systemic Sample Vancomycin Tissue Concentration - End of Caseperioperatively
  • Capsule or Synovium Sample Vancomycin Tissue Concentrationimmediately after the procedure
  • Distal Tibia Sample Vancomycin Tissue Concentrationimmediately after the procedure
  • Talar Bone Sample Vancomycin Tissue Concentrationimmediately after the procedure