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New treatment option for Infections
Official title Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
ClinicalTrials.gov ID: NCT06384651
What this study is testing
What is Intraosseous Vancomycin Injection?
Intraosseous Vancomycin Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from...
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.