Comparing two ways to give antibiotics during ankle surgery
Official title: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Run by The Methodist Hospital Research Institute · NCT06384651 · Data updated 2026-11-12
This study is testing whether giving antibiotics directly into the bone or through an IV during ankle surgery works equally well to prevent infections after the operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | December 3, 2024 |
| Main results expected | April 2027 |
| Study ends | December 2027 |
| Registry record updated | January 24, 2025 |
| Trial ID | NCT06384651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are scheduled for total ankle arthroplasty and can provide informed consent.
✕Probably not a fit
Patients with previous lower extremity surgeries, high BMI, or contraindications to vancomycin will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares intraosseous and intravenous administration of vancomycin in patients undergoing total ankle arthroplasty. The primary objective is to determine if both methods achieve comparable levels of the antibiotic in bone, soft tissue, and systemic samples. Additionally, the study will assess the rates of post-operative complications, specifically infections, at 30 and 90 days after surgery. The hypothesis is that there will be no significant difference in infection rates between the two groups.
Why it matters
Potential benefit: If successful, this study could optimize antibiotic delivery methods during ankle surgeries, potentially reducing infection rates.
How similar studies have gone: While there is limited data on intraosseous administration of antibiotics in this context, similar studies have shown promise in other surgical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria * 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
Where it's running
-
Houston Methodist Hospital
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Jason S Ahuero, MD — The Methodist Hospital Research Institute
- Study coordinator: Thomas C Sullivan, BS
- Email: tsullivan@houstonmethodist.org
- Phone: 346-238-1603
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Custom 3D-printed total ankle and talus replacement for severe bone loss
This project will try a custom 3D-printed ankle and talus implant to restore function in adults aged 35–75 with severe talar bone loss or compromised ankle bone.
-
Evaluating outcomes of total ankle replacement surgery
This study looks at how well total ankle replacement surgeries work and what results patients get from different types of ankle implants.
-
Nasal Dilator Therapy for Patulous Eustachian Tube
This study tests whether wearing a nasal dilator helps reduce symptoms in adults with patulous Eustachian tube dysfunction.
-
IL-2 plus semaglutide in Alzheimer's disease
This study tests a combination of IL-2 and semaglutide to see if it can help people with Alzheimer's disease.
-
VR-based cognitive games to help prevent delirium after big surgery
A VR-based cognitive stimulation game is being tested to see if it can help prevent delirium in adults 65 and older after major surgery.
-
Anti-CMV treatment for breast cancer that has spread to the brain with CMV infection
This trial tests whether adding the anti-CMV drug valganciclovir to standard care helps adults with breast cancer that has spread to the brain who have detectable CMV.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.