Comparing two ways to give antibiotics during ankle surgery
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
PHASE4 · The Methodist Hospital Research Institute · NCT06384651
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06384651 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for total ankle arthroplasty and can provide informed consent.
Not a fit: Patients with previous lower extremity surgeries, high BMI, or contraindications to vancomycin will not benefit from this study.
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 performed: While there is limited data on intraosseous administration of antibiotics in this context, similar studies have shown promise in other surgical settings.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infections, Ankle Arthritis