NCT06384651 Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
| NCT ID | NCT06384651 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-12-03 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Eligibility 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
Contact & Investigator
Jason S Ahuero, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06384651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06384651 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06384651 currently recruiting?
Yes, NCT06384651 is actively recruiting participants. Contact the research team at tsullivan@houstonmethodist.org for enrollment information.
Where is the NCT06384651 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06384651 clinical trial?
NCT06384651 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Jason S Ahuero, MD at The Methodist Hospital Research Institute. The trial plans to enroll 40 participants.