Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06384651
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06384651
Study Brief:
Protocol Section:
NCT06384651