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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT07283068
Eligibility Criteria:
Inclusion Criteria:
* Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.
* Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
* Age \> 18 years.
Exclusion Criteria:
* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
* Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.
* Any hardware, condition, or anatomic status that prevents the medial malleolus from being a viable intraosseous injection site.
* Refusal to participate
* Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07283068
Study Brief:
Protocol Section:
NCT07283068