About this trial
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Intraosseous Vancomycin
DrugIO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision.
Treatment groups
Trial outcomes
Primary outcomes
Level of Vancomycin
The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: