IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intraosseous Vancomycin

    Drug

    IO 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

40 Participants
are divided into 2 treatment groups
Group A: Intraosseous (IO) VancomycinExperimental treatment 1 intervention
Group B: Intravenous (IV) VancomycinNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During the surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: