IO Vancomycin Administration in TKA

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.

Eligibility criteria

Qualifiers

Is a patient over the age of 18 receiving treatment at UC San Diego

Is undergoing primary unilateral total knee arthroplasty

Is able to provide consent

Is candidate for IO administration of Vancomycin

Disqualifiers

Has had a previous surgery on the knee of interest (with the exception of arthroscopy)

Has a BMI >35

Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)

Has diabetes with A1c >7.5% (unless with controlled fructosamine)

Trial design

Treatments tested in this trial

  • Intraosseous Vamcomycin Administration

Treatment groups

30 Participants
are divided into 2 treatment groups