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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Intraosseous Vamcomycin Administration
DrugIO Vancomycin Administration in TKA
Treatment groups
Trial outcomes
Primary outcomes
Serum Vancomycin Levels
Serum Vancomycin Levels following IO Vancomycin administration
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: