IO vs IV Vancomycin in Tourniquetless TKA
Infection, Surgical Site
About this trial
This is an interventional prevention trial for Infection, Surgical Site focused on measuring Vancomycin, Total Knee Arthroplasty, Tourniquetless
Eligibility Criteria
Inclusion Criteria: Patient is undergoing a primary total knee arthroplasty. Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study. Age >18 years. Total knee arthroplasty performed without the use of a tourniquet. Exclusion Criteria: Previous surgery on the knee (including arthroscopic knee surgery) BMI above 35 Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). Inability to locate the tibial tubercle or administer the IO infusion Refusal to participate Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5. Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
Sites / Locations
- Houston Methodist Hospital Outpatient CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Intravenous Vancomycin Administration
Intraosseous Vancomycin Administration
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS).
IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group. IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS). Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.