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Recruiting
NCT05705843
IO vs IV Vancomycin in Tourniquetless TKA
Conditions: Infection, Surgical Site
Sex: All
Ages: 19 Years – 80 Years
Phase: PHASE4
Enrollment: 40
Sponsor: The Methodist Hospital Research Institute
Location: United States
Summary
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.
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 35Contraindication 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 infusionRefusal to participateUncontrolled 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)
Source: ClinicalTrials.gov (NCT05705843). StuddyBuddy aggregates publicly available trial information.