Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty

PRO00035759

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

2023-01-25

2024-01-25

2024-01-25

Recruiting

Early phase I

40

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IV', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '* Participant will be blinded to their mode of vancomycin administration.\n* Lab will be blinded to which group subject samples come from when doing concentration level testing.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-01-31