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NCT06640491PHASE1, PHASE2Recruiting

Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

The Methodist Hospital Research Institute

Start Date

5/15/2025

Completion Date

12/1/2035

Summary

The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are: Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs? Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patient is scheduled to undergo an elective primary total knee arthroplasty. * Patient is able to understand the study design and intervention and gives informed consent to participate in the study. * Patient is 18 years or older. Exclusion Criteria: * Contraindication to receiving vancomycin or cefazolin. * Body mass index (BMI) \> 40. * Uncontrolled Diabetes (defined as A1c \> 7.5%). * Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure. * Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site. * Refusal to participate * Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.

Interventions

DRUG

IO Administration of Cefazolin

DRUG

IO Administration of Vancomycin

DRUG

IV Administration of Cefazolin

DRUG

IV Administration of Vancomycin

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Conditions

Total Knee Arthroplasty

Locations

Houston Methodist Hospital

Houston, Texas 77030

United States