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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllThe Methodist Hospital Research Institute
NCT06640491 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • IO Administration of Cefazolin
  • IO Administration of Vancomycin
  • IV Administration of Cefazolin
  • IV Administration of Vancomycin
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Where

1 site
Houston Methodist Hospital
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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