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

Last updated: May 16, 2025
Sponsor: The Methodist Hospital Research Institute
Overall Status: Active - Recruiting

Phase

1/2

Condition

Knee Replacement

Treatment

IO Vancomycin and Cefazolin

IV Administration of Vancomycin

IO Administration of Cefazolin

Clinical Study ID

NCT06640491
PRO00038477
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 informedconsent to participate in the study.

  • Patient is 18 years or older.

Exclusion

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 daysprior to their planned procedure.

  • Any hardware, condition, or anatomic status that prevents the tibial tubercle frombeing a viable intraosseous injection site.

  • Refusal to participate

  • Any condition, in the opinion of the primary investigator, that deems theparticipant unsuitable for participation in the research study.

Study Design

Total Participants: 40
Treatment Group(s): 6
Primary Treatment: IO Vancomycin and Cefazolin
Phase: 1/2
Study Start date:
May 15, 2025
Estimated Completion Date:
December 01, 2035

Connect with a study center

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

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