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NCT Number: NCT06640491

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

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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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IO Administration of Cefazolin

Drug

Intraosseous injection of cefazolin to guard against infection.

IO Administration of Vancomycin

Drug

Intraosseous injection of vancomycin to guard against infection.

IV Administration of Cefazolin

Drug

Intravenous dose of cefazolin to guard against infection.

IV Administration of Vancomycin

Drug

Intravenous dose of vancomycin to guard against infection.

Primary outcomes

  1. Rate of Postoperative Infections

    Time frame: 30 days postop and 90 days postop

    Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections.

Secondary outcomes

  1. Postoperative Wound Complications

    Time frame: 30 days postop and 90 days postop

    Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any wound complications.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Oct 15, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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