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NCT Number: NCT07283068

IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.
  • Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
  • Age > 18 years.

Exclusion criteria

  • Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
  • Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.
  • Any hardware, condition, or anatomic status that prevents the medial malleolus 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

Intraosseous Vancomycin

Drug

IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision.

Primary outcomes

  1. Level of Vancomycin

    Time frame: During the surgery

    The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 15, 2025
Registry last updated
Apr 20, 2026

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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