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NCT Number: NCT07633418

IO Vancomycin Administration in TKA

This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.

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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 4

Primary location

UC San Diego

San Diego, California, 92093, United States

Location contact

Dominic Baun

CONTACT

[email protected]

858-534-8268

Scott Ball, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is a patient over the age of 18 receiving treatment at UC San Diego
  • Is undergoing primary unilateral total knee arthroplasty
  • Is able to provide consent
  • Is candidate for IO administration of Vancomycin

Exclusion criteria

  • Has had a previous surgery on the knee of interest (with the exception of arthroscopy)
  • Has a BMI >35
  • Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)
  • Has diabetes with A1c >7.5% (unless with controlled fructosamine)
  • Is immunocompromised/immunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)
  • Has a history of active infection
  • Inability to provide consent
  • Prisoner
  • Pregnant women

Treatment and study plan

Intraosseous Vamcomycin Administration

Drug

IO Vancomycin Administration in TKA

Primary outcomes

  1. Serum Vancomycin Levels

    Time frame: From administration up to 30 minutes post-administration.

    Serum Vancomycin Levels following IO Vancomycin administration

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Baun

CONTACT

[email protected]

858-534-8268

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty

Acronym: IO Vanco

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jun 8, 2026
Registry last updated
Jun 8, 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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