IO Vancomycin Administration in TKA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraosseous Vamcomycin Administration.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty
Overview
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.
Interventions
- Drug Intraosseous Vamcomycin Administration
IO Vancomycin Administration in TKA
Primary outcome measures
- Serum Vancomycin Levels [Time frame: From administration up to 30 minutes post-administration.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UC San Diego — San Diego
Publications
- Olsen Kipp J, Hanberg P, Slater J, Moller Nielsen L, Storgaard Jakobsen S, Stilling M, Bue M. Vancomycin bone and tissue concentrations following tibial intraosseous administration - evaluated in a porcine model. J Bone Jt Infect. 2021 Feb 12;6(4):99-106. doi: 10.5194/jbji-6-99-2021. eCollection 2021. PMID 34084697
- Hu M, Zhang Y, Yang X, Wang Y, Xu H, Xiang S. Intraarticular vancomycin decreased the risk of acute postoperative periprosthetic joint infection without increasing complication in primary total joint arthroplasty-a prospective study. Int J Infect Dis. 2023 Nov;136:64-69. doi: 10.1016/j.ijid.2023.09.004. Epub 2023 Sep 14. PMID 37714404
- McNamara CA, Wininger AE, Sullivan TC, Brown TS, Clyburn TA, Incavo SJ, Park KJ. The AAHKS Best Podium Presentation Research Award: Intraosseous Vancomycin Reduces the Rate of Periprosthetic Joint Infection Following Aseptic Revision Total Knee Arthroplasty. J Arthroplasty. 2025 Sep;40(S19):S28-S32. doi: 10.1016/j.arth.2025.04.060. Epub 2025 May 6. PMID 40339929
Identifiers
NCT: NCT07633418 · 804904