NCT07633418

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
35mo left

Started Jun 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Apr 2029

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2029

Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Serum Vancomycin Levels

    Serum Vancomycin Levels following IO Vancomycin administration

    From administration up to 30 minutes post-administration.

Study Arms (2)

Non tourniquet IO Vancomycin

OTHER

TKA IO Vancomycin administration with no tourniquet.

Drug: Intraosseous Vamcomycin Administration

Tourniquet IO Vancomycin

OTHER

TKA IO Vancomycin Administration with tourniquet

Drug: Intraosseous Vamcomycin Administration

Interventions

Intraosseous Vamcomycin AdministrationDRUG

IO Vancomycin Administration in TKA

Non tourniquet IO VancomycinTourniquet IO Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Diego

San Diego, California, 92093, United States

Location

Related Publications (3)

  • 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: 34084697BACKGROUND

  • 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: 37714404BACKGROUND

  • 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(9S1):S28-S32. doi: 10.1016/j.arth.2025.04.060. Epub 2025 May 6.

    PMID: 40339929BACKGROUND

Central Study Contacts

Dominic Baun

CONTACT

858-534-8268jbaun@health.ucsd.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

April 29, 2027

Study Completion (Estimated)

April 29, 2029

Last Updated

June 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)