This study is not yet accepting patients

IO Vancomycin Administration in TKA

a study on Knee Replacement

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Scott Ball, MD (ucsd)

Description

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.

Official Title

Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty, Intraosseous Vamcomycin Administration, Tourniquet IO Vancomycin

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  1. Has had a previous surgery on the knee of interest (with the exception of arthroscopy)
  2. Has a BMI >35
  3. Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)
  4. Has diabetes with A1c >7.5% (unless with controlled fructosamine)
  5. 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)
  6. Has a history of active infection
  7. Inability to provide consent
  8. Prisoner
  9. Pregnant women

Location

  • UC San Diego
    San Diego California 92093 United States

Lead Scientist at University of California Health

  • Scott Ball, MD (ucsd)
    Clinical Professor, Orthopedic Surgery, Vc-health Sciences-schools. Authored (or co-authored) 56 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07633418
Phase
Phase 4 Knee Replacement Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated