Summary

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

Description

Summary

Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would/tissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. We proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.

Keywords

Total Knee Arthroplasty, Vancomycin, Intravenous (IV) Vancomycin, Intraosseous (IO) Vancomycin, Intraarticular (IA) Vancomycin

Eligibility

You can join if…

Open to people ages 18 years and up

  • Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
  • Undergoing primary unilateral TKA
  • Ability to provide consent

You CAN'T join if...

  • previous surgery on the knee (with the exception of arthroscopy)
  • BMI > 35
  • contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)
  • diabetics with A1c>7.5% (unless controlled fructosamine)
  • immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)
  • no history of active infections
  • no history of chronic kidney disease

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07282782
Phase
Phase 4 Knee Replacement Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated