Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT07282782

A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty

Led by University of California, San Diego · Updated on 2025-12-15

30

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
  • Undergoing primary unilateral total knee arthroplasty
  • Ability to provide consent
Not Eligible

You will not qualify if you...

  • Previous surgery on the knee (except arthroscopy)
  • Body mass index (BMI) greater than 35
  • Allergy or contraindication to vancomycin, cefepime, or cefazolin
  • Diabetes with A1c greater than 7.5% unless controlled fructosamine is documented
  • Immunocompromised or immunosuppressed conditions (including HIV, Hepatitis C, end stage renal disease, post-transplant status, chemotherapy or radiation within 6 months, or use of immunomodulating medications)
  • History of active infections
  • History of chronic kidney disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Diego

San Diego, California, United States, 92093

Actively Recruiting

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Research Team

D

Dominic Baun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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