Recruiting

Vancomycin Injection

Sponsor:

UCLA

Code:

NCT07282782

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vancomycin

Study Details

Brief 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. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.

Conditions

Total Knee Arthroplasty

Study ID

NCT07282782

Start date

Jun 10, 2024

Status verified date

Oct, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Intravenous (IV) Vancomycin

Standard of care dose based on patient weight, organ function, and clinical factors at the discretion of the treating physician

experimental: Intraosseous (IO) Vancomycin

500mg dose Vancomycin (in 100mL saline)

experimental: Intraarticular (IA) Vancomycin

500mg dose Vancomycin (in 30mL saline)

Interventions

Vancomycin

Intraosseous or Intraarticular administration of Vancomycin

Primary outcome measure

  • Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood [ Time Frame: Intraoperative ]

Central Contacts and Locations

Central contacts

Dominic Baun

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

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Dominic Baun, MS

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

Principal Investigator:

Scott Ball, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 3, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-03.