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

NCT07282782 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 810594
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood

  Intraoperative

Study Arms (3)

Intravenous (IV) Vancomycin

NO INTERVENTION

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

Intraosseous (IO) Vancomycin

EXPERIMENTAL

500mg dose Vancomycin (in 100mL saline)

Drug: Vancomycin

Intraarticular (IA) Vancomycin

EXPERIMENTAL

500mg dose Vancomycin (in 30mL saline)

Drug: Vancomycin

Interventions

Vancomycin DRUG

Intraosseous or Intraarticular administration of Vancomycin

Intraarticular (IA) Vancomycin; Intraosseous (IO) Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dominic Baun

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

US (1)