Vancomycin in TKAs

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT07282782
Phase
PHASE4
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vancomycin — DRUG
    Intraosseous or Intraarticular administration of Vancomycin

Study Details

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.

Key Dates

Start date
Jun 10, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Dominic Baun, MS
[email protected]
858-534-8268
Scott Ball, MD (PRINCIPAL_INVESTIGATOR)

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