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Vancomycin in TKAs

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07282782
Enrollment
30
Registered
2025-12-15
Start date
2024-06-10
Completion date
2028-12-31
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty

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.

Interventions

DRUGVancomycin

Intraosseous or Intraarticular administration of Vancomycin

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum bloodIntraoperative

Countries

United States

Contacts

CONTACTDominic Baun
jbaun@health.ucsd.edu858-534-8268

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026