Vancomycin in TKAs

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vancomycin

    Drug

    Intraosseous or Intraarticular administration of Vancomycin

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Intravenous (IV) VancomycinNo intervention 0 interventions
Group B: Intraosseous (IO) VancomycinExperimental treatment 1 intervention
Group C: Intraarticular (IA) VancomycinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Intraoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.