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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
California
University of California, San Diego
RECRUITING
San Diego
Contact Information
Primary
Dominic Baun
jbaun@health.ucsd.edu
858-534-8268
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 30
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov