NCT06640491

Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are: Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs? Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	IO Administration of Cefazolin	Intraosseous injection of cefazolin to guard against infection.
DRUG	IO Administration of Vancomycin	Intraosseous injection of vancomycin to guard against infection.
DRUG	IV Administration of Cefazolin	Intravenous dose of cefazolin to guard against infection.
DRUG	IV Administration of Vancomycin	Intravenous dose of vancomycin to guard against infection.

Timeline

• Start date: 2025-05-15
• Primary completion: 2030-12-01
• Completion: 2035-12-01
• First posted: 2024-10-15
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study