RecruitingPhase 1Phase 2NCT06640491

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

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

Sponsor

The Methodist Hospital Research Institute

Enrollment

40 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Total Knee Arthroplasty

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Patient is scheduled to undergo an elective primary total knee arthroplasty.
Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
Patient is 18 years or older.

Exclusion Criteria7

Contraindication to receiving vancomycin or cefazolin.
Body mass index (BMI) > 40.
Uncontrolled Diabetes (defined as A1c > 7.5%).
Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
Refusal to participate
Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.