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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Total Knee Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

Study Record Dates

2035-12-01