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

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Total Knee Arthroplasty

Treatments: Drug: IO Administration of Vancomycin; Drug: IV Administration of Vancomycin; Drug: IO Administration of Cefazolin; Drug: IV Administration of Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT06640491

PRO00038477

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intraosseous Administration of Vancomycin and Cefazolin

Experimental group

Description:

Intraosseous vancomycin plus cefazolin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision and after the tourniquet has been inflated. The injection will take place into the tibial tubercle, which is a known safe IO injection site. The IO injection will include 500mg of vancomycin and a 1g dose of cefazolin, previously used in prior IO studies of cefazolin.

Treatment:

Drug: IO Administration of Cefazolin

Drug: IO Administration of Vancomycin

Standard IV Administration of Vancomycin and Cefazolin

Active Comparator group

Description:

Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics cefazolin will be started in the pre-operative period approximately 1 hour prior to incision. The cefazolin dose is generally 2g if patient is under 120kg, and 3g is the patient is above 120kg in line with guidelines. Vancomycin IV administration will be dosing will be weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS.

Treatment:

Drug: IV Administration of Cefazolin

Drug: IV Administration of Vancomycin