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

Phase 1

Recruiting

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: IO Administration of Cefazolin; Drug: IV Administration of Cefazolin; Drug: IO Administration of Vancomycin; Drug: IV Administration of Vancomycin

• Registration Number: NCT06640491
• Lead Sponsor: The Methodist Hospital Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Status Verified: 2025-05
• Study Start: 2025-05-15
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2030-12-01
• Study Completion: 2035-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intraosseous Administration of Vancomycin and Cefazolin	IO Administration of Cefazolin	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.
Intraosseous Administration of Vancomycin and Cefazolin	IO Administration of Vancomycin	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.
Standard IV Administration of Vancomycin and Cefazolin	IV Administration of Cefazolin	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.
Standard IV Administration of Vancomycin and Cefazolin	IV Administration of Vancomycin	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.

Primary Outcome Measures

Name	Time	Method
Rate of Postoperative Infections	30 days postop and 90 days postop	Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections.

Secondary Outcome Measures

Name	Time	Method
Postoperative Wound Complications	30 days postop and 90 days postop	Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any wound complications.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States