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

NCT06640491 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PRO00038477
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Rate of Postoperative Infections

  Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections.

  30 days postop and 90 days postop

Secondary Outcomes (1)

• Postoperative Wound Complications

  30 days postop and 90 days postop

Study Arms (2)

Intraosseous Administration of Vancomycin and Cefazolin

EXPERIMENTAL

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.

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

Standard IV Administration of Vancomycin and Cefazolin

ACTIVE COMPARATOR

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.

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

Interventions

IO Administration of Cefazolin DRUG

Intraosseous injection of cefazolin to guard against infection.

Intraosseous Administration of Vancomycin and Cefazolin

IO Administration of Vancomycin DRUG

Intraosseous injection of vancomycin to guard against infection.

Intraosseous Administration of Vancomycin and Cefazolin

IV Administration of Cefazolin DRUG

Intravenous dose of cefazolin to guard against infection.

Standard IV Administration of Vancomycin and Cefazolin

IV Administration of Vancomycin DRUG

Intravenous dose of vancomycin to guard against infection.

Standard IV Administration of Vancomycin and Cefazolin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Related Publications (25)

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Central Study Contacts

Thomas Sullivan

CONTACT

346-238-1603; tsullivan@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)