Recruiting
Phase 1
Phase 2

Cefazolin & Vancomycin

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06640491

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IO Administration of Cefazolin

IO Administration of Vancomycin

IV Administration of Cefazolin

IV Administration of Vancomycin

Study Details

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

Study ID

NCT06640491

Start date

May 15, 2025

Status verified date

May, 2025

Completion date

Dec 1, 2035

Anticipated

Primary completion date

Dec 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intraosseous Administration of Vancomycin and 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.

active comparator: Standard IV Administration of Vancomycin and 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.

Interventions

IO Administration of Cefazolin

Intraosseous injection of cefazolin to guard against infection.

IO Administration of Vancomycin

Intraosseous injection of vancomycin to guard against infection.

IV Administration of Cefazolin

Intravenous dose of cefazolin to guard against infection.

IV Administration of Vancomycin

Intravenous dose of vancomycin to guard against infection.

Primary outcome measure

  • Rate of Postoperative Infections [ Time Frame: 30 days postop and 90 days postop ]

Central Contacts and Locations

Central contacts

Thomas Sullivan

346-238-1603tsullivan@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

May 18, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-05-18.