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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06640491
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IO Administration of Cefazolin — DRUG
    Intraosseous injection of cefazolin to guard against infection.
  • IO Administration of Vancomycin — DRUG
    Intraosseous injection of vancomycin to guard against infection.
  • IV Administration of Cefazolin — DRUG
    Intravenous dose of cefazolin to guard against infection.
  • IV Administration of Vancomycin — DRUG
    Intravenous dose of vancomycin to guard against infection.

Study Details

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.

Key Dates

Start date
May 15, 2025
Status verified
May 2025
Primary completion
Dec 1, 2030
Completion
Dec 1, 2035

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-

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By research site
Houston Methodist Hospital· Houston, TX

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