Recruiting

IO vs. IV Vancomycin

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT05705843

Conditions

Infection, Surgical Site

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Intraosseous Vancomycin Injection

Intravenous Vancomycin

Study Details

Brief summary:

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.

Conditions

Infection, Surgical Site

Study ID

NCT05705843

Start date

Jan 25, 2023

Status verified date

Jan, 2023

Completion date

Jan 25, 2024

Anticipated

Primary completion date

Jan 25, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient is undergoing a primary total knee arthroplasty.
  • Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study.
  • Age >18 years.
  • Total knee arthroplasty performed without the use of a tourniquet.

Exclusion Criteria:

  • Previous surgery on the knee (including arthroscopic knee surgery)
  • BMI above 35
  • Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
  • Inability to locate the tibial tubercle or administer the IO infusion
  • Refusal to participate
  • Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.
  • Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intravenous Vancomycin Administration

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 (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg \[12,13\] generally 1000-1750mg in 500mL NS).

experimental: Intraosseous Vancomycin Administration

  • IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group.
  • IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
  • Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.

Interventions

Intraosseous Vancomycin Injection

• IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).

Intravenous Vancomycin

IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS).

Primary outcome measure

  • Vancomycin Bone/Tissue Concentrations [ Time Frame: immediate post-op ]
  • Systemic Vancomycin Concentrations [ Time Frame: will be recorded day of surgery ]

Central Contacts and Locations

Central contacts

Thomas C Sullivan, BS

346-238-1603tsullivan@houstonmethodist.org

Haley Goble, MHA

7134413930hmgoble@houstonmethodist.org

Locations

Houston Methodist Hospital Outpatient Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Sonya Hadrigan

713-790-3311irbstaff@houstonmethodist.org

Principal Investigator:

Timothy S Brown, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jan 31, 2023

Last verified

Jan, 2023

Keywords

  • Vancomycin
  • Total Knee Arthroplasty
  • Tourniquetless

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2023-01-31.