IO vs IV Vancomycin in Tourniquetless TKA

The Methodist Hospital Research Institute40 enrolled

Overview

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

Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups. Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Infection, Surgical Site

Interventions

Intraosseous Vancomycin InjectionDRUG

• 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 VancomycinDRUG

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).

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Houston Methodist Hospital Outpatient Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Vancomycin Bone/Tissue Concentrations

Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,

Time frame: immediate post-op

Systemic Vancomycin Concentrations

Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.

Time frame: will be recorded day of surgery

Secondary Outcomes

30 day & 90 day post-operative complication rates

Monitor charts and clinic visits during the study subject's standard of care postoperative visit schedule and monitor for adverse events including periprosthetic joint infection and wound issues.

Time frame: 30 days post-op, 90 days post-op

Central Contacts

Thomas C Sullivan, BS

CONTACT

346-238-1603 tsullivan@houstonmethodist.org

Haley Goble, MHA

CONTACT

7134413930 hmgoble@houstonmethodist.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.