IO vs IV Vancomycin in Tourniquetless TKA

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 4

Conditions: Infection, Surgical Site

Treatments: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05705843

PRO00035759

Details and patient eligibility

About

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

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Intravenous Vancomycin Administration

Active Comparator group

Description:

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).

Treatment:

Drug: Intravenous Vancomycin

Intraosseous Vancomycin Administration

Experimental group

Description:

* 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.

Treatment:

Drug: Intraosseous Vancomycin Injection