IO vs IV Vancomycin in Tourniquetless TKA

Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty

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

Study Overview

• Status: Recruiting
• Conditions: Infection, Surgical Site
• Intervention / Treatment: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin Injection

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thomas C Sullivan, BS; Phone Number: 346-238-1603; Email: tsullivan@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital Outpatient Center
      • Contact: Sonya Hadrigan; Phone Number: 713-790-3311; Email: irbstaff@houstonmethodist.org
      • Principal Investigator: Timothy S Brown, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: 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).
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.	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vancomycin Bone/Tissue Concentrations	Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,	immediate post-op
Systemic Vancomycin Concentrations	Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.	will be recorded day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post-op, 90 days post-op

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2023
• Primary Completion (Anticipated): January 25, 2024
• Study Completion (Anticipated): January 25, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Vancomycin; Total Knee Arthroplasty; Tourniquetless
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: PRO00035759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No