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IO vs IV Vancomycin in Tourniquetless TKA

Primary Purpose

Infection, Surgical Site

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intraosseous Vancomycin Injection
Intravenous Vancomycin
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Surgical Site focused on measuring Vancomycin, Total Knee Arthroplasty, Tourniquetless

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Houston Methodist Hospital Outpatient CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous Vancomycin Administration

Intraosseous Vancomycin Administration

Arm 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).

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.

Outcomes

Primary Outcome Measures

Vancomycin Bone/Tissue Concentrations
Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
Systemic Vancomycin Concentrations
Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.

Secondary Outcome Measures

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.

Full Information

First Posted
January 19, 2023
Last Updated
January 27, 2023
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05705843
Brief Title
IO vs IV Vancomycin in Tourniquetless TKA
Official Title
Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Anticipated)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
January 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Surgical Site
Keywords
Vancomycin, Total Knee Arthroplasty, Tourniquetless

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IV
Masking
ParticipantOutcomes Assessor
Masking Description
Participant will be blinded to their mode of vancomycin administration. Lab will be blinded to which group subject samples come from when doing concentration level testing.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Vancomycin Administration
Arm Type
Active Comparator
Arm 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).
Arm Title
Intraosseous Vancomycin Administration
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Intraosseous Vancomycin Injection
Intervention Description
• 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).
Intervention Type
Drug
Intervention Name(s)
Intravenous Vancomycin
Intervention Description
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 Information:
Title
Vancomycin Bone/Tissue Concentrations
Description
Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
Time Frame
immediate post-op
Title
Systemic Vancomycin Concentrations
Description
Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.
Time Frame
will be recorded day of surgery
Secondary Outcome Measure Information:
Title
30 day & 90 day post-operative complication rates
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas C Sullivan, BS
Phone
346-238-1603
Email
tsullivan@houstonmethodist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Goble, MHA
Phone
7134413930
Email
hmgoble@houstonmethodist.org
Facility Information:
Facility Name
Houston Methodist Hospital Outpatient Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Hadrigan
Phone
713-790-3311
Email
irbstaff@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Timothy S Brown, MD
First Name & Middle Initial & Last Name & Degree
Stephen J Incavo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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IO vs IV Vancomycin in Tourniquetless TKA

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