IO vs IV Vancomycin in Tourniquetless TKA

Infection, Surgical Site Clinical Trial

Official title:

Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705843
• Other study ID #: PRO00035759
• Status: Recruiting
• Phase: Phase 4
• Start date: January 25, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2023
• Source: The Methodist Hospital Research Institute
• Contact: Thomas C Sullivan, BS
• Phone: 346-238-1603
• Email: tsullivan[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infection, Surgical Site
• Surgical Wound Infection

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Houston Methodist Hospital Outpatient Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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