IO vs IV Vancomycin in Tourniquetless TKA

NCT05705843 | Unknown Phase 4 FDA Drug

• 1 other identifier: PRO00035759
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infection, Surgical Site

Keywords

Vancomycin; Total Knee Arthroplasty; Tourniquetless

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 30 day & 90 day post-operative complication rates

  30 days post-op, 90 days post-op

Study Arms (2)

Intravenous Vancomycin Administration

ACTIVE COMPARATOR

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

Intraosseous Vancomycin Administration

EXPERIMENTAL

* 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

Interventions

Intraosseous Vancomycin Injection DRUG

• 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).

Intraosseous Vancomycin Administration

Intravenous Vancomycin DRUG

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).

Intravenous Vancomycin Administration

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital Outpatient Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas C Sullivan, BS

CONTACT

346-238-1603; tsullivan@houstonmethodist.org

Haley Goble, MHA

CONTACT

7134413930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 31, 2023
• Study Start: January 25, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)