Intraosseous Vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty (IOTAA)

The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).

Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.

Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.

Study Overview

• Status: Recruiting
• Conditions: Infections; Ankle Arthritis
• Intervention / Treatment: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin Injection

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

Contacts and Locations

• Study Contact: Name: Thomas C Sullivan, BS; Phone Number: 346-238-1603; Email: tsullivan@houstonmethodist.org
• Study Contact Backup: Name: Blesson Varghese, BS; Phone Number: 713-441-3814; Email: bvarghese6@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Thomas C Sullivan, BS; Phone Number: 346-238-1603; Email: tsullivan@houstonmethodist.org
      • Contact: Jason S Ahuero, MD
      • Contact: Kevin Varner, MD
      • Contact: Kwan J Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Patient is undergoing total ankle arthroplasty.
• Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
• Age Range >18

Exclusion Criteria

• Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
• BMI > 40.
• Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
• Inability to administer the IO infusion.
• Patient 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, medications).
• Vulnerable populations

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous Vancomycin; Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))	Drug: Intravenous Vancomycin; • Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))
Experimental: Intraosseous Vancomycin; 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 given preoperatively in this group. IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). IO Injection will take place into the medial malleolus.	Drug: Intraosseous Vancomycin Injection; IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).; IO Injection will take place into the medial malleolus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systemic Sample Vancomycin Tissue Concentration - Start of Case	perioperatively
Systemic Sample Vancomycin Tissue Concentration - End of Case	perioperatively
Capsule or Synovium Sample Vancomycin Tissue Concentration	immediately after the procedure
Distal Tibia Sample Vancomycin Tissue Concentration	immediately after the procedure
Talar Bone Sample Vancomycin Tissue Concentration	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
90 day post-operative wound complication and infection rates	90 days after the procedure

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Jason S Ahuero, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Arthritis; Anti-Bacterial Agents; Anti-Infective Agents; Vancomycin
• Other Study ID Numbers: PRO00037789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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