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NCT Number: NCT06384651

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

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.

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Key information

Conditions

Infections Ankle Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Jason S Ahuero, MD

PRINCIPAL_INVESTIGATOR

Kevin Varner, MD

SUB_INVESTIGATOR

Kwan J Park, MD

SUB_INVESTIGATOR

Thomas C Sullivan, BS

CONTACT

[email protected]

346-238-1603

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraosseous Vancomycin Injection

Drug
  • 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.

Intravenous Vancomycin

Drug
  • 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))

Primary outcomes

  1. Systemic Sample Vancomycin Tissue Concentration - Start of Case

    Time frame: perioperatively

  2. Systemic Sample Vancomycin Tissue Concentration - End of Case

    Time frame: perioperatively

  3. Capsule or Synovium Sample Vancomycin Tissue Concentration

    Time frame: immediately after the procedure

  4. Distal Tibia Sample Vancomycin Tissue Concentration

    Time frame: immediately after the procedure

  5. Talar Bone Sample Vancomycin Tissue Concentration

    Time frame: immediately after the procedure

Secondary outcomes

  1. 90 day post-operative wound complication and infection rates

    Time frame: 90 days after the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Blesson Varghese, BS

CONTACT

[email protected]

713-441-3814

Thomas C Sullivan, BS

CONTACT

[email protected]

346-238-1603

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Acronym: IOTAA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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