Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Infections Clinical Trial

— IOTAA  

Official title:

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384651
• Other study ID #: PRO00037789
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Arthritis
• Arthritis
• Infections

Intervention

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.
• 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))

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	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	Systemic Sample Vancomycin Tissue Concentration - Start of Case		perioperatively
Primary	Systemic Sample Vancomycin Tissue Concentration - End of Case		perioperatively
Primary	Capsule or Synovium Sample Vancomycin Tissue Concentration		immediately after the procedure
Primary	Distal Tibia Sample Vancomycin Tissue Concentration		immediately after the procedure
Primary	Talar Bone Sample Vancomycin Tissue Concentration		immediately after the procedure
Secondary	90 day post-operative wound complication and infection rates		90 days after the procedure