Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

NCT06384651 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00037789
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections; Ankle Arthritis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 90 day post-operative wound complication and infection rates

  90 days after the procedure

Study Arms (2)

Intravenous Vancomycin

ACTIVE COMPARATOR

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

Intraosseous Vancomycin

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 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

Interventions

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.

Intraosseous Vancomycin

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))

Intravenous Vancomycin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Infections

Study Officials

• Jason S Ahuero, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas C Sullivan, BS

CONTACT

346-238-1603; tsullivan@houstonmethodist.org

Blesson Varghese, BS

CONTACT

713-441-3814; bvarghese6@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Model Details: This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 25, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (1)