Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06384651
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ankle Arthritis
  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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))

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
Jan 2025
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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))
  • 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.

Primary Outcome Measure

Systemic Sample Vancomycin Tissue Concentration - Start of Case [ Time Frame: perioperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Thomas C Sullivan, BS
[email protected]
346-238-1603
Jason S Ahuero, MD (PRINCIPAL_INVESTIGATOR)
Kevin Varner, MD (SUB_INVESTIGATOR)
Kwan J Park, MD (SUB_INVESTIGATOR)

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By research site
Houston Methodist Hospital· Houston, TX

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