Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Phase 4RecruitingNCT06384651

The Methodist Hospital Research Institute40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Infections Ankle Arthritis

Interventions

Intravenous VancomycinDRUG

• 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))

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Systemic Sample Vancomycin Tissue Concentration - Start of Case

Time frame: perioperatively

Systemic Sample Vancomycin Tissue Concentration - End of Case

Time frame: perioperatively

Capsule or Synovium Sample Vancomycin Tissue Concentration

Time frame: immediately after the procedure

Distal Tibia Sample Vancomycin Tissue Concentration

Time frame: immediately after the procedure

Talar Bone Sample Vancomycin Tissue Concentration

Time frame: immediately after the procedure

Secondary Outcomes

90 day post-operative wound complication and infection rates

Time frame: 90 days after the procedure

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts