Clinical trial NCT06384651: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Official title: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infections
Ankle Arthritis
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Systemic Sample Vancomycin Tissue Concentration - Start of Case
timeFrame: perioperatively
measure: Systemic Sample Vancomycin Tissue Concentration - End of Case
timeFrame: perioperatively
measure: Capsule or Synovium Sample Vancomycin Tissue Concentration
timeFrame: immediately after the procedure
measure: Distal Tibia Sample Vancomycin Tissue Concentration
timeFrame: immediately after the procedure
measure: Talar Bone Sample Vancomycin Tissue Concentration
timeFrame: immediately after the procedure
Secondary outcomes:
measure: 90 day post-operative wound complication and infection rates
timeFrame: 90 days after the procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Jason S Ahuero, MD
role: PRINCIPAL_INVESTIGATOR
References: