Intraosseous Vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty (IOTAA)

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 4

Conditions: Infections; Ankle Arthritis

Treatments: Drug: Intravenous Vancomycin; Drug: Intraosseous Vancomycin Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06384651

PRO00037789

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Intravenous Vancomycin

Active Comparator group

Description:

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))

Treatment:

Drug: Intravenous Vancomycin

Intraosseous Vancomycin

Experimental group

Description:

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.

Treatment:

Drug: Intraosseous Vancomycin Injection