Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraosseous Vancomycin Injection, Intravenous Vancomycin.
- Who it may be relevant to
- Registry conditions: Infections, Ankle Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Intraosseous Vancomycin Injection
* 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 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))
Primary outcome measures
- 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 outcome measures (1)
- 90 day post-operative wound complication and infection rates [Time frame: 90 days after the procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Identifiers
NCT: NCT06384651 · PRO00037789