What this study is
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.
What's being tested
- Intraosseous Vancomycin Injection
Intervention · 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
Intervention · 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
- Sponsor
- The Methodist Hospital Research Institute
- Conditions
- Infections · Ankle Arthritis
- Enrolling
- 40 people
- Starts
- 2024-12-03
- Est. completion
- 2027-12
- Design
- Double-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHouston Methodist Hospital
Houston, Texas, United States
- Thomas C Sullivan, BS · Contact346-238-1603tsullivan@houstonmethodist.org
- Jason S Ahuero, MD · Principal investigator
- Kevin Varner, MD · Sub-investigator
- Kwan J Park, MD · Sub-investigator
Recruiting
Study team
Sponsor
The Methodist Hospital Research Institute
Study ID PRO00037789
Principal investigator
Jason S Ahuero, MD
The Methodist Hospital Research Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.