Ankle Arthritis, Infections
Conditions
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.
Interventions
* 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.
• 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))
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic Sample Vancomycin Tissue Concentration - Start of Case | perioperatively |
| Systemic Sample Vancomycin Tissue Concentration - End of Case | perioperatively |
| Capsule or Synovium Sample Vancomycin Tissue Concentration | immediately after the procedure |
| Distal Tibia Sample Vancomycin Tissue Concentration | immediately after the procedure |
| Talar Bone Sample Vancomycin Tissue Concentration | immediately after the procedure |
Secondary
| Measure | Time frame |
|---|---|
| 90 day post-operative wound complication and infection rates | 90 days after the procedure |
Countries
United States
Contacts
Primary ContactThomas C Sullivan, BS
Backup ContactBlesson Varghese, BS
Outcome results
None listed