Health TrialsbyHealthPanel

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

ConditionsInfectionsAnkle Arthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraosseous Vancomycin Injection

    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

    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))

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intravenous VancomycinActive comparator 1 intervention
Group B: Intraosseous VancomycinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Systemic Sample Vancomycin Tissue Concentration - Start of Case

Time frame
perioperatively
2

Systemic Sample Vancomycin Tissue Concentration - End of Case

Time frame
perioperatively
3

Capsule or Synovium Sample Vancomycin Tissue Concentration

Time frame
immediately after the procedure
4

Distal Tibia Sample Vancomycin Tissue Concentration

Time frame
immediately after the procedure

Secondary outcomes

1

90 day post-operative wound complication and infection rates

Time frame
90 days after the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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