Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
Recruiting
Phase 4
Interventional Study
Infections
Ankle Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- The Methodist Hospital Research Institute · Other
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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 administrati…
Trial Locations
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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…
Contacts