Comparing Intraosseous vs. Intravenous Vancomycin in Ankle Surgery
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
Who this trial is looking for
This trial is looking for adults who are having ankle surgery. Participants will receive one of two different ways to give an antibiotic to help prevent infections after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
- I am having total ankle arthroplasty.
- I can give informed consent to participate.
- I am over 18 years old.
You may not be able to join if
- I have had previous surgery on my lower leg.
- My BMI is over 40.
- I cannot take vancomycin or other standard antibiotics.
- I cannot receive the IO infusion.
- I do not want to participate.
- I have uncontrolled diabetes with an A1C over 7.5.
- I am immunocompromised or on certain immunosuppressive treatments.
- I belong to a vulnerable population.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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