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Anti-infective

Intraosseous Vancomycin for Ankle Arthritis (IOTAA Trial)

Phase 4

Recruiting

Led By Jason S Ahuero, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is undergoing total ankle arthroplasty

Age Range >18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the procedure

Awards & highlights

IOTAA Trial Summary

This trial aims to compare two different ways of giving antibiotics during ankle surgery. The main goal is to see if the levels of antibiotics in the bone, tissue, and blood are similar between the two groups

Who is the study for?

This trial is for individuals undergoing total ankle arthroplasty who can safely receive vancomycin. It's not suitable for those with allergies to this antibiotic, other specific medical conditions that could interfere with the study, or those unable to follow the protocol.Check my eligibility

What is being tested?

The study compares two ways of giving vancomycin during ankle surgery: directly into the bone (intraosseous) versus into a vein (intravenous). The goal is to see if both methods result in similar drug levels in bone and tissue and have comparable infection rates after surgery.See study design

What are the potential side effects?

Vancomycin may cause side effects like kidney problems, hearing issues, allergic reactions, and infusion-related discomfort. These risks are generally similar whether the drug is given intraosseously or intravenously.

IOTAA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for total ankle replacement surgery.

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I am older than 18 years.

IOTAA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Capsule or Synovium Sample Vancomycin Tissue Concentration

Distal Tibia Sample Vancomycin Tissue Concentration

Systemic Sample Vancomycin Tissue Concentration - End of Case

+2 more

Secondary outcome measures

90 day post-operative wound complication and infection rates

IOTAA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intraosseous VancomycinExperimental Treatment1 Intervention

IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group. 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.

Group II: Intravenous VancomycinActive Control1 Intervention

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))

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

275 Previous Clinical Trials

80,505 Total Patients Enrolled

Jason S Ahuero, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still eligible to apply for participation in this ongoing trial?

"The trial is actively seeking participants as shown on clinicaltrials.gov. It was initially listed on 12/13/2023 and last revised on 4/24/2024."

Answered by AI

What is the current number of participants being admitted to this clinical study?

"Indeed, information sourced from clinicaltrials.gov affirms the ongoing patient recruitment for this medical investigation. The trial was first listed on 12/13/2023 and had its latest update on 4/24/2024. A total of 40 participants are being sought at a single designated site."

Answered by AI

What is the safety profile of Intraosseous Vancomycin for individuals?

"According to our assessment at Power, Intraosseous Vancomycin is rated 3 for safety. This rating corresponds with a Phase 4 trial status, indicating that the treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Jason S. Ahuero 2023. "Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06384651.

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