RECRUITING

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty

Quick Facts

Study Start:2023-12-13
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06384651

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Thomas C Sullivan, BS
CONTACT
346-238-1603
tsullivan@houstonmethodist.org
Blesson Varghese, BS
CONTACT
713-441-3814
bvarghese6@houstonmethodist.org

Principal Investigator

Jason S Ahuero, MD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Jason S Ahuero, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-13
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-12-13
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Infections
  • Ankle Arthritis