RECRUITING

Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

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 goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are: Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs? Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.

Official Title

Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty

Quick Facts

Study Start:2025-04
Study Completion:2035-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06640491

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. * Patient is scheduled to undergo an elective primary total knee arthroplasty.
  2. * Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
  3. * Patient is 18 years or older.
  1. * Contraindication to receiving vancomycin or cefazolin.
  2. * Body mass index (BMI) \> 40.
  3. * Uncontrolled Diabetes (defined as A1c \> 7.5%).
  4. * Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
  5. * Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
  6. * Refusal to participate
  7. * Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.

Contacts and Locations

Study Contact

Thomas Sullivan
CONTACT
346-238-1603
tsullivan@houstonmethodist.org

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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 Date2025-04
Study Completion Date2035-12-01

Study Record Updates

Study Start Date2025-04
Study Completion Date2035-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty