Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Oct 10, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating two different ways to give antibiotics—using an intravenous (IV) line or directly into the bone (called intraosseous or IO)—during total knee replacement surgery. The main goal is to see if the IO method is as effective as the standard IV method in preventing infections and other complications after surgery. This study will take place at Houston Methodist Hospital and aims to determine whether the IO method can protect patients better from risks related to the surgery.
To be eligible for this trial, participants must be adults aged 18 or older who are scheduled for a total knee replacement and can understand and agree to join the study. Some individuals may not be suitable for the trial, such as those with certain health conditions or who have received specific medications recently. If you choose to participate, you will be randomly assigned to receive either the standard IV antibiotics or the new IO method. This trial is currently recruiting participants, and your involvement could help improve treatment options for future knee surgery patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient is scheduled to undergo an elective primary total knee arthroplasty.
- • Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- • Patient is 18 years or older.
- Exclusion Criteria:
- • Contraindication to receiving vancomycin or cefazolin.
- • Body mass index (BMI) \> 40.
- • Uncontrolled Diabetes (defined as A1c \> 7.5%).
- • Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
- • Any hardware, condition, or anatomic status that prevents the tibial tubercle from being a viable intraosseous injection site.
- • Refusal to participate
- • Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.
About The Methodist Hospital Research Institute
The Methodist Hospital Research Institute (MHRI) is a leading clinical research organization dedicated to advancing medical science through innovative research and collaboration. Affiliated with the Methodist Hospital system, MHRI focuses on a broad spectrum of clinical trials, aiming to translate cutting-edge discoveries into effective therapies that enhance patient care. With a commitment to ethical standards and patient safety, the institute fosters partnerships between researchers, clinicians, and industry stakeholders, driving progress in fields such as cancer, cardiology, neurology, and more. Through its robust infrastructure and multidisciplinary approach, MHRI strives to improve health outcomes and contribute to the advancement of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported