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NCT06640491 | NOT YET RECRUITING | Total Knee Arthroplasty

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

The Methodist Hospital Research Institute

Information provided by (Responsible Party):

Brian Parsley

Brief Summary:

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.

Condition or disease

Total Knee Arthroplasty

Intervention/treatment

IO Administration of Cefazolin

IO Administration of Vancomycin

IV Administration of Cefazolin

IV Administration of Vancomycin

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2030-12-01
Estimated Study Completion Date : 2035-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

Location Details

NCT06640491

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030