Total Knee Arthroplasty
Conditions
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.
Interventions
DRUGIO Administration of Vancomycin
Intraosseous injection of vancomycin to guard against infection.
DRUGIV Administration of Cefazolin
Intravenous dose of cefazolin to guard against infection.
DRUGIV Administration of Vancomycin
Intravenous dose of vancomycin to guard against infection.
DRUGIO Administration of Cefazolin
Intraosseous injection of cefazolin to guard against infection.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Postoperative Infections | 30 days postop and 90 days postop | Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Wound Complications | 30 days postop and 90 days postop | Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any wound complications. |
Countries
United States
Contacts
Primary ContactThomas Sullivan
Outcome results
None listed