Total Knee Arthroplasty
Conditions
Brief summary
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.
Interventions
DRUGIntraosseous Vamcomycin Administration
IO Vancomycin Administration in TKA
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is a patient over the age of 18 receiving treatment at UC San Diego 2. Is undergoing primary unilateral total knee arthroplasty 3. Is able to provide consent 4. Is candidate for IO administration of Vancomycin
Exclusion criteria
1. Has had a previous surgery on the knee of interest (with the exception of arthroscopy) 2. Has a BMI \>35 3. Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy) 4. Has diabetes with A1c \>7.5% (unless with controlled fructosamine) 5. Is immunocompromised/immunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications) 6. Has a history of active infection 7. Inability to provide consent 8. Prisoner 9. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Vancomycin Levels | From administration up to 30 minutes post-administration. | Serum Vancomycin Levels following IO Vancomycin administration |
Countries
United States
Contacts
CONTACTDominic Baun
Outcome results
None listed