Infection, Surgical Site
Conditions
Keywords
Vancomycin, Total Knee Arthroplasty, Tourniquetless
Brief summary
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during tourniquetless total knee arthroplasty.
Detailed description
Primary Objective: Comparable levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, as well as in systemic levels, between the intravenous and intraosseous administration groups. Secondary Objective: Compare 30- and 90-day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) versus the interventional group (intraosseous administration of vancomycin). The research team hypothesizes that there will be no difference in complication (infection) rates between groups
Interventions
• IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep and draping has occurred prior to skin incision (500mg in 150mL NS).
IV Vancomycin will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS).
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
* Participant will be blinded to their mode of vancomycin administration. * Lab will be blinded to which group subject samples come from when doing concentration level testing.
Intervention model description
This study is a prospective, randomized, single-blinded, controlled trial. The anticipated total number of participants in this study is 20 patients in each treatment arm: 20 patients will be given IV Vancomycin, 20 patients will be given IO vancomycin. This sample size is based on previous studies examining vancomycin concentration in primary TKA between IO vs IV
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is undergoing a primary total knee arthroplasty. * Patient is able to understand the study design and intervention and gives informed consent to participate in the study. No LAR consents will be utilized for this study. * Age \>18 years. * Total knee arthroplasty performed without the use of a tourniquet.
Exclusion criteria
* Previous surgery on the knee (including arthroscopic knee surgery) * BMI above 35 * Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). * Inability to locate the tibial tubercle or administer the IO infusion * Refusal to participate * Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C \>7.5. * Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vancomycin Bone/Tissue Concentrations | immediate post-op | Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues, |
| Systemic Vancomycin Concentrations | will be recorded day of surgery | Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 day & 90 day post-operative complication rates | 30 days post-op, 90 days post-op | Monitor charts and clinic visits during the study subject's standard of care postoperative visit schedule and monitor for adverse events including periprosthetic joint infection and wound issues. |
Countries
United States
Contacts
Primary ContactThomas C Sullivan, BS
Backup ContactHaley Goble, MHA
Outcome results
None listed