Intraosseous Vancomycin vs Intravenous Vancomycin in Tourniquetless Primary Total Knee Arthroplasty
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Systemic Vancomycin Concentrations
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •Immunocompromised or immunosuppressed patients (HIV, Hep C, End-Stage Renal Disease, dialysis, transplant, chemo/radiation treatment in last 6 months, and immunosuppresive medications)
Arms & Interventions
Intravenous Vancomycin Administration
Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS).
Intervention: Intravenous Vancomycin (Drug)
Intraosseous Vancomycin Administration
- IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be administered preoperatively in this group.
- 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).
- Injection will take place into the tibial tubercle (within a pre-specified region) immediately prior to incision.
Intervention: Intraosseous Vancomycin Injection (Drug)
Outcomes
Primary Outcomes
Systemic Vancomycin Concentrations
Time Frame: will be recorded day of surgery
Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.
Vancomycin Bone/Tissue Concentrations
Time Frame: immediate post-op
Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,
Secondary Outcomes
- 30 day & 90 day post-operative complication rates(30 days post-op, 90 days post-op)
Investigators
Timothy S. Brown
Principal Investigator
The Methodist Hospital Research Institute