IO vs IV Vancomycin in Tourniquetless TKA

Phase 4

Recruiting

Interventions: Drug: Intravenous Vancomycin
Drug: Intraosseous Vancomycin Injection

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

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Intravenous Vancomycin Administration	Intravenous Vancomycin	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).
Intraosseous Vancomycin Administration	Intraosseous Vancomycin Injection	* 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.

Primary Outcome Measures

Name	Time	Method
Systemic Vancomycin Concentrations	will be recorded day of surgery	Compare systemic vancomycin levels between the intravenous and intraosseous vancomycin administration groups.
Vancomycin Bone/Tissue Concentrations	immediate post-op	Compare levels of vancomycin will be found in distal femur, proximal tibia, and periarticular soft tissues,

Secondary Outcome Measures

Name	Time	Method
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.

Locations (1): Houston Methodist Hospital Outpatient Center
🇺🇸
Houston, Texas, United States

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