Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Study Overview
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Brief Summary
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The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.

Detailed Description
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Patients are randomized to one of two groups. GROUP A - Will receive IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 milliliters (mL) normal saline (NS). GROUP B - Will have IV cefepime started in pre-op within 1 hour of incision. Intraosseous (IO) administration of vancomycin (500mg in 250 milliliters NS) will be administered in the OR after sterile prep and draping has occurred. Injection will take place into the greater trochanter (within a pre-specified region). Both Groups will be monitored during surgery and immediately post-operatively for adverse injection reactions (i.e. Red Man Syndrome). Both groups will otherwise follow identical post-operative protocols (including post-operative antibiotic administration). TISSUE SAMPLES Five (5) tissue samples will be taken from each patient, 2 soft tissue samples and 3 bone samples will be taken throughout the course of the procedure. One blood sample will be taken in both groups intraoperatively at the time of initiation of closure. These samples will immediately be sent to a lab for analysis.

Official Title
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Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Conditions
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Prosthetic Joint Infection, Vancomycin, Joint Diseases

Intervention / Treatment
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* Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS
* Drug: Standard IV administration of vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is undergoing a primary total hip arthroplasty Patient gives informed consent to participate in the study. Age Range >18 Exclusion Criteria: Previous surgery on the hip (including hip scopes) BMI above 35 Contraindication to receiving vancomycin or cefepime (allergy, medical issue, etc) Inability to locate the greater trochanter or administer the IO infusion Refusal to participate Diabetes Immunocompromised or immunosuppressed patients (HIV, Hep C, End stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV administration of vancomycin<br>Standard IV vancomycin administration protocol. | Drug: Standard IV administration of vancomycin<br>* IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).<br>|
| Experimental: IO Vancomycin 500mg in 250 mL NS<br>Experimental Intraosseous administration protocol. | Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS<br>* 500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Vancomycin level | vancomycin blood level at time of initiation of closure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue vancomycin level | at start and end of case. | 1 year | 
| Femur vancomycin level | at start and end of case. | 1 year | 
| Acetabulum vancomycin level | at start and end of case. | 1 year | 
| 30-Day Complications | Complications 30 days post surgery i.e. infection. | From the administration of antibiotics perioperatively to 30 days post op. | 
| 90-Day Complications | Complications 90 days post surgery i.e. infection | From the administration of antibiotics perioperatively to 90 days post op. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, vancomycin, intraosseous vancomycin