Intraosseous vs. Intravenous Vancomycin Administration in Total Shoulder Arthroplasty: Changing the Paradigm
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Systemic Levels of Vancomycin
Study Overview
Brief Summary
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty.
Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Detailed Description
This study is a prospective, randomized, single-blinded, controlled trial. 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 tourniquetless primary total knee arthroplasty between IO vs IV [12,13].
Once the participant has been enrolled, they will be randomized into either the control group or the experimental group by an excel-based software program prior to their procedure.
Control - Standard IV administration of vancomycin
1) Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (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 [6,7] generally 1000-1750mg in 500mL NS).
Intervention - Intraosseous (IO) administration of vancomycin
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double blinded study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Previous shoulder surgery
- •BMI above 35
- •Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- •Inability to administer the IO infusion
- •Refusal to participate
- •Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
Arms & Interventions
Control - Standard IV administration of vancomycin
Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for primary total shoulder arthroplasty patients. This includes IV abx (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 [6,7] generally 1000-1750mg in 500mL NS).
Intervention: Control - Standard IV administration of vancomycin (Drug)
Intervention - Intraosseous (IO) administration of vancomycin
- IV antibiotics (per physician's standard of care): Typically ancef or cefepime is started in pre-op within 1 hour of incision
- IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
- Injection will take place into the proximal humerus
Intervention: Intervention - Intraosseous (IO) administration of vancomycin (Drug)
Outcomes
Primary Outcomes
Systemic Levels of Vancomycin
Time Frame: 24 hours
Comparable levels of vancomycin will be found in systemic samples between patient groups.
Vancomycin Levels in the Initial Deltoid
Time Frame: 24 hours
Comparable levels of vancomycin will be found in the initial deltoid samples between patient groups.
Vancomycin Levels in the Humeral Head
Time Frame: 24 hours
Comparable levels of vancomycin will be found in humeral head samples between patient groups.
Levels of Vancomycin in Synovium
Time Frame: 24 hours
Comparable levels of vancomycin will be found in synovium samples between patient groups.
Levels of Vancomycin in Labrum
Time Frame: 24 hours
Comparable levels of vancomycin will be found in labrum samples between patient groups.
Levels of Vancomycin in Glenoid Reaming
Time Frame: 24 hours
Comparable levels of vancomycin will be found in glenoid reaming samples between patient groups.
Levels of Vancomycin in Bicep Tendon
Time Frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Levels of Vancomycin in End Deltoid
Time Frame: 24 hours
Comparable levels of vancomycin will be found in end deltoid samples between patient groups.
Vancomycin Levels in Bicep Tendon
Time Frame: 24 hours
Comparable levels of vancomycin will be found in bicep tendon samples between patient groups.
Secondary Outcomes
- Post-operative Complication (Infection) Rates(30 days, 90 days)
Investigators
Patrick McCulloch,MD
Principal Investigator
The Methodist Hospital Research Institute