Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Completed; Phase 4

Conditions: Vancomycin; Prosthetic Joint Infection; Joint Diseases

Treatments: Drug: Standard IV administration of vancomycin; Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS

Study type: Interventional

Funder types: Other

Identifiers

NCT04042233

Pro00022651

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

IV administration of vancomycin

Active Comparator group

Description:

Standard IV vancomycin administration protocol.

Treatment:

Drug: Standard IV administration of vancomycin

IO Vancomycin 500mg in 250 mL NS

Experimental group

Description:

Experimental Intraosseous administration protocol.

Treatment:

Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS