Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

Joint Diseases Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Joint Diseases
• Prosthetic Joint Infection
• Vancomycin

• NCT number: NCT04042233
• Study type: Interventional
• Source: The Methodist Hospital Research Institute
• Status: Completed
• Phase: Phase 4
• Start date: December 31, 2019
• Completion date: September 1, 2022