NCT04042233

Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prosthetic Joint Infection
• Vancomycin
• Joint Diseases

Interventions

Type	Name	Description
DRUG	Experimental Intraosseous vancomycin 500mg in 250 mL NS	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.
DRUG	Standard IV administration of vancomycin	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).

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-05-25
• Completion: 2022-09-01
• First posted: 2019-08-01
• Last updated: 2025-03-13
• Results posted: 2025-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study