Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

NCT ID: NCT04042233

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2022-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IV administration of vancomycin

Standard IV vancomycin administration protocol.

Group Type: ACTIVE_COMPARATOR

Standard IV administration of vancomycin

Intervention Type: DRUG

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).

IO Vancomycin 500mg in 250 mL NS

Experimental Intraosseous administration protocol.

Group Type: EXPERIMENTAL

Experimental Intraosseous vancomycin 500mg in 250 mL NS

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Terry Clyburn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terry A Clyburn, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Pro00022651

Identifier Type: -

Identifier Source: org_study_id