Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Prosthetic Joint Infection; Vancomycin
• Intervention / Treatment: Drug: Standard IV administration of vancomycin; Drug: Experimental Intraosseous vancomycin 500mg in 250 mL NS

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV administration of vancomycin; Standard IV vancomycin administration protocol.	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).
Experimental: IO Vancomycin 500mg in 250 mL NS; Experimental Intraosseous administration protocol.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Vancomycin Level - Start of Case	vancomycin blood level before the time of incision - typically taken approximately 10 minutes before incision.	approximately 10 minutes before incision
Systemic Vancomycin Level - End of Case		end of surgical case
Vancomycin Concentration of Pulvinar Soft Tissue	vancomycin concentration (ug/mL) of pulvinar soft tissue. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.	intraoperative
Vancomycin Concentration of Intramedullary Bone	Vancomycin Concentration of Intramedullary Bone in units ug/mL. Vancomycin tissue concentration measured by high performance liquid chromotagraphy.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft Tissue Vancomycin Level - Start of Case	at start , soft tissue. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.	at start of case within 15 minutes after incision
Femur Vancomycin Concentration Level	Intraoperative femur bone sample measured for vancomycin concentration (ug/mL). Vancomycin tissue concentration measured by high performance liquid chromatography.	intraoperative
Acetabulum Vancomycin Level	Intra-operative Acetabulum bone vancomycin concentrations (ug/mL) measured by high performance liquid chromatography.	intraoperative
30-Day Complications	Complications 30 days post surgery eg. infection.	From the administration of antibiotics perioperatively to 30 days post op.
90-Day Complications	Complications 90 days post surgery eg. infection	From the administration of antibiotics perioperatively to 90 days post op.
Soft Tissue Vancomycin Level - End of Case	soft tissue taken at end of case, right before wound closure is initiated. Vancomycin tissue concentration (ug/mL) measured by high performance liquid chromatography.	right before wound closure is initiated at the end of the case

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Terry A Clyburn, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: total hip arthroplasty; vancomycin; intraosseous vancomycin
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Anti-Bacterial Agents; Anti-Infective Agents; Vancomycin
• Other Study ID Numbers: Pro00022651

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes