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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042233
• Other study ID #: Pro00022651
• Status: Completed
• Phase: Phase 4
• Start date: December 31, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: The Methodist Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 1, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Joint Diseases
• Prosthetic Joint Infection
• Vancomycin

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Vancomycin level	vancomycin blood level at time of initiation of closure.	1 year
Secondary	Tissue vancomycin level	at start and end of case.	1 year
Secondary	Femur vancomycin level	at start and end of case.	1 year
Secondary	Acetabulum vancomycin level	at start and end of case.	1 year
Secondary	30-Day Complications	Complications 30 days post surgery i.e. infection.	From the administration of antibiotics perioperatively to 30 days post op.
Secondary	90-Day Complications	Complications 90 days post surgery i.e. infection	From the administration of antibiotics perioperatively to 90 days post op.