Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    30
  • sponsor
    The Methodist Hospital Research Institute
Updated on 5 September 2021
hip arthroplasty
total hip replacement

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.

Details
Condition Prosthetic Joint Infection, vanco, arthrosis, joint disease, Arthropathy, joint disorders, Musculoskeletal Diseases, Vancomycin, joint dysfunction, Musculoskeletal Disease
Treatment Experimental Intraosseous vancomycin 500mg in 250 mL NS, Standard IV administration of vancomycin
Clinical Study IdentifierNCT04042233
SponsorThe Methodist Hospital Research Institute
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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