Status:
COMPLETED
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Prosthetic Joint Infection
Vancomycin
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- Patient is undergoing a primary total hip arthroplasty
- Patient gives informed consent to participate in the study.
- Age Range \>18
Exclusion
- 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).
Key Trial Info
Start Date :
December 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04042233
Start Date
December 31 2019
End Date
September 1 2022
Last Update
March 13 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030