Phase 4
N=23
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Prosthetic Joint Infection · Vancomycin · Joint Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04042233 ↗Enrolled (actual)
23
Serious AEs
10.0%
Results posted
Mar 2025
Primary outcome: Primary: Systemic Vancomycin Level - Start of Case — 27.98; 0 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Experimental Intraosseous vancomycin 500mg in 250 mL NS (Drug); Standard IV administration of vancomycin (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Vancomycin Level - Start of Case |
27.98; 0 | — |
| PRIMARY Systemic Vancomycin Level - End of Case |
21; 5.75 | — |
| PRIMARY Vancomycin Concentration of Pulvinar Soft Tissue |
61.58; 71.79 | — |
| PRIMARY Vancomycin Concentration of Intramedullary Bone |
33.93; 59.39 | — |
| SECONDARY Soft Tissue Vancomycin Level - Start of Case |
63.77; 69.08 | — |
| SECONDARY Femur Vancomycin Concentration Level |
20.90; 41.45 | — |
| SECONDARY Acetabulum Vancomycin Level |
67.97; 130.88 | — |
| SECONDARY 30-Day Complications |
3; 0 | — |
| SECONDARY 90-Day Complications |
0; 0 | — |
| SECONDARY Soft Tissue Vancomycin Level - End of Case |
57.14; 78.22 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04042233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.