Phase 4
Completed N=23
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
Prosthetic joint infection · Vancomycin · Joint Diseases
Source: ClinicalTrials.gov NCT04042233 ↗
Enrolled (actual)
23
Serious AEs
10.0%
Results posted
Mar 2025
Primary outcomePrimary: Systemic Vancomycin Level - Start of Case — 27.98; 0 ug/mL
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.