Phase 3
Completed N=22
Regional Prophylactic Vancomycin in Revision Total Knee Replacement
Arthropathy of Knee Joint
Source: ClinicalTrials.gov NCT02020031 ↗
Enrolled (actual)
22
Serious AEs
20.0%
Results posted
Nov 2016
Primary outcomePrimary: Mean Concentration of Vancomycin in Subcutaneous Fat — 94.1; 3.2; 88.3; 5.0 µg/g — p=<0.0001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Concentration of Vancomycin in Subcutaneous Fat |
94.1; 3.2; 88.3; 5.0; 69.4; 4.2 | <0.0001 sig |
| PRIMARY Mean Concentration of Vancomycin in Bone Samples |
90.7; 7.9; 193; 8.6; 59.8; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- Revision total knee arthroplasty
- Informed consent given
Exclusion Criteria
- Current treatment with IV Vancomycin within the preceding 7 days
- Previous hypersensitivity to vancomycin
- Significant cardiac or respiratory abnormality
- Contraindications to using the intraosseous vascular access system (EZ-IO)
- Sepsis
Data sourced from ClinicalTrials.gov (NCT02020031). 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.