Phase 3
Completed N=24
Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement
Arthropathy of Knee Joint
Source: ClinicalTrials.gov NCT03506347 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Vancomycin Concentration in Fat — 6.0; 40.5 ug/g — p=0.001
◆ Published Evidence
Established
32citations · ~8 / year
Higher Tissue Concentrations of Vancomycin Achieved With Low-Dose Intraosseous Injection Versus Intravenous Despite Limited Tourniquet Duration in Primary Total Knee Arthroplasty: A Randomized Trial.
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 obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of intraosseous regional administration (IORA) of vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimised.
Linked Publications
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Higher Tissue Concentrations of Vancomycin Achieved With Low-Dose Intraosseous Injection Versus Intravenous Despite Limited Tourniquet Duration in Primary Total Knee Arthroplasty: A Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vancomycin Concentration in Fat |
6.0; 40.5 | 0.001 sig |
| PRIMARY Vancomycin Concentration in Bone |
8.3; 26.9 | 0.009 sig |
Eligibility Criteria
Inclusion Criteria
Primary Total Knee Arthroplasty for osteoarthritis Informed consent given
Exclusion Criteria
Current or treatment with IV Vancomycin within preceding 7 days Previous hypersensitivity to vancomycin Significant cardiac or respiratory abnormality Patient has contraindications to IO vascular access using the EZ-IO
Data sourced from ClinicalTrials.gov (NCT03506347) and the linked publication. 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.