Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement

Completed · Phase 2/Phase 3

Conditions studied: Arthropathy of Knee Joint

In brief

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.

Key facts

Study ID

NCT03506347

Run by

Mayo Clinic

People needed

24

Starts

2018-09-24

Expected to finish

2019-01-17

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary Total Knee Arthroplasty for osteoarthritis Informed consent given

You may not qualify if…

• 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

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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