CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Vancomycindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03506347
NCT03506347Phase 3Completed

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

Mayo Clinic·interventional·Posted Apr 24, 2018·Updated Jan 27, 2020

In Brief

A Phase 3 clinical trial evaluating Vancomycin for Arthropathy of Knee Joint. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 24, 2018
Enrollment StartSep 24, 2018
Primary CompletionJan 17, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.2 years ago

Interventions

Vancomycindrug

Antibiotic