Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

IRB Number

10-070

ClinicalTrials.gov Identifier

NCT01084772

Trial Status

Open for Enrollment
Phase Post Market

Why is this study being done?

This study is being done to study instruments used in surgery during total knee replacement. The instruments are surgical guides which help the surgeon align and match the final artificial knee implant to your anatomy.

Who is eligible to participate?

People having a total knee replacement.

What is involved?

A computer will assign patients into one of two groups. Group 1 … the surgeon will be use standard instrumentation for the surgery. An MRI will not be required. Group 2 ... the surgeon will use patient matched instruments made by Smith and Nephew. The instrument guides’ design and shape are determined by an MRI of the patient’s knee.

How long is the study?

Patients will be in the trial approximately 2 years from the date of surgery.

Who can I contact for additional information?

Please contact Julie Bullard, CCRP, at (217) 545-7879 or email jbullard@siumed.edu

Who is the Principal Investigator of this study?

Khaled Saleh, MD

Where is the trial located?

Springfield, Illinois