Visionaire: A Prospective Study

Stopped early · Not applicable

Conditions studied: Osteoarthritis

In brief

The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system. 1. It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee. 2. It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.

Key facts

Study ID

NCT01937572

Run by

The Hawkins Foundation

People needed

149

Starts

2011-11-01

Expected to finish

2017-02-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA

You may not qualify if…

• prior TKA
• ipsilateral upper tibial or distal femoral osteotomy
• ipsilateral total hip arthroplasty
• patient with significant >15o varus or valgus
• morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)

Where it is running

• Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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