NCT01072019

A Randomized Prospective Trial of Total Knee Arthroplasty Options Comparing Standard Knee Cutting Guides and MRI Generated Patient Specific Custom Cutting Guides

Comparative Clinical Study of the Vanguard® Knee System Using Signature™ Custom Guides & Conventional Techniques

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the surgical and clinical outcomes of patients receiving total knee replacement with the same implant using two different types of cutting guides during surgery: 1. Standard knee cutting guides; 2. MRI generated patient specific custom cutting guides. Both types of cutting guides used in this study are registered with the U.S. Food and Drug Administration (FDA) and are routinely used for knee replacement surgery. However, it is unknown if one type of cutting guide has risks or benefits over the other.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
OTHER	Instrument	Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-02-19
• Last updated: 2018-06-27

Locations

1 site across 1 country: United States