Signature Versus Computer Assisted Surgery Study

Status Completed

Clinical Trial Summary

The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.

Clinical Trial Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery.

FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01256216
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	September 2010
Completion date	May 2016

View Details

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