NCT01256216

Signature Versus Computer Assisted Surgery Study

A Comparison of Signature Custom Cutting Guides and Computer Assisted Surgery Techniques With the Vanguard Knee System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Joint Disease

Interventions

Type	Name	Description
DEVICE	Total Knee Replacement with Vanguard Total Knee	Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

Timeline

• Start date: 2010-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2010-12-08
• Last updated: 2017-06-19

Locations

1 site across 1 country: United Kingdom