NCT01410786

Oxford Partial Knee Comparative Instrument Pilot Study

A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.

Detailed description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation. The FDA has approved the Oxford Partial Knee via Premarket Approval P010014. Also, by being CE marked, the Oxford Partial Knee also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. 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. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol for both treatment groups and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	Conventional Instrumentation	Standard Oxford surgical instruments
PROCEDURE	Signature Custom Guides	Signature Custom Guides used with Instruments in surgical technique

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2011-08-05
• Last updated: 2017-08-02

Locations

1 site across 1 country: New Zealand