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Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Osteoarthritis Clinical Trial

Official title:
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Clinical Trial Summary

The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.

Clinical Trial Description

The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00854295
Study type Interventional
Source Zimmer Biomet
Contact
Status Completed
Phase N/A
Start date April 2009
Completion date June 2021
View Details
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