Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-29 @ 10:33 PM
Study NCT ID:
NCT00854295
Status:
COMPLETED
Last Update Posted:
2023-02-14
First Post:
2009-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Sponsor:
Zimmer Biomet
Organization:
Study Overview
Official Title:
Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: