NCT00854295

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis
• Traumatic Arthritis
• Avascular Necrosis of the Femoral Condyle
• Moderate Varus
• Valgus
• Flexion Deformities

Interventions

Type	Name	Description
DEVICE	NexGen LPS-Flex Mobile Bearing Knee	Total Knee Replacement

Timeline

• Start date: 2009-04-01
• Primary completion: 2020-06-01
• Completion: 2021-06-01
• First posted: 2009-03-03
• Last updated: 2023-02-14
• Results posted: 2023-02-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study