NCT00763386

A Study to Compare the NexGen LPS and LPS-Flex Knee Implants

Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.

Detailed description

This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Conditions

• Total Knee Arthroplasty
• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	NexGen LPS-Flex Fixed Bearing Knee	NexGen LPS-Flex Fixed Bearing femoral component
DEVICE	NexGen Legacy Posterior Stabilized Knee	NexGen Legacy Posterior Stabilized femoral component

Timeline

• Start date: 2001-06-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2008-09-30
• Last updated: 2012-06-04
• Results posted: 2012-05-25

Locations

15 sites across 2 countries: United States, Canada