NCT00761956

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

Prospective Randomized Multicenter Study of NexGen CR-Flex Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (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, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.

Detailed description

This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative 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 CR-Flex Fixed Bearing Knee	NexGen CR-Flex Fixed Bearing femoral component
DEVICE	NexGen CR Knee	NexGen Complete Knee Solution Cruciate Retaining femoral component

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-09-30
• Last updated: 2012-07-16
• Results posted: 2012-07-16

Locations

8 sites across 1 country: United States