NCT01422642

Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?

Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 48 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.

Detailed description

We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	legacy posterior stabilized high-flexion (NexGen LPS-Flex)	NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
DEVICE	legacy posterior stabilized standard (NexGen LPS)	NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Timeline

• Start date: 2001-01-01
• Primary completion: 2001-04-01
• Completion: 2011-06-01
• First posted: 2011-08-24
• Last updated: 2011-08-30

Locations

1 site across 1 country: South Korea