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OpenTrials
Completed

NCT Number: NCT01422642

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

48 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hosptial

Seoul, 158-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion criteria

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Treatment and study plan

legacy posterior stabilized high-flexion (NexGen LPS-Flex)

Device

NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system

Other names: NexGen LPS-Flex

legacy posterior stabilized standard (NexGen LPS)

Device

NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Other names: NexGen LPS

Primary outcomes

  1. Improvement in Knee Society Knee Score

    Time frame: 10 years

    change in knee score will be compared with initial score, until mean follow up of 10.3 year

Secondary outcomes

  1. Improvement in the range of motion

    Time frame: 10 years

    change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 10.3 years

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2001
Study completion
2011
First posted
Aug 24, 2011
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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