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Completed

NCT Number: NCT01335438

Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hosptial

Seoul, South Korea

About this study

Out comes measures were to determine:

  • whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
  • whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
  • whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
  • whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless 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

Cementless (Nexgen)

Device

Cementless fixation of Nexgen CR TKR

Other names: Cementless Nexgen

Cemented (Nexgen)

Device

Cemented fixation of Nexgen CR TKR

Other names: Cemented Nexgen

Primary outcomes

  1. Improvement in Knee Society Knee Score

    Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

    change in knee score will be compared with initial score, until mean follow up of 25 years.

Secondary outcomes

  1. Improvement in the Range of Motion

    Time frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

    change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.

Sponsors and collaborators

Lead sponsor

Young Hoo Kim

Other

Registry information

Official study title

Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis

Important dates

Study start
1997
Primary completion
1998
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
Oct 5, 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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