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Completed

NCT Number: NCT01361152

Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old

The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

1. functional scores 2. rates of radiographic failure 3. revision rates 4. survivorship

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

29 year–50 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

The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

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

anatomic modular fixed-bearing

Device

anatomic modular (AMK; DePuy) fixed-bearing prosthesis

Other names: AMK

low contact stress rotating platform mobile-bearing

Device

low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis

Other names: LCS RP

Primary outcomes

  1. Improvement in Knee Society Knee Score

    Time frame: 18 years

    change in knee score will be compared with initial score, until follow up of 18 years

Secondary outcomes

  1. Improvement in the range of motion

    Time frame: 18 years

    change in the range of motion of knee joint will be compared with the initial value, until follow up of 18 years.

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Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties in Patients With Osteoarthritis Younger Than Fifty Years of Age

Important dates

Study start
1993
Primary completion
1996
Study completion
2011
First posted
May 26, 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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