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Completed

NCT Number: NCT01520571

Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up

The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

49 year–88 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

Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.

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 who require total knee arthroplasty with bilateral lesions.

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

Non-Computer Assistance TKA

Procedure

Non-Computer Assistance Total Knee Arthroplasty

Other names: Non-Computer Assistance Total Knee Arthroplasty

Computer Assistance TKA

Procedure

Computer Assistance Total Knee Arthroplasty

Other names: Computer Assistance Total Knee Arthroplasty

Primary outcomes

  1. Improvement in Knee Society Knee Score

    Time frame: 10.5 years

    change in knee score will be compared with initial score, until follow up of 10.5 years

Secondary outcomes

  1. Improvement in the range of motion

    Time frame: 10.5 years

    change in the range of motion of knee joint will be compared with the initial value, until follow up of 10.5 years.

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Important dates

Study start
2000
Primary completion
2001
Study completion
2011
First posted
Jan 30, 2012
Registry last updated
Jan 30, 2012

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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