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Clinical Trials/NCT01520571
NCT01520571
Completed
Phase 4

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

Ewha Womans University1 site in 1 country520 target enrollmentJanuary 2000
ConditionsOsteoarthritis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Ewha Womans University
Enrollment
520
Locations
1
Primary Endpoint
Improvement in Knee Society Knee Score
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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?

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2000
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Young Hoo Kim

Professor and Director

Ewha Womans University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Improvement in the range of motion(10.5 years)

Study Sites (1)

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