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Clinical Trials/NCT01520571
NCT01520571CompletedPhase 4

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

Ewha Womans University2 sites in 2 countries520 target enrollmentStarted: January 2000Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
520
Locations
2
Primary Endpoint
Improvement in Knee Society Knee Score

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
49 Years to 88 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Non-Computer Assistance TKA

Active Comparator

Non-Computer Assistance TKA

Intervention: Non-Computer Assistance TKA (Procedure)

Computer Assistance TKA

Experimental

Computer Assistance TKA

Intervention: Computer Assistance TKA (Procedure)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Young Hoo Kim

Professor and Director

Ewha Womans University

Study Sites (2)

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