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

Ewha Womans University logo

Ewha Womans University

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis

Treatments

Procedure: Computer Assistance TKA
Procedure: Non-Computer Assistance TKA

Study type

Interventional

Funder types

Other

Identifiers

NCT01520571
Computer Assistance TKA

Details and patient eligibility

About

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?

Full 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.

Enrollment

520 patients

Sex

All

Ages

49 to 88 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

520 participants in 2 patient groups

Non-Computer Assistance TKA
Active Comparator group
Description:
Non-Computer Assistance TKA
Treatment:
Procedure: Non-Computer Assistance TKA
Computer Assistance TKA
Experimental group
Description:
Computer Assistance TKA
Treatment:
Procedure: Computer Assistance TKA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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