NCT01520571

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 49 Years – 88 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Non-Computer Assistance TKA	Non-Computer Assistance Total Knee Arthroplasty
PROCEDURE	Computer Assistance TKA	Computer Assistance Total Knee Arthroplasty

Timeline

• Start date: 2000-01-01
• Primary completion: 2001-12-01
• Completion: 2011-12-01
• First posted: 2012-01-30
• Last updated: 2012-01-30

Locations

1 site across 1 country: South Korea