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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Computer Assistance TKA; Procedure: Non-Computer Assistance TKA

• Registration Number: NCT01520571
• Lead Sponsor: Ewha Womans University

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 Timeline

• Study Start: 2000-01
• Primary Completion: 2001-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-25
• Last Update Submitted: 2012-01-25
• Study First Posted: 2012-01-30
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer Assistance TKA	Computer Assistance TKA	Computer Assistance TKA
Non-Computer Assistance TKA	Non-Computer Assistance TKA	Non-Computer Assistance TKA

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	10.5 years	change in knee score will be compared with initial score, until follow up of 10.5 years

Secondary Outcome Measures

Name	Time	Method
Improvement in the range of motion	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.

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hosptial; 🇰🇷 Seoul, Korea, Republic of