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

Study Overview
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Brief Summary
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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
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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
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Osteoarthritis

Intervention / Treatment
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* Procedure: Non-Computer Assistance TKA
* Procedure: Computer Assistance TKA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 88 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Computer Assistance TKA<br>Non-Computer Assistance TKA | Procedure: Non-Computer Assistance TKA<br>* Non-Computer Assistance Total Knee Arthroplasty<br>* Other names: Non-Computer Assistance Total Knee Arthroplasty;|
| Experimental: Computer Assistance TKA<br>Computer Assistance TKA | Procedure: Computer Assistance TKA<br>* Computer Assistance Total Knee Arthroplasty<br>* Other names: Computer Assistance Total Knee Arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Knee Society Knee Score | change in knee score will be compared with initial score, until follow up of 10.5 years | 10.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the range of motion | change in the range of motion of knee joint will be compared with the initial value, until follow up of 10.5 years. | 10.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer Assistance, Total Knee Arthroplasty, conventional