Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?

Study Overview
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Brief Summary
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The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.

Detailed Description
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We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.

Official Title
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Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)
* Device: legacy posterior stabilized standard (NexGen LPS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease 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: 48 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: legacy posterior stabilized high-flexion<br>NexGen LPS-Flex total knee system | Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)<br>* NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system<br>* Other names: NexGen LPS-Flex;|
| Experimental: legacy posterior stabilized standard<br>standard NexGen LPS prosthesis | Device: legacy posterior stabilized standard (NexGen LPS)<br>* NexGen legacy posterior stabilized standard (NexGen LPS) total knee system<br>* Other names: NexGen LPS;|

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 mean follow up of 10.3 year | 10 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 mean follow up of 10.3 years | 10 years |