Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

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 radiographic differences in cemented and cementless fixation in total knee replacement.

Detailed Description
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Out comes measures were to determine: whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.

Official Title
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Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Cementless (Nexgen)
* Device: Cemented (Nexgen)


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: 30 Years
Maximum Age: 90 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: Cementless Nexgen CR<br>Cementless fixation of Nexgen CR TKR | Device: Cementless (Nexgen)<br>* Cementless fixation of Nexgen CR TKR<br>* Other names: Cementless Nexgen;|
| Active Comparator: Cemented Nexgen CR<br>Cemented fixation of Nexgen CR TKR | Device: Cemented (Nexgen)<br>* Cemented fixation of Nexgen CR TKR<br>* Other names: Cemented Nexgen;|

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 25 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery | 

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 25 years. | Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, cemented, cementless, fixation, posterior stabilized, cruciate retaining