Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

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 non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

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 PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Official Title
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Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty A Prospective, Randomized Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: PFC-Sigma RP
* Device: LPS RP


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: PFC sigma RP<br>Posterior stabilized rotating platform knee (press Fit Condylar Sigma rotating-platform, Depuy, Warsaw, Indiana) | Device: PFC-Sigma RP<br>* Posterior stabilizing rotating platform total knee components<br>* Other names: PFC sigma RP;|
| Active Comparator: LCS RP<br>non posterior stabilized Low Contact Stress Rotating-Platform; Depuy, Warsaw, Indiana | Device: LPS RP<br>* non-posterior stabilized rotating platform design<br>* Other names: LCS RP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society knee score |  | at 3 months, 1 year, than annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion |  | at 3 months, 1 year, than annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotating platform, posterior stabilized, non-posterior stabilized