Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

Detailed Description
-----------------
A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.

Official Title
-----------------
Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)
* Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of primary osteoarthritis of knee A candidate for total knee replacement arthroplasty Exclusion Criteria: A diagnosis other than primary osteoarthritis A history of previous open knee surgery
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Knees that will be implanted with standard posterior stabilized RP-MB knee prostheses | Device: Standard PS RP-MB (P.F.C Sigma Rotating Platform knee)<br>* Comparison of different types of knee prosthesis<br>* Other names: P.F.C Sigma Rotating Platform knee;|
| Active Comparator: High-flexion<br>Knees that will be implanted with high-flexion posterior stabilized RP-MB knee prostheses | Device: High-flexion PS RP-MB (P.F.C Sigma Rotating Platform Flex)<br>* Comparison of different types of knee prosthesis<br>* Other names: P.F.C Sigma Rotating Platform Flex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Knee, Range of Motion