Comparison of Multiradius and Singleradius Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The Investigators would like to compare multiradius and single-radius total knee arthroplasty using with association between sagittal patellar offset and anterior knee pain in subjects having undergone bilateral total knee replacement.

Detailed Description
-----------------
A prospective, interventional study. A total of to 494 subjects requiring bilateral multiradius( n=247) and singlerasius(n=247) knee arthroplasty will be enrolled. Anterior femoral offset, femoral diameter and patellar offset will be measured by orthopaedic surgeons. In addition, Visual Analogue Scale Score, Oxford Knee Score, WOMAC, SF12 and SF36 will be evaluated postoperative in patients long-term follow up to see if there is a relationship between anterior femoral offset and anterior knee pain. In the direct lateral knee joint radiograph, the distance between the two parallel axis extending from both cortices of the femur is measured as femoral diameter.The remaining length between the anterior axis and the maximum peak at the anterior of the prosthesis is considered as an anterior femoral offset. Sagittal patellar offset is accepted by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography.

Official Title
-----------------
Comparison of Multiradius and Singleradius Prosthesis Design in Total Knee Arthroplasty Using With Association Sagittal Patellar Offset and Anterior Knee Pain

Conditions
-----------------
Gonarthrosis; Primary, Gonarthrosis, Gonarthrosis; Primary, Bilateral, Knee Osteoarthritis, Knee Arthritis

Intervention / Treatment
-----------------
* Procedure: singleradius and multiradius total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and radiological diagnosis of end-stage primary gonarthrosis Exclusion Criteria: History of malignancy, Severe extraarticular deformity, Posttraumatic and septic arthritis sequel

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: singleradius<br>Single Radius(SR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Single Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics | Procedure: singleradius and multiradius total knee arthroplasty<br>* singleradius and multiradius total knee arthroplasty<br>|
| Experimental: Multiradius<br>Multi Radius(MR) femoral design will be perfomed to patients who is going to total knee arthroplasty. Multi Radius femoral design is one of knee prosthesis' pattern which shows variation in knee kinematics | Procedure: singleradius and multiradius total knee arthroplasty<br>* singleradius and multiradius total knee arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anterior patellar offset ratio | The distance between the anterior cortex of the femur and the maximum peak at the anterior of the prosthesis is considered as an anterior femoral offset.Sagittal patellar offset defined by us as the ratio of the anterior femoral offset to the remaining distance between the maximum anterior point of the patella and the posterior vertex in the direct lateral knee joint radiography. | From the date of randimization until the final follow up of last patient, assessed up to 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiradius, singleradius, total knee arthroplasty, sagittal patellar offset, anterior knee pain