Motion Analysis of EMP Knee Versus Posterior Stabilized Knee Arthroplasty for Osteoarthritis

Study Overview
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Brief Summary
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The purpose of the current study is to analyze and compare the lower-limb joint motions and muscle activation patterns during activities of daily living as well as self reported health related functional outcomes for patients with osteoarthritis of the knee undergoing one of two types of knee replacements: the Evolution Medial Pivot knee (Wright Medical) or the Triathlon Posterior Stabilized (PS) knee (Stryker Orthopaedics).

Detailed Description
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Inclusion: 40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI. Patients who do not meet any exclusion criteria. Exclusion: Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded. Exclusion for patient group Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty. Patients with any other joint replacement in the ipsilateral and contralateral limb. Patients with evidence of active infection. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function. Patients with neuropathic joints. Patients requiring structural bone grafts. Patients with a documented allergy to cobalt chromium molybdenum. Patient with a BMI larger than 30 kg/m2.

Official Title
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3D Motion Analysis of Evolution Medial Pivot Knee VS Posterior Stabilized Knee Arthroplasty for Osteoarthritis of the Knee.Feasibility Pilot for a Prospective Randomized Controlled Trial.

Conditions
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Arthropathy of Knee Joint

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty
* Procedure: Motion analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 patients between the ages of 50 and 75 yrs undergoing unilateral total knee replacement for non-inflammatory degenerative osteoarthritis will participate, as well as 10 control participants will be recruited from the general population for the present study matching to experimental groups for age, gender and BMI.Patients who do not meet any exclusion criteria. Exclusion Criteria: Potential participants for the control group will be asked if they have had degenerative osteoarthritis of lower-limb joints (hip, knee and ankle) and if they have they will be excluded. Exclusion for patient group Patients suffering from any other lower-limb joint disorders other than the one for which total knee arthroplasty. Patients with any other joint replacement in the ipsilateral and contralateral limb. Patients with evidence of active infection. Patients with neurologic or musculoskeletal disease that may adversely affect gait, weight-bearing or quadriceps function. Patients with neuropathic joints. Patients requiring structural bone grafts. Patients with a documented allergy to cobalt chromium molybdenum. Patient with a BMI larger than 30 kg/m2.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolution Medial Pivot Knee<br>20 Patients will receive the EMP Knee Implant | Procedure: Total Knee Arthroplasty<br>* Total Knee Arthroplasty<br>* Other names: non applicable;Procedure: Motion analysis<br>* Motion analysis (Gait/EMG during walking and functional tasks)<br>* Other names: non applicable;|
| Active Comparator: Triathlon PS Knee<br>20 Patients will receive the Triathlon PS Knee | Procedure: Total Knee Arthroplasty<br>* Total Knee Arthroplasty<br>* Other names: non applicable;Procedure: Motion analysis<br>* Motion analysis (Gait/EMG during walking and functional tasks)<br>* Other names: non applicable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The motion analysis assessments of the knee |  | pre-op,6,12 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires: RAND-36, Knee injury and Osteoarthritis Outcome Score (KOOS) and Satisfaction survey. |  | pre-op,6,12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee replacement motion analysis