Post-Market Study of the 3DKnee™ System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

Detailed Description
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Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.

Official Title
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Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700

Conditions
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Degenerative Joint Disease, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

Intervention / Treatment
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* Device: 3DKnee™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This must be a primary knee replacement on this knee. Patient is over 18 years of age or older Have knee joint disease related to one or more of the following degenerative joint disease, including osteoarthritis or traumatic arthritis Avascular necrosis of the femoral condyles Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy Moderate valgus, varus, or flexion deformities Rheumatoid arthritis Patient is likely to be available for evaluation for the duration of the study Able and willing to sign the informed consent and follow study procedures Patient is not pregnant Exclusion Criteria: Is younger than 18 years of age If there has been a total knee replacement on this knee in the past (no revisions allowed in study) Infection, or history of infection, acute or chronic, local or systemic Alcoholism or other addictions Muscular, neurological or vascular deficiencies which compromise the affected extremity Obesity Insufficient bone quality Loss of ligamentous structures High levels of physical activity Materials sensitivity Prisoner Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements Patient is pregnant

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3DKnee<br>Post Market Study | Device: 3DKnee™ System<br>* Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of total knee system |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Knee Society Score |  | 5 year | 
| change in pain from pre-op to post-op |  | 5 year | 
| patient satisfaction |  | 5 year | 
| change in WOMAC Osteoarthritis Index from pre-surgery |  | 5 year | 
| change in Oxford Knee Score from pre-surgery |  | 5 year | 

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