The 3DKnee™ System: A Post-Market Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

Official Title
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The 3DKnee™ System: A Post-Market Study

Conditions
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Varus Deformity, Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: 3DKnee


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This must be a primary knee replacement on this knee. 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 Patient must be over 18 years of age Exclusion Criteria: 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 Is younger than 18 years of age

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary<br>Post market study | Device: 3DKnee<br>* 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 |
| --- | --- | --- |
| Knee Society Score Evaluation | The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70). | 2 year | 
| Knee Society Function Score | The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. | 2-year | 
| Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. | Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component. | 2-year | 
| Safety Assessment | Number of device related adverse events and device failures at the 2 year time frame. | 2-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score | Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function. | 2-year |