Post Market Study of the 3DKnee™ With E-plus Insert (e-plus)

• Knee Society Score Evaluation [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture and is calculated on a total possible score of 100. The function portion of the KSS, also calculated out of a total of 100 possible points, gives points for walking distance and stair climbing and deducts points for walking aids. Overall success will be defined as a KSS score ≥ 80 at two years.
  
  
• Number of Participants With Radiologic Failure of Device [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
  Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line
  
  

• Change in Knee Society Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  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).
  
  
• Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  The Western Ontario McMaster Arthritis Index is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It can be self-administered. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability.
  
  
• Change in Oxford Knee Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]
  The Oxford Knee Score (OKS) is a patient-based outcomes measure consisting of 12 questions that is sensitive, simple and validated. It is based on a maximum score of 48.
  
  

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. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).