The 3DKnee™ System: A Post-Market Study

The 3DKnee™ System: A Post-Market Study

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.

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