Clinical trial: The 3DKnee™ System: A Post-Market Study (NCT00764673)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment