Clinical trial: Robotic Arm Assisted Total Knee Arthroplasty (NCT02058069)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female subjects may be recruited in to the Investigation.

          -  Age - The subject must be at least 21 years of age and skeletally mature as
             demonstrated radiographically by complete closure of the distal femoral and proximal
             tibial epiphyses.

          -  Subjects who are able to give voluntary, written informed consent to participate in
             this investigation and from whom consent has been obtained.

          -  Subjects who, in the opinion of the Investigators and Approved Study Staff, are able
             to understand this Investigation and cooperate with the Investigation procedures and
             are willing to comply with all the required post-operative follow-ups.

          -  Subjects who require a total knee arthroplasty for primary surgical management of
             osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities
             or femoral condyle osteonecrosis as defined below.

          -  Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an
             absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or
             loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral
             sclerosis, or peripheral osteophytes.

          -  Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history
             of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of
             motion; and with radiographic evidence of joint space narrowing, sub-chondral
             sclerosis, or peripheral osteophytes.

          -  Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or
             higher, with a clinical history that demonstrates the following: morning stiffness for
             at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or
             serum rheumatoid factor; and radiographic findings of narrow joint space,
             peri-articular osteopenia, and/or per-articular erosions.

          -  Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities
             of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8°
             assessed radiographically.

          -  Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle
             characterized by sudden onset of pain, possibly triggered by a specific seemingly
             routine activity or minor injury. Pain is often increased with activity and at night
             time and may cause swelling of the knee and sensitivity to touch and pressure and may
             result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray.

          -  Subjects whose anatomy is appropriate for the available range of implant sizes.

        Exclusion Criteria:

          -  Patients who have had previous surgical procedures requiring implantation of hardware
             in their operative side knee, hip, or ankle that would result in metal artifact
             scatter in a CT scan.

          -  Patients who have a fracture malunion of the distal femur or proximal tibia within
             12cm of the knee center, assessed radiographically.

          -  Patients who are pregnant, may become pregnant during the course of the Investigation,
             or are currently lactating.

          -  Patients with allergies or suspected sensitivity to any patient-contacting component
             of the investigational device or the implant to be used in the study as listed below:

          -  Femoral component: Cobalt Chromium alloy (CoCr)

          -  Tibial component: Titanium alloy (Ti6Al4V)

          -  Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight
             polyethylene (UHMWPE)

          -  Saw blade: 440C Stainless Steel

          -  Patients who require bilateral total knee arthroplasty.

          -  Patients who are currently on medical leave from their employment due to Workmen's
             Compensation.

          -  Patients who are currently state or federal prisoners.

          -  Patients who are currently Wards of the state.

          -  Patients who are at high risk for poor healing or confounding outcomes or at excessive
             risk for surgery i.e.: clinically significant/being actively treated for renal,
             hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes
             (HbA1c > 10 mg/dL) or previous history of joint infection.

          -  Patients who are known drug or alcohol abusers or with psychological disorders as
             defined by DSM V that could affect follow-up care or treatment outcomes.

          -  Patients who are currently involved in another clinical study with an investigational
             device.

          -  Patients with current litigation pending related to medical treatment of any sort.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 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