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8/16/16

New Multicenter Functional Outcomes Study of iTotal® CR vs. Off-the-Shelf Implants

In an update to an ongoing multi-center prospective study of 740 consecutively enrolled total knee replacement patients, those who received an iTotal® CR implant were significantly faster than patients with an off-the-shelf implant at completing three functional tests of daily living: walking, getting in and out of a chair and walking up and down stairs. Study investigators used a validated functional test known as the Aggregated Locomotor Function (ALF) test, in which blinded operators assessed patients’ ability to perform these activities of daily living. Additionally, an analysis using the 2011 New Knee Society Score (KSS) found no statistically significant differences. This study was presented at the 2016 ICJR Pan Pacific Orthopaedic Congress. ConforMIS provided financial support for this study.

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Improved Knee Function With Customized vs. Off-The-Shelf TKA Implant

Important Safety Information

The iTotal CR Knee Replacement Systems are intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. Only a licensed physician can help you determine the appropriate medical treatment. There are potential risks to knee replacement surgery, and individual results may vary. Before making any decisions concerning medical treatment, consult your physician regarding your options and the risks of those options. The longevity, performance and feel of any knee implant will depend on various factors, including your physical condition, your activity level, adherence to your physician’s instructions, and other factors.

The Indications for Use of iTotal CR include:

  • Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
  • Post traumatic loss of joint function.
  • Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
  • Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
  • Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The implant is intended for cemented use only.

Caution: Federal law restricts this device to sale by or on the order of a physician.

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