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8/17/16

Study Finds High Satisfaction Amongst Patients with iTotal® CR

Interim results from an ongoing, multi-center, prospective study of iTotal® CR in the United States, in which more than 300 patients have been enrolled were presented at the 2016 ICJR Pan Pacific Orthopaedic Congress.

As a part of this interim data analysis, researchers examined patient satisfaction after total knee replacement with the iTotal® CR and found that 92% of patients were satisfied on average at the 1-year post-operative time point. In comparison, a previously published study indicates that approximately 20% of patients who receive an off-the-shelf total knee replacement are not satisfied with the results.1

This new analysis corroborates a previously published matched-pair study in Germany that showed statistically significantly higher satisfaction rates with the ConforMIS iTotal® CR as compared to off-the-shelf implants. This matched-pair study, presented at the 2015 ICJR World Arthroplasty Congress, compared 35 iTotal® CR patients with 35 off-the-shelf patients. At one-year follow-up, 94% of iTotal® patients reported that they were satisfied with their procedure, while only 74% of off-the-shelf patients reported that they were satisfied (p<0.05). This study also reported iTotal® CR patients had a statistically significantly higher patient reported outcome score (Knee injury and Osteoarthritis Outcome Score, or KOOS) and were able to return to activities of daily living statistically significantly faster when compared to off-the-shelf patients.

Additional data from the multi-center prospective study was also presented at SICOT, which found that iTotal® CR patients experienced statistically significant improvements from baseline pre-operative scores across all 5 domains of the KOOS (pain, symptoms, activities of daily living, recreation and quality of life).

References:
1: According to a study of 1,703 patients published by Robert Bourne in 2009 in the peer-reviewed journal Clinical Orthopaedics and Related Research (In this study entitled Patient Satisfaction after Total Knee Arthroplasty: Who is Satisfied and Who is Not?, “the overall satisfaction question was used to determine a two category satisfaction outcome by combining patients who answered very dissatisfied, dissatisfied, or neutral into one group, and patients who answered satisfied or very satisfied into the second group.”)

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Outcomes after Customized Individually Made Total Knee Anthroplasty

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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