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.1This 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).

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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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