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Internal Compartment Knee Osteoarthritis: ODRA (Orthosis Distraction and Rotation for osteoArthritis) Made-to-measure Hinged Knee Brace Versus Usual Care.

Centre Hospitalier Universitaire Dijon · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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knee-osteoarthritisna
This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups: * 60 patients in the "usual care" group: these patients will receive the usual care proposed by their doctor for 12 months. * 60 patients in the "ODRA" group: these patients will wear the ODRA brace for 12 months in addition to their usual care. They will be instructed to wear the brace for at least 6 hours per day, 5 days per week and to take it off during rest periods when lying down. The distribution of patients in the groups will be randomized. For this study, patients will be followed for 12 months, spread over 3 visits: inclusion visit, follow-up visit at 6 months and 12 months.
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