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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
120
Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.
The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the "usual" said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers.
CHU Dijon Bourgogne
Dijon, France
Pain measured using a VAS (visual analogue scale) by the patient
Time frame: 12 months
Ratio differential cost-utility
Time frame: 12 months
Evolution of pain measured by VAS in the form of a self-questionnaire
Time frame: 6 months
Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire
Time frame: 12 months
Evolution of quality of life measured by the AMIQUAL self-questionnaire
Time frame: 12 months
Evolution de overall disease activity measured by VAS
Time frame: 12 months
Consumption of care relative to the knee osteoarthritis
Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support
Time frame: 12 months
Local or general adverse effects
Time frame: 12 months
Compliance with wearing the brace
Average number of hours of port of the brace a day, the average number of days of port of the brace a week. The possible motives for non-observance will be brought together. The patient will be considered compliant if he carries his brace at least 15 hours a week on average.
Time frame: 12 months
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