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This is a biomedical study on a medical device. 120 patients will participate in this study and will be split into 2 groups:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODRA | Experimental |
| |
| usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brace ODRA (PROTEOR company) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured using a VAS (visual analogue scale) by the patient | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio differential cost-utility | 12 months | |
| Evolution of pain measured by VAS in the form of a self-questionnaire | 6 months | |
| Evolution of the Function score- Everyday life of the KOOS (Knee injury and osteoarthritis outcome score) self-questionnaire |
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Inclusion Criteria:
Age ≥ 18
Knee osteoarthritis (defined according to American College of Reumatology criteria):
Patients who have provided written consent
Patients able to understand simple instructions, to read, write, and to give informed consent
Patients with national health insurance cover
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Dijon | 21079 | France |
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|
| Usual care | Other | 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. |
|
| 12 months |
| Evolution of quality of life measured by the AMIQUAL self-questionnaire | 12 months |
| Evolution de overall disease activity measured by VAS | 12 months |
| Consumption of care relative to the knee osteoarthritis | Surgical operation, injectable medicinal treatments and anti-osteoarthritic of slow action, care of Support | 12 months |
| Local or general adverse effects | 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. | 12 months |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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