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The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.
This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.
Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTHRUM H 2% | Device | ARTHRUM H 2% |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS) |
| 6 months |
| To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS) |
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Inclusion Criteria:
Exclusion Criteria:
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Men or Women aged aver 40 ans suffering fromm knee osteoarthritis
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| Name | Affiliation | Role |
|---|---|---|
| CHRISTIAN PASCARETTI, MD | Le Ronceray Rhumatologie | Study Director |
| Paolo INSALACO, MD | Le Ronceray Rhumatologie | Study Director |
| ANTOINE LESORT, MD | Hopital Prive des Peupliers | Study Chair |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 6 months |
| To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A) |
| 6 months |
| D012216 |
| Rheumatic Diseases |