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This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.
This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).
All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | The total number of treatment emergent adverse events | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain subscale | change from baseline in WOMAC (WOMAC Osteoarthritis Index) pain subscale | 6, 12, 24, 36, 48 and 60 months |
| WOMAC stiffness subscale | change from baseline in WOMAC (WOMAC Osteoarthritis Index) stiffness subscale |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from participating rheumatology or orthopedic centers.
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| Name | Affiliation | Role |
|---|---|---|
| Dorthe Tvinnemose, DVM. | Contura | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute | Copenhagen | Denmark | ||||
| Reumatolog i Odense |
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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, 12, 24, 36, 48 and 60 months |
| WOMAC physical function subscale | change from baseline in WOMAC (WOMAC Osteoarthritis Index) physical function subscale | 6, 12, 24, 36, 48 and 60 months |
| Patient's global assessment of impact of osteoarthritis | An eleven point, numeric rating scale (0-10) where 0 =" No impact" and 10 = "Worst imaginable impact" | 6, 12, 24, 36, 48 and 60 months |
| Odense |
| Denmark |
| AP-HM hopitaux | Marseille | France |
| Clinique Saint Louis | Poissy | France |
| AmBeNet Hausarztpraxis | Leipzig | Germany |
| University Medical Center of Johannes Gutenberg-University Mainz (UMC-Mainz) | Mainz | 55131 | Germany |
| Ospedale San Pietro Fatebenefratelli | Rome | Italy |
| London North West University Healthcare | London | United Kingdom |
| Royal Cornwall Hospital | Truro | United Kingdom |
| D012216 |
| Rheumatic Diseases |