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Multicenter, independent study of Synolis VA 80/160 over a period of 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNOLIS VA 80/160 | Experimental | Single guided intra-articular injection of SYNOLIS VA 80/160 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNOLIS VA 80/160 | Device | SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Oxford Hip Score (OXFORD 12) | Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms. | 6 months (M6) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the Oxford Hip Score (OXFORD 12) | Oxford Hip Score (OXFORD 12) composed of 12 questions measuring pain and hip function. Question includes 5 possible answers corresponding to a value from 1 to 5, with 5 representing the highest level of severity, and 1, the total or almost total absence of symptoms. | Month 3, Month 3 to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SYNOLIS VA 80/160 | Serious adverse event occurrence | Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduard Vidovic, MD | Contact | +41225522104 | clinic@aptissen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatologie, Hôpital Nord Franche-Comté | Recruiting | Belfort | France |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Self-assessment symptoms evolution |
7-point Likert scale (-3 to +3) |
| Month 3, Month 3 to Month 6 |
| MCID Oxford Hip Score (OXFORD 12) | Minimum clinically important difference on the Oxford Hip Score (OXFORD 12) | Month 3, Month 3 to Month 6 |
| Hip prosthesis placement after the injection | Number of Participants with Hip prosthesis placement | Month 6 |
| Service de chirurgie orthopédique et traumatologie Centre Hospitalier de Dunkerque CHD | Recruiting | Dunkirk | France |
|
| Service d'Orthopédie II (Membre Inférieur, Chirurgie du Sport et Chirurgie Septique) Hôpital Salengro, CHRU de Lille | Recruiting | Lille | France |
|