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| Name | Class |
|---|---|
| EVAMED | OTHER |
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Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.
Inclusion period: 6 months
Follow-up period:
6-month follow-up, after intra-articular injection with extension
Duration of the study: Overall time estimated at 18 months
In this open-label CI, the group itself is used as a control, by comparing the scores on inclusion with those of the various control visits.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular injection of hyaluronic acid | Device | The injection must necessarily be performed by a practitioner in compliance with the rules of asepsis. Procedure of use:
|
| Measure | Description | Time Frame |
|---|---|---|
| device performance | evolution of the pain sub-score of the WOMAC (universities of Western Ontario and McMaster) index (A). The higher the score, the more the knee osteoarthritis has a functional impact. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | complication rate | 1 year |
| recovery of autonomy | Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with knee osteoarthritis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrice VINCENT | Contact | 02 37 33 39 30 | +033 | pvin@lca-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Dominique BARON | CRRF en Milieu Marin de Trestel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRRF en Milieu Marin de Trestel | Recruiting | Saint-Brieuc | 22000 | France |
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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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| 1 year |
| Evolution of the pain | Evolution of the pain sub-score (WOMAC A)(universities of Western Ontario and McMaster) index (A). (Higher scores mean worse outcome) | 1 year |
| Stiffness | Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome) | 1 year |
| Function | Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome) | 1 year |
| responder patients | Rate of responder patients according to the OMERACT-OARSI criteria (to the treatment, in knee osteoarthritis) (0% (no responder) to 100% (all responder)) | 1 year |
| Impact of the injection on concomitant treatments | Recording of the consumption of analgesics and NSAIDs | 1 year |
| long-term performance of the SYNOVIUM HCS device | Rate of patients having reached 1 year, without intervention on the knee concerned | 1 year |
| Investigator's general assessment | General assessment by the investigator at the end of the study. (Likert scale 0-3, higher scores mean better outcome) | 1 year |
| D012216 |
| Rheumatic Diseases |