Gonarthrosis Clinical Trial
— YNOVIUMOfficial title:
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
NCT number | NCT06087705 |
Other study ID # | YNOVIUM |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 7, 2023 |
Est. completion date | August 1, 2024 |
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.
Status | Recruiting |
Enrollment | 134 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Adult patient - Patient with radiologically characterized gonarthrosis (stages Kellgren & Lawrence grades I to III) - Patient with walking pain (WOMAC A1) at least equal to 2 on the Likert scale 0-4 - Patient to benefit from an injection of SYNOVIUM HCS as part of his treatment - Patient agreeing to participate in the study - Patient affiliated to a social security scheme or benefiting from such a scheme Exclusion Criteria: - Viscosupplementation less than 6 months old - Intra-articular corticosteroid injection less than 2 months old - Inflammatory arthritis or active infectious of the knee studied - History of surgery of the lower limb concerned - Kellgren & Lawrence grades not defined - Known hypersensitivity to hyaluronic acid or chondroitin sulfate - Pregnant or breastfeeding women - Patient under guardianship, curatorship or judicial safeguard - Patient participating in another clinical investigation, at the time of inclusion |
Country | Name | City | State |
---|---|---|---|
France | CRRF en Milieu Marin de Trestel | Saint-Brieuc |
Lead Sponsor | Collaborator |
---|---|
LCA Pharmaceutical | EVAMED |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Complication | complication rate | 1 year | |
Secondary | recovery of autonomy | Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome) | 1 year | |
Secondary | 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 | |
Secondary | Stiffness | Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome) | 1 year | |
Secondary | Function | Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome) | 1 year | |
Secondary | 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 | |
Secondary | Impact of the injection on concomitant treatments | Recording of the consumption of analgesics and NSAIDs | 1 year | |
Secondary | long-term performance of the SYNOVIUM HCS device | Rate of patients having reached 1 year, without intervention on the knee concerned | 1 year | |
Secondary | 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 |
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