Informations générales (source: ClinicalTrials.gov)
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device (YNOVIUM)
Observational
LCA Pharmaceutical (Voir sur ClinicalTrials)
février 2023
août 2024
29 juin 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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CRRF en Milieu Marin de Trestel - 22000 - Saint-Brieuc - France | Dominique BARON | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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