Overview
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.
Description
Inclusion period: 6 months
Follow-up period:
- 6-month follow-up, after intra-articular injection with extension
- 1 single syringe of SYNOVIUM HCS (3 mL),
- Controls scheduled at 1 week, 1, 3, 6 months and up to 1 year
- Additional control (single) in the event of leaving the study if this takes place outside the scheduled visit dates and before 1 year, for medical reasons
- 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.
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