Status:
UNKNOWN
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Lead Sponsor:
LCA Pharmaceutical
Collaborating Sponsors:
EVAMED
Conditions:
Gonarthrosis
Eligibility:
All Genders
18-90 years
Brief Summary
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 SYN...
Detailed 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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06087705
Start Date
February 7 2023
End Date
August 1 2024
Last Update
October 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CRRF en Milieu Marin de Trestel
Saint-Brieuc, France, 22000