Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device — YNOVIUM  

Gonarthrosis Clinical Trial

Official title: Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device

Status Recruiting

Clinical Trial 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

• NCT number: NCT06087705
• Study type: Observational
• Source: LCA Pharmaceutical
• Contact: Patrice VINCENT
• Phone: 02 37 33 39 30
• Email: pvin@lca-pharma.com
• Status: Recruiting
• Start date: February 7, 2023
• Completion date: August 1, 2024