NCT06087705

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 134 (estimated)
• Sponsor: LCA Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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, 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.

Conditions

• Gonarthrosis

Interventions

Type	Name	Description
DEVICE	Intra-articular injection of hyaluronic acid	The injection must necessarily be performed by a practitioner in compliance with the rules of asepsis. Procedure of use: * Before the injection, a rigorous prior disinfection of the area to be treated will be carried out. * Check the integrity of the sterility protector. * Take the syringe and remove the protective tip. * Hold the syringe body and insert a sterile intra-articular injection needle into the Luer-Lock system. * Gently turn the needle clockwise to secure the needle in the Luer-Lock system. * A visual check of the attachment of the needle will be carried out. * Remove the needle cap. * Inject slowly.

Timeline

• Start date: 2023-02-07
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-10-18
• Last updated: 2023-10-18

Locations

1 site across 1 country: France