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

LCA Pharmaceutical

Status: Enrolling

Conditions: Gonarthrosis

Treatments: Device: Intra-articular injection of hyaluronic acid

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06087705

YNOVIUM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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