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NCT06087705 | RECRUITING | Gonarthrosis

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

LCA Pharmaceutical

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 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.

Condition or disease

Gonarthrosis

Intervention/treatment

Intra-articular injection of hyaluronic acid

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 134 participants
Official Title : Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Actual Study Start Date : 2023-02-07
Estimated Primary Completion Date : 2024-08-01
Estimated Study Completion Date : 2024-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device

Location Details

NCT06087705

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France,

CRRF and Environment Marin de Trestel

Saint-Brieuc, France, 22000