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

NCT ID: NCT06087705

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-08-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EVAMED

OTHER

Sponsor Role: collaborator

LCA Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique BARON

Role: PRINCIPAL_INVESTIGATOR

CRRF en Milieu Marin de Trestel

Locations

CRRF en Milieu Marin de Trestel

Saint-Brieuc, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrice VINCENT

Role: CONTACT

pvin@lca-pharma.com

02 37 33 39 30 ext. +033

Facility Contacts

Dominique BARON

Role: primary

DBARON@ch-lannion.fr

02 96 05 65 61

Other Identifiers

YNOVIUM

Identifier Type: -

Identifier Source: org_study_id