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

NCT06087705 | Unknown

• 1 other identifier: YNOVIUM
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis

Keywords

hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• device performance

  evolution of the pain sub-score of the WOMAC (universities of Western Ontario and McMaster) index (A). The higher the score, the more the knee osteoarthritis has a functional impact.

  6 months

Secondary Outcomes (9)

• Complication

  1 year

• recovery of autonomy

  1 year

• Evolution of the pain

  1 year

• Stiffness

  1 year

• Function

  1 year

Interventions

Intra-articular injection of hyaluronic acid DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LCA Pharmaceutical: lead
• EVAMED: collaborator

Study Sites (1)

CRRF en Milieu Marin de Trestel

Saint-Brieuc, 22000, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Dominique BARON

  CRRF en Milieu Marin de Trestel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice VINCENT

CONTACT

02 37 33 39 30; pvin@lca-pharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: October 18, 2023
• Study Start: February 7, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)