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

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.

Study Overview

• Status: Recruiting
• Conditions: Gonarthrosis
• Intervention / Treatment: Device: 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
• Enrollment (Estimated): 134

Contacts and Locations

• Study Contact: Name: Patrice VINCENT; Phone Number: +033 02 37 33 39 30; Email: pvin@lca-pharma.com

Study Locations

• France
  • Saint-Brieuc, France, 22000
    • Recruiting
    • CRRF en Milieu Marin de Trestel
    • Contact: Dominique BARON; Phone Number: 02 96 05 65 61; Email: DBARON@ch-lannion.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication	complication rate	1 year
recovery of autonomy	Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome)	1 year
Evolution of the pain	Evolution of the pain sub-score (WOMAC A)(universities of Western Ontario and McMaster) index (A). (Higher scores mean worse outcome)	1 year
Stiffness	Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome)	1 year
Function	Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome)	1 year
responder patients	Rate of responder patients according to the OMERACT-OARSI criteria (to the treatment, in knee osteoarthritis) (0% (no responder) to 100% (all responder))	1 year
Impact of the injection on concomitant treatments	Recording of the consumption of analgesics and NSAIDs	1 year
long-term performance of the SYNOVIUM HCS device	Rate of patients having reached 1 year, without intervention on the knee concerned	1 year
Investigator's general assessment	General assessment by the investigator at the end of the study. (Likert scale 0-3, higher scores mean better outcome)	1 year

Collaborators and Investigators

• Sponsor: LCA Pharmaceutical
• Collaborators: EVAMED
• Investigators: Principal Investigator: Dominique BARON, CRRF en Milieu Marin de Trestel

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hyaluronic acid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: YNOVIUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No