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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gonarthrosis

Intervention / Treatment
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* Device: Intra-articular injection of hyaluronic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyaluronic acid