Gonarthrosis
Conditions
Keywords
hyaluronic acid
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.
Interventions
DEVICEIntra-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.
Sponsors
EVAMED
LCA Pharmaceutical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| device performance | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery of autonomy | 1 year | Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome) |
| Evolution of the pain | 1 year | Evolution of the pain sub-score (WOMAC A)(universities of Western Ontario and McMaster) index (A). (Higher scores mean worse outcome) |
| Stiffness | 1 year | Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome) |
| Function | 1 year | Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome) |
| Complication | 1 year | complication rate |
| Impact of the injection on concomitant treatments | 1 year | Recording of the consumption of analgesics and NSAIDs |
| long-term performance of the SYNOVIUM HCS device | 1 year | Rate of patients having reached 1 year, without intervention on the knee concerned |
| Investigator's general assessment | 1 year | General assessment by the investigator at the end of the study. (Likert scale 0-3, higher scores mean better outcome) |
| responder patients | 1 year | Rate of responder patients according to the OMERACT-OARSI criteria (to the treatment, in knee osteoarthritis) (0% (no responder) to 100% (all responder)) |
Countries
France
Contacts
Primary ContactPatrice VINCENT
Outcome results
None listed