Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
- Conditions
- Gonarthrosis
- Registration Number
- NCT06087705
- Lead Sponsor
- LCA Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 134
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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))
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)
Impact of the injection on concomitant treatments 1 year Recording of the consumption of analgesics and NSAIDs
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)
Complication 1 year complication rate
recovery of autonomy 1 year Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better 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)
long-term performance of the SYNOVIUM HCS device 1 year Rate of patients having reached 1 year, without intervention on the knee concerned
Trial Locations
- Locations (1)
CRRF en Milieu Marin de Trestel
🇫🇷Saint-Brieuc, France