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

Gonarthrosis Clinical Trial

— YNOVIUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087705
• Other study ID #: YNOVIUM
• Status: Recruiting
• Start date: February 7, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: LCA Pharmaceutical
• Contact: Patrice VINCENT
• Phone: 02 37 33 39 30
• Email: pvin[@]lca-pharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonarthrosis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
France	CRRF en Milieu Marin de Trestel	Saint-Brieuc

Sponsors (2)

Lead Sponsor	Collaborator
LCA Pharmaceutical	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication	complication rate	1 year
Secondary	recovery of autonomy	Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome)	1 year
Secondary	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
Secondary	Stiffness	Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome)	1 year
Secondary	Function	Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome)	1 year
Secondary	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
Secondary	Impact of the injection on concomitant treatments	Recording of the consumption of analgesics and NSAIDs	1 year
Secondary	long-term performance of the SYNOVIUM HCS device	Rate of patients having reached 1 year, without intervention on the knee concerned	1 year
Secondary	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