Clinical trial NCT06087705: Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Official title: Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gonarthrosis
Keywords: hyaluronic acid
Lead sponsor: LCA Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-10-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis

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.

Eligibility criteria: 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

Primary outcomes:
measure: device performance
timeFrame: 6 months
Secondary outcomes:
measure: Complication
timeFrame: 1 year
measure: recovery of autonomy
timeFrame: 1 year
measure: Evolution of the pain
timeFrame: 1 year
measure: Stiffness
timeFrame: 1 year
measure: Function
timeFrame: 1 year
measure: responder patients
timeFrame: 1 year
measure: Impact of the injection on concomitant treatments
timeFrame: 1 year
measure: long-term performance of the SYNOVIUM HCS device
timeFrame: 1 year
measure: Investigator's general assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint-Brieuc
country: France
facility: CRRF en Milieu Marin de Trestel
Study officials:
affiliation: CRRF en Milieu Marin de Trestel
name: Dominique BARON
role: PRINCIPAL_INVESTIGATOR
References: