GonarthrosisYNOVIUMNCT06087705
Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
An observational study of Gonarthrosis, run by LCA Pharmaceutical at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Intra-articular injection of hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with knee osteoarthritis
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnant or breastfeeding women
- Patient under guardianship, curatorship or judicial safeguard
- Patient participating in another clinical investigation, at the time of inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CRRF en Milieu Marin de Trestel
Saint-Brieuc, 22000
Dominique BARON, 02 96 05 65 61, DBARON@ch-lannion.fr
About this study
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.
Read the 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.
- Conditions
- Gonarthrosis
- Being tested
- Intra-articular injection of hyaluronic acid
- Keywords
- hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection of hyaluronic acidDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
Complication
complication rate
Measured: 1 year
recovery of autonomy
Evolution of the disability according to the patient (Likert scale 0-10, higher scores mean better outcome)
Measured: 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)
Measured: 1 year
Stiffness
Evolution of the stiffness sub-score (WOMAC B) (universities of Western Ontario and McMaster) index (B). (Higher scores mean worse outcome)
Measured: 1 year
Function
Evolution of the function sub-score (WOMAC C) (universities of Western Ontario and McMaster) index (C). (Higher scores mean worse outcome)
Measured: 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))
Measured: 1 year
Impact of the injection on concomitant treatments
Recording of the consumption of analgesics and NSAIDs
Measured: 1 year
long-term performance of the SYNOVIUM HCS device
Rate of patients having reached 1 year, without intervention on the knee concerned
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start7 Feb 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LCA Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Dominique BARON, Principal investigator, CRRF en Milieu Marin de Trestel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087705
- Sponsor's protocol ID
- YNOVIUM
- Acronym
- YNOVIUM
- Status last verified
- Oct 2023
- First submitted
- 6 Feb 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device
- ClinicalTrials.gov ID
- NCT06087705
- Acronym / sponsor ID
- YNOVIUM / YNOVIUM
- Conditions
- Gonarthrosis
- Keywords
- hyaluronic acid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- LCA PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular injection of hyaluronic acidThe 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. | Device | – |
Primary outcome
device performance
Time frame: 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.
9 secondary outcomes
Complication
Time frame: 1 year
recovery of autonomy
Time frame: 1 year
Evolution of the pain
Time frame: 1 year
Stiffness
Time frame: 1 year
Function
Time frame: 1 year
responder patients
Time frame: 1 year
Impact of the injection on concomitant treatments
Time frame: 1 year
long-term performance of the SYNOVIUM HCS device
Time frame: 1 year
Investigator's general assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique BARON principal investigator
CRRF en Milieu Marin de Trestel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonarthrosis, run by LCA Pharmaceutical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrice VINCENT (02 37 33 39 30 ext. +033, pvin@lca-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
device performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.