Knee OsteoarthritisRESYFNCT04321668
Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®
A study testing Synvisc-One in people with Knee Osteoarthritis and Intra-Articular Injection, run by Pulsalys at 3 sites in Belgium.
Trial summary
The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Intra-Articular Injection
- What is being tested?
- Synvisc-One
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesBelgium
- Study dates
- 12 Feb 2020to 15 Feb 2022
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 40 years of age with BMI ≤ 35 kg/m2
- Femorotibial knee OA (Uni- or bilateral):
- Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- Symptomatic for more than 6 months in the most painful knee
- Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) ≥ 40 over the last month at the inclusion visit (the most painful knee is considered)
- Eligible for knee viscosupplementation using SYNVISC-ONE®
- Knee swelling justifying SF aspiration at baseline - Able to follow the instructions of the study
- Having signed an informed consent
Who cannot join
- Related to the OA pathology
- Recent macro-trauma (< 6 months) of the knee responsible of the symptomatic knee. Micro-trauma are allowed according the Investigator's discretion
- Concurrent articular disease interfering with the evaluation of OA and/or pain such as but not limited to articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis, infectious arthritis, radiculalgia in the lower limbs, arteritis, chondrocalcinosis x-rays diagnosed and Calcium PyroPhosphate Dihydrate crystal deposition disease (CPPD)
- Hemarthrosis
- Prosthesis in the target knee
- Related to treatment
Show all 27Show fewer
- Corticosteroids injection in the target knee in the last 3 months before injection (excepted for low dose injection following SF aspiration at V1 as recommended by standard treatment guidelines)
- Hyaluronan injection in the target knee in the last 6 months before injection
- Arthroscopy in the last 3 months before injection
- Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months before injection
- Change in the dosage regimen of symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before injection
- An anticipated need for any forbidden OA treatments during the trial
- Contraindications to SYNVISC-ONE®: hypersensitivity or allergy to the product components and infections or skin diseases in the area of the injection site
- Anticoagulant anti-vitamin K (such as coumarinic) before injection
- Related to associated diseases
- Severe and uncontrolled diseases (type I diabetes, liver failure, renal failure, lung/heart disease, progressive malignant neoplasia or in remission for less than 5 years, HIV)
- Malignancy or history of malignancy, or other major disease (e.g., systemic fungal infection) or other severe uncontrolled conditions (e.g., drug or alcohol abuse), that are significant and/or that may pose a health risk to the subject in the study or may have an impact on the study assessments
- High risk of hemorrhage and risk of infection at the site of injection
- Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- Related to patients
- Close collaborators to the Sponsor, the study coordinator or the Investigator
- Participation in a clinical trial in the last 3 months before injection
- Patient under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device), tubal ligation or hysterectomy
- Related to MRI counter-indication
- Risk groups for MRI scanning due to magnetic field: metal in body: pacemaker/AICD/ICD (coronary defibrillator), nervus vagus stimulator, artificial heart valve (depending on type), metal clips on cerebral arteries or veins, metal particles in eye, port-a-cath, metal stents, hydrocephalic pump/insuline pump, metal implants; f/e screws, prostheses, piercings
- Claustrophobia or serious mobility problem (uncontrolled Parkinson, tremors)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Hopital Delta, CHIREC
Auderghem, 1160
Centre Medical Chant d'Oiseau
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, 1150
Cliniques Universitaires Saint Luc - UCL
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe
About this study
Official title: A Proof of Concept Study in Patients Suffering of Knee Osteoarthritis (OA) and Receiving Intra-articular (IA) Injection of Synvisc-one® to Assess the Clinical Pertinence of a New Analytical Tool of Synovial Fluid
The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.
Read the detailed description
In a recent study on animal model (results not yet published), the use of drop deposition combined to Raman spectroscopy provided for the first time the Raman spectral signature of healthy SF. Tribological analysis of simple dried drops of SF showed the potentiality to observe physical and chemical changes due to OA process. HA concentration was correlated with the dried drop area and the increase of protein content was correlated with the height of the peripheral rim. Spectral acquisitions detailed/specified these observations as degradation of cartilage and bone tissues was measured using specific Raman band ratios. These results suggested that DDRS could be an innovative tool in OA clinical research. In this context, the Sponsor would like to assess the clinical pertinence of this innovative analytical tool in a PoC study using OA patients receiving IA injection of SYNVISC ONE®.
- Conditions
- Knee Osteoarthritis, Intra-Articular Injection
- Being tested
- Synvisc-One
- Keywords
- Osteoarthritis, food supplement, SYNVISC, Synovial Fluid analysis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc-OneDevice
Also called SYNVISC, Hylan G-F 20
SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication
| Study group | Role | What they receive |
|---|---|---|
| Injection of SYNVISC-ONE | Other | Patients suffering from symptomatic knee osteoarthritis (OA), receiving intra-articular (IA) injection of SYNVISC-ONE® (Hylan G-F 20; 10 mL single-injection viscosupplement) Receives: Device: Synvisc-One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection
Tribological properties (i.e. the dried drop surface and the peripheral height profile) of the synovial fluid will be analyzed through optical microscopy (2D morphological examinations) in OA patients receiving SYNVISC-ONE® injection
Measured: 6 months (between T0 and T6 visit)
Secondary outcomes (9)
Detection of Synovial fluid tribological properties through interferometry
Topography measurement (3D tribological examination) will be performed using white light interferometry (smartWLI-microscope, GBS mbH, Germany) on the periphery of the drops.
Measured: 6 months (between T0 and T6 visit)
Detection of Synovial fluid molecular structural and chemical changes using a Raman confocal microscope
Based on Raman spectroscopy
Measured: 6 months (between T0 and T6 visit)
Detection of dried drops physicochemical index
Based on surface of dried drops and Raman ratios
Measured: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month
The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme.
Measured: 6 months (between T0 and T6 visit)
Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire
The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
Measured: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for patient global assessment of disease activity
The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length, anchored by one verbal descriptors for Global Assessment of disease activity.
Measured: 6 months (between T0 and T6 visit)
Determination of Semi-quantitative Whole ORgan Magnetic Imaging Score score of the joint
MRI Imaging will be analyzed for WORMS by central reading in order to find correlation between the Imaging and the synovial fluid composition.
Measured: At baseline visit (T0)
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to OMERACT OARSI criteria
Responder criteria for osteoarthritis clinical trials will be based on the questionnaires describe above.
Measured: 6 months (between T0 and T6 visit)
Tolerance to the product
Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of SOC and LLT using the last version of MedDRA) and drop offs
Measured: 6 months (between T0 and T6 visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start12 Feb 2020
- Primary completion1 Oct 2021
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of Concept (PoC), monocentric, non-comparative, interventional trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulsalys
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
- Investigators
- Jean-Emile Dubuc, MD, Principal investigator, Cliniques Universitaires Saint-Luc UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321668
- Sponsor's protocol ID
- RESYF
- Acronym
- RESYF
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2020
- Last updated
- 22 Apr 2022
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study in Patients Suffering of Knee Osteoarthritis (OA) and Receiving Intra-articular (IA) Injection of Synvisc-one® to Assess the Clinical Pertinence of a New Analytical Tool of Synovial Fluid
- ClinicalTrials.gov ID
- NCT04321668
- Acronym / sponsor ID
- RESYF / RESYF
- Conditions
- Knee Osteoarthritis, Intra-Articular Injection
- Keywords
- Osteoarthritis, food supplement, SYNVISC, Synovial Fluid analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PulsalysIndustry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 25 Mar 2020 (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.
The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.
Detailed description
In a recent study on animal model (results not yet published), the use of drop deposition combined to Raman spectroscopy provided for the first time the Raman spectral signature of healthy SF. Tribological analysis of simple dried drops of SF showed the potentiality to observe physical and chemical changes due to OA process. HA concentration was correlated with the dried drop area and the increase of protein content was correlated with the height of the peripheral rim. Spectral acquisitions detailed/specified these observations as degradation of cartilage and bone tissues was measured using specific Raman band ratios. These results suggested that DDRS could be an innovative tool in OA clinical research. In this context, the Sponsor would like to assess the clinical pertinence of this innovative analytical tool in a PoC study using OA patients receiving IA injection of SYNVISC ONE®.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of Concept (PoC), monocentric, non-comparative, interventional trial
| Arm | Type | Receives |
|---|---|---|
| Injection of SYNVISC-ONE | Other | Device: Synvisc-OnePatients suffering from symptomatic knee osteoarthritis (OA), receiving intra-articular (IA) injection of SYNVISC-ONE® (Hylan G-F 20; 10 mL single-injection viscosupplement) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥ 40 years of age with BMI ≤ 35 kg/m2
- Femorotibial knee OA (Uni- or bilateral):
- Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) ≥ 40 over the last month at the inclusion visit (the most painful knee is considered)
- Eligible for knee viscosupplementation using SYNVISC-ONE®
- Knee swelling justifying SF aspiration at baseline - Able to follow the instructions of the study
Key exclusion criteria (27 listed)
- Related to the OA pathology
- Related to treatment
- Related to associated diseases
- Related to patients
- Related to MRI counter-indication
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 |
|---|---|---|
| Synvisc-OneAlso: SYNVISC, Hylan G-F 20SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication | Device | Injection of SYNVISC-ONE |
Primary outcome
Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection
Time frame: 6 months (between T0 and T6 visit)
Tribological properties (i.e. the dried drop surface and the peripheral height profile) of the synovial fluid will be analyzed through optical microscopy (2D morphological examinations) in OA patients receiving SYNVISC-ONE® injection
9 secondary outcomes
Detection of Synovial fluid tribological properties through interferometry
Time frame: 6 months (between T0 and T6 visit)
Detection of Synovial fluid molecular structural and chemical changes using a Raman confocal microscope
Time frame: 6 months (between T0 and T6 visit)
Detection of dried drops physicochemical index
Time frame: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month
Time frame: 6 months (between T0 and T6 visit)
Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire
Time frame: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for patient global assessment of disease activity
Time frame: 6 months (between T0 and T6 visit)
Determination of Semi-quantitative Whole ORgan Magnetic Imaging Score score of the joint
Time frame: At baseline visit (T0)
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to OMERACT OARSI criteria
Time frame: 6 months (between T0 and T6 visit)
Tolerance to the product
Time frame: 6 months (between T0 and T6 visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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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.
Jean-Emile Dubuc, MD principal investigator
Cliniques Universitaires Saint-Luc UCL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synvisc-One in people with Knee Osteoarthritis and Intra-Articular Injection, run by Pulsalys at 3 sites in Belgium.
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 8 inclusion and 27 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection (time frame: 6 months (between T0 and T6 visit)). 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 22 Apr 2022.