An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Study Overview
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Brief Summary
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Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks

Official Title
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An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: SYNOLIS VA 80/160
* Device: SYNOLIS VA 40/80


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient between 35 and 75 years old Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification: Knee pain Positive radiography (presence of osteophytes) Morning stiffness < 30 min and/or crepitus while walking Symptoms related to knee osteoarthritis for at least 6 months Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography) WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated Contralateral knee pain < 10 mm (VAS) compared to treated knee Patient signed inform consent form- Exclusion Criteria: Inability to understand the study or language used to be informed/sign the consent Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion Rheumatoid arthritis, joint condition or any other inflammation and arthritis Lupus Dermatological disorder or any epidermal conditions that prevent an intraarticular injection Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee Osteonecrosis (1 or both knees) Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA Fibromyalgia Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study Excessive and repeated consumption of alcohol or illicit substances Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYNOLIS VA 80/160<br>SYNOLIS VA 80/160 (hyaluronic acid 80 mg, sorbitol 160 mg) Intra-articular injection | Device: SYNOLIS VA 80/160<br>* Single 4mL intra-articular injection of SYNOLIS VA 80/160<br>|
| Experimental: SYNOLIS VA 40/80<br>SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg) Intra-articular injection | Device: SYNOLIS VA 40/80<br>* Single 2mL intra-articular injection of SYNOLIS VA 40/80<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit | The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image) | 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0 | The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image) | up to 168 days | 
| Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0 | The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image) | up to 168 days | 
| Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0 | The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image) | up to 168 days | 
| Percentage of subjects using analgesics | New NSAID / analgesics drugs usage | up to 168 days | 
| Measurement of relief satisfaction by the patient | 7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied) | 168 days | 
| Measurement of therapeutic efficacy by the investigator (assessor) | 7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied) | 168 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee Osteoarthritis, Hyaluronic acid