An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Study Details
Study Description
Brief Summary
Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SYNOLIS VA 40/80 SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg), intra-articular injection |
Device: SYNOLIS VA 40/80
Three 2mL injections of SYNOLIS VA 40/80, one week apart
|
Outcome Measures
Primary Outcome Measures
- Difference in total Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit. [168 days]
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)
Secondary Outcome Measures
- Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) pain severity index, as compared to D0 [up to 168 days]
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)
- Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) functional severity index, as compared to D0 [up to 168 days]
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)
- Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) stiffness severity index, as compared to D0 [up to 168 days]
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)
- Pain at walking on a 100 mm VAS [up to 168 days]
- Percentage of subjects using analgesics [up to 168 days]
New NSAID / analgesics drugs usage
- Measurement of relief satisfaction by the patient [168 days]
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
- Measurement of therapeutic efficacy by the investigator (assessor) [168 days]
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Other Outcome Measures
- Safety and tolerability of SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration [168 days]
Eligibility Criteria
Criteria
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)
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VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
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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
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Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
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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
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Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
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Rheumatoid arthritis, joint condition or any other inflammation and arthritis
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Lupus
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Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
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Visible remarkable 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)
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Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study
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Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
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Fibromyalgia
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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
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Excessive and repeated consumption of alcohol or illicit substances
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Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carolina Medical Center | Warszawa | Poland | 02-757 | |
| 2 | SPORTO oddzial na ulicy Miedzianej | Łódź | Poland | 09-038 | |
| 3 | SPORTO oddzial na ulicy Książka (2nd site location) | Łódź | Poland | 91-603 |
Sponsors and Collaborators
- Aptissen SA
- Noblewell
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF2ML Multishot