An interventional study of SYNOLIS VA 40/80 in Osteo Arthritis Knee, sponsored by Aptissen SA. Completed at 3 sites in Poland. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Aptissen SA · Not applicable, Interventional, and Treatment
Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 51 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Aptissen SA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
Exclusion Criteria:
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
Difference in total 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)
Time frame: 168 days
Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (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)
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis (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)
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis (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)
Time frame: up to 168 days
Pain at walking on a 100 mm VAS
Time frame: up to 168 days
Percentage of subjects using analgesics
New NSAID / analgesics drugs usage
Time frame: 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)
Time frame: 168 days
Measurement of therapeutic efficacy by the investigator (assessor)
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Time frame: 168 days
Safety and tolerability of SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration
Time frame: 168 days
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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