An interventional study of Hyruan ONE® and Durolane® in Osteoarthritis (OA) of the Knee, sponsored by LG Chem. Completed at 1 site in Poland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by LG Chem · Not applicable, Interventional, and Treatment
To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 284 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Hyruan ONE®
Device: Durolane®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question). Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows: Pain = 0-20 Stiffness = 0-8 Physical function = 0-68.
Time frame: from Baseline to 13 weeks post injection.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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