Osteoarthritis (OA) of the Knee
Conditions
Brief summary
To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Interventions
DEVICEHyruan ONE®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
DEVICEDurolane®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥40 years old. 2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit. 3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.
Exclusion criteria
1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis. 2. Subject has a documented history of hypersensitivity to HA. 3. Subject has a documented infection or severe inflammation of the target knee joint. 4. Subject has a skin disease in the area of the injection site. 5. Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap). 6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore | from Baseline to 13 weeks post injection. | 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. |
Countries
Poland
Outcome results
None listed