An observational study in Knee Osteoarthritis, Osteoarthritis of the Knee and Degenerative Joint Disease, sponsored by Yuria-Pharm. Completed at 1 site in Ukraine. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by Yuria-Pharm · Observational
This study looked at how safe and effective a hyaluronic acid-based injection (called DIART ONE or EASYGO ONE) is for people with knee osteoarthritis. The injection helps replace the natural fluid in the knee joint to reduce pain and improve movement. Patients received one injection, and their symptoms were tracked over 6 months using phone calls and clinic visits. The goal was to see how much pain and joint function improved, and to check for any side effects.
This was a post-marketing, observational clinical study designed to evaluate the safety, tolerability, and effectiveness of a single intra-articular injection of a stabilized hyaluronic acid-based medical device, marketed under the names DIART ONE (in Ukraine) and EASYGO ONE (in Poland). The study focused on adults diagnosed with knee osteoarthritis, a common joint disease that causes pain, stiffness, and reduced mobility due to the breakdown of joint cartilage and decreased synovial fluid.
A total of 55 participants were enrolled across multiple centers. Each participant received one injection of the investigational product into the affected knee. The specific formulation (either 20 mg/mL - 2 mL or 30 mg/mL - 3 mL) was selected by the treating physician based on clinical needs and product availability.
The primary goal of the study was to assess the change in pain levels 3 months after injection, using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain subscale, a validated questionnaire used to evaluate joint pain. Secondary outcomes included changes in pain at other time points (1, 2, 4, 5, and 6 months), as well as changes in joint stiffness and physical function.
Participants were monitored over a 6-month period through a mix of in-person and phone follow-ups. Adverse events, including any side effects related to the product or injection, were documented and analyzed.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 55 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
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The study population consisted of adult men and women aged 21 years and older with radiographically confirmed knee osteoarthritis (Kellgren-Lawrence grade 2-4). Participants were eligible if they were prescribed a single intra-articular injection of stabilized hyaluronic acid (DIART ONE or EASYGO ONE) as part of routine clinical care for synovial fluid deficiency. All participants had a Body Mass Index (BMI) between 18.5 and 35 kg/m². Individuals with other joint diseases, recent joint surgery, infections, or contraindications to hyaluronic acid were excluded.
Exclusion Criteria:
Change in the WOMAC Pain Subscale Score at 3 Months
Mean change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score (5-point Likert-type scale, range 0-20) at 3 months after a single intra-articular injection of hyaluronic acid.
Time frame: 3 months after injection (Day 90 ± 5 days)
Change in the Total WOMAC Score at 1, 2, 3, 4, 5, and 6 Months
Mean change from baseline in the total WOMAC index score (Likert-type scale, total range 0-96: pain = 0-20, stiffness = 0-8, physical functioning = 0-68) at multiple time points following injection.
Time frame: 1, 2, 3, 4, 5, and 6 months after injection
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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