Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis

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.

Inclusion criteria

• Age ≥ 21 years.
• Body Mass Index (BMI) ≥ 18.5 kg/m².
• Body Mass Index (BMI) < 35 kg/m².
• Presence of trauma or degenerative diseases (e.g., osteoarthritis) confirmed by radiographic imaging (Kellgren-Lawrence score 2-4).
• The subject is prescribed an injection of stabilized hyaluronic acid (DIART ONE 20 mg/mL - 2 mL or 30 mg/mL - 3 mL) for temporary replacement of synovial fluid in the knee joint.
• Signed written informed consent to participate in the study.

Exclusion criteria

• Age < 21 years.
• Body Mass Index (BMI) < 18.5 kg/m².
• Body Mass Index (BMI) ≥ 35 kg/m².
• Pregnancy or lactation.
• No radiographic confirmation of osteoarthritis (Kellgren-Lawrence score 0-1).
• Known hypersensitivity to hyaluronic acid, its metabolites, or excipients in the injectable implant.
• Increased bleeding tendency.
• Injury or infection at the injection site.
• Confirmed infectious joint disease.
• Systemic connective tissue diseases (e.g., active rheumatoid arthritis, ankylosing spondylitis).
• Non-osteoarthritis arthritis.
• Planned total knee joint replacement.
• Gait disorders of neurological origin.
• Intra-articular hyaluronic acid injection in the study knee within 3 months prior to enrollment.
• Surgery or orthopedic intervention on the study knee in the last 3 months.
• Cancer
• Decompensated diabetes mellitus.
• Hematological diseases.
• Inability or unwillingness to comply with study procedures.
• Language barriers that prevent understanding of the informed consent form.
• Any other condition deemed by the investigator to preclude participation.
• Participation in another clinical study.