Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis
Postmarketing, Prospective, Multicenter, Single-Arm Study of Subjects Who Receive an Injection of Medical Device Based on Hyaluronic Acid Marketed in Ukraine and Poland Administered Intra-Articularly to Patients Affected by Knee Osteoarthritis
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kyiv, Ukraine, 02192
- Pharmaxi Clinical Research LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the WOMAC Pain Subscale Score at 3 Months
Time Frame: 3 months after injection (Day 90 ± 5 days)
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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.
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3 months after injection (Day 90 ± 5 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Total WOMAC Score at 1, 2, 3, 4, 5, and 6 Months
Time Frame: 1, 2, 3, 4, 5, and 6 months after injection
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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.
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1, 2, 3, 4, 5, and 6 months after injection
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIART/REG-21 (Registry Identifier: Sponsor Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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