Knee OsteoarthritisNCT06927934
Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Osteoarthritis of the Knee, run by Yuria-Pharm at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis of the Knee, Degenerative Joint Disease
- How many people
- 55 participants
- Where
- 1 siteUkraine
- Study dates
- 14 Aug 2021to 27 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Keywords
- Hyaluronic acid, Intra-articular injection, DIART ONE, EASYGO ONE, Synovial fluid replacement, Joint pain, Single-arm study, Osteoarthritis treatment, Knee joint mobility, Degenerative joint disease, Diaco Biofarmaceutici, Yuria-Pharm
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases, Arthralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after injection (Day 90 ± 5 days)
Secondary outcomes (1)
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.
Measured: 1, 2, 3, 4, 5, and 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start14 Aug 2021
- Primary completion6 Jun 2022
- Study completion27 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuria-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaxi Clinical Research LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927934
- Sponsor's protocol ID
- DIART/REG-21
- Other IDs
- DIART/REG-21
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06927934
- Acronym / sponsor ID
- DIART/REG-21
- Keywords
- Hyaluronic acid, Intra-articular injection, DIART ONE, EASYGO ONE, Synovial fluid replacement, Joint pain, Single-arm study, Osteoarthritis treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Yuria-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaxi Clinical Research LLC
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the WOMAC Pain Subscale Score at 3 Months
Time frame: 3 months after injection (Day 90 ± 5 days)
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Osteoarthritis of the Knee, run by Yuria-Pharm at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the WOMAC Pain Subscale Score at 3 Months (time frame: 3 months after injection (Day 90 ± 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.