Status:
COMPLETED
Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis
Lead Sponsor:
Yuria-Pharm
Collaborating Sponsors:
Pharmaxi Clinical Research LLC
Conditions:
Knee Osteoarthritis
Osteoarthritis of the Knee
Eligibility:
All Genders
21+ years
Brief 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 ...
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 med...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06927934
Start Date
August 14 2021
End Date
June 27 2022
Last Update
April 15 2025
Active Locations (1)
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1
Pharmaxi Clinical Research LLC
Kyiv, Ukraine, 02192