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

NCT06927934 | Completed DMC

• 1 other identifier: DIART/REG-21
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Knee Osteoarthritis; Osteoarthritis of the Knee; Degenerative Joint Disease

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1, 2, 3, 4, 5, and 6 months after injection

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuria-Pharm: lead
• Pharmaxi Clinical Research LLC: collaborator

Study Sites (1)

Pharmaxi Clinical Research LLC

Kyiv, 02192, Ukraine

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No samples will be retained. This study involved only clinical assessments and questionnaire-based outcomes (e.g., WOMAC index). No biological specimens were collected or stored.

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Arthralgia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 15, 2025
• Study Start: August 14, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 27, 2022
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)