Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 8:15 AM
Study NCT ID:
NCT06927934
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postmarketing Multicenter Study of Intra-Articular DIART ONE / EASYGO ONE for Knee Osteoarthritis
Sponsor:
Yuria-Pharm
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DIART/REG-21 | REGISTRY | Sponsor Registry | View |