Degenerative Joint Disease of the Knee, Knee Osteoarthritis, Osteoarthritis, Osteoarthritis of the Knee
Conditions
Brief summary
This study is designed to evaluate the effects of intra-articular injections of polyacrylamide hydrogel (Arthrosamid®) in patients with knee osteoarthritis. A total of 387 patients (593 knees) were treated across three medical centers in Türkiye. The purpose of the study is to determine whether this injection can reduce knee pain and improve physical function in everyday life. Pain is being measured using a Visual Analogue Scale (VAS), and function is being assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Interventions
BIOLOGICALPolyacrylamide hydrogel 2.5% intra-articular injection
A single intra-articular injection of 2.5% cross-linked polyacrylamide hydrogel (iPAAG), composed of 2.5% polyacrylamide and 97.5% non-pyrogenic water. The product (Arthrosamid®, Contura, Denmark) was administered under ultrasound guidance into the knee joint. Patients were followed retrospectively for 12 months to evaluate safety and effectiveness in reducing pain (VAS) and improving function (WOMAC).
Sponsors
Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye
Contura International A/S, Copenhagen, Denmark
Bursa City Hospital, Bursa, Türkiye
Feza Korkusuz MD
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 40 years * Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4) * Received intra-articular 2.5% polyacrylamide hydrogel injection
Exclusion criteria
* Prior knee surgery before PAAG injection * Malignancy, local infection, or septic arthritis * Inflammatory joint disease (e.g., rheumatoid arthritis) * Pregnancy * Avascular necrosis * Advanced varus or valgus knee deformity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Knee Pain (VAS Score) | Baseline and 12 months after injection | Pain intensity will be measured using the Visual Analogue Scale (VAS; 0-10, with 0 = no pain and 10 = worst pain). Baseline values will be compared with values at 12 months after injection. |
| Change in Physical Function (WOMAC Function Subscale) | Baseline and 12 months after injection | Physical function will be assessed using the WOMAC Function subscale (0-68; higher scores indicate worse function). Baseline values will be compared with values at 12 months after injection. |
| Change in Total WOMAC Score | Baseline and 12 months after injection | Overall knee function and symptoms will be assessed using the WOMAC total score (0-100; higher scores indicate worse symptoms and function). Baseline values will be compared with values at 12 months after injection. |
Countries
Turkey (Türkiye)
Outcome results
None listed