Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis

N/ACompletedNCT07193368

Feza Korkusuz MD387 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

387

Conditions

Knee Osteoarthritis Osteoarthritis Osteoarthritis of the Knee Degenerative Joint Disease of the Knee

Interventions

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).

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Knee Pain (VAS Score)

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.

Time frame: Baseline and 12 months after injection

Change in Physical Function (WOMAC Function Subscale)

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.

Time frame: Baseline and 12 months after injection

Change in Total WOMAC Score

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.

Time frame: Baseline and 12 months after injection

Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes