Skip to main content
OpenTrials
Completed

NCT Number: NCT07193368

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Degenerative Joint Disease of the Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis of the Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University, Faculty of Medicine, Department of Sports Medicine

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyacrylamide hydrogel 2.5% intra-articular injection

Biological

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).

Other names: Arthrosamid®, iPAAG injection

Primary outcomes

  1. Change in Knee Pain (VAS Score)

    Time frame: 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.

  2. Change in Physical Function (WOMAC Function Subscale)

    Time frame: 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.

  3. Change in Total WOMAC Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Feza Korkusuz MD

Other

Collaborators

  • Bursa City Hospital
  • Contura International A/S, Copenhagen, Denmark
  • Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye

Registry information

Official study title

Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis: A Multicenter Retrospective Study.

Acronym: HYDRO-KNEE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.