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

NCT07193368 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 387

Last updated 2025-09-25

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Polyacrylamide 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 & Collaborators

  • Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye

    collaborator UNKNOWN

  • Contura International A/S, Copenhagen, Denmark

    collaborator UNKNOWN

  • Bursa City Hospital, Bursa, Türkiye

    collaborator UNKNOWN

  • Feza Korkusuz MD

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-11
Primary Completion
2025-06-24
Completion
2025-06-24

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193368 on ClinicalTrials.gov