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

NCT07193368 | Completed

• 1 other identifier: Approval No: 2025-14/3
• Study Type: observational
• Target: 387
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 12 months after injection

Study Arms (1)

Knee Osteoarthritis Patients

Patients diagnosed with knee osteoarthritis (Kellgren-Lawrence grade 2-4) who received a single intra-articular injection of 2.5% polyacrylamide hydrogel (Arthrosamid®, Contura, Denmark). Followed retrospectively for 12 months to assess pain (VAS) and function (WOMAC).

Biological: Polyacrylamide hydrogel 2.5% intra-articular injection

Interventions

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).

Also known as: Arthrosamid®, iPAAG injection

Knee Osteoarthritis Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 40 years and older diagnosed with knee osteoarthritis (KL grade 2-4) who were treated with a single intra-articular polyacrylamide hydrogel injection at three medical centers in Türkiye and followed retrospectively for 12 months.

You may qualify if:

• Age ≥ 40 years
• Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)
• Received intra-articular 2.5% polyacrylamide hydrogel injection

You may not qualify if:

• 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

Sponsors & Collaborators

• Feza Korkusuz MD: lead
• Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye: collaborator
• Contura International A/S, Copenhagen, Denmark: collaborator
• Bursa City Hospital, Bursa, Türkiye: collaborator

Study Sites (1)

Hacettepe University, Faculty of Medicine, Department of Sports Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

polyacrylamide gels; Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Feza Korkusuz, MD - Professor of Sports Medicine, Hacettepe University Faculty of Medicine

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 25, 2025
• Study Start: February 11, 2023
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)