CClinicalTrials.gg
CompletedNCT07193368HYDRO-KNEEUpdated Sep 25, 2025

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

An observational study in Knee Osteoarthritis, Osteoarthritis and Osteoarthritis of the Knee, sponsored by Feza Korkusuz MD. Completed at 1 site in Turkey (Türkiye). Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Feza Korkusuz MD · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
387
Ages
40 Years and older
Sex
All
01

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).

02

Conditions studied

  • Knee Osteoarthritis
  • Osteoarthritis
  • Osteoarthritis of the Knee
  • Degenerative Joint Disease of the Knee
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 387 is above the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Feza Korkusuz MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
387 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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).

    Also known as: Arthrosamid®, iPAAG injection

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Hacettepe University, Faculty of Medicine, Department of Sports Medicine
    Ankara, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07193368
Lead sponsor
Feza Korkusuz MD
Collaborators
Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye, Contura International A/S, Copenhagen, Denmark, Bursa City Hospital
Responsible party
Feza Korkusuz MD (Feza Korkusuz, MD - Professor of Sports Medicine, Hacettepe University Faculty of Medicine, Hacettepe University) — Sponsor-investigator
First posted
Sep 25, 2025
Start date
Feb 11, 2023
Primary completion
Jun 24, 2025
Completion
Jun 24, 2025
Last update
Sep 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion