Knee OsteoarthritisHYDRO-KNEENCT07193368
Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Osteoarthritis, run by Feza Korkusuz MD at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Osteoarthritis, Osteoarthritis of the Knee
- What is being tested?
- Polyacrylamide hydrogel 2.5% intra-articular injection
- Type of treatment
- Injection or infusion
- How many people
- 387 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2023to 24 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 40 years
- Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- Received intra-articular 2.5% polyacrylamide hydrogel injection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Medicine, Department of Sports Medicine
Ankara
About this study
Official title: Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis: A Multicenter Retrospective Study.
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
- Being tested
- Polyacrylamide hydrogel 2.5% intra-articular injection
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyacrylamide hydrogel 2.5% intra-articular injectionBiological
Also called Arthrosamid®, iPAAG 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Polyacrylamide hydrogel 2.5% intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start11 Feb 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feza Korkusuz MD
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye, Contura International A/S, Copenhagen, Denmark, Bursa City Hospital
- Responsible party
- Sponsor-investigator, Feza Korkusuz MD, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193368
- Sponsor's protocol ID
- Approval No: 2025-14/3
- Acronym
- HYDRO-KNEE
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis: A Multicenter Retrospective Study.
- ClinicalTrials.gov ID
- NCT07193368
- Acronym / sponsor ID
- HYDRO-KNEE / Approval No: 2025-14/3
- Conditions
- Knee Osteoarthritis, Osteoarthritis, Osteoarthritis of the Knee, Degenerative Joint Disease of the Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Feza Korkusuz MDUniversity, hospital or other
- Collaborators
- Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye, Contura International A/S, Copenhagen, Denmark, Bursa City Hospital
- Study start
- 11 Feb 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee Osteoarthritis Patients | – | Biological: Polyacrylamide hydrogel 2.5% intra-articular injectionPatients 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 40 years
- Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- Received intra-articular 2.5% polyacrylamide hydrogel injection
Key exclusion criteria (6 listed)
- Prior knee surgery before PAAG injection
- Malignancy, local infection, or septic arthritis
- Inflammatory joint disease (e.g., rheumatoid arthritis)
- Pregnancy
- Avascular necrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyacrylamide hydrogel 2.5% intra-articular injectionAlso: Arthrosamid®, iPAAG injectionA 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). | Biological | Knee Osteoarthritis Patients |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Osteoarthritis, run by Feza Korkusuz MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Pain (VAS Score) (time frame: Baseline and 12 months after injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.