Intra-Articular Polyacrylamide Hydrogel Injections Improve Pain and Function in Knee Osteoarthritis
NCT ID: NCT07193368
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
387 participants
OBSERVATIONAL
2023-02-11
2025-06-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee Osteoarthritis
NCT03200288
The Effect of Hyaluronic Acid Injection on TNF-Alpha and IL-1β in Knee Osteoarthritis
NCT06960564
Cross-linked Hyaluronic Acid in Knee Osteoarthritis
NCT07241442
Knee Osteoarthritis: Platelet Rich Plasma or Hyaluronic Acid
NCT03801564
Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)
NCT06141018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Radiographic diagnosis of knee osteoarthritis (Kellgren-Lawrence grade 2-4)
* Received intra-articular 2.5% polyacrylamide hydrogel injection
Exclusion Criteria
* Malignancy, local infection, or septic arthritis
* Inflammatory joint disease (e.g., rheumatoid arthritis)
* Pregnancy
* Avascular necrosis
* Advanced varus or valgus knee deformity
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Özgür Oktay Nar Private Clinic, Bursa, Türkiye
UNKNOWN
Contura International A/S, Copenhagen, Denmark
UNKNOWN
Bursa City Hospital, Bursa, Türkiye
UNKNOWN
Feza Korkusuz MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Feza Korkusuz MD
Feza Korkusuz, MD - Professor of Sports Medicine, Hacettepe University Faculty of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hacettepe University, Faculty of Medicine, Department of Sports Medicine
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Approval No: 2025-14/3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.