One shot could ease knee pain for a year: new hydrogel tested
NCT ID NCT07465601
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a single injection of Arthrosamid, a hydrogel made mostly of water, in 29 people with painful knee osteoarthritis. The goal is to see if it improves daily activity and reduces symptoms over 12 months. Participants wear an activity tracker to measure changes, and the results could lead to a simple, non-surgical option for knee pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Arthrosamid (a hydrogel made mostly of water and a small amount of polyacrylamide)
- What this could lead to
- If it works, this could offer a simple, one-time injection to help people with knee osteoarthritis move better and feel less pain for up to a year.
- What could go wrong
- This is a small, early study with only 29 people, so results may not apply to everyone. It is also a device, not a drug, so it may not work for all types of knee arthritis.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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29 people
The number who actually took part.
- Started
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Jul 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects \> 18 years of age at the time of injection * Advanced osteoarthritis, involving one or multiple of the following phenotypes: tricompartmental osteoarthritis, isolated or severe patella-femoral osteoarthritis, and/or a Kellgren and Lawrence grade II or III classification: * Patellofemoral osteoarthritis referring to symptoms, including pain, that are principally of patellofemoral origin (Patellar syndrome). * Radiological Kellgren and Lawrence grade II to III from a standing knee radiograph taken less than 6 months previously. * Subjects with a normal BMI ≥ 18.5 kg/m² and \< 30 kg/m² * Symptomatic osteoarthritis diagnosed via radiographic assessment and according to the clinical and radiological criteria of the American College of Rheumatology * Fully ambulatory patient for functional evaluation. * Able to understand and follow the instructions of the study. * Having signed a written informed consent Exclusion Criteria: * Meeting one of the following contraindications as stated in the instructions for use (IFU) of Arthrosamid®: * If an active skin disease or infection is present at or near the injection site * If the joint is infected or severely inflamed * If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to the manufacturer's information for the specific product, before injection with Arthrosamid® * Other medical conditions contributing to the rehabilitation process of the injection according to the surgeon * Important medical conditions such as, Parkinson's Disease, dementia, multiple sclerosis and cerebral vascular accident, which can disturb the patient's rehabilitation after injection according to the surgeon * Patient is participating in another clinical trial or has participated in a clinical trial in the last three months * Patients who did not met all the inclusion criteria
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Medisch Centrum Latem
Sint-Martens-Latem, Oost-Vlaanderen, 9830, Belgium
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Other studies related to the condition(s) this trial covers.
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