WithdrawnNot Applicable

Knee OsteoArthritis Long-term Assessment

Stopped: Change in scope

Belgium0Started 2025-05

Plain-language summary

The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is: \- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)? All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.

Who can participate

Age range35 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol. * Unilateral symptomatic tibiofemoral KOA confirmed by a "standing knee" X-ray. In case of bilateral KOA on X-ray only one knee (indexed knee) presents symptomatic OA pain. * Age 35 ≤ 75 years. * BMI 20 ≤ 35. * Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25-85. * Radiological Kellgren and Lawrence (K\&L) grade II and III from a standing knee radiograph with minimum joint space of 1 mm in the study knee. * Fully ambulatory for functional assessments. * Willingness to refrain from taking any pain medication for 48 hours prior to each study visit. * Female subjects must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year. Females must show a negative pregnancy test at the treatment visit. Exclusion Criteria: * Bilateral tibiofemoral KOA where the non-symptomatic knee presents worse radiological grade of KOA. * Radiological K\&L grade 0, I, or IV from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of mo…

What they're measuring

Safety of Hydrogel OA 2% in subjects with symptomatic KOA

Timeframe: From the treatment to the end of the follow up at 26 weeks

Trial details

NCT IDNCT06839222

SponsorAllegro NV/SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11