RecruitingNot Applicable

Hydrogel Assessment for Local Treatment of Osteoarthritis

Belgium20 participantsStarted 2026-04

Plain-language summary

The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.

Who can participate

Age range35 Years – 75 Years

SexALL

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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 "stand-ing knee" X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain.
✓. Age 35 ≤ 75 years.
✓. BMI 20 ≤ 35.
✓. Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score 25 ≤ 70.
✓. Patients impacted by pain in the index knee during daily activi-ties.
✓. Radiological Kellgren and Lawrence (K\&L) grade II and III of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent X-ray taken either im-mediately or within the past 3 months.
✓. Fully ambulatory for functional assessments.

Exclusion criteria

✕. Bilateral tibiofemoral KOA where the non-index knee presents a worse radiological grade of KOA than the index knee.
✕. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees.
✕. Extension deficit of the index knee higher than 5 degrees.
✕. Bilateral symptomatic tibiofemoral KOA or combined ipsilateral symptomatic tibiofemoral knee and hip OA.
✕. Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain.
✕. Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma).
✕. Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment.
✕. Synovial infection, skin infection or skin diseases in the area of the injection site.

What they're measuring

Occurrence of Device- or Procedure-Related Serious Adverse Events

Timeframe: 13 weeks

Trial details

NCT IDNCT07516457

SponsorAllegro NV/SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Kris Van den Cruys

clinical@allegro.bio

View on ClinicalTrials.gov More Osteo Arthritis of the Knee trials