Actively Recruiting
A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability of Hydrogel OA 2% in Patients With Knee Osteoarthritis
Led by Allegro NV/SA · Updated on 2026-05-11
20
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a single intra-articular injection of Hydrogel OA 2% for treating symptoms of knee osteoarthritis (KOA). The study focuses on adults aged 35 to 75 years who have symptomatic KOA confirmed by X-ray and experience pain in one knee. The investigation includes primary safety assessments up to 13 weeks after injection, with additional monitoring extending to 12 months, and explores clinical effectiveness during this period. Participants receive one injection of the investigational Hydrogel OA 2% device directly into the affected knee. This open-label, multi-center study does not involve a placebo or comparison group. Follow-up visits will occur to monitor safety outcomes and any device- or procedure-related serious adverse events. The study aims to gather information on both short-term and longer-term responses to the injection. During the study, participants will undergo functional assessments, pain evaluations, and radiological examinations, including X-rays taken before enrollment. Safety checks will include monitoring for adverse events related to the device or procedure. Participants must agree to avoid pain medications 48 hours before injection and comply with contraception requirements if applicable. Overall study participation may last up to 12 months, with regular assessments to measure knee function, pain levels, and safety.
CONDITIONS
Brief Title
Hydrogel Assessment for Local Treatment of Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 35 to 75 years who agree to participate and sign informed consent
- Unilateral symptomatic tibiofemoral knee osteoarthritis confirmed by a standing knee X-ray
- Body mass index (BMI) between 20 and 35
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain score between 25 and 70
- Experience pain in the affected knee during daily activities
- Kellgren and Lawrence grade II or III on radiological assessment of the affected knee
- Fully ambulatory and able to perform functional assessments
- Willing to avoid pain medication for 48 hours before the injection visit
- Female participants must use effective contraception or be surgically sterile or postmenopausal with a negative pregnancy test at treatment visit
You will not qualify if you...
- Bilateral tibiofemoral osteoarthritis where the non-affected knee has a worse condition than the affected knee
- Significant varus or valgus knee deformity greater than 10 degrees
- Extension deficit of the affected knee greater than 5 degrees
- Bilateral symptomatic tibiofemoral osteoarthritis or combined symptomatic knee and hip osteoarthritis on the same side
- Clinical signs of significant swelling, effusion, or inflammation causing severe pain
- Blood disorders, clotting issues, blood cancers, or active infections requiring hospitalization or intravenous antibiotics
- Skin or synovial infection or skin diseases at the injection site
- History of autoimmune diseases causing chronic joint pain and inflammation in the knee
- Known or suspected chronic generalized pain disorders
- Severe mobility impairments preventing functional assessment
- Allergy or hypersensitivity to components of Hydrogel OA 2%
- Other conditions causing pain in the lower limbs that might interfere with knee osteoarthritis pain assessment
- Symptomatic patellofemoral knee osteoarthritis
- Oral corticosteroid use in the last 3 months
- Regular or recent opioid use within 3 months or 7 days before injection
- Severe acute illness within 14 days before injection
- High Pain Catastrophizing Scale score (30 or higher)
- Recent intra-articular injections, surgery, or invasive procedures on the affected knee within 6 months
- Anticipated need for invasive knee procedures during the study
- Any significant medical condition posing risk or affecting study assessments
- Participation in another clinical trial within 3 months before injection
- Pregnancy or breastfeeding
- Legal incapacity or limited ability to consent
- Recent trauma to the affected knee within 6 months before injection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 13 weeks after injection
Participants receive a single injection of Hydrogel OA 2% as a local treatment for knee osteoarthritis.
1 injection visit and multiple follow-up visits over 13 weeks
Duration - Up to 12 months after injection
Participants are monitored for safety and tolerability of the Hydrogel OA 2% device up to 12 months after the injection.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 3 locations
1
AZ Sint Jan
Bruges, Belgium
Actively Recruiting
2
AZ Monica
Deurne, Belgium
Actively Recruiting
3
AZ Delta
Roeselare, Belgium
Actively Recruiting
Research Team
K
Kris Van den Cruys
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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