Actively Recruiting
Hydrogel Assessment for Local Treatment of Osteoarthritis
Led by Allegro NV/SA · Updated on 2026-05-11
20
Participants Needed
3
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 can understand study instructions
- Unilateral symptomatic tibiofemoral knee osteoarthritis confirmed by 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
- Experiencing pain in the affected knee during daily activities
- Radiological Kellgren and Lawrence grade II or III in the affected knee from recent X-ray
- Fully ambulatory for functional assessments
- Willing to avoid pain medication for 48 hours before the injection
- Female participants must use effective contraception or be surgically sterile or postmenopausal for at least one year with a negative pregnancy test at treatment visit
You will not qualify if you...
- Bilateral tibiofemoral knee osteoarthritis where the other knee has worse radiological grade
- Significant varus or valgus deformity of the affected knee over 10 degrees
- Extension deficit of the affected knee greater than 5 degrees
- Bilateral symptomatic tibiofemoral knee osteoarthritis or combined symptomatic knee and hip osteoarthritis on the same side
- Significant swelling, inflammation, or effusion causing severe pain in the affected knee
- Active lymphatic or venous stasis, serious blood disorders, bleeding disorders, blood clots, or blood cancers
- Active bacterial infection requiring hospitalization or intravenous antibiotics
- Synovial or skin infection or skin diseases near the injection site
- Autoimmune diseases causing chronic joint pain and inflammation in the knee
- Known or suspected generalized chronic pain disorder
- Severe mobility impairment preventing functional assessments
- Allergy or hypersensitivity to Hydrogel OA 2% components
- Other orthopedic, rheumatologic, musculoskeletal, or inflammatory conditions causing pain in lower limbs that may interfere with knee pain assessment
- Symptomatic patellofemoral knee osteoarthritis
- Oral corticosteroid use within 3 months prior to injection
- Regular or chronic opioid use within 3 months or any opioid use within 7 days before injection
- Severe acute illness within 14 days before injection
- Pain Catastrophizing Scale score of 30 or higher
- Intra-articular injections, arthroscopy, surgery, cell-based therapy, or invasive procedures on the affected knee within 6 months before injection
- Expected need for surgical or invasive procedure on the knee during the study
- Any condition posing substantial risk or impacting study assessments as assessed by investigator
- Participation in another clinical trial within 3 months prior to injection
- Pregnancy or breastfeeding
- Legal incapacity or limited capacity to consent
- 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
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
CONTACT
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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