226
Participants
Start Date
June 30, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
Hydrogel OA 2%
Hydrogel OA 2% is a sterile, nonpyrogenic viscoelastic hydrogel suspension, designed using highly purified biopolymers in a phosphate-buffered saline solution. The main component is a cross-linked protein (ultra-pure bovine gelatin). The other main component is a polysaccharide cellulose nanocrystal (CNC) that acts as the crosslinker. Hydrogel OA 2% is supplied in pre-filled 2.25ml Luer lock syringe. Each package contains one syringe containing 2.0 mL Hydrogel OA 2%. Hydrogel OA 2% is designed to provide symptomatic relief by restoring joint lubrication and cushioning, potentially leading to reduced pain and improved joint function. The device is suitable for use in early and moderate OA (Kellgren and Lawrence, K\&L, II-III).
Hyaluronic Acid (Durolane)
DUROLANE contains 20 mg/mL of stabilized non-animal hyaluronic acid in buffered physiological sodium chloride solution pH 7. DUROLANE is a sterile, transparent viscoelastic gel supplied in a 3 mL glass syringe.
More Institute, Antwerp
AZ Sint Jan Brugge, Bruges
UZ Antwerpen, Edegem
CHU Liège, Liège
AZ DELTA, Roeselare
QbD Clinical
INDUSTRY
Allegro NV/SA
INDUSTRY