Knee OsteoArthritis Long-term Assessment

NANot yet recruitingINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Knee Osteoarthritis (Knee OA)
Interventions
DEVICE

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).

DEVICE

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.

Trial Locations (5)

Unknown

More Institute, Antwerp

AZ Sint Jan Brugge, Bruges

UZ Antwerpen, Edegem

CHU Liège, Liège

AZ DELTA, Roeselare

All Listed Sponsors
collaborator

QbD Clinical

INDUSTRY

lead

Allegro NV/SA

INDUSTRY