NCT06839222

Knee OsteoArthritis Long-term Assessment

Randomized Controlled Single-Blind Multi-Centre Evaluation of the Safety and Performance of an Injection of Hydrogel OA 2% in Subjects With Knee Osteoarthritis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allegro NV/SA · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is: \- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)? All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.

Conditions

• Knee Osteoarthritis (Knee OA)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-02-21
• Last updated: 2026-04-13

Locations

5 sites across 1 country: Belgium