NCT06611098

New Treatment of Knee Osteoarthritis

A Randomized, Controlled, Prospective and Multicenter Clinical Investigation Evaluating the Safety and Performance of ABIO3419 in Treating Knee Osteoarthritis.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Symatese · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint marginal osteophyte formation and synovitis. It is also characterized by a decrease of the concentration and molecular weight of the hyaluronic acid in the synovial fluid which ultimately leads to poor viscoelastic properties of synovial fluid and induction of proinflammatory pathways. The intra-articular injection of viscosupplementation gel (mainly exogenous hyaluronic acid) represents one of the most used therapeutic strategies to treat osteoarthritis symptoms. Several studies on knee Osteoarthritis, have shown that one or more weekly injection of viscosupplementation gel significantly relieves articular pain and ameliorates mobility and joint function for at least 6 months and more. Repeated courses of intra-articular injections are an effective and safe treatment for knee osteoarthritis symptoms. Based on studies conducted on intra-articular viscosupplementation gels, the most common side effects expected are local transient and short-lived adverse events such as pain, swelling and arthralgia in the site of administration, which are fully reversible in the days following the injection. Furthermore, such local effects may occur in a minority of cases and are usually treated conservatively with ice, non-steroidal anti-inflammatory drugs, and relative rest.

Detailed description

Pivotal clinical investigation, interventional, prospective, comparative, single-blinded, controlled with two arms, randomized, multicentre clinical trial designed to assess the performance and safety of ABIO3419 for the treatment of osteoarthritis of the knee.

Conditions

• Knee Osteoarthristis

Interventions

Type	Name	Description
DEVICE	Viscosupplements	intra-articular injection

Timeline

• Start date: 2025-02-21
• Primary completion: 2025-09-01
• Completion: 2026-03-01
• First posted: 2024-09-24
• Last updated: 2025-02-26

Locations

2 sites across 2 countries: Georgia, Latvia