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Study on Knee Osteoarthritis — PILHAC  

Knee Osteoarthritis Clinical Trial

Official title:
A Prospective, Multicenter Clinical Investigation Evaluating the Safety of ABIO3419 in Treating Knee Osteoarthritis: Pilot Study

Clinical Trial 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.

Clinical Trial Description

The study is a pilot, prospective, multicenter, clinical trial that aims to evaluate the safety and efficacy of ABIO3419 for the treatment of knee osteoarthrosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06097988
Study type Interventional
Source Symatese
Contact Carla LIPPENS
Phone (0)6 72 94 76 13
Email carla.lippens@complifegoup.com
Status Recruiting
Phase N/A
Start date January 18, 2024
Completion date August 8, 2024
View Details
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