Trials / Completed
CompletedNCT06097988
Study on Knee Osteoarthritis
A Prospective, Multicenter Clinical Investigation Evaluating the Safety of ABIO3419 in Treating Knee Osteoarthritis: Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- 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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ABIO3419 | Intra-articular injection |
Timeline
- Start date
- 2024-02-02
- Primary completion
- 2024-06-19
- Completion
- 2024-09-16
- First posted
- 2023-10-24
- Last updated
- 2024-11-19
Locations
2 sites across 1 country: Latvia
Source: ClinicalTrials.gov record NCT06097988. Inclusion in this directory is not an endorsement.