Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611098
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Study on Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Prospective and Multicenter Clinical Investigation Evaluating the Safety and Performance of ABIO3419 in Treating Knee Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIVHAC
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None