Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652893
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Efficacy and Safety of SinovialHL Single Injection in the Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real-world Efficacy and Safety of SinovialHL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis an Observational Study
Status:
COMPLETED
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:
None
Brief Summary:
The prevalence of knee osteoarthritis OA is rising worldwide leading to disability and a reduced quality of life particularly in elderly patients While there are several treatment options there is little consensus in the scientific community over which methods are most effective Viscosupplementation with hyaluronic acid HA has been found to reduce pain in patients with knee OA over a period of up to 6 months with little to no side effects The aim of this prospective open-label uncontrolled observational single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice
Fifty patients who met the inclusion criteria participated in the study A single intra-articular ultrasound-guided injection of hybrid HA Sinovial was administered Patients submitted Visual Analog Scale VAS and Western Ontario and McMaster Universities Arthritis Index WOMAC questionnaires at 28- 42- 84- and 168-days post-treatment
Fifty patients who met the inclusion criteria participated in the study A single intra-articular ultrasound-guided injection of hybrid HA Sinovial was administered Patients submitted Visual Analog Scale VAS and Western Ontario and McMaster Universities Arthritis Index WOMAC questionnaires at 28- 42- 84- and 168-days post-treatment
Detailed Description:
None
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