Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429319
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2020-08-14
Brief Title:
Intra-articular Polyacrylamide Hydrogel in Gonarthrosis
Sponsor:
Research Centre BIOFORM
Organization:
Research Centre BIOFORM
Study Overview
Official Title:
Multicenter Open Post-registration Study of the Safety and Effectiveness of the Medical Device HBIS Endoprosthesis of Synovial Fluid NOLTREX According to TU 9398-00152820385-2015 for Intraarticular Administration in the Treatment of Gonarthrosis
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this open post-marketing study is to assess safety and efficacy duration of HBIS IA injection after 1st and 2nd course in patients with gonarthrosis with long-term follow-up
Detailed Description:
Hydrous biopolymer with silver ions further - HBIS under trademark NOLTREX based on polyacrylamide hydrogel is intended for a symptomatic effect leading to the decrease of joint pain intensity and improvement of functional joint characteristics Therefore HBIS is intended for symptom-modifying therapy of joint osteoarthritis hereinafter - OA The aim of this study is to estimate safety and efficacy of intra-articular injections of HBIS after 1st and 2nd course in patients with gonarthrosis with long-term follow-up Patients who received 1 сourse - 2 injections of NOLTREX in first 6-month study IAPAAG-SIOA2019 will receive a repeated course of treatment strictly according to indications The scheme of the 2nd Course is one or two 40 ml dosage injections of NOLTREX with 1-week interval on week 0 or week 13 of the study Outcomes will estimate by WOMAC Index at Week 13 and at Week 25
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None