Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523491
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-13
Brief Title:
Intra-articular Polyacrylamide Hydrogel in the Treatment of Gonarthrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analysis of the Results of a Survey for the Purpose of Long-term Assessment of the Safety and Effectiveness of the Medical Device NOLTREX When Administered Intra-articularly in the Treatment of Gonarthrosis
Status:
COMPLETED
Status Verified Date:
2024-05
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 aim of this observational study is to evaluate the long-term safety and efficacy of a single or repeated course of use of the medical device MD NOLTREX with intra-articular administration in the treatment of gonarthrosis II-III radiographic stage according to Kellgren-Lawrence
Detailed Description:
Polyacrylamide hydrogel hereinafter - PAAG is intended for a symptomatic effect leading to the decrease of joint pain intensity and improvement of functional joint characteristics Therefore PAAG is intended for symptom-modifying therapy of joint for intra-articular administration in the treatment of gonarthrosis II-III radiological stage according to Kellgren-Lawrence The aim of this observational study is to evaluate the long-term safety and efficacy of a single or repeated course of use of the medical device MD NOLTREX with intra-articular administration in the treatment of gonarthrosis II-III radiographic stage according to Kellgren-Lawrence The design of the study is a prospective and retrospective non-interventional open-label study to evaluate the long-term efficacy and safety of the medical device NOLTREX in the context of the IAPAAG-SIOA2019 and IAPAAG-SIOA2020 studies in patients with Kellgren-Lawrence stage II-III gonarthrosis This study was an open-label non-interventional study involving patients with gonarthrosis who received a course of injections of MD NOLTREX in the context of the IAPAAG-SIOA2019 and IAPAAG-SIOA2020 studies The study was prospective and retrospective in cause of the data were collected during a telephone interviewquestionnaire with patients conducted in April-July 2022 12 months after the completion of IAPAAG-SIOA2020 study and retrospective data included results from Visit 1 week 1 of the IAPAAG-SIOA2019 study visit 0 screening and Visit 5 week 23 of the IAPAAG-SIOA2020 study
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