Intra-articular Polyacrylamide Hydrogel in Gonarthrosis

Status Completed

Clinical Trial 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

Clinical Trial 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 IA/PAAG-SI/OA/2019, will receive a repeated course of treatment strictly according to indications. The scheme of the 2nd Course is one or two 4.0 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06429319
Study type	Interventional
Source	Research Centre BIOFORM
Contact
Status	Completed
Phase	N/A
Start date	May 28, 2020
Completion date	February 20, 2024

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