Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

Status Active, not recruiting

Clinical Trial Summary

The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular polyacrylamide hydrogel with ions of silver in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis

Clinical Trial Description

Polyacrylamide hydrogel (hereinafter - PAHG) is intended for a symptomatic effect leading to the decrease of joint pain intensity and improvement of functional joint characteristics. Therefore PAHG is intended for symptom-modifying therapy of joint osteoarthritis (hereinafter - OA). The aim of this study is to estimate efficacy and safety of intra-articular injections of PAHG in comparison with saline solution. Men and women above 50 years with verified knee osteoarthritis in accordance with the ACR criteria will be randomized 2 groups depends on treatment (PAHG or saline solution). Each patient will receive to the target knee joint 4.0 ml for one injection either PAHG or placebo with one-week interval between injections. Course - 2 injections. To avoid the joint overfilling with the dense, slowly resorbing material, with a good clinical result, the course of injections will be stopped. Primary and secondary efficacy endpoints, and safety parameters will be assessed on visits on Week 6, 13 and 25. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03897686
Study type	Interventional
Source	Research Centre BIOFORM
Contact
Status	Active, not recruiting
Phase	N/A
Start date	November 29, 2019
Completion date	December 2020

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