NCT03897686

Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

Multicenter Double-blind Randomized Comparative Placebo-controlled Study of Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid (NOLTREX™) in Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Research Centre BIOFORM · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Polyacrylamide hydrogel (hereinafter - PAAG) is intended for a symptomatic effect leading to decrease of joint pain intensity and improvement of functional joint characteristics. Therefore PAAG is regarded as symptom-modifying therapy for joint osteoarthritis (hereinafter - OA). The aim of this study was to estimate efficacy and safety of intra-articular injections of PAAG in comparison with saline solution. Men and women above 50 years with verified knee osteoarthritis in accordance with the American College of Rheumatology (ACR) criteria were randomly assigned to one of 2 groups (PAAG or saline solution). Each patient received to the target knee joint one injection of 4.0 ml either PAAG or placebo with one-week interval. Course - 2 injections. To avoid the joint overfilling with the dense, slowly resorbing material in patients with a good clinical result, the course of injections was to be stopped. Primary and secondary efficacy endpoints, and safety parameters were assessed at weeks 6, 13 and 25 visits .

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	hydrous biopolymer with silver ions "Argiform"	2 once-weekly intra-articular injections of NOLTREX™ 4.0 ml
DEVICE	saline solution	2 once-weekly intra-articular injections of saline solution 4 ml

Timeline

• Start date: 2019-11-29
• Primary completion: 2020-06-02
• Completion: 2020-12-17
• First posted: 2019-04-01
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

4 sites across 1 country: Russia