NCT06523491

Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

Survey Data Analysis to Assess the Long-term Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Research Centre BIOFORM · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

1-year follow-up of a randomized controlled trial with open-label extension to assess the long-term efficacy and safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis.

Detailed description

HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility. The aim of this 1-year follow-up was to evaluate the long-term safety and efficacy of IA Polyacrylamide hydrogel with silver ions in patients with Kellgren-Lawrence grade 3 and 4 knee osteoarthritis who had received one or two treatment courses in the IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020 studies. Follow-up data were collected in telephone interviewing (using questionnaire) in April-July 2022, 12 months after the completion of OLE (IA/PAAG-SI/OA/2020).

Conditions

• Osteoarthritis, Knee

Timeline

• Start date: 2022-05-07
• Primary completion: 2024-05-18
• Completion: 2024-05-18
• First posted: 2024-07-26
• Last updated: 2025-09-17
• Results posted: 2025-02-19

Locations

2 sites across 1 country: Russia