Status:
COMPLETED
Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis
Lead Sponsor:
Research Centre BIOFORM
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
50+ years
Brief 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 Osteo...
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. Th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- The study included patients with KL grade 2-3 knee osteoarthritis who had completed study IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020.
- Exclusion criteria:
- Declining participation in the survey Lost to follow-up
Exclusion
Key Trial Info
Start Date :
May 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 18 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06523491
Start Date
May 7 2022
End Date
May 18 2024
Last Update
September 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
Saint Petersburg, Russia
2
State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Yaroslavl, Russia