Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis
NCT ID: NCT06523491
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
57 participants
OBSERVATIONAL
2022-05-07
2024-05-18
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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Group NOLTREX 2 courses
Group NOLTREX 2 courses consisted of 30 patients who had received 2 NOLTREX™ courses in the parent study (IA/PAAG-SI/OA/2019) and OLE (IA/PAAG-SI/OA/2020)
No interventions assigned to this group
Group NOLTREX 1 course
Group NOLTREX 1 course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019)
No interventions assigned to this group
Placebo group
Placebo group consisted of 10 patients who had received placebo in the parent study IA/PAAG-SI/OA/2019 and had not taken part in OLE. Of 72 patients approached, only 10 agreed to participate and completed the survey.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Research Centre BIOFORM
INDUSTRY
Responsible Party
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Principal Investigators
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Sergey M Noskov, Prof. PhD
Role: PRINCIPAL_INVESTIGATOR
State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Locations
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Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
Saint Petersburg, , Russia
State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Yaroslavl, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IA/PAAG-SI/OA/2021
Identifier Type: -
Identifier Source: org_study_id
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