Intra-articular Polyacrylamide Hydrogel in the Treatment of Gonarthrosis
NCT Number: NCT06523491
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Gonarthrosis|Intra-articular|Polyacrylamide Hydrogel
Sponsor: Research Centre BIOFORM
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-12
Completion Date: 2024-05-16
Locations: Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg, Saint Petersburg, Russian Federation|State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3", Yaroslavl, Russian Federation

Summary:
The aim of this observational study is to evaluate the long-term safety and efficacy of a single or repeated course of use of the medical device (MD) NOLTREX™ with intra-articular administration in the treatment of gonarthrosis II-III radiographic stage according to Kellgren-Lawrence

Primary Outcome Measures: Change of the total WOMAC score (WOMAC-T), The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints., 12 months after completion of IA/PAAG-SI/OA/2020 study compared with the baseline at (screening) of the IA/PAAG-SI/OA/2020 study, compared with baseline Vi1 (week 1) of the IA/PAAG-SI/OA/2019 study and last value at V 5 (week 23) of IA/PAAG-SI/OA/2020
Secondary Outcome Measures: Change in the Pain subscale score (WOMAC-A), The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.12 months after completion of IA/PAAG-SI/OA/2020 study compared with the baseline at (screening) of the IA/PAAG-SI/OA/2020 study, compared with baseline Vi1 (week 1) of the IA/PAAG-SI/OA/2019 study and last value at V 5 (week 23) of IA/PAAG-SI/OA/2020, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Change in Stiffness subscale score (WOMAC-B), The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.12 months after completion of IA/PAAG-SI/OA/2020 study compared with the baseline at (screening) of the IA/PAAG-SI/OA/2020 study, compared with baseline Vi1 (week 1) of the IA/PAAG-SI/OA/2019 study and last value at V 5 (week 23) of IA/PAAG-SI/OA/2020, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Change in Functionality subscale score (WOMAC-C), The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.12 months after completion of IA/PAAG-SI/OA/2020 study compared with the baseline at (screening) of the IA/PAAG-SI/OA/2020 study, compared with baseline Vi1 (week 1) of the IA/PAAG-SI/OA/2019 study and last value at V 5 (week 23) of IA/PAAG-SI/OA/2020, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Change in pain severity in the target knee according to 100-mm VAS, Visual Analogue Scale (VAS) 100-mm12 months after completion of IA/PAAG-SI/OA/2020 study compared with the baseline at (screening) of the IA/PAAG-SI/OA/2020 study, compared with baseline Vi1 (week 1) of the IA/PAAG-SI/OA/2019 study and last value at V 5 (week 23) of IA/PAAG-SI/OA/2020, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Dynamics of change in the score on the WOMAC scale and subscales during study visits, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.Dynamics of change in the score by study visits V1 IA/PAAG-SI/OA/2019, IA/PAAG-SI/OA/2020 by study visits V0, V3, V5 and IA/PAAG-SI/OA/2023, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Dynamics of change in the score on the WOMAC scale and subscales by study visits, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.Dynamics of change in the score by study visits V1 IA/PAAG-SI/OA/2019, IA/PAAG-SI/OA/2020 by study visits V0, V3, V5 and IA/PAAG-SI/OA/2023, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Dynamics of change in the severity of pain in the target knee joint according to the 100-mm VAS, Visual Analogue Scale (VAS) 100-mmDynamics of change in the score by study visits V1 IA/PAAG-SI/OA/2019, IA/PAAG-SI/OA/2020 by study visits V0, V3, V5 and IA/PAAG-SI/OA/2023, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Need for MD NOLTREX™ administration outside the clinical trials., Number of tablets, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Types of alternative treatment with indication of the therapy regimen, Other kinds of therapy, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020|Reasons for refusal to continue the course of MI NOLTREX™ administration, Kinds of reasons, 2 years from the study IA/PAAG-SI/OA/2019 and 1 year from the study IA/PAAG-SI/OA/2020