Clinical trial NCT06523491: Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis
Official title: Survey Data Analysis to Assess the Long-term Efficacy and Safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: IA PAAG HBISA Hydrous biopolymer with silver ions "Argiform"
Lead sponsor: Research Centre BIOFORM
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 57 patients divided into 3 subgroups based on treatment received:

* Group NOLTREX™ 2 courses - 30 patients (52.63%)
* Group NOLTREX™ 1 course - 17 patients (29.82%)
* Placebo group - 10 patients (17.54%)

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Total WOMAC Score (WOMAC-T)
timeFrame: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)
Secondary outcomes:
measure: Change in the WOMAC Pain Score (WOMAC-A)
timeFrame: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)
measure: Change in the WOMAC Stiffness (WOMAC-B) Score
timeFrame: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)
measure: Change in the WOMAC Physical Function (WOMAC-C) Score
timeFrame: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)
measure: Change in the 100-mm VAS Pain Score
timeFrame: From Visit 1 Study 1 (Baseline), OLE Visit 0 (6 months post Baseline Visit 1 Study 1; coincided with Visit 5 in Study 1), OLE Visit 5 (12 months post Baseline Visit 1 Study 1) to the EOF (up to 24 months post Baseline Visit 1 Study 1)
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg
city: Yaroslavl
country: Russian Federation
facility: State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
Study officials:
affiliation: State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"
name: Sergey M Noskov, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References: