Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

Research Centre BIOFORM57 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis, Knee

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

Change in the Total WOMAC Score (WOMAC-T)

Mean change in the total WOMAC score from visit 1 of the parent study (baseline), visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF) up to 24 months post Baseline Visit 1 Study 1. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100-mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-500 for Pain, 0-200 for Stiffness, and 0-1700 for Physical Function. Higher scores represent worse pain, stiffness, and functional limitations. A sum of the scores for all three subscales gives a total WOMAC score (0-2400), where 0 represents the best and 2400 the worst possible health status.

Time frame: 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

Change in the WOMAC Pain Score (WOMAC-A)

Mean change in WOMAC-A from baseline (visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate pain, stiffness and physical functioning of the joints in patients with knee and/or hip osteoarthritis. The WOMAC Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS. The WOMAC pain scale consists of five items: (1) walking on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. The scores for the Pain subscale are summed up, with a possible score range of 0-500. Higher scores represent worse pain.

Data from ClinicalTrials.gov

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Change in the WOMAC Stiffness (WOMAC-B) Score

Mean change in WOMAC-B from baseline (visit 1 \[week 1\] of the parent study IA/PAAG-SI/OA/2019, visits 0 \[screening\] and 5 \[week 23\] of OLE IA/PAAG-SI/OA/2020) to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-200 for Stiffness. Higher scores represent worse stiffness.

Change in the WOMAC Physical Function (WOMAC-C) Score

Mean change in WOMAC-C from the baseline visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF). Patients were asked to complete the questionnaire during the study visit. The Western Ontario and McMaster Universities Osteoarthritis Index Version 3.1 Visual Analog Scale Format (WOMAC VA 3.1) applies a 100 mm VAS and consists of three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). The scores for each subscale are summed up, with a possible score range of 0-1700 for Physical Function. Higher scores represent worse functional limitations. The higher the score, the poorer the function.

Change in the 100-mm VAS Pain Score

Mean change in the VAS pain score from the baseline visit 1 \[week 1\] of the parent study, visits 0 \[screening\] and 5 \[week 23\] of OLE to the end of 12-month follow-up (EOF). The visual analog scale (VAS) is one of the most commonly used measures of pain intensity. The pain VAS was self-completed by the respondent. The respondent was asked to place the slider perpendicular to the VAS line at the point that represents their pain intensity. The score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.