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Osteoarthritis, KneeNCT06523491

Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

An observational study of Osteoarthritis, Knee, run by Research Centre BIOFORM at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Osteoarthritis, Knee
How many people
57 participants
Where
2 sitesRussia
Study dates
7 May 2022to 18 May 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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%)

Who may be able to join

  • 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.

Who cannot join

  • Declining participation in the survey Lost to follow-up

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • Private Healthcare Facilty "Clinical hospital "RZHD-Medicina" of the city Saint-Petersburg

    Saint Petersburg

  • State budgetary healthcare facility of Yaroslavl Region "Clinical hospital №3"

    Yaroslavl

Other trials in Russia

About this study

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

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.

Read the 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).

Keywords
IA PAAG HBISA Hydrous biopolymer with silver ions "Argiform"
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06523491
Study groupRoleWhat they receive
Group NOLTREX 2 coursesGroup 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)
Group NOLTREX 1 courseGroup NOLTREX 1 course comprised 17 patients who received 1 NOLTREX™ course in the parent study (IA/PAAG-SI/OA/2019)
Placebo groupPlacebo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 (4)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start7 May 2022
  3. Primary completion18 May 2024
  4. Study completion18 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06523491
Sponsor's protocol ID
IA/PAAG-SI/OA/2021
Status last verified
Sep 2025
First submitted
13 Jun 2024
Last updated
17 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Knee, run by Research Centre BIOFORM at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Total WOMAC Score (WOMAC-T) (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06523491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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