Intra-articular Polyacrylamide Hydrogel in Gonarthrosis

NCT06429319 | Completed Results

• 1 other identifier: IA/PAAG-SI/OA/2020
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 4

Brief Summary

The OLE was aimed to assess long-term safety and efficacy of one and two courses of IA HBISA in patients with knee osteoarthritis.

Conditions

Osteoarthritis

Keywords

intra-articular; polyacrylamide hydrogel; PAAG; HBISA (Hydrous biopolymer with silver ions "Argiform"); NOLTREX

Outcome Measures

Primary Outcomes (1)

• Change in the Total WOMAC Score (WOMAC-T)

  Mean change in WOMAC-T from baseline (visit 0 \[screening\] of OLE and visit 1 (week 1) of the parent study) to visit 3 (week 11) and visit 5 (week 23). Patients were asked to complete the questionnaire during the study visits. 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. The higher the score, the poorer the function. Therefore, an improvement was achieved by reducing the overall score.

  baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)

Secondary Outcomes (9)

• Change in the WOMAC Pain Score (WOMAC-A)

  baseline (OLE visit 0 and visit 1 study 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)

• Change in the WOMAC Stiffness (WOMAC-B) Score

  baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)

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

  baseline (OLE visit 0 and parent study visit 1 [week 1]), visits 3 (week 11) and 5 (week 23)

• Change in the 100-mm VAS Pain Score Visual Analogue Scale (100 mm VAS)

  baseline (OLE visit 0 and study 1 visit 1 [week 1]), OLE visits 3 (week 11) and 5 (week 23)

• Patient's Assessment of the Treatment Efficacy

  visits 3 (week 13) and 5 (week 25)

Study Arms (1)

Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™

OTHER

Sixty-five (65) patients were included in the study and divided into three groups based on the number of NOLTREX™ courses received: * Group A consisted of 5 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 1/2 of OLE (IA/PAAG-SI/OA/2020) study. * Group B comprised 43 patients who received 2 NOLTREX™ courses, the first course in the IA/PAAG-SI/OA/2019 study and the second one at Visits 3/4 of OLE. * Group C consisted of 17 patients who had received only 1 NOLTREX™ course in the parent study.

Device: Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™

Interventions

Hydrous biopolymer with silver ions "Argiform" (HBISA) endoprosthesis of synovial fluid NOLTREX™ DEVICE

If clinically indicated patients received a repeat course of NOLTREX™ (one or two weekly intra-articular injections of 4.0 NOLTREX™ at the investigator's discretion depending on the stage of OA and clinical response to treatment).

Also known as: Polyacrylamide hydrogel with silver ions

Medical Device: HBISA (polyacrylamide hydrogel) synovial fluid endoprosthesis NOLTREX™

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 50 years of age;
• Provision of signed informed consent form;
• Patients met ACR classification criteria for knee osteoarthritis (pain in the knee and at least three of the following: age \>50 years, stiffness \<30 min, crepitus, bony tenderness, bony enlargement and no palpable warmth);
• OA grades 2 and 3 on the Kellgren-Lawrence scale with the predominant involvement of the medial tibiofemoral region of the knee joint;
• Patients from the NOLTREX™ group of the parent study (IA/PAAG-SI/OA/2019) who completed all (5) study visits

You may not qualify if:

• Pregnancy and breastfeeding;
• History of trauma or surgery on the target knee joint;
• Instability of the target knee joint;
• Microcrystalline arthropathies (according to the history and taking into account clinical manifestations);
• History of systemic inflammatory diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Seronegative spondyloarthritis and reactive arthritis;
• Increased rheumatoid factor;
• Increased uric acid \> 360 µmol/l;
• Intra-articular injection into the target knee joint:
• hyaluronates - within 12 months prior to patient enrollment in the study;
• other synovial fluid endoprostheses (except for NOLTREX™ in the IA/PAAG- SI/OA/2019 study) within 24 months;
• glucocorticoids - within 1 month before enrollment in the study;
• NSAIDs - intra-articular injection at any time in the history.
• Systemic pain medications (NSAIDs, opioid analgesics) within 1 week prior to Visit 0;
• Effusion in the target joint;

Sponsors & Collaborators

• Research Centre BIOFORM: lead

Study Sites (4)

Non-budgetary healthcare facility "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"

Moscow, Russia

Location

"Clinical Diagnostic Center "Ultramed", LLC

Omsk, Russia

Location

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

Saint Petersburg, Russia

Location

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

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Julia Melentyeva Commercial Director
• Organization: RCBIOFORM

md@bioform.ru

84952237095

Study Officials

• Vladimir V Popov, DSc

  Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was an open-label extension (OLE) of the IA/PAAG-SI/OA/2019 study designed to evaluate the long-term safety and efficacy of MD NOLTREX™ in patients with knee osteoarthritis (OA). The study was expected to enroll 72 patients who had completed the parent study. Actually 67 patients rolled over into the OLE, 2 of them were classified as screen failures and 65 were enrolled into the trial.

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: May 24, 2024
• Study Start: May 28, 2020
• Primary Completion: December 28, 2020
• Study Completion: May 12, 2021
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2024-11

Locations

RU (4)