Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

NCT03897686 | Completed Results

• 1 other identifier: IA/PAAG-SI/OA/2019
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this double-blinded controlled study is to assess clinical efficacy and safety of intra-articular HBISA Endoprosthesis of Synovial Fluid (polyacrylamide hydrogel) in comparison with placebo (0.9% sodium chloride solution) in Kellgren Lawrence radiological grade II-III knee osteoarthritis

Conditions

Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Mean change from baseline (week 1) to visit 5 (Week 25) in the total WOMAC score. Patients were asked to complete the questionnaire during the study visit 5. 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 health status and 2400 the worst possible status. The higher the score, the poorer the function.

  baseline (week 1), week 25

Secondary Outcomes (9)

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

  baseline (week 1), week 13 (visit 4)

• The Pain Subscale Score WOMAC-A Changes

  baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5)

• The Stiffness (WOMAC-B) and Functionality (WOMAC-C) Subscale Scores Changes

  baseline (week 1), week 6 (visit 3), 13 (visit 4) and 25 (visit 5)

• Patient Assessment of Treatment Efficacy

  Week 6, Week 13 and Week 25

• Investigator Assessment of Treatment Efficacy

  Week 6, Week 13 and Week 25

Study Arms (2)

NOLTREX™, OA grade II-III

EXPERIMENTAL

72 patients with gonarthrosis grade II-III were randomised to receive PAHG

Device: hydrous biopolymer with silver ions "Argiform"

Placebo,OA grade II-III

PLACEBO COMPARATOR

72 patients with gonarthrosis grade II-III were randomised to receive saline solution

Device: saline solution

Interventions

hydrous biopolymer with silver ions "Argiform" DEVICE

2 once-weekly intra-articular injections of NOLTREX™ 4.0 ml

Also known as: polyacrylamide hydrogel with silver ions, Synovial fluid endoprosthesis NOLTREX™

NOLTREX™, OA grade II-III

saline solution DEVICE

2 once-weekly intra-articular injections of saline solution 4 ml

Placebo,OA grade II-III

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 above 50 years;
• Verified knee osteoarthritis in accordance with the ACR (knee pain combined with one of the following signs: age above 50 years, knee crepitus or morning joint stiffness lasting for less than 30 minutes combined with radiologic signs of knee osteoarthritis);
• Kellgren Lawrence radiological grade II-III knee osteoarthritis with the predominant involvement of the medial tibiofemoral region of the knee joint;
• Joint space width (JSW) of the target knee joint at least 2.5 mm.

You may not qualify if:

• History of any injury or surgical intervention on the target knee joint (except for diagnostic arthroscopy made not longer than 60 days at the study entry);
• Severe degenerative changes in the target knee joint determined as the joint space narrowing less than 2 mm;
• Varus or valgus deformation of the target knee joint;
• Instability of the target knee joint;
• Active inflammation of the target knee joint (edema, hyperemia, present effusion) at the study entry;
• Microcrystalline arthropathies;
• Systemic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Seronegative spondyloarthritis and reactive arthritis;
• Inflammatory diseases of the skin and soft tissues in the proposed injection site for the test MD or placebo in the target joint;
• History of venous thrombosis and thromboembolia;
• Coagulogram abnormalities (APTT, prothrombin time, prothrombin index, fibrinogen);
• Inflammatory changes in the complete blood count (leukocytosis, increase of erythrocyte sedimentation rate \[ESR\]);
• Platelet count abnormality (in accordance with the reference ranges of the local laboratory;
• Increase of rheumatoid factor level;
• Increase of uric acid level \> 360 μmol/l;

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

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Julia Melentyeva Commercial Director
• Organization: RCBIOFORM

md@bioform.ru

+7 (495) 223-70-95

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A patient, study investigator and Sponsor representative (monitoring specialist) will not know to which group a patient is included. to preserve blinding of any patient and study team, an independent unblended physician is to be engaged, he/she will receive the product per randomization code and perform the procedure of intra-articular injection of the study MD and placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter double-blind randomized comparative placebo-controlled

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: November 29, 2019
• Primary Completion: June 2, 2020
• Study Completion: December 17, 2020
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)