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Intra-articular Polyacrylamide Hydrogel in Knee Osteoarthritis

NCT03897686 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-01-30

Study results available
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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

Interventions

DEVICE

hydrous biopolymer with silver ions "Argiform"

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

DEVICE

saline solution

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

Sponsors & Collaborators

  • Research Centre BIOFORM

    lead INDUSTRY

Principal Investigators

  • Vladimir V Popov, DSc · Non-budgetary HCF "Railway clinical hospital n.a. Semashko N.A. at Lublino, OJSC "Russian Railways"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2020-06-02
Completion
2020-12-17

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897686 on ClinicalTrials.gov