To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is ≥40 years old.
Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.

Exclusion criteria

Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
Subject has a documented history of hypersensitivity to HA.
Subject has a documented infection or severe inflammation of the target knee joint.
Subject has a skin disease in the area of the injection site.
Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.

Treatment and study plan

Hyruan ONE®

Device

For use as a symptomatic treatment of osteoarthritis (OA) of the knee

Durolane®

Device

For use as a symptomatic treatment of osteoarthritis (OA) of the knee

Primary outcomes

The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore

Time frame: from Baseline to 13 weeks post injection.

The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question).

Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows:

Pain = 0-20 Stiffness = 0-8 Physical function = 0-68.

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Prospective, Active Controlled, Randomised, Parallel Group, Double Blind, Multicentre Study to Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 1, 2021
Registry last updated: Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed