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

NCT04732793 | Completed

• 1 other identifier: LG-HACL026
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee

Outcome Measures

Primary Outcomes (1)

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

  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.

  from Baseline to 13 weeks post injection.

Study Arms (2)

Hyruan ONE®

EXPERIMENTAL

Device: Hyruan ONE®

Durolane®

ACTIVE COMPARATOR

Device: Durolane®

Interventions

Hyruan ONE® DEVICE

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

Hyruan ONE®

Durolane® DEVICE

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

Durolane®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: February 1, 2021
• Study Start: February 3, 2021
• Primary Completion: June 11, 2021
• Study Completion: December 7, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

PL (1)