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

LG Chem

Status: Completed

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Device: Hyruan ONE®; Device: Durolane®

Study type: Interventional

Funder types: Industry

Identifiers

NCT04732793

LG-HACL026

Details and patient eligibility

About

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

Enrollment: 284 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥40 years old.
2. 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.
3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.

Exclusion criteria

1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
2. Subject has a documented history of hypersensitivity to HA.
3. Subject has a documented infection or severe inflammation of the target knee joint.
4. Subject has a skin disease in the area of the injection site.
5. 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).
6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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284 participants in 2 patient groups

Hyruan ONE®

Experimental group

Treatment:

Device: Hyruan ONE®

Durolane®

Active Comparator group

Treatment:

Device: Durolane®