Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis

Thammasat University

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Normal saline; Drug: Hylan G-F 20; Drug: Hyruan-One

Study type: Interventional

Funder types: Other

Identifiers

NCT03484091

OrthoTU09

Details and patient eligibility

About

We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.

Enrollment: 276 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic primary knee osteoarthritis with failed conservative treatment at least 3 months
• Kellgren-Lawrence grade I-III
• Gave informed consent
• Can do questionnaires

Exclusion criteria

• Severe deformity (varus or values from mechanical axis more than 5 degrees
• Allergy to hyaluronic acid
• Pain on hip or ankle
• Post-traumatic or post surgery of lower extremity
• Post infection of knee
• Previous hyaluronic acid injection within 6 months
• Pregnancy or lactation
• Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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276 participants in 3 patient groups, including a placebo group

H group

Experimental group

Description:

Single dose of Hyruan-One 3 mL intra-articular knee injection.

Treatment:

Drug: Hyruan-One

S group

Active Comparator group

Description:

Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.

Treatment:

Drug: Hylan G-F 20

N group

Placebo Comparator group

Description:

Single dose of normal saline 6 mL intra-articular knee injection.

Treatment:

Drug: Normal saline