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

NCT ID: NCT03484091

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blind, placebo controlled RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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H group

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

Group Type EXPERIMENTAL

Hyruan-One

Intervention Type DRUG

single dose intra-articular injection

S group

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

Group Type ACTIVE_COMPARATOR

Hylan G-F 20

Intervention Type DRUG

single dose intra-articular injection

N group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

single dose intra-articular injection

Interventions

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Hyruan-One

single dose intra-articular injection

Intervention Type DRUG

Hylan G-F 20

single dose intra-articular injection

Intervention Type DRUG

Normal saline

single dose intra-articular injection

Intervention Type DRUG

Other Intervention Names

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Synvisc

Eligibility Criteria

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Inclusion Criteria

* Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months
* Gave informed consent
* Can do questionnaires

Exclusion Criteria

* Severe deformity (varus or valgus from a mechanical axis more than 10 degrees
* Allergy to hyaluronic acid
* Pain in the hip or ankle
* Post-traumatic or post surgery of lower extremity
* Post-infection of the knee
* Previous hyaluronic acid injection within 6 months
* Pregnancy or lactation
* Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Supakit Kanitnate

Department of orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nattapol Tammachote, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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OrthoTU09

Identifier Type: -

Identifier Source: org_study_id

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