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

September 16, 2025 updated by: Supakit Kanitnate, Thammasat University

Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Changwat Pathum Thani
      • Khlong Luang, Changwat Pathum Thani, Thailand, 12120
        • Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H group
Single dose of Hyruan-One 3 mL intra-articular knee injection.
Drug: Hyruan-One
single dose intra-articular injection
Active Comparator: S group
Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.
Drug: Hylan G-F 20
single dose intra-articular injection
Other Names:
  • Synvisc
Placebo Comparator: N group
Single dose of normal saline 6 mL intra-articular knee injection.
Drug: Normal saline
single dose intra-articular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 6 months after injection
visual analog scale for pain (0-100) in between groups
6 months after injection
Change from pre-injection pain level at 6 months
Time Frame: 6 months
compare visual analog scale for pain (0-100) between pre-injection and post-injection
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain level in any time pints
Time Frame: post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
visual analog scale for pain (0-100)
post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
Modified WOMAC
Time Frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure modified WOMAC score (0-96)
post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Lequesne index
Time Frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure Lequesne index for knee osteoarthritis (4-24)
post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
SF-36
Time Frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure short from health survey 36 items
post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Time up and go test
Time Frame: post-injection 1, 3, 6 months
recorded time Up and Go test (minutes)
post-injection 1, 3, 6 months
Complications
Time Frame: post-injection 1, 2 weeks
assess complications after injection by phone
post-injection 1, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Nattapol Tammachote, MD, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

June 27, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 24, 2018

First Submitted That Met QC Criteria

March 24, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Estimated)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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