NCT03484091

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 22, 2025

Status Verified

March 1, 2018

Enrollment Period

5.2 years

First QC Date

February 24, 2018

Last Update Submit

September 16, 2025

Conditions

Knee Osteoarthritis

Keywords

Hyruan-OneHylan G-F 20Hyaluronic acidKnee osteoarthritisPain level

Outcome Measures

Primary Outcomes (2)

  • Pain level

    visual analog scale for pain (0-100) in between groups

    6 months after injection

  • Change from pre-injection pain level at 6 months

    compare visual analog scale for pain (0-100) between pre-injection and post-injection

    6 months

Secondary Outcomes (6)

  • pain level in any time pints

    post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks

  • Modified WOMAC

    post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

  • Lequesne index

    post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

  • SF-36

    post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

  • Time up and go test

    post-injection 1, 3, 6 months

  • +1 more secondary outcomes

Study Arms (3)

H group

EXPERIMENTAL

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

Drug: Hyruan-One

S group

ACTIVE COMPARATOR

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

Drug: Hylan G-F 20

N group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Hyruan-OneDRUG

single dose intra-articular injection

H group
Hylan G-F 20DRUG

single dose intra-articular injection

Also known as: Synvisc
S group
Normal salineDRUG

single dose intra-articular injection

N group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

hylanSaline Solution

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Nattapol Tammachote, MD

    Thammasat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A double-blind, placebo controlled RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of orthopaedics

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 30, 2018

Study Start

April 1, 2018

Primary Completion

June 27, 2023

Study Completion

December 31, 2023

Last Updated

September 22, 2025

Record last verified: 2018-03

Locations

TH(1)