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OpenTrials
Completed

NCT Number: NCT03484091

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyruan-One

Drug

single dose intra-articular injection

Hylan G-F 20

Drug

single dose intra-articular injection

Other names: Synvisc

normal saline

Drug

single dose intra-articular injection

Primary outcomes

  1. Pain level

    Time frame: 6 months after injection

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

  2. 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

Secondary outcomes

  1. 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)

  2. Modified WOMAC

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

    measure modified WOMAC score (0-96)

  3. Lequesne index

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

    measure Lequesne index for knee osteoarthritis (4-24)

  4. SF-36

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

    measure short from health survey 36 items

  5. Time up and go test

    Time frame: post-injection 1, 3, 6 months

    recorded time Up and Go test (minutes)

  6. Complications

    Time frame: post-injection 1, 2 weeks

    assess complications after injection by phone

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2018
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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