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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03484091
Recruitment Status : Unknown
Verified March 2018 by Supakit Kanitnate, Thammasat University.
Recruitment status was:  Recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Information provided by (Responsible Party):
Supakit Kanitnate, Thammasat University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Hyruan-One Drug: Hylan G-F 20 Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A double-blind, placebo controlled RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: Synvisc

Placebo Comparator: N group
Single dose of normal saline 6 mL intra-articular knee injection.
Drug: Normal saline
single dose intra-articular injection

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03484091

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Contact: Nattapol Tammachote +662-9269775

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Thammasat University Recruiting
Khlong Luang, Pathum Thani, Thailand, 12120
Contact: Nattapol Tammachote, MD    6629269775   
Sponsors and Collaborators
Thammasat University
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Principal Investigator: Nattapol Tammachote, MD Thammasat University
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Responsible Party: Supakit Kanitnate, Department of orthopaedics, Thammasat University Identifier: NCT03484091    
Other Study ID Numbers: OrthoTU09
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Supakit Kanitnate, Thammasat University:
Hylan G-F 20
Hyaluronic acid
Knee osteoarthritis
Pain level
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Protective Agents
Physiological Effects of Drugs