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

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ClinicalTrials.gov 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
Sponsor:
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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03484091


Contacts
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Contact: Nattapol Tammachote +662-9269775 tammachotemd@gmail.com

Locations
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Thailand
Thammasat University Recruiting
Khlong Luang, Pathum Thani, Thailand, 12120
Contact: Nattapol Tammachote, MD    6629269775    tammachotemd@gmail.com   
Sponsors and Collaborators
Thammasat University
Investigators
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Principal Investigator: Nattapol Tammachote, MD Thammasat University
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Responsible Party: Supakit Kanitnate, Department of orthopaedics, Thammasat University
ClinicalTrials.gov 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:
Hyruan-One
Hylan G-F 20
Hyaluronic acid
Knee osteoarthritis
Pain level
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hylan
Viscosupplements
Protective Agents
Physiological Effects of Drugs