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The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HYAJOINT Plus
Hyalgan
Sponsored by
SciVision Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Hyaluronan, synovial fluid supplement

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic knee osteoarthritis for at least 6 months despite nonoperative treatment and/or physical therapy
  • Average knee pain score ≧ 30 mm on a 100-mm VAS
  • Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on radiographs taken within previous 6 months 18
  • If the VAS pain score of the contralateral knee with radiographic evidence of bilateral knee osteoarthritis was < 30 mm

Exclusion Criteria:

  • Hip OA
  • Kellgren-Lawrence grade 4 on target knee
  • Clinical apparent active symptoms like infections
  • Intra-articular injections of hyaluronan within the past 6 months
  • Previous orthopaedic surgery on spine or lower limb
  • Intra-articular injections of steroid type drugs within the past 3 months
  • Diagnosed as Lupus erythematosus, Rheumatoid arthritis, Hemiparesis, Neoplasm or received hemodialysis
  • Known allergy to avian proteins or hyaluronic acid products
  • Women ascertained or suspected pregnancy or lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    HYAJOINT Plus group

    Hyalgan group

    Arm Description

    The HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.

    The Hyalgan group received intraarticular injection of 2 ml Hyalgan for three continuously weeks and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.

    Outcomes

    Primary Outcome Measures

    VAS pain score
    The change from baseline in a Visual analog scale score for pain. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
    The reported adverse events
    Any adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit.

    Secondary Outcome Measures

    WOMAC, Likert Scale
    a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
    VAS stiffness score
    The change from baseline in the Visual analog scale score for stiffness. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.
    Timed Up-and-Go test (TUG)
    A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down.
    VAS satisfaction score
    Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.

    Full Information

    First Posted
    August 21, 2018
    Last Updated
    August 22, 2018
    Sponsor
    SciVision Biotech Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03643588
    Brief Title
    The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
    Official Title
    Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 4, 2015 (Actual)
    Primary Completion Date
    September 19, 2016 (Actual)
    Study Completion Date
    April 12, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SciVision Biotech Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement used on the single and repeat treatment of knee osteoarthritis that has the same safety and effectiveness as three-injection hyaluronan, Hyalgan.
    Detailed Description
    The study was a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who have been suffered from the osteoarthritis pain under conventional nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups, HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks post-treatment for the safety and effectiveness evaluation. After complete 52-week visit, subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4 weeks to assess the safety of repeat treatment or cross reactions of the use from three-injections to single-injection hyaluronan treatment. The primary endpoints were the incidence of any adverse events during the study, as well as the objective assessment of pain visual analog scale at baseline and every visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    Hyaluronan, synovial fluid supplement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HYAJOINT Plus group
    Arm Type
    Experimental
    Arm Description
    The HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.
    Arm Title
    Hyalgan group
    Arm Type
    Active Comparator
    Arm Description
    The Hyalgan group received intraarticular injection of 2 ml Hyalgan for three continuously weeks and be followed for 52 weeks. A single injection of HYAJOINT Plus was performed if criteria was met at 52 weeks, and a 4-weeks follow-up of adverse events was conducted.
    Intervention Type
    Device
    Intervention Name(s)
    HYAJOINT Plus
    Intervention Description
    Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
    Intervention Type
    Device
    Intervention Name(s)
    Hyalgan
    Intervention Description
    Three-injection, 20 mg / 2 ml (1%) linear hyaluronan
    Primary Outcome Measure Information:
    Title
    VAS pain score
    Description
    The change from baseline in a Visual analog scale score for pain. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
    Time Frame
    Baseline, 1, 3, 6, 9 and 12 months post-injection
    Title
    The reported adverse events
    Description
    Any adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit.
    Time Frame
    1, 3, 6, 9 and 12 months post-injection
    Secondary Outcome Measure Information:
    Title
    WOMAC, Likert Scale
    Description
    a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
    Time Frame
    Baseline, 1, 3, 6, 9 and 12 months post-injection
    Title
    VAS stiffness score
    Description
    The change from baseline in the Visual analog scale score for stiffness. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.
    Time Frame
    Baseline, 1, 3, 6, 9 and 12 months post-injection
    Title
    Timed Up-and-Go test (TUG)
    Description
    A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down.
    Time Frame
    Baseline, 1, 3, 6, 9 and 12 months post-injection
    Title
    VAS satisfaction score
    Description
    Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.
    Time Frame
    1, 3, 6, 9 and 12 months post-injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Symptomatic knee osteoarthritis for at least 6 months despite nonoperative treatment and/or physical therapy Average knee pain score ≧ 30 mm on a 100-mm VAS Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on radiographs taken within previous 6 months 18 If the VAS pain score of the contralateral knee with radiographic evidence of bilateral knee osteoarthritis was < 30 mm Exclusion Criteria: Hip OA Kellgren-Lawrence grade 4 on target knee Clinical apparent active symptoms like infections Intra-articular injections of hyaluronan within the past 6 months Previous orthopaedic surgery on spine or lower limb Intra-articular injections of steroid type drugs within the past 3 months Diagnosed as Lupus erythematosus, Rheumatoid arthritis, Hemiparesis, Neoplasm or received hemodialysis Known allergy to avian proteins or hyaluronic acid products Women ascertained or suspected pregnancy or lactating

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34162365
    Citation
    Huang TL, Tsai CH. Safety and efficacy of single CHAP Hyaluronan injection versus three injections of linear Hyaluronan in pain relief for knee osteoarthritis: a prospective, 52-week follow-up, randomized, evaluator-blinded study. BMC Musculoskelet Disord. 2021 Jun 23;22(1):572. doi: 10.1186/s12891-021-04467-3.
    Results Reference
    derived

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    The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

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