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Trial record 1 of 1 for:    NCT03643588
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The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT03643588
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
SciVision Biotech Inc.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: HYAJOINT Plus Device: Hyalgan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain
Actual Study Start Date : September 4, 2015
Actual Primary Completion Date : September 19, 2016
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HYAJOINT Plus group
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.
Device: HYAJOINT Plus
Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan

Active Comparator: Hyalgan group
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.
Device: Hyalgan
Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Primary Outcome Measures :
  1. VAS pain score [ Time Frame: Baseline, 1, 3, 6, 9 and 12 months post-injection ]
    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'.

  2. The reported adverse events [ Time Frame: 1, 3, 6, 9 and 12 months post-injection ]
    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 :
  1. WOMAC, Likert Scale [ Time Frame: Baseline, 1, 3, 6, 9 and 12 months post-injection ]
    a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.

  2. VAS stiffness score [ Time Frame: Baseline, 1, 3, 6, 9 and 12 months post-injection ]
    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'.

  3. Timed Up-and-Go test (TUG) [ Time Frame: Baseline, 1, 3, 6, 9 and 12 months post-injection ]
    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.

  4. VAS satisfaction score [ Time Frame: 1, 3, 6, 9 and 12 months post-injection ]
    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'.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SciVision Biotech Inc.
ClinicalTrials.gov Identifier: NCT03643588    
Other Study ID Numbers: RDCT-CHP
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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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 SciVision Biotech Inc.:
synovial fluid supplement
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents