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Completed

NCT Number: NCT03643588

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

HYAJOINT Plus

Device

Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan

Hyalgan

Device

Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Primary outcomes

  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 outcomes

  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'.

Sponsors and collaborators

Lead sponsor

SciVision Biotech Inc.

Industry

Registry information

Official study title

Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 23, 2018
Registry last updated
Aug 24, 2018

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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