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Completed

NCT Number: NCT04000204

The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain

The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.

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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

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age from 35 to 85 years;
  • radiographic Kellgren-Lawrence grade II to III;
  • symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
  • average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
  • radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee <30mm.

Exclusion criteria

  • previous orthopedic surgery in the lower extremity;
  • disabling osteoarthritis of hip or ankle;
  • previous IAHA within 6 months;
  • IA steroid or joint puncture within 3 months;
  • characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
  • Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
  • confirmed or suspected pregnancy or lactating;
  • known allergy history to any avian protein or HA product.

Treatment and study plan

HYAJOINT Plus

Device

60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.

Durolane

Device

60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.

Primary outcomes

  1. The change from baseline VAS pain score at 6 months post-injection.

    Time frame: 6 months post-injection

    The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'

Secondary outcomes

  1. Visual analog scale (VAS) score for pain change

    Time frame: Baseline, 1, 3, 9 and 12 months post-injection

    The change from baseline VAS pain score at 1, 3, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'

  2. Adverse events reported from the baseline and during the study period

    Time frame: 1, 3, 6, 9 and 12 months post-injection

    The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period.

  3. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change

    Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection

    The change from baseline WOMAC score at 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.

  4. Visual analog scale (VAS) score for stiffness change

    Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection

    The change from baseline VAS stiffness score at 1, 3, 6, 9 and 12 months post-injection. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.

  5. Visual analog scale (VAS) score for satisfaction change

    Time frame: 1, 3, 6, 9 and 12 months post-injection

    The change from baseline VAS satisfaction score at 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'.

  6. Timed Up-and-Go test (TUG) change

    Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection

    The change from baseline TUG time at 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.

  7. Single-leg stance test (SLS) change

    Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection

    The change from baseline SLS time at 1, 3, 6, 9 and 12 months post-injection. A simple measurement of time in seconds for a subject raising one foot up without touching it to the supported lower extremity with knee OA and maintain balance for as long as possible.

  8. Knee joint inflammatory state change by ultrasonic inspection

    Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection

    The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection.

Sponsors and collaborators

Lead sponsor

SciVision Biotech Inc.

Industry

Registry information

Official study title

The Comparison of Safety and Effectiveness Between HYAJOINT Plus and Bioventus Durolane for the Treatment of Knee Osteoarthritis Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 27, 2019
Registry last updated
May 27, 2020

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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