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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: HYAJOINT Plus
* Device: Durolane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYAJOINT Plus<br> | Device: HYAJOINT Plus<br>* 60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.<br>|
| Active Comparator: Durolane<br> | Device: Durolane<br>* 60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline VAS pain score at 6 months post-injection. | The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain' | 6 months post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) score for pain change | 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' | Baseline, 1, 3, 9 and 12 months post-injection | 
| Adverse events reported from the baseline and during the study period | 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. | 1, 3, 6, 9 and 12 months post-injection | 
| The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert scale score change | 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. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| Visual analog scale (VAS) score for stiffness change | 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'. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| Visual analog scale (VAS) score for satisfaction change | 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'. | 1, 3, 6, 9 and 12 months post-injection | 
| Timed Up-and-Go test (TUG) change | 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. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| Single-leg stance test (SLS) change | 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. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 
| Knee joint inflammatory state change by ultrasonic inspection | The change from baseline of the subject knee inflammatory state at 1, 3, 6, 9 and 12 months post-injection through ultrasonic inspection. | Baseline, 1, 3, 6, 9 and 12 months post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, synovial fluid supplement, hyaluronic acid