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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
National Cheng-Kung University Hospital
Tainan, Taiwan
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'
Time frame: 6 months post-injection
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'
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Visual analog scale (VAS) score for satisfaction change
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection