This clinical trial aims to evaluate and compare the efficacy and safety of Conjuran® and Hyruan in patients with knee osteoarthritis following first and second cycle (repeat) administration.
Age ≥40 years
Knee osteoarthritis diagnosed according to ACR criteria
KL grade I-III
Weight-bearing pain VAS ≥40 mm
Inflammatory or secondary arthritis
Recent treatment in the target knee
Significant uncontrolled medical conditions
Hypersensitivity to study device components
Parallel
Conjuran
DeviceOnce a week for 5 injections
Hyruan
DrugOnce a week for 5 injections
Weight-Bearing Pain (WBP) Visual Analog Scale (VAS)
Change from baseline in WBP after the first treatment assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 to 100. Higher scores indicate worse pain
Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS
Change from baseline in WBP, RP, and MP after the first and second treatment cycles, assessed using a 100-mm VAS (0-100). Higher scores indicate worse pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Change from baseline in WOMAC total and subscale scores after the first and second treatment cycles. WOMAC is a 24-item questionnaire with scores ranging from 0 to 96. Higher scores indicate worse symptoms.
EQ-5D (EuroQol 5-Dimension Health Questionnaire)
Change from baseline in EQ-5D score after the first and second treatment cycles. EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and an EQ Visual Analog Scale (EQ VAS; 0-100). Higher scores indicate better health status.
Patient Global Assessment (PGA), Investigator Global Assessment (IGA)
Change from baseline in PGA and IGA after the first and second treatment cycles, assessed using a 100-mm Visual Analog Scale (VAS) (0-100). Higher scores indicate worse disease status.
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