This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.
Age 19 years and older
Age ≥50 years
Morning stiffness <30 minutes
Crepitus on active motion
Body Mass Index (BMI) ≥32 kg/m²
Chronic inflammatory joint disease (e.g., rheumatoid arthritis)
Inflammatory joint disease (e.g., septic arthritis)
Secondary knee osteoarthritis due to ochronosis, hemochromatosis, or systemic disease
Parallel
CartiPRO
DeviceClinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Dalim Tissen's CartiPRO. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.
Synovian®
DrugClinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Synovian®. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.
Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm)
The change from baseline in Weight-Bearing Pain will be assessed using a 100-mm visual analogue scale ranging from 0 mm, no pain, to 100 mm, worst imaginable pain. Higher scores indicate more severe pain.
Change from Baseline in Weight-Bearing Pain Visual Analogue Scale Score (0-100 mm)
The change from baseline in Weight-Bearing Pain will be assessed using a 100-mm visual analogue scale ranging from 0 mm, no pain, to 100 mm, worst imaginable pain. Higher scores indicate more severe pain.
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index Total and Subscale Scores
The change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index will be assessed for the pain, stiffness, and physical function subscales, as well as the total score. Each item is rated from 0 to 4, where 0 indicates no symptoms and 4 indicates extreme symptoms. Subscale scores are calculated by summing item scores, and the total score is calculated as the sum of the subscale scores. Higher scores indicate worse symptoms and poorer function.
Change from Baseline in 36-Item Short Form Health Survey Domain Scores (SF-36)
The change from baseline in the 36-Item Short Form Health Survey (SF-36) will be assessed using the eight domain scores: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain score ranges from 0 to 100, where higher scores indicate better health status/quality of life.
Change from Baseline in Rest Pain Visual Analogue Scale Score (0-100 mm)
The change from baseline in Rest Pain will be assessed using a 100-mm visual analogue scale ranging from 0 mm, no pain, to 100 mm, worst imaginable pain. Higher scores indicate worse pain.
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