About this trial
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.
Eligibility criteria
Qualifiers
Age 19 years and older
Age ≥50 years
Morning stiffness <30 minutes
Crepitus on active motion
Disqualifiers
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
Trial design
Treatments tested in this trial
- CartiPRO
- Synovian®