Long-term Efficacy and Safety of CartiPRO Injection to Alleviate Knee Pain in Patients With Osteoarthritis and/or Diverse Cartilage Defects: a Multicenter, Single-blind, Randomized, Non-inferiority, Sponsor Initiated 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.
• Age 19 years and older
• Diagnosed with unilateral or bilateral knee osteoarthritis according to American College of Rheumatology (ACR) criteria, with at least 3 of the following 6 features:
‣ Age ≥50 years
⁃ Morning stiffness \<30 minutes
⁃ Crepitus on active motion
⁃ Bony tenderness
⁃ Bony enlargement
⁃ No palpable warmth
• Radiographic evidence of Kellgren-Lawrence grade I, II, or III osteoarthritis within 6 months prior to screening or at screening visit
• Weight-bearing pain Visual Analogue Scale (VAS) score ≥40 mm in at least one knee joint at screening
• Able to walk without assistive devices (walkers or canes), OR if using a walking aid routinely for past 6 months, able to continue using the same device throughout the study
• Able to understand and complete efficacy assessment questionnaires
• Willing and able to provide written informed consent