Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage

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.

Knee osteoarthritis (OA) is the most common joint disorder, primarily caused by the destruction of articular cartilage. Symptoms typically include joint pain, stiffness, and muscle contraction. According to the World Health Organization, in 2013, an estimated 10-15% of adults over the age of 60 were affected by OA, significantly impacting their quality of life. Collagen degradation is a key feature of cartilage damage in OA. Collagen-based injectable materials, such as atelocollagen, are being explored as potential therapeutic options to restore collagen and improve clinical outcomes. Unlike other injectable substances like hyaluronic acid or corticosteroids, collagen's stable triple helix structure and long half-life make it more resistant to enzymatic degradation, offering a potentially longer-lasting effect. Despite this, long-term and repeated use data for atelocollagen injections in knee OA are limited both domestically and internationally. This study aims to provide robust clinical evidence on the efficacy and safety of repeated intra-articular atelocollagen injections for knee pain relief in patients with knee OA. This is a randomized, single-blind, active-controlled study comparing CartiPRO with Synovian. Subjects with knee OA and symptomatic knee pain will receive the investigational device intra-articularly. A second dose will be administered at 24 weeks. The primary outcome is the change in 100-mm weight-bearing pain (WBP) VAS score at 12 weeks compared to baseline. Secondary outcomes include VAS changes in WBP, resting pain (RP), motion pain (MP), and night pain (NP) at multiple time points, as well as changes in WOMAC and SF-36 scores. Long-term efficacy will be assessed after re-injection. Safety assessments include adverse events, local reactions, physical examination, vital signs, and laboratory tests. Study Visits: Visit 1: Screening Visit 2: First injection (baseline) Visit 3: 2 weeks after injection Visit 4: 4 weeks after injection Visit 5: 12 weeks after injection Visit 6: 24 weeks after injection (second dose) Visit 7: 36 weeks after first injection