No phaseActive, not recruitingAge-related condition
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
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
- Sponsor
- DALIM TISSEN Co., Ltd. (Industry)
- Enrolment
- 194 planned
- Conditions
- Osteoarthritis; Knee Pain Arthritis; Cartilage Defects of the Knee; Knee Osteoarthritis; Degenerative Joint Disease of Knee
- Interventions
- CartiPRO; Synovian®
- Ages
- adults, older adults
- Registry
- NCT07267793
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started