RecruitingNot ApplicableNCT07267793

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.

Enrollment

194 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Osteoarthritis Degenerative Joint Disease of Knee Knee Pain Arthritis Cartilage Defects of the Knee

Summary

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the long-term effectiveness and safety of CartiPRO, an injectable atelocollagen product, for relieving knee pain in adults with osteoarthritis, compared to another established injection treatment called Synovian. Collagen-based injections may help protect cartilage and provide longer-lasting pain relief than some other options. You may be eligible if you are 19 or older, have been diagnosed with knee osteoarthritis (Kellgren-Lawrence grade I to III), have a pain score of at least 40 out of 100, can walk without an assistive device, and do not have inflammatory arthritis, severe heart disease, or an active infection. Participation involves receiving two injections 24 weeks apart and attending scheduled clinic visits over 36 weeks to track pain and function changes. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECartiPRO

Clinical 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.

DRUGSynovian®

Clinical 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.