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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorDALIM TISSEN Co., Ltd.

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®

Treatment groups

194 Participants
are divided into 2 treatment groups

Sponsors and collaborators