Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage (NCT07267793) | Clinical Trial Compass
RecruitingNot Applicable
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
South Korea194 participantsStarted 2025-07-03
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Painful musculoskeletal conditions (e.g., Sudeck's atrophy, Paget's disease, herniated intervertebral disc)
* Polyarticular disease with severe osteoarthritis in other joints (e.g., hip) that may affect knee pain evaluation
* Radiographic evidence of definite loss of patellofemoral joint space
* Moderate to severe joint effusion con…
What they're measuring
1
Change from baseline in 100-mm Weight-Bearing Pain (WBP) Visual Analogue Scale (VAS) score (0-100 mm)
Timeframe: at week 12 after the first administration