Cartilage Disease Clinical Trial
— JUNOVOOfficial title:
Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients With Closed Epiphyses
Verified date | November 2023 |
Source | Tetec AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART 3D in the Treatment fo cartilage defects of the knee in pediatric patients wieh closed epiphyseal growth plates.
Status | Active, not recruiting |
Enrollment | 42 |
Est. completion date | June 2026 |
Est. primary completion date | June 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - 13 - 17 years old - Medicinal indication for NOVOCART 3D treatment Exclusion criteria: • none |
Country | Name | City | State |
---|---|---|---|
Germany | Lubinus Clinicum Kiel | Kiel | Schleswig-Holstein |
Germany | Theresienkrankenhaus und St. Hedwig-Klinik GmbH | Mannheim | Baden-Württemberg |
Germany | Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie | München | Bayern |
Germany | Klinikum rechts der Isar der technischen Universität München | München | Bayern |
Germany | Univerisätsklinikum Regensburg | Regensburg | Bayern |
Germany | Sportklinik Stuttgart | Stuttgart | Baden Württemberg |
Lead Sponsor | Collaborator |
---|---|
Tetec AG | Aesculap AG, Winicker Norimed GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score) | Change of KOOS defined as the average of the 5 subscale scores (range 0-100, higher values represent a better outcome) | 24 months Follow Up (FU) | |
Secondary | Change of 5 subscores KOOS | Change of the 5 subscores of KOOS (range 0-100, higher values represent a better outcome) | 24 months FU | |
Secondary | IKDC subjective | Change of IKDC (International Knee Documentation Committee) subjective (range 0-100, higher values represent a better outcome) | 24 month FU | |
Secondary | pain VAS | Change in pain VAS (Visual Analogue Scale) (range 0-10, higher values represent a better outcome) | 24 month FU | |
Secondary | MOCART | In vivo Performance via MRI (Magnetic Resonance Imaging), MOCART Score (Magnetic Resonance Observation of Cartilage Repair Tissue) (range 0-100, higher values represent a better outcome) | 24 month FU | |
Secondary | KOOS responder rate | KOOS responder rate defined as Proportion of patients with > 10 Points improvement in KOOS | 24 month FU | |
Secondary | IKDC subjective responder rate | IKDC subjective responder rate defined as Proportion of patients with >20.5 Points improvement in IKDC subjective | 24 months FU | |
Secondary | Proportion of patients with Treatment failures | Proportion of patients with Treatment failures | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | |
Secondary | Health economics variable (Days of missing work/school ) to NOVOCART 3D treatment | Days of missing work/school due to knee pain/function issues in the target knee | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | |
Secondary | Health economics variable (Days of hospitalization ) to NOVOCART 3D treatment | Days of hospitalization due to knee pain/function issues in the target knee | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months | |
Secondary | Health economics variable (Number of postoperative doctor visits) to NOVOCART 3D treatment | Number of postoperative doctor visits | 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months |
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