Non-interventional Study With NOVOCART® 3D for the Treatment of Cartilage Defects of the Knee in Pediatric Patients
JUNOVO
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
1 other identifier
observational
42
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2017
CompletedFirst Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
December 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedMay 14, 2025
May 1, 2025
6.1 years
January 7, 2019
May 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Change of 5 subscores KOOS
24 months FU
IKDC subjective
24 month FU
pain VAS
24 month FU
MOCART
24 month FU
KOOS responder rate
24 month FU
- +5 more secondary outcomes
Interventions
Autologous Chondrocyte Implantation
Eligibility Criteria
This study will include pediatric patients (\< 18 years of age) with closed epiphyses who suffer from a full-thickness cartilage defect of the knee caused by acute or repetitive trauma or by osteochondritis dissecans and who are scheduled for treatment with NOVOCART® 3D. Further inclusion/exclusion criteria are given in the current version of the NOVOCART® 3D SmPC, where the therapeutic indications, contraindications, special warnings and precautions for use are listed in detail. The decision to treat patients with NOVOCART® 3D must be made independently from the patient's participation in the study.
You may qualify if:
- years old
- Medicinal indication for NOVOCART 3D treatment
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tetec AGlead
- Aesculap AGcollaborator
- Winicker Norimed GmbHcollaborator
Study Sites (6)
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Mannheim, Baden-Wurttemberg, 68165, Germany
Sportklinik Stuttgart
Stuttgart, Baden-Wurttemberg, 70372, Germany
Klinik und Poliklinik für Orthophädie, Physikalische Medizin und Rehabilitation Knie- und Schulterorthopädie
München, Bavaria, 81377, Germany
Klinikum rechts der Isar der technischen Universität München
München, Bavaria, 81675, Germany
Univerisätsklinikum Regensburg
Regensburg, Bavaria, 93047, Germany
Lubinus Clinicum Kiel
Kiel, Schleswig-Holstein, 24106, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Angele, Prof. MD
Universitätsklinikum Regensburg
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2019
First Posted
December 4, 2019
Study Start
April 25, 2017
Primary Completion
June 14, 2023
Study Completion (Estimated)
June 1, 2026
Last Updated
May 14, 2025
Record last verified: 2025-05