Clinical trial

Prospective, Non-interventional Study to Evaluate the Efficacy and Safety of NOVOCART Inject for the Treatment of Cartilage Defects in the Knee in Pediatric Patients With Closed Epiphyses

Name
AAG-O-H-2123
Description
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with radiologically proven closed epiphyseal growth plates.
Trial arms
Trial start
2024-05-31
Estimated PCD
2029-05-01
Trial end
2032-05-01
Status
Not yet recruiting
Treatment
NOVOCART Inject
Autologous Chondrocyte Implantation
Size
30
Primary endpoint
Responder rate of overall KOOS
24-months Follow-up
Eligibility criteria
Inclusion Criteria: * Pediatric patients (\< 18 years of age at implantation) * Closure of the epiphysis adjacent to the biopsy harvest site or the defect to be treated confirmed by an adequate imaging modality * Localized full-thickness cartilage defect (ICRS grade III or IV) of the knee * Medicinal indication for NOVOCART® Inject treatment Exclusion Criteria: see NOVOCART Inject SmPC
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '5 Years', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-11-24

1 organization

1 product

1 indication

Organization
TETEC
Product
NOVOCART