Clinical trial

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

Name

AAG-O-H-1633

Description

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 arms

Trial start

2017-04-25

Estimated PCD

2023-06-14

Trial end

2026-06-01

Status

Active (not recruiting)

Treatment

NOVOCART 3D

Autologous Chondrocyte Implantation

Size

Primary endpoint

Change of Overall KOOS (Knee Injury and Osteoarthritis Outcome Score)

24 months Follow Up (FU)

Eligibility criteria

Inclusion Criteria: * 13 - 17 years old * Medicinal indication for NOVOCART 3D treatment Exclusion criteria: • none

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

Updated at

2023-11-24

1 organization

1 product

1 indication

Product

NOVOCART 3D

Indication

Cartilage Disorders

Organization

TETEC