Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Cartilage Diseases Clinical Trial

— NISANIK  

Official title:

Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348697
• Other study ID #: AAG-O-H-1418
• Secondary ID: 2015-000166-62
• Status: Completed
• Start date: June 2015
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2019
• Source: Tetec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.

Description:

A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male and female adult patients

• Children and adolescents with closed epiphysial plate

• Defect size =2.5 and =10 cm2 post-debridement

• Localized full thickness articular cartilage defect of the knee (Grade 3 & 4 International Cartilage Repair Society (ICRS) classification)

Exclusion Criteria:

• Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2

• More than 2 defects or 2 corresponding lesions

• Ankylosis

• Arthrofibrosis

• Diffuse chondromalacia

• Total/subtotal resected meniscus

• Insufficient Ligament guidance

• Patella malignement

• Inflammatory joint disease

• General cartilage degeneration or increased joint deterioration

• Cancer, present or within the last 5 years

• Primary treatment in children and adolescents with open epiphysial plate

• Chronical infection diseases

• Untreated coagulation disorder

• Pregnancy and lactating

• Known history of allergies against ingredients of NOVOCART® 3D

Related Conditions & MeSH terms

• Cartilage Diseases

Intervention

Biological:
• NOVOCART 3D
Autologous Chondrocyte Implantation

Locations

Country	Name	City	State
Germany	Sozialstiftung Bamberg, Klinikum am Bruderwald	Bamberg
Germany	Gelenk Klinik Orthopaedic Clinic	Gundelfingen
Germany	Diakoniekrankenhaus Henriettenstiftung gGmbH	Hannover
Germany	Heidelberg University Hospital	Heidelberg
Germany	Lubinus Clinicum	Kiel
Germany	Theresienkrankenhaus	Mannheim
Germany	Klinik rechts der Isar	München
Germany	Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich	Munich
Germany	University Hospital Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
Tetec AG	Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety	Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety	36 month
Secondary	Efficacy - International Knee Documentation Committee (IKDC) 2000	International Knee Documentation Committee (IKDC) 2000	36 month