This trial is active, not recruiting.

Condition cartilage diseases
Treatment novocart 3d
Sponsor Tetec AG
Collaborator Aesculap AG
Start date June 2015
End date September 2019
Trial size 82 participants
Trial identifier NCT02348697, 2015-000166-62, AAG-O-H-1418


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
time frame: 36 month

Secondary Outcomes

Efficacy - International Knee Documentation Committee (IKDC) 2000
time frame: 36 month

Eligibility Criteria

Male or female participants from 14 years up to 50 years old.

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

Additional Information

Official title Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Tetec AG.