Clinical trial NCT02348697: Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
Official title: Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Diseases
Keywords: Cartilage Defect in the Knee
MACT
Lead sponsor: Tetec AG
Sponsor class: INDUSTRY
Collaborators: name: Aesculap AG
First posted: 2015-01-28
Enrollment: 81
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: specialist clinical centre

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
timeFrame: 36 month
Secondary outcomes:
measure: Efficacy - International Knee Documentation Committee (IKDC) 2000
timeFrame: 36 month
Other outcomes:
Locations:
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald
city: Gundelfingen
country: Germany
facility: Gelenk Klinik Orthopaedic Clinic
city: Hannover
country: Germany
facility: Diakoniekrankenhaus Henriettenstiftung gGmbH
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Kiel
country: Germany
facility: Lubinus Clinicum
city: Mannheim
country: Germany
facility: Theresienkrankenhaus
city: Munich
country: Germany
facility: Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich
city: München
country: Germany
facility: Klinik rechts der Isar
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: TETEC AG Reutlingen
name: Alexandra Kirner, PhD
role: STUDY_DIRECTOR
References: