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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cartilage Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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NOVOCART 3D

Autologous Chondrocyte Implantation

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No