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Completed

NCT Number: NCT02348697

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

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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Key information

Conditions

Cartilage Diseases Connective Tissue Diseases Musculoskeletal Diseases Skin and Connective Tissue Diseases

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sozialstiftung Bamberg, Klinikum am Bruderwald, Bamberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOVOCART 3D

Biological

Autologous Chondrocyte Implantation

Primary outcomes

  1. Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety

    Time frame: 36 month

    Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety

Secondary outcomes

  1. Efficacy - International Knee Documentation Committee (IKDC) 2000

    Time frame: 36 month

    International Knee Documentation Committee (IKDC) 2000

Sponsors and collaborators

Lead sponsor

Tetec AG

Industry

Collaborators

  • Aesculap AG

Registry information

Acronym: NISANIK

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2015
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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