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

December 2, 2019 updated by: Tetec AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bamberg, Germany, 98049
        • Sozialstiftung Bamberg, Klinikum am Bruderwald
      • Gundelfingen, Germany, 79194
        • Gelenk Klinik Orthopaedic Clinic
      • Hannover, Germany, 30171
        • Diakoniekrankenhaus Henriettenstiftung GgmBH
      • Heidelberg, Germany, 69118
        • Heidelberg University Hospital
      • Kiel, Germany, 24106
        • Lubinus Clinicum
      • Mannheim, Germany, 68165
        • Theresienkrankenhaus
      • Munich, Germany, 81377
        • Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich
      • München, Germany, 81675
        • Klinik rechts der Isar
      • Regensburg, Germany, 93053
        • University Hospital Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

specialist clinical centre

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - International Knee Documentation Committee (IKDC) 2000
Time Frame: 36 month
International Knee Documentation Committee (IKDC) 2000
36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tetec AG

Collaborators

Aesculap AG

Investigators

  • Study Director: Alexandra Kirner, PhD, TETEC AG Reutlingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 30, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1418
  • 2015-000166-62 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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