Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects
NISANIK
2 other identifiers
observational
81
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedDecember 3, 2019
January 1, 2019
4.4 years
January 13, 2015
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety
36 month
Secondary Outcomes (1)
Efficacy - International Knee Documentation Committee (IKDC) 2000
36 month
Interventions
Autologous Chondrocyte Implantation
Eligibility Criteria
specialist clinical centre
You may qualify if:
- 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)
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tetec AGlead
- Aesculap AGcollaborator
Study Sites (9)
Sozialstiftung Bamberg, Klinikum am Bruderwald
Bamberg, 98049, Germany
Gelenk Klinik Orthopaedic Clinic
Gundelfingen, 79194, Germany
Diakoniekrankenhaus Henriettenstiftung gGmbH
Hanover, 30171, Germany
Heidelberg University Hospital
Heidelberg, 69118, Germany
Lubinus Clinicum
Kiel, 24106, Germany
Theresienkrankenhaus
Mannheim, 68165, Germany
Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich
Munich, 81377, Germany
Klinik rechts der Isar
München, 81675, Germany
University Hospital Regensburg
Regensburg, 93053, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexandra Kirner, PhD
TETEC AG Reutlingen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 28, 2015
Study Start
June 1, 2015
Primary Completion
October 30, 2019
Study Completion
October 30, 2019
Last Updated
December 3, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share