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

Completed

• Conditions: Cartilage Diseases

• Registration Number: NCT02348697
• Lead Sponsor: Tetec AG

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.

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Study Start: 2015-06
• Status Verified: 2019-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety	36 month	Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety

Secondary Outcome Measures

Name	Time	Method
Efficacy - International Knee Documentation Committee (IKDC) 2000	36 month	International Knee Documentation Committee (IKDC) 2000

Trial Locations

Locations (9)

Sozialstiftung Bamberg, Klinikum am Bruderwald; 🇩🇪 Bamberg, Germany

Department of Orthopedic Surgery and the Department of Physical Medicine and Rehabilitation LMU Munich; 🇩🇪 Munich, Germany

Gelenk Klinik Orthopaedic Clinic; 🇩🇪 Gundelfingen, Germany

Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany

Diakoniekrankenhaus Henriettenstiftung gGmbH; 🇩🇪 Hannover, Germany

Lubinus Clinicum; 🇩🇪 Kiel, Germany

Theresienkrankenhaus; 🇩🇪 Mannheim, Germany

Klinik rechts der Isar; 🇩🇪 München, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Germany