Non-Interventional Study to Evaluate Safety and Efficacy... | NCT02348697

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

NCT02348697

Sponsor

Tetec AG

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

81Actual

Phase

Not provided

Conditions

Cartilage Diseases

Interventions

NOVOCART 3D

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-000166-62	EudraCT Number

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Oct 30, 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Jan 13, 2015

First Submission Date that Met QC Criteria

Jan 27, 2015

First Posted Date

Jan 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2019

Last Update Posted Date

Dec 3, 2019Actual

Name	Class
Aesculap AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Name	Type	Description	Arm Group Labels	Other Names
NOVOCART 3D	Biological	Autologous Chondrocyte Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

specialist clinical centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandra Kirner, PhD	TETEC AG Reutlingen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sozialstiftung Bamberg, Klinikum am Bruderwald		Bamberg		98049	Germany
Gelenk Klinik Orthopaedic Clinic

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002357	Cartilage Diseases

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided