Non-interventional Study With NOVOCART® Inject in the Rec... | NCT02941120

Studies
Non-interventional Study With NOVOCART® Inject in the Reconstruction of the Knee Cartilage Defects

NCT02941120

Sponsor

Tetec AG

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

245Actual

Phase

Not provided

Conditions

Cartilage Disease

Interventions

Not provided

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

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

Dec 2015Actual

Primary Completion Date

May 2019Actual

Completion Date

May 2019Actual

First Submitted Date

Oct 18, 2016

First Submission Date that Met QC Criteria

Oct 19, 2016

First Posted Date

Oct 21, 2016Estimated

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
Winicker Norimed GmbH	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

Retrospective non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full-thickness cartilage defects in the knee joint.

Detailed Description

Retrospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with localized full-thickness cartilage defects in the knee joint.

Safety: Measuring the number of adverse drug reactions/serious adverse drug reactions since treatment and up to the present time.

Efficacy: Evaluate symptoms and functional status at the present time using IKDC 2000 (International Knee Documentation Committee) and KOOS (Knee injury osteoarthritis outcome 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

245Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NOVOCART® Inject patients		Patients who where treated with NOVOCART® Inject autologous chondrocyte implantation in the knee joint.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse drug reaction/serious adverse drug reaction	Number of adverse drug reaction/serious adverse drug reaction as a measurement of safety	Up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
Outcome of IKDC 2000	Outcome of the IKDC 2000 as measurements of symptoms and function	Up to 24 months
Outcome of KOOS	Outcome of KOOS as measurements of symptoms and function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male and female patients
juvenile patients with closed epiphysial plate
insulated full-thickness cartilage damage of the knee Joint, ICRS (International Cartilage Repair Society) grade 3-4
defect size ≥ 2.5 and ≤ 10 cm2
intact or reconstructed bony subchondral plate
in the case of deep bony substance defects, additional bony reconstruction is needed

Exclusion Criteria:

radiographic signs of osteoarthritis of Kellgren and Lawrence > 2
joint stiffness
arthrofibrosis
malalignment in the knee (valgus- or varus deformity) > 3° (correction contemporary to the ACT)
insufficient reconstructed ligaments (correction contemporary to the ACT)
defective position patella (correction contemporary to the ACT)
sled prosthesis implants or carbon pin
inflammatory joint diseases (f.e. rheumatoid arthritis)
corresponding cartilage defects ("kissing lesions")
more than two independent cartilage defects in one knee
primary cartilage reconstructive treatment in children and juvenile with open epiphysial plate
diffuse chondromalacia
congenital or gained deformity of patella

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

Orthopaedic clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hochtaunus-Kliniken gGmbH Krankenhaus Bad Homburg		Bad Homburg		61348	Germany
Gelenk-Klinik Gundelfingen

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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