Observational Study With NOVOCART® Inject in the Reconstr... | NCT02179346

Studies
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects

NCT02179346

Sponsor

Tetec AG

Status

Completed

Last Update Posted

Dec 6, 2019Actual

Enrollment

21Actual

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

Dec 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 2014Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 18, 2018Actual

First Submitted Date

Jun 27, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jul 1, 2014Estimated

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 4, 2019

Last Update Posted Date

Dec 6, 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® Inject in patients with full thickness cartilage defects in the hip.

Detailed Description

Prospective and multicenter non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with impingement syndrom in the hip.

Safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions.

Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.

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

21Actual

Label	Type	Description	Intervention Names
Cartilage defects in the hip joint		NOVOCART® Inject Autologous Chondrocyte Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	12 months
Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	Number of adverse drug reactions/serious adverse drug reactions as a measurement of safety.	24 months

Secondary Outcomes

Measure	Description	Time Frame
iHOT 33 (international HIP Outcome Tool) as a measurement of function and Quality of life	Outcome of iHOT 33 as a measurement of function and Quality of life	12 and 24 months
EQ-5D-5L (5-level EQ-5D ) as a measurement of function and Quality of life

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients between 18 and 60 years
Insulated full thickness cartilage damage of the hip joint after ICRS grade 3
Received subchondral bone lamella
received or reconstructed labrum in labrum cartilage defects
defect size ≥ 1.5 and ≤ 10 cm2
Intact surrounding cartilage structure around the defect, and the corresponding articular surface
existence of the written informed consent of the patients after Enlightenment

Exclusion Criteria:

More than 2 defects or 2 corresponding defects
defects in both lower extremities simultaneously
Radiographic signs of osteoarthritis of Kellgren & Lawrence > 1
Profound bony lesion > 0.5 cm in the defect area
Presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases
Skin injury to the limb to be operated on
cartilage defect of the corresponding articular surface
Existing medications, drugs or alcohol
Acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases
impairment of the upper extremity, which prevents discharge by Crutches
Known bleeding disorder, such as Hemophilia A / B or thrombophilia
pregnancy and lactation, which represent the time of treatment is a contraindication
Known allergy to the ingredients
inmates in prisons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

specialist clinical centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaus-Peter Guenther, Prof. MD	Universitätsklinikum Carls Gustav Carus der TU Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Carl Gustav of TU Dresden		Dresden		01307	Germany
Essen University Hospital

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

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