Comparison of Microfracture Treatment and CARTIPATCH® Cho... | NCT00945399

Studies
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

NCT00945399

Sponsor

TBF Genie Tissulaire

Status

Terminated

Last Update Posted

Apr 28, 2015Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Knee Chondral
Osteochondral Defect

Interventions

CARTIPATCH® procedure
Microfracture

Countries

Belgium

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Manufacturing stopped

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2012Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

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

Apr 25, 2015

Last Update Posted Date

Apr 28, 2015Estimated

Description Module

Brief Summary

CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:

Arthroscopy to collect cartilage;
Implantation following arthrotomy about 6 weeks following arthroscopy.

Both groups will follow the same rehabilitation program.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous Chondrocytes Implantation	Experimental		Procedure: CARTIPATCH® procedure
Microfracture	Active Comparator		Procedure: Microfracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARTIPATCH® procedure	Procedure	Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.

Measure	Description	Time Frame
Clinical evaluation scoring system: IKDC		18 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

isolated femoral osteochondral lesion
aged 18 to 45
grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
lesion depth under 10mm
IKDC score below 55
no prior surgical treatment

Exclusion Criteria:

pregnancy or breastfeeding
allergy
arthrosis
varus or valgus angle greater than 6°
kissing lesion
affection of the patella
excessive laxity
meniscal pathology history
severe chronic disease
BMI > 30
HIV, Hepatitis B, C, HTLV, Syphilis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gent University Hospital, Dept of Orthopaedic Surgery		Ghent		9000	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D054544	Arthroplasty, Subchondral

Ancestor Terms

ID	Term
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures

Browse Leaves

Not provided

Browse Branches

Not provided