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

This study has been terminated.
(Manufacturing stopped)
Information provided by (Responsible Party):
TBF Genie Tissulaire Identifier:
First received: July 23, 2009
Last updated: April 25, 2015
Last verified: April 2015

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:

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

Both groups will follow the same rehabilitation program.

Condition Intervention Phase
Knee Chondral
Osteochondral Defect
Procedure: CARTIPATCH® procedure
Procedure: Microfracture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions

Further study details as provided by TBF Genie Tissulaire:

Primary Outcome Measures:
  • Clinical evaluation scoring system: IKDC [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2008
Study Completion Date: September 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Chondrocytes Implantation Procedure: CARTIPATCH® procedure
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
Active Comparator: Microfracture Procedure: Microfracture
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00945399

Gent University Hospital, Dept of Orthopaedic Surgery
Gent, Belgium, 9000
Sponsors and Collaborators
TBF Genie Tissulaire
  More Information

Responsible Party: TBF Genie Tissulaire Identifier: NCT00945399     History of Changes
Other Study ID Numbers: 2007-003481-18 
Study First Received: July 23, 2009
Last Updated: April 25, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Norway: Norwegian Medicines Agency
Israel: Ministry of Health processed this record on October 27, 2016