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

This study has been terminated.
(Manufacturing stopped)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945399
First Posted: July 24, 2009
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
TBF Genie Tissulaire
  Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945399


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

Responsible Party: TBF Genie Tissulaire
ClinicalTrials.gov Identifier: NCT00945399     History of Changes
Other Study ID Numbers: 2007-003481-18
First Submitted: July 23, 2009
First Posted: July 24, 2009
Last Update Posted: April 28, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Fractures, Stress
Fractures, Bone
Wounds and Injuries