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

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ClinicalTrials.gov Identifier: NCT00945399
Recruitment Status : Terminated (Manufacturing stopped)
First Posted : July 24, 2009
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
TBF Genie Tissulaire

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:

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

Both groups will follow the same rehabilitation program.


Condition or disease Intervention/treatment Phase
Knee Chondral Osteochondral Defect Procedure: CARTIPATCH® procedure Procedure: Microfracture Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2014

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Clinical evaluation scoring system: IKDC [ Time Frame: 18 months ]


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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

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

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

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