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Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial (Cartipatch)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560664
First Posted: November 20, 2007
Last Update Posted: July 31, 2014
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.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Brest
November 19, 2007
November 20, 2007
July 31, 2014
April 2007
October 2012   (Final data collection date for primary outcome measure)
Clinical evaluation scoring system [ Time Frame: IKDC ]
Same as current
Complete list of historical versions of study NCT00560664 on ClinicalTrials.gov Archive Site
  • MRI [ Time Frame: at 2 years ]
  • Arthroscopy with biopsy [ Time Frame: at 2 years ]
Same as current
Not Provided
Not Provided
 
Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial
Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
Numerous surgical techniques have been developped for the treatment of chondral and osteochondral defects of the knee. Among those techniques autologous chondrocyte transplantation (ACT) was promising but have potential drawbacks. A novel development by TBF is available. The aim of this randomized trial is to compared this new ACT technique to mosaicoplasty. Final outcomes were measured at 2 years using clinical evaluation scoring system (International Knee Documentation Committee), MRI and arthroscopy with biopsy. 64 patients are needed to detect a mean IKDC difference of at least 15 points with 90% power at a 5% alpha level. Twelve surgical centers in France are involved.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Knee Chondral or Osteochondral Defect
  • Procedure: Autologous chondrocytes transplantation
    Cartilage was harvested, then transferred for cell isolation and culture. Cells are suspended in agarose and transferred to cylindrical molds and surgically implanted 4 weeks later.
    Other Name: Tissue Bank France
  • Procedure: Mosaicoplasty
    Osteochondral patch are sampled and then implanted during the same surgical procedure
  • Experimental: 1
    Autologous chondrocytes transplantation
    Intervention: Procedure: Autologous chondrocytes transplantation
  • Active Comparator: 2
    Mosaicoplasty
    Intervention: Procedure: Mosaicoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2013
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • isolated femoral osteochondral lesion
  • aged 18 to 50
  • grade 3 or 4 lesion (ICRS) sized 2,5 cm2 to 7,5 cm2.
  • IKDC score below 55

Exclusion Criteria:

  • pregnancy
  • allergy
  • arthrosis
  • varus or valgus angle greater than 10°
  • ACL laxity
  • Severe chronic disease
  • BMI > 30 Kg/m2
  • HIV, B or C Hepatitis
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00560664
BB-01-C-01-OT
RB 06.031
No
Not Provided
Not Provided
University Hospital, Brest
University Hospital, Brest
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: F DUBRANA, PhD MD University Hospital, Brest
University Hospital, Brest
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP