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

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.
 
ClinicalTrials.gov Identifier: NCT00560664
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : July 31, 2014
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE November 19, 2007
First Posted Date  ICMJE November 20, 2007
Last Update Posted Date July 31, 2014
Study Start Date  ICMJE April 2007
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
Clinical evaluation scoring system [ Time Frame: IKDC ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
  • MRI [ Time Frame: at 2 years ]
  • Arthroscopy with biopsy [ Time Frame: at 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty: a Randomized Trial
Official Title  ICMJE Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Chondral or Osteochondral Defect
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Autologous chondrocytes transplantation
    Intervention: Procedure: Autologous chondrocytes transplantation
  • Active Comparator: 2
    Mosaicoplasty
    Intervention: Procedure: Mosaicoplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2014)
58
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2007)
64
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00560664
Other Study ID Numbers  ICMJE BB-01-C-01-OT
RB 06.031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: F DUBRANA, PhD MD University Hospital, Brest
PRS Account University Hospital, Brest
Verification Date July 2014

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