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

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.

Condition or disease Intervention/treatment Phase
Knee Chondral or Osteochondral Defect Procedure: Autologous chondrocytes transplantation Procedure: Mosaicoplasty Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty
Study Start Date : April 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: 1
Autologous chondrocytes transplantation
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

Active Comparator: 2
Procedure: Mosaicoplasty
Osteochondral patch are sampled and then implanted during the same surgical procedure

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

Secondary Outcome Measures :
  1. MRI [ Time Frame: at 2 years ]
  2. Arthroscopy with biopsy [ Time Frame: at 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00560664

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Orthopaedic surgery Departement Brest University Hospital
Brest, France, 29200
CHU de Caen
Caen, France, 14 033
Centre médico chirurgical de Dracy-Le-Fort
Dracy-Le-Fort, France, 71 640
CHU de Grenoble
Grenoble, France, 38 042
Ch Versailles
Le Chesnay, France, 78 150
Clinique Chenieux
Limoges, France, 87 000
CHU de Lyon
Lyon, France, 69300
CH Nord Mayenne
Mayenne, France, 53 103
CHU de Nancy
Nancy, France, 54 035
HIA Bégin
Saint Mandé, France, 94 160
CHU de Strasbourg
Strasbourg, France, 67 400
Clinique du cours Dillon
Toulouse, France
Sponsors and Collaborators
University Hospital, Brest
Institut National de la Santé Et de la Recherche Médicale, France
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Principal Investigator: F DUBRANA, PhD MD University Hospital, Brest
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Responsible Party: University Hospital, Brest Identifier: NCT00560664    
Other Study ID Numbers: BB-01-C-01-OT
RB 06.031
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Brest:
chondral defect
osteochondral defect
Additional relevant MeSH terms:
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Bone Diseases
Musculoskeletal Diseases