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

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00560664
First received: November 19, 2007
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Knee Chondral or Osteochondral Defect
Procedure: Autologous chondrocytes transplantation
Procedure: Mosaicoplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparison of Autologous Chondrocyte Implantation Versus Mosaicoplasty

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Clinical evaluation scoring system [ Time Frame: IKDC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Arthroscopy with biopsy [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: April 2007
Study Completion Date: August 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Mosaicoplasty
Procedure: Mosaicoplasty
Osteochondral patch are sampled and then implanted during the same surgical procedure

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560664

Locations
France
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
Investigators
Principal Investigator: F DUBRANA, PhD MD University Hospital, Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00560664     History of Changes
Other Study ID Numbers: BB-01-C-01-OT, RB 06.031
Study First Received: November 19, 2007
Last Updated: August 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
knee
chondral defect
osteochondral defect

ClinicalTrials.gov processed this record on July 23, 2014