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

July 30, 2014 updated by: University Hospital, Brest

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29200
        • Orthopaedic surgery Departement Brest University Hospital
      • Caen, France, 14 033
        • CHU de Caen
      • Dracy-Le-Fort, France, 71 640
        • Centre médico chirurgical de Dracy-Le-Fort
      • Grenoble, France, 38 042
        • CHU de Grenoble
      • Le Chesnay, France, 78 150
        • CH Versailles
      • Limoges, France, 87 000
        • Clinique Chenieux
      • Lyon, France, 69300
        • CHU de Lyon
      • Mayenne, France, 53 103
        • CH Nord Mayenne
      • Nancy, France, 54 035
        • CHU de Nancy
      • Saint Mandé, France, 94 160
        • HIA Begin
      • Strasbourg, France, 67 400
        • CHU de Strasbourg
      • Toulouse, France
        • Clinique du cours Dillon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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 Names:
  • Tissue Bank France
Active Comparator: 2
Mosaicoplasty
Osteochondral patch are sampled and then implanted during the same surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical evaluation scoring system
Time Frame: IKDC
IKDC

Secondary Outcome Measures

Outcome Measure
Time Frame
MRI
Time Frame: at 2 years
at 2 years
Arthroscopy with biopsy
Time Frame: at 2 years
at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: F DUBRANA, PhD MD, University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-01-C-01-OT
  • RB 06.031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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