- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00560664
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
Status
Completed
Conditions
Intervention / Treatment
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
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Dracy-Le-Fort, France, 71 640
- Centre médico chirurgical de Dracy-Le-Fort
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Grenoble, France, 38 042
- CHU de Grenoble
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Le Chesnay, France, 78 150
- CH Versailles
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Limoges, France, 87 000
- Clinique Chenieux
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Lyon, France, 69300
- CHU de Lyon
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Mayenne, France, 53 103
- CH Nord Mayenne
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Nancy, France, 54 035
- CHU de Nancy
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Saint Mandé, France, 94 160
- HIA Begin
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Strasbourg, France, 67 400
- CHU de Strasbourg
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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:
|
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.
Sponsor
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
Keywords
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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