- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945399
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Phase III Protocol Comparing a Microfracture Treatment to a CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
CARTIPATCH® is an Autologous Chondrocyte Implantation product including functional cells in a matrix, indicated for the treatment of isolated osteocartilaginous lesions. The submitted protocol is a Phase III multicentric, prospective, controlled and randomized clinical trial, sponsored by TBF Génie Tissulaire, France. The main objective of the protocol is to compare the clinical improvement of the IKDC subjective score between the microfracture-treated group and the CARTIPATCH® chondrocyte graft-treated group , 18 months following surgery. Several secondary objectives were determined. The microfracture procedure will be conducted in one operative step, during arthroscopy and CARTIPATCH® procedure will be conducted in two operative steps:
- Arthroscopy to collect cartilage;
- Implantation following arthrotomy about 6 weeks following arthroscopy.
Both groups will follow the same rehabilitation program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Gent, Belgium, 9000
- Gent University Hospital, Dept of Orthopaedic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- isolated femoral osteochondral lesion
- aged 18 to 45
- grade 3 or 4 lesion (ICRS) sized 2,5 to 7,5cm2
- lesion depth under 10mm
- IKDC score below 55
- no prior surgical treatment
Exclusion Criteria:
- pregnancy or breastfeeding
- allergy
- arthrosis
- varus or valgus angle greater than 6°
- kissing lesion
- affection of the patella
- excessive laxity
- meniscal pathology history
- severe chronic disease
- BMI > 30
- HIV, Hepatitis B, C, HTLV, Syphilis
Study Plan
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 |
---|---|
Active Comparator: Microfracture
|
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
|
Experimental: Autologous Chondrocytes Implantation
|
Cartilage is harvested and treated for chondrocytes isolation and culture.
After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical evaluation scoring system: IKDC
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-003481-18
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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