Status:
TERMINATED
Comparison of Microfracture Treatment and CARTIPATCH® Chondrocyte Graft Treatment in Femoral Condyle Lesions
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Knee Chondral
Osteochondral Defect
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief Summary
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 Ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00945399
Start Date
October 1 2008
End Date
September 1 2014
Last Update
April 28 2015
Active Locations (1)
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1
Gent University Hospital, Dept of Orthopaedic Surgery
Ghent, Belgium, 9000