Osteochondral Defect Clinical Trial
Official title:
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:
1. Arthroscopy to collect cartilage;
2. Implantation following arthrotomy about 6 weeks following arthroscopy.
Both groups will follow the same rehabilitation program.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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