A Phase 3 interventional study of CARTIPATCH® procedure and Microfracture in Knee Chondral and Osteochondral Defect, sponsored by TBF Genie Tissulaire. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-04-28.
Sponsored by TBF Genie Tissulaire · Phase 3, Interventional, and Treatment
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:
Both groups will follow the same rehabilitation program.
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Procedure: CARTIPATCH® procedure
Procedure: Microfracture
Cartilage is harvested and treated for chondrocytes isolation and culture. After multiplication, the chondrocytes are transferred into a biomaterial support and surgically implanted.
Tiny fractures are created at the cartilage surface to stimulate cartilage growth.
Clinical evaluation scoring system: IKDC
Time frame: 18 months
This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire