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BioSyntech Completes Patient Enrollment For Canadian-European Pivotal Trial Of Its Cartilage Repair Device

BioSyntech, Inc. announced that the planned objective of patient enrollment has been completed for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel. The company achieved the objective enrolling 80 patients into the randomized trial. This randomized trial compares the treatment of cartilage lesions using BST-CarGel applied following microfracture to treatment with microfracture alone. The trial enrolled subjects aged 18 to 55 years of age with focal cartilage lesions less than 10 cm(2) located on the femoral condyles of the knee. Subjects are further stratified by their lesion type, either characterized as acute (i.e. traumatic) or chronic (i.e. degenerative). The primary endpoint for this trial is cartilage repair at twelve months, defined by the quantity and quality of the repaired tissue as measured with quantitative magnetic resonance imaging (MRI). Secondary endpoints are safety and knee-related pain, stiffness and function as measured using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index questionnaire.