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A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC

Shetty-Kim Research Foundation · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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Study Title: A study to compare two articular cartilage repair techniques in the knee joint: Autologous Collagen Induced Chondrogenesis (ACIC) Vs. Mesenchymal Cell Induced Chondrogenesis (MCIC). Study hypothesis: We start with the hypothesis that both treatments are equally effective. Trial Design: This is a prospective study. The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will not be randomised or blinded. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty, who is one half of the team that devised both techniques. Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital. Planned Sample Size: 50 patients in each arm. Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores; cartilage growth will be measured by the MOCART score. Planned Trial Period: Two to three years Primary Objective: To establish superiority, if any, of either procedure over the other. Primary Endpoint: At the end of the 2 year follow up for all participating patients.
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