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A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

TiGenix n.v. · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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repair
The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period. The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting. The secondary objectives are: * Clinical outcome as assessed by patient reported EuroQoL-5D * Structural repair as assessed by MRI * The number of treatment failures and the time to treatment failure * The ease of use of ChondroMimetic as reported by the surgeon
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