Clinical Study Report: BMTI-2005-04
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چکیده
Study Title: A Prospective, Randomized, Controlled, MultiCenter Human Clinical Feasibility Trial to Evaluate the Preliminary Safety and Effectiveness of GEM OS1 Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device Study Number: BMTI-2005-04 Study Phase: Pilot (Feasibility) Study Design: Prospective, randomized, controlled, multi-center trial Product Name: GEM OS1TM Formulation: Two Components: Package of β-TCP with rhPDGF-BB (becaplermin) solution Indication: Bone Regeneration Device for Foot and Ankle Arthrodesis IDE No.: G050118 Study Initiated (first subject enrolled): 07 Mar 2006 Study Completed (all subjects followed for 36 weeks): 05 Apr 2007
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