Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

STUDY DESIGN: Prospective, randomized, controlled, non-inferiority, multi-center trial NUMBER OF STUDY CENTERS: 25 NUMBER OF SUBJECTS: 299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01) STUDY POPULATION: Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure. TREATMENT GROUPS: Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft). ROUTE OF ADMINISTRATION: Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space STUDY DURATION: Twenty-four month follow-up post-surgery