Foot Fusion Clinical Trial
Official title:
A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold
standard" (ABG) in a representative clinical model (hindfoot and ankle fusions)
STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous
bone graft in applications as shown by non-inferiority analysis
STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to
facilitate fusion in conditions or injuries requiring bone graft in a representative clinical
fusion model and thus the opportunity to provide equivalent union rates as ABG without
necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA)
Application as a bone regeneration system, pivotal phase
n/a