Ankle/Hindfoot Fusion Clinical Trial
Official title:
Prospective, Randomized, Controlled, Multi-Center, Pivotal Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Study Objective: To demonstrate equivalent clinical and radiologic outcomes as "gold
standard" (ABG) in a representative clinical model (foot and ankle fusions)
Study Hypothesis: Augment™ Injectable is an equivalent bone grafting substitute to
autologous bone graft in applications as shown by superiority analysis for safety and
non-inferiority analysis for effectiveness
Study Rationale: Evaluate a fully synthetic bone graft material 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
Musculoskeletal problems are pervasive throughout the population in all age groups and in
both sexes. Half of Americans will need services for fractures at some point in their
lifetime according to a widely published article presented at the 2003 annual meeting of the
American Academy of Orthopedic Surgeons (AAOS). Many musculoskeletal problems, such as
fractures and non-unions require bone graft to ensure adequate bone healing. One of the most
widely used options for bone graft is autologous bone however; clinical difficulties have
been associated with ABG (autologous bone graft). Most of these difficulties result from the
harvest of the bone graft, including increased operative time, hospital stay and cost,
increased blood loss, post-operative pain, risk of infection and/or fracture. The morbidity
associated with ABG and its limited amount available to be harvested has directed surgeons
to look for a better alternative for a chemotactic, mitogenic, and angiogenic bone graft
substitute as an alternative for fracture augmentation to accelerate healing (St. John et
al, 2003).
Currently, there are no generally accepted alternatives to ABG for fusion procedures of the
foot or ankle. In order to demonstrate a product's effectiveness, it is necessary to show
equivalence to autogenous bone graft in terms of safety and effectiveness. The purpose of
this study is to examine the safety and efficacy of Augment™ Injectable Bone Graft
(Beta-TCP/ Bovine Collagen matrix + rhPDGF-BB) in facilitating equivalent mean time to union
as ABG in this foot and ankle fusion model. Our hypothesis is that the intraoperative
application of Augment™ Injectable Bone Graft (Augment™ Injectable) in foot and ankle fusion
procedures will demonstrate at least equivalent efficacy to that of the gold standard of
autogenous bone graft while avoiding the trauma and sequelae associated with an additional
surgical procedure.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment