Improving Fracture Healing with Active Plating Technology

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Each year, over 6 million fractures are treated in the United States at a cost in excess of $13 billion. Between 5-8% of these fractures experience complications, particularly in the steadily increasing population with osteoporosis. By providing better fixation in osteoporotic bone, locked plating technology rapidly transformed fracture treatment with bone plates. Locked plating has captured 83% of the $1.9 billion US plating market, despite the virtual absence of clinical data supporting improvements in outcome. However, the wave of enthusiasm has been tempered by failure rates of 13-21% reported in clinical studies on locked plating. Research has confirmed that deficient fracture healing observed with locking plates is largely due to their inherent stiffness, which suppresses interfragmentary motion required to stimulate bone healing by callus formation. Extensive preliminary studies delivered conclusive proof that an innovative plating concept, termed Active Plating, retains the superior fixation strength of locking plates and delivers controlled interfragmentary motion known to promote fracture healing. Active Plating provides controlled interfragmentary motion by elastic suspension of screw holes inside a plate 2. This Active Plating solution has shown to stimulate natural fracture healing, yielding significantly faster, stronger, and more consistent healing than standard locking plates. The proposed Phase II research and development efforts will support translation of Active Plating technology into a clinical product by completion of two aims: First, an advanced Active Plating design will be implemented into a distal femur plate system. Second, an in vivo study will be conduct to quantify improvements in the strength, speed, symmetry, and consistency of fracture healing provided by Active Plating in comparison to standard locked plating. Completion of the two aims will provide two distinct deliverables: translation of Active Plating technology into a commercially viable implant solution; and a performance evaluation in vivo to document its effects on fracture healing. Since Active Plating technology is scalable, our vision is to expand the technology to a wide range of plating solutions, and to trigger a paradigm shift towards fracture fixation that harnesses the potential of biologic fracture healing induced by axially flexible implant solutions. Given the proven potential of controlled interfragmentary motion to accelerate and amplify the fracture healing cascade, successful completion of the proposed research and development is poised to deliver the benefits of faster, stronger healing to patients, and to decrease the substantial economic and societal burden of non-unions.