Improving Fracture Healing with Active Plating Technology - 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.
