SBIR-STTR Award

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 has rapidly transformed fracture treatment with bone plates. Over the past decade, locked plating captured 88% of the $1.1 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 recent 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. The proposed research will assess the feasibility of an innovative locked plating strategy aimed at resolving the growing concern of non-unions with current locked plating technology. Our proposed product is an elastic locking plate (E-Lock plate) with flexibly suspended screw holes that permit controlled motion at the fracture site to actively promote fracture healing by callus formation. This feasibility study will test the hypothesis that E-Lock plates can deliver controlle interfragmentary motion within the range known to promote fracture healing, while providing fixation strength comparable to that of a standard locked plating construct. For this purpose, the preliminary E-Lock plate design will be computationally optimized to deliver the required stiffness and interfragmentary motion for promotion of callus formation, while maximizing construct strength. The optimized solution will be translated into functional prototype E-Lock plates for bench-top testing. E-Lock plating constructs will be tested in direct comparison to standard locked plating constructs in all principal loading modes. Results of this research will be essential to translate this promising technology into an advanced fracture treatment, particularly for treatment of osteoporotic fractures in the elderly population. Successful completion of this research will determine the feasibility of E-Lock technology to actively promote fracture healing while retaining the improved fixation strength of locking plates. This technology will furthermore be poised to prevent non-unions by reducing the staggering non-union rate associated with standard locking plates in the over 200,000 patients that are treated each year with locking plates in the United States alone.

Public Health Relevance:
By providing superior stabilization of bone fractures, locking plate technology has been implemented in 88% of all bone plates, but recent studies indicate that these locking plates are too stiff and suppress fracture healing, requiring revision surgery i approximately one out of five patients. The proposed research evaluates the feasibility of an innovative design that makes locking plates less stiff and that can actively promote fracture healing. If this novel technology can be successfully transferred into a commercial solution, it will reduce the staggering cost and societal burden caused by deficient fracture healing in over 200,000 patients that are treated each year in the USA with locking plates.