SBIR-STTR Award

Direct to Phase II

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 thesteadily increasing population with osteoporosis. By providing better fixation in osteoporoticbone, locked plating technology rapidly transformed fracture treatment with bone plates. Lockedplating has captured 83% of the $1.9 billion US plating market, despite the virtual absence ofclinical data supporting improvements in outcome. However, the wave of enthusiasm has beentempered by failure rates of 13-21% reported in clinical studies on locked plating. Research hasconfirmed that deficient fracture healing observed with locking plates is largely due to theirinherent stiffness, which suppresses interfragmentary motion required to stimulate bone healingby callus formation. Extensive preliminary studies delivered conclusive proof that an innovative platingconcept, termed Active Plating, retains the superior fixation strength of locking plates anddelivers controlled interfragmentary motion known to promote fracture healing. Active Platingprovides 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 significantlyfaster, stronger, and more consistent healing than standard locking plates. The proposed PhaseII research and development efforts will support translation of Active Plating technology into aclinical product by completion of two aims: First, an advanced Active Plating design will beimplemented into a distal femur plate system. Second, an in vivo study will be conduct toquantify improvements in the strength, speed, symmetry, and consistency of fracture healingprovided by Active Plating in comparison to standard locked plating. Completion of the two aims will provide two distinct deliverables: translation of ActivePlating technology into a commercially viable implant solution; and a performance evaluation invivo to document its effects on fracture healing. Since Active Plating technology is scalable, ourvision is to expand the technology to a wide range of plating solutions, and to trigger a paradigmshift towards fracture fixation that harnesses the potential of biologic fracture healing induced byaxially flexible implant solutions. Given the proven potential of controlled interfragmentarymotion to accelerate and amplify the fracture healing cascade, successful completion of theproposed research and development is poised to deliver the benefits of faster, stronger healingto patients, and to decrease the substantial economic and societal burden of non-unions.

Public Health Relevance Statement:
By providing superior stabilization of bone fractures, locking plate technology has been implemented in 83% of all bone plates. However, recent studies indicate that these locking plates are too stiff and suppress fracture healing, requiring revision surgery in approximately one out of five patients. The proposed research and development efforts will translate a flexible locked plating technology into a clinical plating solution capable of actively promoting the speed and strength of fracture healing by provision of controlled fracture motion. 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.

Project Terms:
Adult ; 21+ years old ; Adult Human ; adulthood ; Bone plates ; Bone callus ; Bony Callus ; Callus ; Clinical Research ; Clinical Study ; Economics ; Limb structure ; Extremities ; Limbs ; Non-Trunk ; Femur ; Fracture Fixation ; Skeletal Fixation ; Fracture ; bone fracture ; Incidence ; instrumentation ; Motion ; Osteoporosis ; Patients ; Research ; research and development ; Development and Research ; R & D ; R&D ; Sheep ; Ovine ; Ovis ; Suspensions ; Suspension substance ; Technology ; Testing ; tibia ; Time ; Translating ; Translations ; United States ; Vision ; Sight ; visual function ; Generations ; Custom ; Fracture Healing ; base ; improved ; Distal ; Clinical ; Phase ; Biological ; Evaluation ; Failure ; Funding ; mechanical ; Mechanics ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; experience ; Performance ; Speed ; Reporting ; Modeling ; preventing ; prevent ; in vivo ; Clinical Data ; sample fixation ; Fixation ; Development ; developmental ; cost ; healing ; virtual ; design ; designing ; improved functioning ; Outcome ; Population ; innovation ; innovate ; innovative ; Implant ; bone healing ; bone wound healing ; osseous wound healing ; flexibility ; flexible ; osteoporotic bone ; Cost efficiency ; manufacturability ; in vivo evaluation ; in vivo testing ;