The purpose of this study is to see how a new device, OSSIGELL, works in a small number of people who need a tibia fractured treated. This is the first time OSSIGEL has been used in humans. Studies in animals suggest that treatment of fractures with OSSIGELL may accelerate bone healing and provide stability to the fracture site. This could allow for earlier cast removal and return to normal function. OSSIGELL is a formulation of recombinant human basic fibroblast growth factor (bFGF) in a hyaluronic acid (HA) gel. The feasibility study is designed to evaluate the safety and pharmocokinetics of bFGF following the intraosseous administration of OSSIGELL. The initial performance of OSSIGEL in the management of stable and unstable closed diaphyseal fractures of the tibia will be assessed. Ten (10) eligible subjects will be randomly assigned for treatment with 0.1mL, 0.3 mL, 1.0 mL, 1.5 mL, 2.0 mL, OSSIGEL in a sequential, ascending manner. The OSSIGEL will be introduced to the fracture site percutaneously at the time of the fracture reduction. The fracture site will be stabilized using either interlocking intramedullary unreamed nailing, casts, or commercially available braces.
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