Development of a Dynamic Compression Fusion Device for Lower Extremity Salvage of the Diabetic Foot

Significant research findings during the research period include: development and testing of a dynamic compression device for use in challenging surgical foot procedures, such as fusion in the diabetic Veteran patient population. Testing results show superior mechanical performance in comparison to FDA-cleared competitor devices, including pull-out, static bending, cyclic bending, torsion, and the capacity for sustained compression in the face of simulated bone resorption. Additional project results include completion of all in vivo procedures for a large animal model for in vivo static and dynamic device evaluation featuring normal and low bone quality, as would be seen in more challenging patients. Implanted dynamic devices were observed to sustain compression over time, as assessed by serial radiograph examination. Microcomputed tomography was utilized to assess new bone formation at the joint fusion complex. Finally, mechanical testing of explanted joint complexes was demonstrated to assess integrity of joint fusion structures.