Development of a Dynamic Compression Fusion Device for Lower Extremity Salvage of the Diabetic Foot
Abstract
Significant research findings during the research period include: design and development of a dynamic compression device for use in challenging surgical foot procedures, such as fusion in the diabetic Veteran patient population. Initial testing results show superior mechanical performance in comparison to FDA-cleared competitor devices, including pull-out and bending performance, as well as the capacity for sustained compression in the face of simulated bone resorption. Additional project findings include introduction of 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2021
- Accession Number
- AD1154991
Entities
People
- David L. Safranski
Organizations
- MedShape (United States)