MedShape Inc, Atlanta, has received a Technology/Therapeutic Development Award funded by the Department of Defense Peer-Reviewed Medical Research Program (PRMRP) to assist in the research and development of a dynamic compression fusion device using superelastic nickel-titanium (Nitinol) for use in diabetic foot limb salvage surgery. The funding award from PRMRP includes $2.6M to complete the research milestones over the next three years.
Nearly five million military Veterans suffer from diabetes mellitus with 15,000 of those also diagnosed with Charcot Foot – a painless, progressive, disease that results in the breakdown of the bones in the midfoot. Diabetic patients reportedly are 10-20 times more at risk of needing an amputation compared to non-diabetics. In addition, those who undergo an amputation are three times more likely to die within one year of surgery compared with patients who are successfully treated through other surgical options. Given the high mortality rate, orthopedic surgeons strive to salvage the limb with alternative surgical treatments. Currently, intramedullary (IM) screws are placed across the midfoot in an attempt to stabilize and realign the foot. However, these “beaming” devices undergo repetitive and significant loading, with 25-60% of the current devices experiencing failure, often due to loss of compressive force, implant loosening, and axial migration.
Through the support of the DOD research grant, MedShape, in collaboration with limb salvage specialists Dan Latt, MD/Ph.D. (University of Arizona) and Naohiro Shibuya, DPM (Texas A&M College of Medicine), will explore the development of novel devices that maintain dynamic compression and effectively stabilize the foot in an effort to preserve the limb in the diabetic Charcot Veteran population. By leveraging MedShape’s patented Nitinol platform technology, devices can be designed to adapt and respond to specific changes in the biological environment that occur during healing while also effectively load-sharing with the bone to reduce stress risers on the device that lead to device failure and additional surgery.
