Evaluation Methods

Our review of the current treatment market and the advice of our stakeholders helped our team identify the problem with current treatment: no treatment combines personalized medicine with autologous bone growth and decreases the risk of infection and rejection. Current bone graft methods have insufficient mechanical and biochemical properties, pain at both the implementation and derived sites, rejection rates in up to 30% of procedures, rates of infection up to 10% in patients, and improper geometry to match that of the calvarium.^,,,, Metal and PMMA-based implants have similar issues in terms of infection, mechanical strength, degradation, and potential multiple procedures. The current treatments, while effective to a certain degree, do not provide total patient care with a personalized approach and bone regeneration.

Radiologists will administer some form of imaging to diagnose a calvarial defect properly usually with either magnetic resonance imaging (MRI) or computed tomography (CT). CT stands as the most reliable imaging technique because of the high contrast between bone and native tissue. Our patient treatment process will begin with creating multiple transverse two-dimensional images of the patient’s skull which compile into a three-dimensional representation of the patient’s skull. The radiologist obtains the CT files as a stack of DICOM images, which the user will input into a MatLab algorithm. Our algorithm will use a slice-by-slice reconstruction software to re-create a three-dimensional image of calvarial defect. A 3D printer will take the reconstruction information and will print the respective porous PCL-based scaffold that will optimally fit into the defected skull. The clinician will implant pre-osteoblast and growth factor loaded scaffold back into the native skull to stimulate bone regrowth within the scaffold and native skull. The overall process will take time, but the patient will have native bone regeneration into a complete skull.

Our solution creates a uniform patient-treatment pipeline that produces personalized outputs. Native calvarial bone regrowth is the ultimate end goal of this project, but current advances in tissue engineering have already proven the possibility of regeneration of parietal bone in rat models. The major innovation in this solution is through the creation of a reconstruction pathway that simply requires an input of 3D-CT images and produces an output of a personalized scaffold that stimulates the aforementioned bone regeneration with a manufactured drug release profile. This well-defined pathway will allow for greater patient outcome and less variability in treatment of patients.