Toward global availability of low-cost, patient-specific cranial implants: creation and validation of automated CranialRebuild freeware application.

PURPOSE: Financial restrictions limit the options for hermetically precise, patient-specific cranial implants (PSCIs) after decompressive hemicraniectomy (DHC) in low-income countries. Use of image segmentation, modeling software, and 3D printers has lowered costs associated with PSCIs. However, requirements of time and technical expertise have prevented widespread utilization. Our objective was to create a fully automated software algorithm that is able to generate a virtual model (.STL) of a negative of an implant using CT imaging following DHC. METHODS: A freeware algorithm (CranialRebuild) was constructed with the following capabilities: (1) after the upload of digital imaging and communications in medicine files, the normal side is analyzed in reference to the side of DHC, (2) Boolean subtraction is used to obtain a virtual image of the desired implant, and (3) a two-piece virtual model (.STL) of the PSCI mold is generated. In four cadaveric specimens, a standard DHC was performed. Post-DHC CT imaging was used to obtain a .STL of the negative of the implant, which was then printed using poly-lactic acid (PLA). Methylmethacrylate cement was used to generate a PSCI from the mold. The PSCIs were implanted into the index specimens; cosmesis was subjectively evaluated using a 5-point Likert scale. RESULTS: Two specimens were graded as 4/5, indicating that minor post-processing modification was needed for optimal cosmesis. Two specimens were graded as 3/5, indicating that optimal cosmesis could be obtained following moderate post-processing modification. CONCLUSIONS: CranialRebuild can be used to create hermetically precise PSCIs at a fraction of the price of third-party vendors. Validation of this technology has significant implications for the accessibility of customized cranial implants worldwide.

Early Challenges in the Implementation of Automated CranialRebuild Freeware for Generation of Patient-Specific Cranial Implant Using Additive Manufacturing: A Pilot Project in Review.

Traumatic Brain Injury (TBI) is a significant global health concern, particularly in low- and middle-income countries (LMICs) where access to medical resources is limited. Decompressive craniectomy (DHC) is a common procedure to alleviate elevated intracranial pressure (ICP) following TBI, but the cost of subsequent cranioplasty can be prohibitive, especially in resource-constrained settings. We describe challenges encountered during the beta-testing phase of CranialRebuild 1.0, an automated software program tasked with creating patient-specific cranial implants (PSCIs) from CT images. Two pilot clinical teams in the Philippines and Ukraine tested the software, providing feedback on its functionality and challenges encountered. The constructive feedback from the Philippine and Ukrainian teams highlighted challenges related to CT scan parameters, DICOM file arrays, software limitations, and the need for further software improvements. CranialRebuild 1.0 shows promise in addressing the need for affordable PSCIs in LMICs. Challenges and improvement suggestions identified throughout the beta-testing phase will shape the development of CranialRebuild 2.0, with the aim of enhancing its functionality and usability. Further research is needed to validate the software's efficacy in a clinical setting and assess its cost-effectiveness.