Abstract
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.
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Data Availability
All data from the study is reported in Table 2.
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Acknowledgements
We would like to acknowledge and thank Kathleen Smith for her contributions to the preparation of this work.
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All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Alice Xu, Vysakh Venugopal, Manish Raj, Yara Alfawares, Abhijith Matur, Joshua Cheng, Ethan Kosco, Matthew McConaha, Omkar Ghalsasi, Demiah Lockett, Gabriella Bal, Norberto Andaluz, Laura Ngwenya, Sam Anand, and Jonathan Forbes. The first draft of the manuscript was written by Alice Xu, Vysakh Venugopal, Manish Raj, Yara Alfawares, and Abhijith Matur, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This study was approved by the Institutional Review Board of the University of Cincinnati College of Medicine, and all specimens were obtained using the standard informed consent protocol in place at the University of Cincinnati Body Donation Program. The protocols used were approved by the institutional Human Research Protection Program. We certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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The authors affirm that human research participants provided informed consent for the publication of the images in Fig. 3.
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Xu, A., Venugopal, V., Aryal, M.R. et al. Toward global availability of low-cost, patient-specific cranial implants: creation and validation of automated CranialRebuild freeware application. Acta Neurochir 165, 2219–2224 (2023). https://doi.org/10.1007/s00701-023-05663-x
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DOI: https://doi.org/10.1007/s00701-023-05663-x