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Current efforts on automating the design process focused mainly on convolutional neural networks (CNN), which have produced state-of-the-art results on reconstructing synthetic defects. However, existing CNN-based methods have been difficult to translate to clinical practice in cranioplasty, as their performance on large and complex cranial defects remains unsatisfactory. In this paper, we present a statistical shape model (SSM) built directly on the segmentation masks of the skulls represented as binary voxel occupancy grids and evaluate it on several cranial implant design datasets. Results show that, while CNN-based approaches outperform the SSM on synthetic defects, they are inferior to SSM when it comes to large, complex and real-world defects. Experienced neurosurgeons evaluate the implants generated by the SSM to be feasible for clinical use after minor manual corrections. Datasets and the SSM model are publicly available at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/github.com\/Jianningli\/ssm\" ext-link-type=\"uri\">https:\/\/github.com\/Jianningli\/ssm<\/jats:ext-link>.<\/jats:p>","DOI":"10.1007\/s10916-024-02066-y","type":"journal-article","created":{"date-parts":[[2024,5,23]],"date-time":"2024-05-23T05:01:57Z","timestamp":1716440517000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Back to the Roots: Reconstructing Large and Complex Cranial Defects using an Image-based Statistical Shape Model"],"prefix":"10.1007","volume":"48","author":[{"given":"Jianning","family":"Li","sequence":"first","affiliation":[]},{"given":"David G.","family":"Ellis","sequence":"additional","affiliation":[]},{"given":"Antonio","family":"Pepe","sequence":"additional","affiliation":[]},{"given":"Christina","family":"Gsaxner","sequence":"additional","affiliation":[]},{"given":"Michele R.","family":"Aizenberg","sequence":"additional","affiliation":[]},{"given":"Jens","family":"Kleesiek","sequence":"additional","affiliation":[]},{"given":"Jan","family":"Egger","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2024,5,23]]},"reference":[{"key":"2066_CR1","doi-asserted-by":"publisher","DOI":"10.7717\/peerj-cs.773","volume":"7","author":"J Egger","year":"2021","unstructured":"Egger J, Pepe A, Gsaxner C, Jin Y, Li J, Kern R (2021) Deep learning-a first meta-survey of selected reviews across scientific disciplines, their commonalities, challenges and research impact. 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