The Polymethylmethacrylate Cranioplasty Using Low-Cost 3D Printing Technology: Clinical Trial
Abstract
Objectives : Various materials are available for cranioplasty, but a consensus on the best options has not yet been reached. The most utilized material is Polymethylmethacrylate (PMMA). However, there are certain drawbacks associated with its use. Firstly, the manual molding process can be challenging, potentially resulting in an asymmetrical implant that does not resemble the original skull's aesthetic. Secondly, the exothermic reaction occurring during the procedure poses a risk of brain tissue injury. Fortunately, introducing 3D printing technology offers a solution to these PMMA-related disadvantages. This study aimed to evaluate the clinical outcomes, cosmetic results, and complications associated with in-hospital fabrication of 3D-printed cranioplasties.
Materials and Methods : This is a prospective study incorporating a historical control group. The prospective group (3D printing) encompasses patients who underwent cranioplasty utilizing prefabricated 3D-printed PMMA implants within the period of August 2021 to July 2022 (n=16). The control group consisted of 17 consecutive patients who had undergone cranioplasty two years prior. Comparisons between the two groups were performed using the chi-square test for categorical data and the student’s t-test for continuous data. The clinical endpoint was analyzed by multivariable Gaussian regression for correlated data.
Results : In the 3D printing group, the mean operative time was 60.50 minutes compared to 112.06 minutes in the conventional group (P<0.001). Intraoperative blood loss was 153.12 cc in the 3D printing group and 250.0 cc in the conventional group (P=0.041). The length of stay was significantly shorter in the 3D printing group (3.94 days) compared to the conventional group (8.65 days) (P<0.001). The mean cosmetic score was higher in the 3D printing group (4.75) than in the conventional group (3.05) (P<0.001). Seizures occurred in 1 case (6.25%) in the 3D printing group and 7 cases (41.18%) in the conventional group (P=0.009). The rate of wound complications did not differ between the two groups (18.75% and 17.65%, respectively; P=1.00).
Conclusions : The 3D-printed PMMA implants resulted in superior clinical outcomes, fewer seizures, and excellent aesthetics. Their manufacturing process was both simple and cost-effective. Based on these findings, we conclude that the presented 3D printing technique is a favorable choice for cranioplasty.
Keywords: 3D printing, cranioplasty, polymethylmethacrylate, custom implants, cranial defect
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