Many diseases of the spine require surgical treatments that are currently performed based on the experience of the surgeon. For pedicle arthrodesis surgery, two critical factors must be addressed: Screws must be applied correctly and exposure to harmful radiation must be avoided. The incorrect positioning of the screws may cause operating failures that lead to subsequent reoperations, an increase in the overall duration of surgery and, therefore, more harmful, real-time X-ray checks. In this paper, the authors solve these problems by developing a method to realize a customized surgical template that acts as a drilling template. The template has two cylindrical guides that follow a correct trajectory previously calculated by means of an automatic algorithm generated on the basis of a vertebra CAD model for a specific patient. The surgeon sets the template (drilling guides) on the patient's vertebra and safely applies the screws. Three surgical interventions for spinal stabilization have been performed using the template. These have had excellent results with regard to the accuracy of the screw positioning, reduction of the overall duration of the intervention, and reduction of the number of times the patient was exposed to X-rays.

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Background The integration of computer‐aided design/computer‐aided manufacturing (CAD/CAM) tools and medicine is rapidly developing for designing medical devices. A novel design for a 3D‐printed patient‐specific surgical template for thoracic pedicle screw insertion, using a procedure based on reverse engineering, is presented. Methods The surgeon chooses the entry point on the vertebra. The optimal insertion direction and the size of the screws are defined via an algorithm on the basis of a patient‐specific vertebra CAD model. The template features an innovative shape for a comfortable and univocal placement and a novel disengaging device. Results Three spinal fusions were performed to test the template. Excellent results were achieved in terms of the accuracy of the screw positioning, reduction in surgery duration, and number of X‐rays. Conclusions A novel design for a customized, 3D‐printed surgical template for thoracic spinal arthrodesis was presented, and improvements in terms of precision, duration, and safety were achieved without changing the standard procedure.

Abstract:In this article, the authors propose a novel procedure for designing a customized 3D-printed surgical template to guide surgeons in inserting screws into the sacral zone during arthrodesis surgeries. The template is characterized by two cylindrical guides defined by means of trajectories identified, based on standard procedure, via an appropriate Computer-Aided-Design (CAD)-based procedure. The procedure is based on the definition of the insertion direction by means of anatomical landmarks that enable the screws to take advantage of the maximum available bone path. After 3D printing, the template adheres perfectly to the bone surface, showing univocal positioning by exploiting the foramina of the sacrum, great maneuverability due to the presence of an ergonomic handle, as well as a break system for the two independent guides. These features make the product innovative. Thanks to its small size and the easy anchoring, the surgeon can simply position the template on the insertion area and directly insert the screws, without alterations to standard surgical procedures. This has the effect of reducing the overall duration of the surgery and the patient's exposure to X-rays, and increasing both the safety of the intervention and the quality of the results.

The most common type of spine instrumentation is the pedicle screw fixation. The recent literature shows how customized drilling templates help surgeons to perform the surgery better. This work aims to validate the design of a customized template for inserting lumbar pedicle screw via a procedure based on rapid prototyping and reverse engineering techniques and to show the benefits. The novelties of this template are its low-invasive sizes, its design based on a patented algorithm, which calculates the sizes of the screws and the optimal insertion direction, the engage/disengage system, and the adaptability to every kind of surgeon’s kit. Accuracy of pedicle screw location, surgery duration, and X-ray exposition have been used to evaluate the performances of the template. Mono-centric in vivo trial was performed. Twenty patients (8 women and 12 men) were enrolled randomly corresponding to sixty vertebrae treated with spinal arthrodesis (30 with and 30 without templates). Accuracy of the screw positioning and reduction in both surgery duration and patients’ exposure to X-rays achieved excellent results because the time spent on the insertion of pedicle screws via the surgical template was cut down by about 63%, while the number of X-ray shots was reduced by about 92%. The proposed template performed better than the standard approach and could be helpful both for skilled and novice surgeons.