Abstract
For decades, the advantages of rapid prototyping for clinical use have been recognized. However, demonstrations of potential solutions to treat spinal problems that cannot be solved otherwise are scarce. In this paper, we describe the development, regulatory process, and clinical application of two types of patient specific 3D-printed devices that were developed at an in-house 3D point-of-care facility. This 3D lab made it possible to elegantly treat patients with spinal problems that could not have been treated in a conventional manner. The first device, applied in three patients, is a printed nylon drill guide, with such accuracy that it can be used for insertion of cervical pedicle screws in very young children, which has been applied even in semi-acute settings. The other is a 3D-printed titanium spinal column prosthesis that was used to treat progressive and severe deformities due to lysis of the anterior column in three patients. The unique opportunity to control size, shape, and material characteristics allowed a relatively easy solution for these patients, who were developing paraplegia. In this paper, we discuss the pathway toward the design and final application, including technical file creation for dossier building and challenges within a point-of-care lab.
Highlights
Publisher’s Note: MDPI stays neutralAdditive manufacturing, commonly known as 3D printing, has been adopted as one of the key elements of future medical care
To aid surgeons with pedicle screw positioning in adults, patient specific 3D-printed drill guides have been developed by several groups [16,20–22]
The surface of the lateral apical processes, needed for optimal rotational stability, is difficult to clean from soft tissue, especially in the pediatric cervical spine where apophyseal cartilage is present
Summary
Commonly known as 3D printing, has been adopted as one of the key elements of future medical care. An increasing number of hospitals are establishing a 3D printing point-of-care facility in which the opportunities of 3D printing, in terms of technical possibilities and legal/regulatory challenges, can be fully explored [5,6] Such a facility, frequently known as a (point-of-care) 3D lab, uses the output of established state-of-the-art clinical image modalities such as the newest CT and MRI and subsequently post-processes the data into digital anatomical models to better embody the patient and to allow interaction with surgeons for the development of custom-made medical devices [7–10]. The with regard to jurisdictional claims in published maps and institutional affiliations This 3D technology is especially important for tertiary referral hospitals, which primarily function as a specialized center for complex cases and as a safety net for last-resort cases [6,11]. Background information is given, followed by the methodology and clinical results
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