A practical methodology for computer-aided design of custom 3D printable casts for wrist fractures

In recent years, breakthroughs in the fields of reverse engineering and additive manufacturing techniques have led to the development of innovative solutions for personalized medicine. 3D technologies are quickly becoming a new treatment concept that hinges on the ability to shape patient-specific devices. Among the wide spectrum of medical applications, the orthopaedic sector is experiencing the most benefits. Several studies proposed modelling procedures for patient-specific 3D-printed casts for wrist orthoses, for example. Unfortunately, the proposed approaches are not ready to be used directly in clinical practice since the design of these devices requires significant interaction among medical staff, reverse engineering experts, additive manufacturing specialists and CAD designers. This paper proposes a new practical methodology to produce 3D printable casts for wrist immobilization with the aim of overcoming these drawbacks. In particular, the idea is to realize an exhaustive system that can be used within a paediatric environment. It should provide both a fast and accurate dedicated scanning of the hand-wrist-arm district, along with a series of easy-to-use semi-automatic tools for the modelling of the medical device. The system was designed to be used directly by the clinical staff after a brief training. It was tested on a set of five case studies with the aim of proving its general reliability and identifying possible major flaws. Casts obtained using the proposed system were manufactured using a commercial 3D printer, and the device\u2019s compliance with medical requirements was tested. Results showed that the designed casts were correctly generated by the medical staff without the need of involving engineers. Moreover, positive feedback was provided by the users involved in the experiment

A CAD-based Procedure for Designing 3D Printable Arm-wrist-hand Cast

Wrist injuries are one of the most common fractures, specifically around 25% of fractures among the pediatric population and up to 18% in the elderly age group are distal radius fractures. To date, the standard treatment entails the use of a tailor-made plaster Paris cast. Although it is a simple and reliable treatment, it presents several disadvantages: its weight generally causes discomfort, it cannot be taken off without breaking it, it can cause skin rashes and prevents ventilation of the treated area. To overcome the limitations of the above mentioned treatment, 3D printed orthopaedic casts based on reverse engineering (RE) and additive manufacturing (AM) techniques have been proposed in literature. Despite these solutions prove to be a valid alternative to the standard treatment, the clinical use of AM-based devices is not trivial due to the need of expert CAD modelers to design the 3D model of the orthosis starting from the patient\u2019s anatomy 3D acquisition. In this work, the authors identify a systematic procedure to create an orthosis model, compliant with medical guidelines, using common CAD tools: the CAD-modeling steps are grouped into five main blocks in view of a future automatization of the process, which can eliminate the necessity of designing expertise to model the orthosis. The produced device is composed of two halves, to ease the application, locked through a zip tie-based mechanism. A preliminary ventilation pattern is proposed and tested with a FEM analysis to ensure structural resistance. The procedure has been tested on six case studies: all the orthoses models were correctly generated without major complications and positive user feedbacks were generally obtained throughout the tests

3D-Printed Patient-Specific Casts for the Distal Radius in Children: Outcome and Pre-Market Survey

Background: Orthopaedic and Trauma surgery is expected to undergo profound trans-formation as a result of the adoption of 3D technology. Among the various applications, patient specific manufacturing of splints and casts would appear to be, particularly in children, an interesting implementation. This study aims to assess the safety of patient specific 3D casts obtained with a newly developed 3D-scanning devise in a small case series. We therefore conducted a clinical outcome and pre-marketing study in 10 consecutive patients with distal radius fractures treated at an Academic Level I Pediatric Trauma Center. After the application of the 3D cast, patients underwent three consecutive evaluations in the following 21 days. The main outcome measurements were: pain, skin lesions and general comfort, and acceptance of the cast. The three domains were measured with the Visual Analogue Scale (VAS), the NPUAP/EPUAP classification and the Positive affect-Negative affect Scale for Children (PANAS-C), the Self-Assessment Manikin (SAM) clinical psychology tests and a Likert-type five item questionnaire, respectively. A final mechanical analysis of the cast was carried out to confirm product integrity. Results: The results obtained were consistently positive in the investigated domains of general comfort, efficacy of contention and mechanical integrity of the 3D-printed cast as well as in the practicability of the supply chain. Conclusions: This study provides Level IV evidence that patient specific 3D printed casts obtained with a specifically designed software were safe in the management of “buckle” fractures of the distal radius in children. These results encourage to extend the technology to the treatment of more demanding fractures

3D-Printed Patient-Specific Casts for the Distal Radius in Children: Outcome and Pre-Market Survey

Background: Orthopaedic and Trauma surgery is expected to undergo profound transformation as a result of the adoption of 3D technology. Among the various applications, patient specific manufacturing of splints and casts would appear to be, particularly in children, an interesting implementation. This study aims to assess the safety of patient specific 3D casts obtained with a newly developed 3D-scanning devise in a small case series. We therefore conducted a clinical outcome and pre-marketing study in 10 consecutive patients with distal radius fractures treated at an Academic Level I Pediatric Trauma Center. After the application of the 3D cast, patients underwent three consecutive evaluations in the following 21 days. The main outcome measurements were: pain, skin lesions and general comfort, and acceptance of the cast. The three domains were measured with the Visual Analogue Scale (VAS), the NPUAP/EPUAP classification and the Positive affect-Negative affect Scale for Children (PANAS-C), the Self-Assessment Manikin (SAM) clinical psychology tests and a Likert-type five item questionnaire, respectively. A final mechanical analysis of the cast was carried out to confirm product integrity. Results: The results obtained were consistently positive in the investigated domains of general comfort, efficacy of contention and mechanical integrity of the 3D-printed cast as well as in the practicability of the supply chain. Conclusions: This study provides Level IV evidence that patient specific 3D printed casts obtained with a specifically designed software were safe in the management of “buckle” fractures of the distal radius in children. These results encourage to extend the technology to the treatment of more demanding fractures