An alternative to plaster cast treatment in a pediatric trauma center using the CAD/CAM technology to manufacture customized three-dimensional-printed orthoses in a totally hospital context: a feasibility study.

The aim of this study is to implement the clinical use of the three-dimensional (3D) design and printing technology in pediatric pathologies requiring immobilization. We describe the manufacturing process of the 3D device in place of the plaster cast usually applied to a child 48/72 h after the access to the Trauma Center Traumatology Hub. This procedure had already been performed at Level II, Trauma Center, Campania Region, Orthopaedic Division of Santobono Children's Hospital, Naples, Italy. The operative phase was performed by two 3D printers and a scanner in the bioengineering laboratory of the hospital's outpatient area. The phase of software elaboration requires close cooperation among physicians and engineers. We decided to use a model with a double-shell design and holes varying in width to ensure complete ventilation and lightness of the device. We chose to treat nondisplaced metaphyseal distal fractures of the radius in 18 patients enrolled from January 2017 to November 2017. The flow chart includes clinical and radiological examinations of every enrolled child, collecting information required by the program and its elaboration by bioengineers, and then transfer of the results to 3D printers. The child, immobilized by a temporary splint, wore his 3D device after 12/24 h. Then, he underwent serial check-ups in which the effectiveness and appropriateness of the treatment were clinically monitored and evaluated using subjective scales: visual analogue scale and patient-rated wrist evaluation. All the fractures consolidated both radiologically and clinically after the treatment, with no complications reported. Only one partial breakage of the device happened because of an accidental fall. The statistical analysis of the visual analogue scale and patient-rated wrist evaluation data shows that children's activities of everyday life improved during the immobilization thanks to this treatment. This first study shows that using a 3D device instead of a traditional plaster cast can be an effective alternative approach in the treatment of pediatric nondisplaced metaphyseal distal radius fractures, with high overall patient satisfaction. We believe that 3D technology could be extended to the treatment of more complex fractures; this will be the subject of our second study.