"In vivo" validation of 3d-printed innovative surgical template for lumbar spinal arthrodesis

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.