Pedicle screws fixation to stabilize lumbar spinal fusion has become the gold standard for posterior stabilization. However their positioning remain difficult due to variation in anatomical shape, dimensions and orientation, which can determine the inefficacy of treatment or severe damages to close neurologic structures. Image guided navigation allows to drastically decrease errors in screw placement but it is used only by few surgeons due to its cost and troubles related to its using, like the need of a localizer in the surgical scenario and the need of a registration procedure. An alternative image guided approach, less expensive and less complex, is the using of patient specific templates similar to the ones used for dental implants or knee prosthesis.

Like proposed by other authors we decided to design the templates using CT scans. (slice thickness of 2.0 mm). Template developing is done, for each vertebra, using a modified version of ITK-SNAP 1.5 segmentation software, which allow to insert cylinders (full or empty) in the segmented images. At first we segment the spine bone and then the surgeon chose screw axes using the same software. We design each template with two hollow cylinders aligned with the axes, to guide the insertion in the pedicle, adding contact points that fit on the vertebra, to obtain a template right positioning. Finally we realize the templates in ABS using rapid prototyping. After same in-vitro tests, using a synthetic spine (by Sawbones), we studied a solution to guarantee template stability with simple positioning and minimizing intervention invasiveness. Preliminary ex-vivo animal testing on porcine specimens has been conducted to evaluate template performance in presence of soft-tissue in place, simulating dissection and vertebra exposure. For verification, the surgeon examined post-operative CT-scans to evaluate Kirschner wires positioning.

During the ex-vivo animal test sessions, template alignment resulted easy thanks to the spinous process contact point. Their insertion required no additional tissue removal respect to the traditional approach. The positioning of contact points on vertebra's lamina and articular processes required just to shift the soft tissue under the cylinders bases. The surgeon in some cases evaluated false stable template positions since not each of the 4 contact points were actually in contact with the bone surface and tried the right position. CT evaluation demonstrate a positive results in 96.5% of the Kirschner wires implanted.

Our approach allows to obtain patient specific templates that does not require the complete removal of soft tissue around vertebra. Guide positioning is facilitated thanks to the using of the spinous processes contact point, while false stable positions can be avoided using four redundant contact points. The templates can be used to guide the drill, the insertion of Kirschner in case of use of cannulated screws or to guide directly the screw. After these preliminary ex-vivo animal tests we obtained the authorization of the Italian Health Ministry to start the human study.

Pedicle screws fixation to stabilise lumbar spinal fusion is the gold standard for posterior stabilisation. Pedicle screws are today positioned in free hand or under fluoroscopic guidance with an error from 20% up to 40–50%, which can determine the inefficacy of treatment or severe damages to close neurologic structures. Surgical navigation drastically increases screws placement accuracy. However its clinical application is limited due to cost reasons and troubles related to the presence of a localiser in the OR and the need to perform a registration procedure before surgery. An alternative image guided approach is the use of patient specific templates similar to the ones used for dental implants or knee prosthesis. Until now, the proposed solutions allow to guide the drill, and in some cases, as templates fit completely around vertebra, they require the complete removal of soft tissues on a large portion of the spine, so increasing intervention invasiveness. To reduce the soft tissue demolition, some authors proposed a fitting based on small “V shape” contact points, but these solutions can determine instability of the template and the reacting of wrong stable positions.

In our solution, after spine CT acquisition, each vertebra is segmented using a modified version of ITK-SNAP software, on which the surgeon plans screws positioning and finally the template is designed around the chosen trajectories, using a tool which allows to insert cylinders (full or empty) in the segmented images. Each template, printed in ABS, contains two hollow cylinders, to guide the screws, and multiple contact points on the bone surface, for template stabilisation.

We made an in-vitro evaluation on synthetic spine models (by Sawbones) to study different template designs. During this first step an ongoing redesign allowed to obtain an optimal template stability and an easy template positioning to minimise the intervention invasiveness. A first contact point, which fits on the sides of the spinous process, is used to simplify template alignment. The other 4 contact points, which consists of cylinders (diameter 5 mm), fit exactly on spine surface in correspondence to the vertebra's lamina and articular processes to stabilise the template in an unique position. Templates can be used to guide not only the drill, but also Kirschner wires, to guide cannulated screws. After the Kirschner wires insertion the template can be dismounted for its removal (the direction of the kirschner wires are not parallel).

After the definitive template design an ex-vivo animal test on 2 porcine specimens has been conducted to evaluate template performance in presence of soft-tissue in place. The specimens have been scanned with CT, we realised a total of 14 templates and we performed the insertion of 28 Kirschner wires. We evaluated that after the soft tissue dissection and the bone exposure, the template can be easily positioned in the right unique position, with no additional tissue removal compared to the traditional approach, requiring just removal of the soft tissue under the small contact points using an electric cutter. The surgeon evaluated (and corrected) some wrong stable template positions when not all the contact points were in contact with the bone surface. The post-op evaluation was made with a CT scan that showed 1 cortical pedicle violation (3.5%) (grade II according to the FU classification).