Radiation dose reduction in thoracic and lumbar spine instrumentation using navigation based on an intraoperative cone beam CT imaging system: a prospective randomized clinical trial.

PURPOSE: Spine surgery still remains a challenge for every spine surgeon, aware of the potential serious outcomes of misplaced instrumentation. Though many studies have highlighted that using intraoperative cone beam CT imaging and navigation systems provides higher accuracy than conventional freehand methods for placement of pedicle screws in spine surgery, few studies are concerned about how to reduce radiation exposure for patients with the use of such technology. One of the main focuses of this study is based on the ALARA principle (as low as reasonably achievable). METHOD: A prospective randomized trial was conducted in the hybrid operating room between December 2015 and December 2016, including 50 patients operated on for posterior instrumented thoracic and/or lumbar spinal fusion. Patients were randomized to intraoperative 3D acquisition high-dose (standard dose) or low-dose protocol, and a total of 216 pedicle screws were analyzed in terms of screw position. Two different methods were used to measure ionizing radiation: the total skin dose (derived from the dose-area product) and the radiation dose evaluated by thermoluminescent dosimeters on the surgical field. RESULTS: According to Gertzbein and Heary classifications, low-dose protocol provided a significant higher accuracy of pedicle screw placement than the high-dose protocol (96.1 versus 92%, respectively). Seven screws (3.2%), all implanted with the high-dose protocol, needed to be revised intraoperatively. The use of low-dose acquisition protocols reduced patient exposure by a factor of five. CONCLUSION: This study emphasizes the paramount importance of using low-dose protocols for intraoperative cone beam CT imaging coupled with the navigation system, as it at least does not affect the accuracy of pedicle screw placement and irradiates drastically less.

Fracture mechanisms in Ti and Co-Cr growing rods and impact on clinical practice.

The widely used treatment of early onset scoliosis based on fusionless spinal instrumentation with growing rods suffers from severe complications due to premature rod failure. Only few studies have explored the fracture mechanisms in single rod constructs, while clinical practice urgently needs guidance. The objectives of this study are (i) to determine the failure mechanisms in Ti-6Al-4V alloy, Ti Cp 2 and Co-Cr alloy rods, and (ii) to propose strategies to reduce the risk of rod fracture. For this purpose, seven rods from three patients treated for early onset scoliosis were characterized by preoperative, pre-fracture X-rays and after-fracture X-rays. Fracture surface analysis, performed using scanning electron microscopy, revealed similar failure mechanisms for all rods, independent of composition and diameter. Fracture is caused by fatigue, associated to repeated bending action in the anteroposterior direction. Cracking initiates at multiple sites. Three-point bending fatigue tests on Ti-6Al-4V bent rods confirmed the fracture scenario. A beam bending model indicates that the failure process is controlled by the combination of cyclic vertical and horizontal forces with amplitudes from 200 N to 400 N and from 70 N to 150 N, respectively. Strategies to minimize fracture involve adaptations of material properties and rod geometry to scoliosis characteristics, including sagittal alignment, and spine behavior.