A novel Laser Navigation System reduces radiation exposure and improves accuracy and workflow of CT-guided spinal interventions: A prospective, randomized, controlled, clinical trial in comparison to conventional freehand puncture

摘要

Purpose: Phantom model evaluation and prospective randomized clinical trial to assess the clinical feasibility and benefit of using a novel Laser Navigation System (LNS) in CT-guided epidural and perineural injections in comparison to the conventional freehand procedure. Methods: The LNS guided puncture technique was compared to the standard CT-guided freehand treatment using a phantom model and a randomized clinical trial. Spinal injections were administered by an experienced interventional team to evaluate needle placement accuracy, treatment time and radiation exposure. Results: In the LNS group of the phantom model study, the needle entrance point accuracy of 0.5 mm (freehand 3.1 mm), needle target point accuracy of 2.0 mm (freehand 3.5 mm), number of control CT slices of 1.4 (freehand 2.7) and needle placement time of 5 min 4 s (freehand: 9 min 18 s) showed significant improvements compared to freehand in 60 punctures. In the clinical trial the LNS group achieved needle entrance point accuracy of 1.3 mm (freehand 4.6 mm), needle angulation accuracy of 0.4° (freehand 2.3°), number of control CT slices of 1.1 (freehand 1.8) and needle placement time of 6 min 54 s (freehand 9 min 00 s), showing significant improvements compared to freehand in a total of 58 CT-guided interventions. Conclusion: The LNS group showed significantly improved results in both study designs. Both the phantom model evaluation and the clinical trial of spinal injections showed feasibility and efficacy of using the novel LNS. Even an experienced interventional team worked with it more precise, faster and with reduced radiation exposure.