The Preclinical Studies Of Minimally Invasive Laser Navigation System

BackgroundWith surgical navigation technology vigorous development in various disciplines,CAOS(computer assisted orthopedic surgery)technology has also made great progress,including positioning and real-time guiding function.The CAOS can greatly improve the accuracy of surgery,reduce surgical trauma,shorten the operation time,speed up the patient's recovery period,greatly ease the patient's pain,while also reducing the radiation exposure of the surgeon during surgery,so that the safety and effectiveness of surgery have made significant improvements.However,the existing variety of surgical navigation systems have their own deficiencies and limitations,and is difficult to completely overcome in the short term,and therefore a need for an accurate,simple and rapid new surgical navigation system that helps the surgeon during surgery lesion precise real-time positioning and guidance,in order to ensure the smooth implementation of the operation..ObjectiveWe confirmed the accuracy of the system and the possibility of clinical application through the clinical application feasibility test.Then do the operations of soft tissue metallic foreign body removal surgery and percutaneous kyphoplasty using the minimally invasive laser navigation system.After that we separately compared these two operations with the traditional C-arm fluoroscopy-assisted surgical to verify the accuracy and applicability of the system,and further assess the possibility of the system's spreading in clinical applications.MethodAccuracy test: First,we divided the test into three groups depending on the distance between the navigation system and precision plate.Then we did the test on the precision plate and recorded every position error between the position and the standard position.Second,we calculated the accuracy distribution within each group of tests we have done.At last,we compared among the three groups in order to evaluate whether the positioning accuracy have differences on different distances.Finally,we evaluated the feasibility of minimally invasive laser navigation system in clinical application.Initial pre-clinical trial application:1,Metallic Foreign Bodies(MFBs)in soft tissue removal surgery:16 patients with metallic foreign bodies in soft tissue were equally divided into two groups.The control group used the traditional surgical methods and the trail group used the minimally invasive laser navigation system.Then we recorded the positioning time,operation time,the number of fluoroscopy,the amount of bleeding and wound size.We took X-ray to assess the effect of surgery after the operation.2,Percutaneous Kyphoplasty(PKP):18 patients with vertebral compression fractures were equally divided into two groups.The control group used the traditional surgical methods and the trail group used the minimally invasive laser navigation system.Then we recorded the vertebral height before and after surgery,operation time,the number of fluoroscopy.We took X-ray and CT to assess the effect of surgery and the complications after the operation.Both groups were evaluated with the Oswestry Disability Index(ODI)and a visual analogue scale(VAS).ResultIn the accuracy test: All the position errors were less than 1.5mm and the positioning accuracy had no differences on different distances.So it has feasibility of clinical application.In the initial pre-clinical trial application:1,the positioning time,operation time,the number of fluoroscopy,the amount of bleeding and wound size were significantly lower in the minimally invasive laser navigation system group compared with the traditional C-arm guidance group(P<0.05).2,the vertebral height before and after surgery,operation time,the number of fluoroscopy were significantly lower in the minimally invasive laser navigation system group compared with the traditional C-arm guidance group(P<0.05).There were no significant differences between the two groups in the preoperative and postoperative ODI and VAS scores(P > 0.05).ConclusionMinimally invasive laser navigation system combines laser positioning and guided surgery technology,to ensure that the surgeon accurately obtain the position and direction of the surface and surgical path in percutaneous surgery.Simple operation,without spending a lot of time for hands-on training,it has the advantages of high speed positioning,high precision and significantly reducing ionizing radiation.Although the Minimally invasive laser navigation system can't replace the traditional three-dimensional navigation,but in some relatively simple surgical procedures,such as intra-articular injection,bone tissue biopsy,which still has the characteristics of simple and rapid application value.Minimally invasive laser navigation system provides a novel,effective and safe surgical positioning and navigation method,should be promoted in clinical practice.