Application And Innovation Research Of Optical And Electromagnetic Navigation Technique In Minimally Invasive Spinal Surgery

BackgroundMinimally invasive spinal surgical technique is developed to improve preservation of the surrounding normal anatomical structures,diminish intraoperative bleeding and complications,thus reducing recovery times.As the special structure of spinal anatomy is adjacent to important vascular and neural tissues.Scoliosis and degeneration can distort the natural spinal anatomical structure,which would magnify the location difficulty and increase radiation exposure in surgery.The longer learning curve and serious complication have been the major obstructive causes in development of minimally invasive spinal surgical technique.The purpose of this study explores the combination of digital navigation technique and minimally invasive spinal surgical technique,through development of navigation equipment and software,integration and optimization of the surgical process,to realize the excellent application of navigation technique during minimally invasive spinal procedure,cut down the learning curve,and enhance the safety of minimally invasive spinal surgery.Moreover,based on the pros and cons of current optical and electromagnetic navigation,this project aims to develop a novel optical and electromagnetic integrated surgical navigation system with independent intellectual property rights.The novel navigation system would reveal the complementary advantages of optical and electromagnetic navigation and realize the free switching function between optical and electromagnetic navigation technique.Part one: Clinical Research of Percutaneous Posterior Cervical Foraminotomy Assisted by O-Arm-Based Navigation for Cervical Spondylotic RadiculopathyPurpose: This study aimed to assess the clinical efficacy,radiological outcome and the factors predicting an excellent outcome of patients who underwent percutaneous posterior cervical foraminotomy procedure assisted by O-arm-based navigation.Methods: Forty-two patients who had single-level foraminal disc herniation or foraminal stenosis were retrospectively reviewed.Radicular arm pain was the most common presenting symptom in patients.All patients underwent full-endoscopic posterior cervical foraminotomy assisted by O-arm-based navigation.Clinical efficacy was assessed by the visual analog scale(VAS)for neck and radicular arm pain,neck disability index(NDI),and the short form-36 health survey questionnaire(SF-36)in the immediate preoperative period,immediately postoperative,and at the final follow-up.The clinical parameters and radiological parameters included cervical curvature(CA),segmental angle(SA),and range of motion(ROM),which were assessed preoperatively and at the last follow-up.Results: The mean follow-up for the patients was 15 months.There were no perioperative complications.The VAS score for radicular arm pain and neck pain and the NDI score improved significantly in all the patients.The SF-36 score reflected significant improvement in all 8 domains.Excellent and good outcomes were achieved in 38 out of 42 patients.The cervical curvature range of motion(CA-ROM)statistically and significantly improved at the final follow-up period compared with the preoperative period.The SA was less kyphotic after PECD at the final follow-up.The postoperative CA and CA-ROM improved but did not significantly change.On the univariate analysis,patients with a symptom duration of less than 3 months had a better outcome than patients with a symptom duration of more than 3 months(excellent,83.33% vs.50.00%).Conclusions: The results of this study show that the percutaneous posterior cervical foraminotomy procedure assisted by O-arm-based navigation is a safe and effective option for cervical radiculopathy,with the advantages of a minimally invasive method.Patients with symptom duration less than 3 months had a better outcome than patients with symptom duration more than 3 months.Part Two: Clinical Outcomes and The Learning Curve Study of Percutaneous Endoscopic Lumbar Discectomy Assisted by O-Arm-Based Navigation for Lumbar Disc HerniationPurpose: There is a steep learning curve with traditional percutaneous endoscopic lumbar discectomy(PELD).The aim of this study is to assess the safety and efficacy of PELD assisted by O-arm-based navigation for treating lumbar disc herniation(LDH).Methods: From September of 2017 to January of 2018,118 patients with symptomatic LDH were enrolled in the prospective cohort study.The patients undergoing PELD with O-arm-based navigation technique were defined as group A(58 cases),and those undergoing traditional X-ray fluoroscopy method were defined as group B(60 cases).We recorded the operation time,cannula placement time,radiation exposure time,visual analog scale(VAS),Oswestry Disability Index(ODI),and Macnab criteria score of the 2 groups.Results: The average operation time(95.21 ± 19.05 mins)and the cannula placement time(36.38 ± 14.67 mins)in group A were significantly reduced compared with group B(operation time,113.83 ± 22.01 mins,P<0.001;cannula placement time,52.63 ± 17.94 mins,P<0.001).The learning curve of PELD in group A was steeper than that in group B and was lower in the relatively flat region of the end.There were significant differences of the clinical parameters at different time points(VAS of low back,P <0.001;VAS of leg,P < 0.001;and ODI,P < 0.001).The VAS scores for low back pain and leg pain improved significantly in both groups after surgery and gradually improved as time went by.No serious complication was observed in all patients.Conclusions: The study indicated that PELD assisted by O-arm navigation is safe,accurate,and efficient for the treatment of lumbar intervertebral disc herniation.It reshaped the learning curve of PELD,reduced the difficulty of surgery,and minimized radiation exposure to surgeons.Part Three: Clinical Safety and efficiency of Percutaneous Transforaminal Endoscopic Lumbar Decompression Assisted by G-Arm-Based Electromagnetic Navigation for Lumbar Spinal StenosisPurpose: This study introduces a novel electromagnetic-based navigation(EMN)endoscopic system for percutaneous transforaminal endoscopic lumbar decompression(PTELD)in patients with lumbar spinal stenosis(LSS)and compares the results in navigation and non-navigation(fluoroscopy)groups.Methods: 88 patients with LSS were randomized into either a navigation or fluoroscopy group.Duration of surgery,cannula placement time,radiation dose,blood loss,intraoperative pain assessment,and postoperative hospitalization stay were analyzed.The clinic outcomes were assessed using a visual analogue scale(VAS),the Oswestry Disability Index(ODI),6-minute walk test,and modified Macnab criteria.Results: Eighty-five patients were followed-up for at least 12 months.The duration of surgery and cannula placement time were significantly more efficient in the navigation group(P<0.05).Intraoperative pain assessment showed significantly less pain in the navigation group(P<0.05).The radiation dose was significantly higher in the fluoroscopy group than the navigation group(P<0.05).The VAS scores for back and leg pain improved significantly in both groups after surgery,as did the ODI scores.Improvements in walking ability and Macnab criteria assessments at the final follow-up,assessed subjective by patient assessments did not differ between the two groups.Conclusions: The EMN system used in PTELD for patients with LSS results in outcomes comparable with results using fluoroscopy.It reduces intraoperative pain,reduces levels of radiation exposure,and it is more efficient for foraminoplasty.Part Four: Innovative Design and Development of a Novel Optical and Electromagnetic Integrated Surgical Navigation SystemPurpose: The purpose of this study is to develop a product prototype,software and matched surgical instruments of the Novel optical and electromagnetic integrated surgical navigation system.Methods: Through addressing the key techniques of optical and electromagnetic equipment integrated,the optical and electromagnetic tracking instruments registration at the same time,the heterogenous deformation medical image fusion and real-time tracking in in-vivo instruments,multi-plane data reconstruction for surgical procedure,and multi-mode image signal detection and so on,is to evaluate the theoretical feasibility for Novel optical and electromagnetic integrated surgical navigation system.Results: The product prototype of novel optical and electromagnetic integrated surgical navigation system was developed successfully,approved in the preliminary detection and completed registration in CFDA.The software and matched surgical instruments of the Novel optical and electromagnetic integrated surgical navigation system were developed successfully.We have applied for and obtained some relevant software copyright and invention patent.Conclusions: Aiming at the advantages and disadvantages of current optical and electromagnetic navigation systems,a novel optical and electromagnetic integrated surgical navigation system with independent intellectual property rights is developed successfully.Part Five: Accuracy and Safety of a Novel Optical and Electromagnetic Integrated Surgical Navigation System: An Animal ExperimentPurpose: The purpose is to evaluate the accuracy of the Novel optical and electromagnetic integrated surgical navigation system through an experimental study in porcine model.Methods: 4 porcine models were randomly assigned to experimental and controlled group.In the experiment group,electromagnetic needle was used to place an appropriate guide wire in the planed target point.The intraoperative puncture point was recorded by screenshot and the postoperative actual position was obtained by O-arm scan.Then the guide wire was removed,optical navigated tube was used to implant 2.5mm K-wire into the pedicle from T7 to L5 vertebrae in the 4 porcine spine models.The intraoperative puncture trajectory and postoperative actual position of K-wire was recorded.Electromagnetic and optical navigation accuracies were evaluated respectively.Results: In the animal experiment,116 punctures with electromagnetic navigation guided and 60 K-wires insertion with optical navigation guided were managed in the experiment group,60 K-wires insertion with optical navigation were completed in the controlled group.The accuracy of electromagnetic navigation is1.82±0.05 mm in the animal experiment.The accuracy of optical navigation was detected no significant difference between two groups.The safety and stability of novel navigation system were excellent in the procedure.Conclusions: The novel optical and electromagnetic integrated surgical navigation system is demonstrated that it not only retains the accuracy and stability of the traditional optical navigation system,but also has high precision electromagnetic navigation function.It would be the first time to achieve the function in optical and electromagnetic equipment integrated,the optical and electromagnetic tracking instruments registration at the same time.Thus,optical and electromagnetic navigation could switch freely,and complement each other.Part Six: The Safety and Efficiency of pedicle screw placement guided with The Novel Optical and Electromagnetic Integrated Surgical Navigation System: A Prospectively Randomly Controlled Clinical StudyPurpose: The purpose is to evaluate the safety and efficiency of the Novel optical and electromagnetic integrated surgical navigation system through a prospective randomly controlled clinical study.Methods: A prospective randomly parallel controlled clinical trial was designed to evaluate the safety and efficiency of the novel navigation system.Patients already planned for instrumented spinal surgery,randomly using either novel navigation system or the Stealthstation navigation(Medtronic)for pedicle screw insertion.The primary outcomes were excellent-good rate of pedicle screws within 1 week after surgery.Results: Currently,19 patients were finally enrolled,81 pedicle screws were inserted totally(48 in the experiment group,33 in the controlled group).The excellent-good rate was both 100% in two groups.The excellent rate was 97.9% in the test group compared with 93.9% in the controlled group,no significant difference was found between two groups about accuracy of pedicle screw insertion.The excellent rate was 97.9% in the test group compared with 93.9% in the controlled group,no significant difference was found between two groups about accuracy of pedicle screw insertion.The pedicle screw time and prepare time were both found no significant difference between two groups.The safety and stability of novel navigation system were excellent in the procedure.Conclusions: The results of the prospective randomly controlled clinical study revealed that pedicle screw insertion with the novel optical and electromagnetic integrated surgical navigation system was safe and efficient,which got a step further to demonstrate the accuracy and stability of the system in progress.It must be the first application in clinical trial.Free switching and advantages complemented function were achieved intraoperatively.