| Safe and accurate puncture,location was the core step of percutaneous endoscopic lumbar discectomy(PELD)and the key to successful operation.C-arm X-ray machine was used for repeatedly fluoroscopy,and puncture needle was gradually adjust until reaching the target in traditional puncture and location method of PELD,which may increase operation time and radiation exposure.Moreover,limited information was needed to be integrated by surgeons during the process of puncture and location,because accurate puncture depth,angle and other parameters could not be provided in the traditional method.And higher requirements were put forward for spatial imagination ability and surgical experience of surgeon.Therefore,the learning curve of PELD was steep.It was difficult for junior surgeons for puncture and location of PELD since they were often lack of good spatial imagination ability and clinical puncture experience,which may lead to more operation time,patient’s pain,radiation exposure of the surgeon and patient,risk of dural sac and nerve root injury,and even surgical failure.Computer-assisted navigation system has been widely used in screw placement of spinal surgeries,and most studies showed that the accuracy of computer-assisted navigation methods were more accurate than that of traditional methods.In accordance with the present problems of traditional puncture method of PELD and advantages of computer-assisted navigation system,this study intended to use computer-assisted navigation system for puncture and location of PELD,and explore its application effect through anatomical and clinical research.Part Ⅰ: Design and Accuracy Research of 3D Printing Navigation Rod ObjectiveTo develop a navigation rod using digital design and 3D printing technology.The 3D navigation rod could be connected to computer-assisted navigation system.Therefore,computer-assisted navigation system could be used for puncture and location of PELD by the 3D printing navigation rod.MethodIn IMAGEWARE V12.1 software,a navigation rod was designed,which included a cannulated rod with an internal diameter of 1mm and a length of 200 mm.The navigation rod was divided into two parts,one distal and one proximal part.The distal part had an internal diameter of 1mm and an external diameter of 2.5mm,a length of 170 mm and a small tip used for development of a stab incision.The proximal part had an internal diameter of 1mm,an external diameter of 8mm,a length of 30 mm,and a handle at the proximal end used for connecting a navigation receiver array.After completion of design,the imaging data were saved in.hbd format and were output to a metal 3D printer.Using titanium alloy(Ti-6Al-4V)as the printing material,a 3D-navigation rod was printed out,which could be used in anatomical and clinical study after heat treatment,surface finishing,and high-temperature sterilization.This 3D-printing navigation rod was designed in general with different lengths according to patient’s BMI.The C-arm X-ray machine was connected with the computer-assisted navigation system.The navigation reference frame with four infrared light-reflecting diodes was fixed on the posterior iliac spine of the cadaver specimen.The infrared transceiver of computer-assisted navigation system was placed at the end of cadaver specimen,facing the navigation reference frame.Next,anteroposterior and lateral position images of lumbar vertebra were obtained,and the images were transferred to the navigation system.Fifty 3D-navigation rod were connected to the navigation adapter respectively,and each 3D-printed navigation rod was verified and registered by using the navigational pointer on the reference frame.With assistance of navigation system,spinous processes of the third lumbar vertebrae(L3),the fourth lumbar vertebrae(L4)and the fifth lumbar vertebrae(L5)were punctured using each navigation rod.After reaching the spinous processes,spinous processes of L3,L4 and L5 were exposed to confirm the location of navigation rod,the accuracy of navigation rod was judged by anteroposterior and lateral X-ray films on the navigation workstation.The accuracy of 3D-navigation rod was excellent when all three points touched by navigation rod were accurate,otherwise it was poor.Anatomical and clinical studies should be carried out in the next step using the 3D-navigation rods with excellent accuracy.ResultsFifty 3D-navigation rods were verified and registered by using the navigational pointer on the reference frame,and accuracy evaluation of these navigation rods were verified by touching spinous processes of L3,L4 and L5 vertebrae.Forty-seven 3D-navigation rods were excellent,three were poor,and the excellent rate was 94%.ConclusionDigital medicine and 3D printing technology could be used to develop 3D-navigation rods with high puncture accuracy.The 3D-navigation rods could be used for puncture and location of PELD.Part Ⅱ: Anatomical study on puncture and location of percutaneous endoscopic lumbar discectomy using computer-assisted navigation systemObjective To explore whether computer-assisted navigation system can reduce the number of times of fluoroscopy,fluoroscopy time,puncture times,puncture time and learning curve of PELD in junior surgeons by anatomical study.The results of anatomical study may provide theory evidence for the clinical application of computer-assisted navigation system in puncture and location of PELD.Method Eight adult cadaver specimens were collected.Three segments including lumbar 3-4(L3-4),lumbar 4-5(L4-5)and lumbar 5-sacral 1(L5-S1)of each cadaver specimen were punctured.There were two puncture points on both left and right sides in each segment,and six puncture points in three segments.Traditional puncture method and navigation puncture method were used for puncture and location of each puncture point by the same surgeon in the same operation group.The puncture points of each lumbar segment in 8 cadavers were marked according to the puncture sequence.There were 16 surgical serial numbers(1-16)in each segment.The total puncture and location time,fluoroscopy times,fluoroscopy time,puncture times and puncture time of both methods were recorded at each segment with different surgical serial numbers.The learning curves of both methods at different lumbar segments were described and compared.The total puncture and location time,fluoroscopy times,fluoroscopy time,puncture times,puncture time of both methods were analyzed and compared in three lumbar segments,and the correlation between these observational indicators were described.ResultsThe learning curve of navigation puncture and location method was lower than that of traditional puncture and location method in each segment with a decreasing trend in total puncture and location time.And the total puncture and location time of traditional puncture and location method decreased,but it fluctuated.The total puncture and location time for navigation method group was(9.57±3.27)minutes and(21.89±3.54)minutes in traditional method group(P<0.05).In navigation method group,fluoroscopy was used(4.52±0.65)times and(25.08±5.00 times)in traditional method group(P<0.05).The fluoroscopy time was(3.36±0.66)minutes in navigation method group and(12.76±1.98)minutes in traditional method group(P<0.05).The number of times puncture attempts were(1.75±0.86)in navigation method group and(5.63±1.51)times in traditional method group(P<0.05).The puncture time was(6.18±2.97)minutes in navigation method group and(9.13±2.30)minutes in traditional method group(P<0.05).There were significant correlations between number of times fluoroscopy was used and total fluoroscopy time(r=0.986,P<0.001),and high correlations between number of times puncture attempts were made and fluoroscopy time(r=0.859,P<0.001),number of times puncture attempts were made and number of times fluoroscopy was used(r=0.873,P<0.001),number of times fluoroscopy was used and total puncture and location time(r=0.926,P<0.001),number of times puncture attempts were made and total puncture and location time(r=0.911,P<0.001),fluoroscopy time and total puncture and location time(r=0.933,P<0.001),puncture time and total puncture and location time(r=0.810,P<0.001).While there were moderate correlations between number of times puncture attempts were made and puncture time(r=0.727,P<0.001),fluoroscopy time and puncture time(r=0.546,P<0.001),number of times fluoroscopy was used and puncture time(r=0.551,P<0.001).Conclusion The learning curve of PELD in junior surgeons was lower using computer-assisted navigation system,which may promote development of PELD technology.Radiation exposure,total puncture and location time of PELD could be reduced using computer-assisted navigation system.There were significant correlations between fluoroscopy times and total fluoroscopy time,and high correlations between puncture times,puncture time,fluoroscopy time,fluoroscopy time,and total puncture-location time.Thus,PELD using computer-assisted navigation system could minimize the radiation exposure and operation time by reducing fluoroscopy times,puncture times and puncture time.Part Ⅲ: Clinical study on percutaneous endoscopic lumbar discectomy using computer-assisted navigation systemObjective This study evaluated clinical application of PELD by using computer-assisted navigation system for puncture and location comparing with traditional methodMethod 70 patients with lumbar disc herniation were selected and randomly divided into traditional operation group and navigation operation group,with 35 cases in each group.All patients underwent PELD operation by the same operation group and the same surgeon.The traditional puncture method and navigation puncture method were used to perform the operations respectively.The fluoroscopy time,fluoroscopy times,puncture time,puncture times and operation time were analyzed and compared between the two groups.In addition,preoperative and postoperative visual analogue scale(VAS),Japanese Orthopaedic Association(JOA),and Oswestry disability index(ODI)scores were recorded.Preoperative and postoperative sagittal and axial MRI views were used to measure canal diameter,obtained and analyzed at a single 3 Tesla MRI scanner before surgery and within two weeks after surgery.A mid-sagittal slice was used to determine anteroposterior canal diameter.An axial slice through the center of the disc was used to measure central canal area.The MRI scanner software(NUMARIS/4)was used to measure linear dimensions and areas.Results The operation time for navigation method group was(69.69±8.20)minutes and(123.29±13.33)minutes in traditional method group(P<0.05).In navigation method group,fluoroscopy was used(5.34±0.48)times and(29.09± 7.55)times in traditional method group(P<0.05).The fluoroscopy time was(11.97±1.54)minutes in navigation method group and(40.14±8.02)minutes in traditional method group(P<0.05).The number of times puncture attempts were(1.34±0.48)in navigation method group and(8.34±2.31)times in traditional method group(P<0.05).The puncture time was(11.34±1.75)minutes in navigation method group and(32.91±4.20)minutes in traditional method group(P<0.05).There were significant correlations between number of times fluoroscopy was used and total fluoroscopy time(r=0.974,P<0.001).While there were high correlations between fluoroscopy time and puncture time(r=0.918,P<0.001),fluoroscopy time and operative time(r=0.929,P<0.001),puncture times and puncture time(r=0.905,P<0.001),puncture time and operative time(r=0.901,P<0.001).In navigation group,the preoperative back visual analogue scale(VAS)score,leg VAS score,Japanese Orthopaedic Association(JOA)score and Oswestry disability index(ODI)were(6.17±0.98),(6.06±1.28),(17.74±2.83),and(40.54±3.53),postoperative back visual analogue scale(VAS)score,leg VAS score,Japanese Orthopaedic Association(JOA)score and Oswestry disability index(ODI)were(1.40±0.77),(1.60±0.77),(24.11±2.43),and(17.15±3.26).While in traditional group,the preoperative back visual analogue scale(VAS)score,leg VAS score,Japanese Orthopaedic Association(JOA)score and Oswestry disability index(ODI)were(5.94±1.39),(5.66±1.19),(17.66±2.59),and(40.37±3.18),postoperative back visual analogue scale(VAS)score,leg VAS score,Japanese Orthopaedic Association(JOA)score and Oswestry disability index(ODI)were(1.60±0.77),(1.63±0.81),(23.29±2.33),(18.26±3.35).There were not significant difference between the two groups(all P>0.05).However,within groups,all measures significantly improved from preoperative to postoperative time points(P<0.05).In navigation group,the preoperative anteroposterior canal diameter and central canal area were(5.23±0.88)mm and(121.21±23.75)mm2,and postoperative anteroposterior canal diameter and central canal area were(8.17 ±0.97)mm and(159.66±4.45)mm2.While in traditional group,the preoperative anteroposterior canal diameter and central canal area were(5.42 ±0.81)mm and(119.64±21.94)mm2,and postoperative anteroposterior canal diameter and central canal area were(8.23 ±1.01)mm and(161.56±4.14)mm2.Dimensional increases of the canal were seen in sagittal and axial MRI views,though there were no statistically significant differences from preoperative to postoperative or between the two groups(P>0.05).There were two patients with herniation recurrence in navigation group and two patients in traditional group.Two patients with postoperative disc remnants were identified in navigation group and four patients in traditional group(P>0.05).ConclusionPELD by using computer-assisted navigation system could reduce operation time,fluoroscopy times,fluoroscopy time,puncture times and puncture time.There were significant correlations between number of times fluoroscopy was used and total fluoroscopy time,and high correlations between fluoroscopy time and puncture time,fluoroscopy time and operative time,puncture tmies and access time,puncture time and operative time.Thus,PELD by using computer-assisted navigation system can minimize the radiation exposure and operation time by reducing number of times fluoroscopy was used,puncture times and puncture time. |
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