| BackgroundPercutaneous transforaminal endoscopic technique have a steep learning curve. Positioning and puncturing need precision, which are the core step of the procedure. The safety space for the puncture is small, anatomy obscured, beginners have less three-dimensional stereoscopic, proficiency of operative and other reasons, resulting in difficulties in positioning and puncturing, prolonging operative time, increasing patient suffering for multiple punctures, increasing infection, increasing risk of injury for dural sac and nerve root. Repeated X-ray fluoroscopy increases radiation for the surgeon and the patient. How to reduce surgery time, reduce fluoroscopy times, improve safety and efficacy of surgery, is the direction we have been exploring.ObjectiveClinical actual situation, based on trigonometric principles proposed design concept, developed transf oraminal lumbar puncture percutaneous devices. Depending on the security space is small and the anatomic characteristics of block proposed design innovation before surgery puncture approach. Design puncture approach before surgery and assisted intraoperative localization biopsy instrument, to improve the accuracy and success rate in transforaminal lumbar puncture, reducing the surgeon and patients X-ray radiation, shortering operative time, less puncture complications.Methods(1) According to percutaneous transforaminal lumbar puncture principle and proposed design concept combined with trigonometric principles. Design percutaneous transforaminal lumbar puncture devices, which can be set to puncture parameters, including operating surface puncture, puncture angle, puncture depth, needle point. Manufacture by Dongguan Desheng mold company.(2) Included64patients with lumbar disc herniation, Guangdong Provincial Hospital of Orthopaedics Hospital undergoing percutaneous transforaminal mirror therapy Which hve L4-5segment section32cases, L5S1segment section32cases, both single segment case. L4/5segment section32patients were randomly divided into experimental group A and control group B,16patients in each group. In pre-surgery used Chen triangle transfer method to design approach in group A patients, used TESSYS method to design approach in group B in pre-surgery. L5/S1segment section32patients were randomly divided into experimental and control group C group D,16patients in each group. Group C patients in pre-surgery using Mimics software design approach, tused TESSYS method to design approach in group D in pre-surgery. Four groups were punctured intervertebral foramen puncture and C-arm X-ray confirmed. Record four groups positioning puncture related indicators, including one-time success rate, number of puncture, puncture required time, the number of projection. Measuring the position of the four groups working pipeline related indicators, calculated the rate of it in line with preoperative design. Statistically analyzed using SPSS19.0software.(3) Included40patients with lumbar disc herniation, Guangdong Provincial Hospital of Orthopaedics Hospital undergoing percutaneous transforaminal mirror therapy Which hve L4-5segment section24cases, L5S1segment section16cases, both single segment case. They were randomly divided into experimental group E and control group F,20patients in each group. In pre-surgery used Chen triangle transfer method or Mimics software to design approach in group E patients, used TESSYS method to design approach in group F in pre-surgery. Two groups were punctured intervertebral foramen puncture and C-arm X-ray confirmed. Record two groups positioning puncture related indicators, including one-time success rate, number of puncture, puncture required time, the number of projection. Record groupA、groupB、groupC、groupD、 groupE、groupF’s operative time. Surgery-related complications and clinical efficacy were compared in groupA、groupB、groupC、roupD、groupE、groupF’ sPostoperative follow-up.Results (1) successfully developed a percutaneous transforaminal lumbar puncture positioning equipment.(2)Puncture related indicators compare:Group A one-time success rate, number of puncture, puncture time, X-ray fluoroscopy times compared with group B, P<0.05, statistically different results. Group C one-time success rate, number of puncture, puncture time, X-ray fluoroscopy times compared with group D, P<0.05, with a statistically significant result. Work pipeline location related indicators:Group A of data of "puncture angle","lateral angle""point","degree" compared with group B, P<0.05, statistically different results, but "anteroposterior angle"compared with group B, P>0.05, undifferentiated results. Group C data of "puncture angle","anteroposterior angle","lateral angle","point","degree" compared with the D group, P<0.05, statistically different results. Compliance rate of Postoperative working pipe contrast with Preoperative design work location:group C compliance rate of"puncture angle","lateral angle""point","degree" compared with group B, P<0.05, statistically different results, but "anteroposterior angle"compared with group B, P>0.05, undifferentiated results, group C compliance rate of "puncture angle","lateral angle""point","degree" compared with group D, P<0.05, with a statistically significant result.Puncture related indicators compare:The experimental group E one-time success rate, number of puncture, puncture time, X-ray fluoroscopy times compared with the control group F, P<0.05, statistically different results. The experimental group E, disposable puncture success rate, number of puncture, puncture time, X-ray fluoroscopy times compared with the experimental group A, P<0.05, statistically different results. The experimental group E disposable success rate, the number of puncture, the puncture needed time, X-ray frequency compared with the experimental group C, P<0.05, statistically different results. The average operation time:Group A90.58min/case, Group C118.79min/case, Group E93.72min/case, Group B115.47min/case, Group D125.14min/case, Group F120min/case.Compared the experimental group with the control group, P<0.05, statistically different results. Complication rates:Group A, GroupB, GroupC, GroupD, GroupF without positioning puncture and postoperative complications; Group E had one case of nerve paresthesia (4%), compared with control Group F P>0.05, the result was not statistically significant. Clinical efficacy:The experimental group A, The experimental groupC, The experimental groupE and control Group B, control Group D, control Group F VAS scores, one day after surgery and the end of the follow-up compared with preoperative VAS scores, Visual analog score was significantly decreased (P<0.05), with a significant difference. On other side, compared the experimental group one day after surgery and the end of the follow-up visual analog scale with control Group was no significant difference (P>0.05), no statistically significant difference. The experimental group A, The experimental groupC, The experimental groupE and control Group B, control Group D, control Group F JOA scores, one day after surgery and the end of the follow-up compared with preoperative JOA scores, JOA score was significantly decreased (P<0.05), with a significant difference. On other side, compared the experimental group one day after surgery and the end of the follow-up visual JOA scale with control Group was no significant difference (P>0.05), no statistically significant difference. Group A good rate of one day after surgery was62.50%, excellent rate of last follow-up was93.75%. Group B good rate of one day after surgery was56.25%, excellent rate of last follow-up was87.50%. Group C good rate of one day after surgery was68.75%, excellent rate of last follow-up was87.50%. Group D good rate of one day after surgery was62.50%, excellent rate of last follow-up was87.50%. Group E good rate of one day after surgery was60.00%, excellent rate of last follow-up was90.00%. Group F good rate of one day after surgery was65.00%, excellent rate of last follow-up was85.00%. At the same time follow-up results in the experimental group and the control rate of excellent and good rate of excellent, with rank sum test analysis, P＞0.05, no statistically significant difference.Conclusions(1) the percutaneous transforaminal lumbar puncture positioning equipment Chen triangle transfer method, or Mimics software to design approach before surgery, which can improve the success puncture rate, reduce the number of puncture, shorte the puncturing time and reduce surgeon and patients’ amount of radiation.(2) Chen triangle transfer method, or Mimics software to design approach before surgery, wich can improve the success puncture rate. Three methods primarily by increasing the puncturing needle point accuracy. Percutaneous transforaminal lumbar puncturing instrument improve the success rate and reduce puncturing angle error by fixed operating plane. Combination both of them can significantly improve the success rate.(3)the percutaneous transforaminal lumbar puncture positioning equipment, Chen triangle transfer method, or Mimics software do not increase the incidence of surgical complications.(4)the percutaneous transforaminal lumbar puncture positioning equipment Chen triangle transfer method, or Mimics software to design approach before surgery were Compared with the traditional puncture.which receive no significant difference in clinical efficacy. |
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