The Innovative Design And Clinical Application Of The Novel Double-cannula Targeted Foraminoplasty Technique

Background and Objectives:Spinal degenerative diseases,such as lumbar intervertebral disc herniation(LDH)and lumbar spinal stenosis(LSS),are the common diseases which are highly disturbing to people's life and work.The patients should undergo surgery if he/she underwent conservative treatment for at least 6 months without effect,whose daily work and life were affected significantly,with cauda equina syndrome,or severe nerve root injury.Percutaneous endoscopic lumbar discectomy(PELD)has become a mature surgical technique of minimally invasive surgery for treating LDH and LSS.However,for the traditional TESSYS technique,the intraoperative puncture should be very precise,the learning curve of traditional PELD is steep,and it is difficult to perform foraminoplasty.Meanwhile,for the treatment of nerve root canal stenosis,the traditional puncture is more difficult,and it is difficult to achieve the target decompression of the intervertebral foramen.Part one: The Innovative Design of the Novel Double-cannula Targeted Foraminoplasty Device.To design a novel percutaneous endoscopic puncture and targeted foraminoplasty device,for helping spine surgeons shorten the learing period of PELD,reduce the surgery difficulty of beginners,reduce the risk of severe iatrogenic complications such as intraoperative nerve injury,and cut down the radiation exposure as much as possible.Part one: The Clinical Comparison study for the Novel Double-cannula Targeted Foraminoplasty Technique and Traditional Foraminoplasty TESSYS Technique in the Treatment of LDH.The objective of this part was to introduce the novel double-cannula targeted foraminoplasty technique in detail,and assume the clinical feasibility,safety and efficiency and compare with the traditional TESYSSYS technique in operation difficulty and postoperative effect.Part three: The Retrospective Study for the Novel Double-cannula Foraminoplasty Device Assisted by O-Arm-Based Navigation in the Treatment of LDH.The objective of this part was to assume the clinical feasibility and efficiency of the novel double-cannula device assisted by O-arm-based navigation in the treatment of LDH.Methods:Part one:According to the concept of double-cannula design with rotary adjustment,draw the design sketches and complete the production and processing of device.Further design and fine-tune to preliminary products based on clinical practice.Part two:From March of 2017,patients from the Department of Orthopaedics,the Second Affiliated Xinqiao Hospital of Army Medical University,with symptomatic LDH undergoing PELD by the same surgeon were collected.According to the different ways of puncture and foraminoplasty during operation,the patients with the the novel double-cannula technique were set to the ZESSYS group(35 cases),meanwhile the patients with the traditional TESSYS technique were set to the TESSYS group(35 cases),and underwent follow-up at least 1 year.We recorded the patient demographic characteristics,cannula introduction time,decompression time,radiation exposure time,intraoperative pain feeling score of the 2 groups.We also recorded visual analog scale(VAS,0-10)of leg and low-back pain,as well as Oswestry Disability Index(ODI)preoperatively,postoperative immediately and postoperative 1 month,3 months,6 months,and 12 months,and measured Macnab score(excellent,good,fair,poor)at 12 months follow-up,which was used to evaluate patients' functional outcomes.Part three:From September of 2017 to January of 2018,30 patients from the Department of Orthopaedics,the Second Affiliated Xinqiao Hospital of Army Medical University,with symptomatic LDH undergoing PELD with double-cannula foraminoplasty technique assisted by O-arm-based navigation were enrolled in the retrospective study,and underwent follow-up at least 7 months.We recorded the patient demographic characteristics,operation time,cannula introduction time,VAS score of leg and low-back pain,as well as ODI score preoperatively,postoperative 1 day,3 months,and 7 months,and measured Macnab score(excellent,good,fair,poor)at 7 months follow-up,which was used to evaluate patients' satisfaction and functional outcomes.Results:Part one:According to the mechanical sketch,a novel double-cannula targeted foraminoplasty device named ZESSYS was made and applied in clinic.We have completed the national utility model patent declaration,as well as obtained the CFDA record.Part two:The average cannula introduction time(17.81±4.05 minutes)and the radiation exposure time(43.69±11.10 seconds)in the ZESSYS group were significantly reduced compared with the TESSYS group(cannula introduction time,21.79±5.55 minutes,P = 0.001;radiation exposure time,53.77±9.14 seconds,P < 0.001).Intraoperative pain feeling score in the ZESSYS group was significantly improved compared with the TESSYS group(P = 0.012).The VAS score and ODI score improved significantly in both groups after surgery and gradually improved as time went by(P < 0.05).There were no significant differences between the 2 groups for decompression time(P = 0.452),Macnab criteria(P = 0.521),or VAS and ODI score(P > 0.05).No serious complication was observed in any patients in either group.Part three:All patients underwent scheduled surgery successfully without any conversion to open surgery.No major complications were observed.The average operation time was 92.87±8.89 minutes,the cannula introduction time was 34.00±7.38 minutes.The patients were generally discharged 1 or 2 days after surgery.The VAS score of leg and low-back and ODI score improved significantly after surgery and gradually improved as time went by(P < 0.05).The excellent and good rates of Macnab criteria were 86.67%.Conclusions:Part one:Our team has innovatively designed and developed a novel double-cannula targeted foraminoplasty device,which can facilitate PELD surgeons to adjust puncture position,reduce the risk of nerve injury and use of intraoperative fluoroscopy,and expand the intervertebral foramen and lateral recess simply and accurately.Part two:The novel double-cannula targeted foraminoplasty technique is effective and safe.It reduces the difficulty of PELD learning,simplifies the operation steps,minimizes radiation exposure,and decreases intraoperative pain associated with foraminoplasty.Part three:PELD with the novel double-cannula foraminoplasty device assisted by O-arm navigation is safe and efficient for the treatment of LDH.It simplifies the methods of puncture,helps surgeons break the technique barriers and reduce the difficulty of surgery,through the double-cannula technique and the guidance of intraoperative real-time navigation.