Invasive Spine Surgery Research Articles

Comparing the efficacy and safety of minimally invasive biportal endoscopic spine surgery versus conventional microscopic discectomy in single-level lumbar herniated intervertebral disc (ENDO-BH Trial): a multicenter, prospective, randomized controlled equivalence trial study protocol

BackgroundBiportal endoscopic surgery has recently been performed in lumbar discectomy, with advantages over conventional surgery, such as less skin scarring and muscle damage. However, the clinical results have not been established. Although previous studies reported no difference between the biportal endoscopic and microscopic discectomy clinical results, the evidence was weak. Therefore, this study aims to evaluate the efficacy and safety of the biportal endoscopic discectomy versus the microscopic discectomy.MethodsThis prospective multicenter randomized controlled equivalence trial is designed to compare the efficacy and safety outcomes of patients who underwent lumbar discectomy using biportal endoscopy or microscopy. We will include 100 participants (50 per group) with a lumbar herniated disc. The primary outcome will be the Oswestry Disability Index (ODI) score 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes will include the visual analog scale score for low back and lower extremity radiating pain, the ODI score, the Euro-Qol-5-Dimensions score, surgery satisfaction, walking time, postoperative return to daily life period, postoperative surgical scar, and surgery-related variables, such as postoperative drainage, operation time, admission duration, postoperative creatine kinase, and implementation status of conversion to open surgery. Radiographic outcomes will also be analyzed using magnetic resonance imaging (MRI) or computed tomography (CT) and simple radiographs. Safety will be assessed by evaluating all adverse and severe adverse events and surgery-related effects. The participants will be assessed by a blinded assessor before surgery (baseline) and 2 weeks and 3, 6, and 12 months after surgery.DiscussionThis trial will be the first prospective, multicenter, randomized controlled trial to analyze the efficacy and safety of biportal endoscopic discectomy in lumbar herniated disc.This trial is designed for evaluating the equivalence of the results between biportal endoscopic and microscopic discectomy including adequate sample size, blinded analyses, and prospective registration to reduce bias. This trial will provide enough data on the effectiveness and safety of biportal endoscopic surgery and will be an important study that allows clear conclusions.Trial registrationClinical Research Information Service (cris.nih.go.kr.) (KCT0006191). Registered on 27 March 2021

Minimally invasive multiple-rod constructs with robotics planning in adult spinal deformity surgery: a case series.

Multiple-rod constructs (MRCs) are often used in deformity correction for increased stability and rigidity. There are currently no reports showing minimally invasive placement of MRCs in adult deformity surgery and its technical feasibility through preoperative software planning. Data were collected retrospectively from medical records of six consecutive patients who underwent minimally invasive MRCs with robotics planning by a single surgeon at an academic center between March-August 2020. A total of six patients (4 females, mean age 69.7years) underwent minimally invasive long-segment (6 +) posterior fixation with multiple rods (3 +) using the Mazor X Stealth Edition robotics platform. Average follow-up was 14.3months. All patients underwent oblique lumbar interbody fusion (OLIF) as a first stage, followed by second stage posterior fixation in the same day. The mean number of levels posteriorly instrumented was 8.8. One patient underwent 3 rod fixation (1 iliac, 2 S2AI) and 5 patients underwent quad rod fixation (2 iliac, 2 S2AI). The mean time to secure all rods was 8min 36s. Mean improvement in spinopelvic parameters was -4.9cm sagittal vertical axis, 18.0° lumbar lordosis, and -10.7° pelvic tilt with an average pelvic incidence of 62.5°. Estimated blood loss (EBL) was 100-250cc with no blood transfusions, and all but one patient ambulated on postoperative day 1 or 2. Spinal robotics brings us into a new era of minimally invasive construct design. To our knowledge, this is the first description of the technical feasibility of MRCs in minimally invasive adult spinal deformity surgery.

Effect Analysis of Minimally Invasive Spinal Trauma Surgery Versus Traditional Open Surgery for Spinal Trauma Patients

Effect Analysis of Minimally Invasive Spinal Trauma Surgery Versus Traditional Open Surgery for Spinal Trauma Patients

Simulation of Robotic Arm for Spinal Surgeries Engineered to Replace a Surgeon’s Tasks

A most common abnormality that affects the vertebrae is the disc prolapse. These conditions normally transpire in lumbosacral region and enmesh the spinal nerve at that point. A detoriation to the motor and sensory nerve at that point has an immediate consequence on that particular organ connected with the ascending and descending tract. Disc prolapse in thoracic region leads either to nerve root irritation or cord compression and it needs an immediate surgery to remove the disc lesion which is usually done by discectomy technique, an invasive spine surgery. However, the proposed system is to create a minimally invasive procedure to detach the disc lesion of the spine. The controlled and patient specific pre-operative planning is done by MIMIC using 3D model of the MRI of that patient. The new techniques on robotic arm like segmentation and surgical simulation will provide information about the positioning of the end effectors. Using 3D model design, the robotic arm with 3 degree of freedom is done by the SOLIDWORKS 3D CAD design software. SimMechanics is a MATLAB tool used for simulation of the physical model which gives control to the robotic arm. Furthermore, the simulation result gives the force used to produce torque at the joints and angle of joint due to torque produced. Finally, we show that the simulation in SimMechanics reduces the error occurrence in proto type construction.

Radiation Protection of a Patient Undergoing an Orthopedic Procedure by Using a Mobile C-Arm X-Ray System

Modern medicine is unthinkable without X-rays. Accurate diagnosis, leading to effective treatment, is largely based on precise X-ray examinations. The creation of new, modern equipment and various medical procedures that meet the increased requirements are a priority in our time. X-ray examinations are of particular importance for the orthopedic and traumatological clinics, where they provide information about presence of a fracture in the patient’s body, about the concrete operation performed or about the effect of a suitable treatment. Along with their benefits X-rays have also a harmful effect. This requires special care to protect from this radiation. In this direction, research is constantly being done to improve the quality of radiation protection. Park MR, Lee KM and co-authors, compare the dose load obtained using C-arm and O-arm X-ray systems (which have the capability of combined 2D fluoroscopy and 3D computed tomography imaging). In their study, an orthopedic surgical procedure using C-arm and O-arm systems in 2D fluoroscopy modes was simulated. The radiation doses to susceptible organs of the operators were investigated. He results obtained show that the O-arm system delivered higher doses to the sensitive organs of the operator in all configurations [1]. The article of Stephen Balte briefly reviews the available technologies for measuring or estimation of patient skin dose in the interventional fluoroscopic environment, created by various X-ray equipment including C-arm systems. Given that many patients require multiple procedures, this documentation also aids in the planning of follow up visits [2]. Chong Hing Wong, Yoshihisa Kotani and co-authors evaluate the radiation exposures (RE) to the patient and surgeon during minimally invasive lumbar spine surgery with instrumentation using C-arm image intensifier or O-arm intraoperative CT. The results they get are in favor of the O-arm system [3]. The article “Virtual fluoroscopy for intraoperative C-arm positioning and radiation dose reduction” discusses positioning of an intraoperative C-arm system to achieve clear visualization of a particular anatomical feature by a system for virtual fluoroscopy (called FluoroSim) that could dramatically reduce time and received dose during the procedures. FluoroSim was found to reduce the radiation exposure required for C-arm positioning without reducing positioning time or accuracy, providing a potentially valuable tool to assist surgeons [4]. In our study, we performed practical measurements to show how the patient can be treated by applying most effective radiation protection when using a mobile C-arm X-ray system. For the study, we used exposure upon a phantom placed on the patient’s table. For an X-ray shielding, we used a protective apron with a lead equivalent of 1 mm, placed in two layers on the phantom. In each subsequent series of exposures, the protective apron was placed on the phantom, in a different position relative to the X-ray beam. The general conclusion of our study is that in order to obtain maximum protection from scattered radiation when using C-arm X-ray systems, the patient must be protected by a shielding with a suitable lead equivalent for the procedure performed which must be placed between patient’s body and X-ray tube, perpendicular to the X-ray beam pointed toward the region of interest.

Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery

Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery

204. A review of time-demand, radiation exposure and outcomes of skin-anchored intraoperative 3D navigation in minimally invasive lumbar spinal surgery

BACKGROUND CONTEXT Real time image-guidance and intraoperative 3-dimensional navigation (ION), which utilize either a bone- or skin-anchored tracker, are increasingly being utilized in spine surgery to provide better visualization of abnormal anatomy, improve accuracy and enable less invasive procedures. However, ION is associated with considerable upfront costs, intraoperative time-demand and potentially greater radiation exposure. PURPOSE To describe the time demand, radiation exposure and outcomes of ION using a skin-anchored tracker in minimally invasive lumbar surgery. STUDY DESIGN/SETTING Retrospective cohort study. PATIENT SAMPLE All patients who underwent 1-level MIS microdiscectomy, laminectomy or TLIF by a single surgeon from April 2017 to January 2018. OUTCOME MEASURES Operative time, fluoroscopy time and radiation dose. METHODS Operative variables, radiation exposure and short-term outcomes of all three surgical procedures were summarized using descriptive statistics. RESULTS Of the 232 patients in this study, 92 underwent a microdiscectomy, 65 a laminectomy and 75 an MI-TLIF. All procedures were performed using a tubular retractor system, operating microscope and skin-anchored ION. Time required for ION set-up, measured as the time taken from completion of anesthesia induction to the start of the surgical procedure was a median of 22 minutes (IQR 19–25) for microdiscectomy, 23 (IQR 21–26) for laminectomy and 24 (IQR 21–28) for MI-TLIF. This accounts for the time required for patient positioning, preparing and draping the incision site, placing the skin-anchored navigation tracker and acquiring a 3D image for real-time navigation. The total fluoroscopy time was a median of 10 seconds (IQR 9–10) for microdiscectomy, 9 (IQR 9–10) for laminectomy and 26 (IQR 20–34) for MI-TLIF. Of this, an average of 9 seconds was required for image-acquisition for ION, while the remaining fluoroscopy time was for the surgical procedure (median 0, 0 and 17 seconds for microdiscectomy, laminectomy and MI-TLIF respectively). The total radiation dose was a median of 15.2mGy (IQR 8.6–23.9) for microdiscectomy, 16.6 (IQR 10.85–27.2) for laminectomy and 44.6 (IQR 35.6–64) for MI-TLIF. Of this, the median radiation dose required for image acquisition for ION was 93%, 95% and 37% of the total dose for microdiscectomy, laminectomy and MI-TLIF respectively, with the rest attributable to the surgical procedure. The operative time was a median of 42 minutes (IQR 35–54) for microdiscectomy, 50 (IQR 39–58) for laminectomy and 92 (IQR 77–101) for MI-TLIF. For all three procedures, median blood loss was 25 ml, the only reported intraoperative complication was durotomy, occurring in 1 patient undergoing laminectomy, and the most common in-hospital complication was urinary retention requiring catheterization, seen 0%, 3.1% and 6.7% of microdiscectomies, laminectomies and MI-TLIFs respectively. There were no wrong-level surgeries in any patients. CONCLUSIONS The use of intraoperative navigation using a skin-anchored navigation tracker is a feasible, safe and accurate approach. For decompression surgeries, a majority of the radiation dose and fluoroscopy time is attributable to image-acquisition for ION. In contrast, image-acquisition accounts for FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Choosing Minimally Invasive Versus Open Surgery in the Treatment of Adult Spinal Deformity (ASD): Analysis of a Prospective, Nonrandomized Multi-Center Study

Abstract INTRODUCTION Surgical planning in adult spinal deformity is a key factor in achieving optimal outcomes. MIS approaches for deformity have been promoted to be an option that results in less postoperative morbidity. However, minimally invasive spine (MIS) surgery can have limitations in the degree of correction achievable. This study analyzes factors involved in determining whether a traditional open vs minimally invasive approach is selected in a prospective, nonrandomized multi-center trial. METHODS Enrollment criteria: only patients treated by surgeons who enrolled both open and MIS patients were included, age = 18 yr, and coronal curve (CC) = 20, SVA >5 cm, PT >25, or thoracic kyphosis (TK) > 60°. Surgical approach selection was at the discretion of the operating surgeon. Preoperative significant differences were included in a multi-variate logistic regression analysis to determine odds ratios for approach selection. RESULTS A total of 120 open and 148 MIS patients were available for analysis. Significant preoperative differences (P < .05) between open and MIS groups were noted for age (61.9 vs 66.7 yr), visual analog scale (VAS) back (7.8 vs 7), CC (36 vs 26.1), PT (26.4 vs 23), TPA (26.1 vs 21), and PI-LL (19.6 vs 14.9). No significant differences in Charlson index, frailty, body mass index (BMI) (29 vs 28.5), VAS leg (5.2 vs 5.7), ODI (48.4 vs 47.2), SRS-22 (2.7 vs 2.8), PI (58.3 vs 57.1), LL (38.9 vs 42.3), SVA (73.8 vs 60.3 cm). Multivariate analysis found that age (OR 1.06, P = .036), CC (OR 1.06, P = .001), and TPA (OR 1.17, P = .017) are significant factors in approach selection. For every 1-yr increase in age there was a 6% increase in MIS approach, and for every 1 degree increase in CC/TPA there was a 6% and 17% increased likelihood for an open approach respectively. CONCLUSION Pain, disability, and comorbidities were not factors in approach selection. Rather age and severity of mal-alignment as reflected by the CC and TPA appear to be the primary drivers for approach selection.

Body Mass Index Greater Than 35 Is Associated With Increased Major and Radiographic Complications After Minimally Invasive Adult Spinal Deformity Surgery

Abstract INTRODUCTION As the obesity epidemic continues and the recognition of adult spinal deformity (ASD) increases, a growing number of obese patients are undergoing surgery to correct ASD. Minimally invasive techniques may be advantageous for obese patients to minimize blood loss. To date, the literature examining the impact of obesity on complications after minimally invasive ASD surgery has been scarce. METHODS A multicenter database of ASD patients was reviewed. Patients who had at least 2 yr of follow-up were analyzed. Demographic, radiographic, clinical outcomes, and postoperative complications were assessed. A body mass index (BMI) threshold of 35 was selected to more accurately reflect real-world practices. RESULTS A total of 220 patients were included: 196 had a BMI <35 and 24 had a BMI >35 (26.3 vs 38.4, P < .001). When comparing patients with a BMI threshold of 35, there was no difference in baseline age, levels instrumented, and most pre- and postoperative radiographic parameters and clinical outcomes. Patients with BMI >35 did have higher preopearative back pain than BMI <35 (visual analog scale 7.9 vs 6.8, P = .013) and postoperative Cobb angle (17.8 vs 12.6, P = .031). There was no difference between groups in overall complications, reoperations, infections, implant failures, surgical site infections, or minor, cardiopulmonary, gastrointestinal, and operative complications. Patients with BMI >35 had more major (45.8% vs 23.0%, P = .015) and radiographic (37.5% vs 19.9%, P = .049) complications than patients with BMI <35. Patients with BMI <35 had more neurological complications (17.3% vs 0%, P = .026). CONCLUSION In this retrospective review of a large database of patients undergoing minimally invasive surgery for ASD, patients with BMI > 35 suffered from more major and radiographic complications but fewer neurological complications than patients with BMI <35.

Optimizing Pain Control in a Patient with Lumbar Spinal Stenosis: A Report of Clinical Management

Lumbar spinal stenosis is a leading cause of low back pain and one of the most common causes of work absences. Treatment is initialized with narcotic and non-narcotic medications, which have been shown to work in the majority of patients. For those who do not find relief with medications and seek pain/symptom relief, invasive spinal surgery is the last resort.This case describes the escalation and dose titration of narcotic and non-narcotic medications in a patient with worsening lumbar spinal stenosis that was unable to proceed with surgical intervention for the next several months and had failed his prior outpatient pain regimen. Proper titration of a basal narcotic dose in addition to optimizing non-narcotic medications, including muscle relaxants, proved to better control pain in the interim until surgical intervention. Our case shows how several different teams of physicians and non-physician providers collaborated to optimize pain control using several different treatment regimens with different doses and routes until a safe and effective plan was created for long-term use.

Safety and efficacy of microwave ablation for breast cancer thoracic metastases.

BackgroundThe objective of the study was to assess the safety and efficacy of microwave ablation (MWA) for breast cancer thoracic metastasis.Materials and methodsTwelve patients in our institution with a single lesion of breast cancer thoracic metastases received MWA and invasive spine surgery from August 2014 to November 2016. MWA was executed using the MWA system (2,450 MHz) at 40 W or 50 W with thermometers to control the ablation end points. The pathology of thoracic metastases was confirmed through intraoperative biopsy before ablation. The postoperative complications were recorded. The patients were followed up at 1, 3 and 6 months with contrast-enhanced computed tomography and magnetic resonance imaging to monitor for tumor recurrence.ResultsThe average duration of follow-up for breast cancer thoracic metastases patients (mean age 52.7±8.4 years) was 10.2 months. The rate of postoperative main complications was 8.3% (1/12). The recurrence rate was 16.6% (2/12) as confirmed by persistent enhancement.ConclusionMWA may be used as the adjuvant treatment for thoracic metastases of breast cancer. Results showed that few significant complications and less local recurrence occurred during the follow-up stage. Future research should aim at discovering more about the time controls for microwave–tissue interaction and treatment parameters before widespread use.

Report and resolution at the 16th International Symposium "Minor invasive and instrumental spinal surgery" conducted on the basis of the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine, Kharkiv under the ausp

Report and resolution at the 16th International Symposium "Minor invasive and instrumental spinal surgery" conducted on the basis of the Sytenko Institute of Spine and Joint Pathology National Academy of Medical Sciences of Ukraine, Kharkiv under the ausp

Comparison of Epidural Anaesthesia and General Anaesthesia with Caudal Epidural Analgesia for Minimally Invasive Lumbosacral Spine Surgeries

Background: Minimally invasive lumbar spine surgeries have become popular due to less tissue trauma involved and reduced hospital stay. General anaesthesia is more frequently used for these surgeries, though regional anaesthesia is proved to be safe in few studies. Purpose: To test the efficacy of Epidural anaesthesia (EA) for these lumbosacral spine surgeries in comparison with General anaesthesia supplemented with caudal analgesia (GA). Method: We randomized 80 patients posted for elective primary minimally invasive lumbosacral decompression spinal procedures into two groups of 40 each. The GA group patients received caudal analgesia with Ropivocaine 0.2% 30 ml with Buprenorphine 75 mcg before incision. The EA group patients received 10 cc of Ropivocaine 0.75% bolus with Buprenorphine 75 mcg through epidural catheter placed two spaces above the surgical incision site. Both groups received IV Paracetamol 1 gm 6th hrly and rescue analgesics given were IV Diclofenac and Tramadol. Outcome measures: We compared the groups for perioperative haemodynamic variables, anaesthesia and surgical time, postoperative analgesic requirement, PONV and length of hospital stay. Results: Intraoperative hypotension was seen more in GA group. The surgical and anaesthesia duration were significantly less in EA group. However, the patients for two level discectomies (3 vs. 1) and bilateral laminoforaminotomies (8 vs. 4) were more in GA group. Postoperative analgesic requirement was significantly more in GA group. There was no significant difference in the PONV and all patients were discharged on the first postoperative day. Conclusion: Epidural anaesthesia can safely replace GA for minimally invasive lumbar spine procedures. It not only avoids the risks of GA, but also the intraoperative blood loss, the duration of anaesthesia and the postoperative IV analgesic requirements are much less with the use of Epidural anaesthesia.

Adjacent segment disease and degeneration after lumbar spine surgery

Lumbar spine fusion surgeries have adverse effects on adjacent segments and lead to adjacent segment disease and degeneration which increase the possibility of revision surgery and affect the final outcome. If new degeneration or aggravation of the primary degeneration in the adjacent segment only occurs in the images but without corresponding clinical symptoms, it would be called adjacent segment degeneration; if the corresponding clinical symptoms co-exist with degeneration in images, it would be called adjacent segment disease. Generally, the stress concentration on adjacent intervertebral discs and facet joints caused by spine fusion is the main pathogeny of adjacent segment degeneration and disease. The damage of normal spinal anatomy structure in surgery and the natural spine degeneration process are also important pathogenic factors. The occurrence of adjacent segment degeneration and disease after lumbar surgery is related to age, body weight, postoperative spinal-pelvic sagittal balance and the preoperative degeneration of adjacent segment. Surgical programs including numbers of the fusion segments, surgical approach and whether to adopt non-fusion technology have great effect on the occurrence of adjacent segment degeneration and disease. In the planning of surgeries, necessary measures and methods should be taken to prevent adjacent segment disease and degeneration according to the different patients. Non-fusion technology, minimally invasive spine surgery technique and Topping-off technique can help reduce the occurrence of adjacent segment disease and degenerative. If the patients are combined with high risk factors of adjacent segment degeneration and disease, more attention should be paid and appropriate and individualized therapies should be chosen.

Use of ultrasound in minimally invasive spinal instrumentation surgery.

Use of ultrasound in minimally invasive spinal instrumentation surgery.

A Short Note on Minimally Invasive Lumbar Spine Surgery

Almost all spine surgeons tout minimally Invasiveness in spine surgery as a beneficial focus. The meaning of minimally invasiveness, however, is actually a concept with different meanings for each surgeon. To some, it is the use of smaller incisions using standard surgical approaches, the use of tubular retractors, and/or the use of surgical magnification with a microscope, or an endoscope. Minimally invasiveness often advertises the use of lasers as a sexy and high tech surgical tool to tout their state- of- the- art surgical technique in minimally invasiveness, but it is not used as a needed part of the surgery unless visually used with endoscopes under irrigation.

Management of massive pulmonary embolus following recent spinal surgery

SummaryWe describe the case of a patient presenting with paraplegia secondary to a thoracic epidural abscess. In the post‐operative period his management was complicated by life threatening pulmonary embolism. The case highlights the complexity in medical decision‐making relating to managing massive pulmonary embolus in the immediate post‐operative period following invasive spinal surgery.

Minimally invasive spine surgery and spinal degenerative diseases

Minimally invasive spine surgery and spinal degenerative diseases

Nutritional risk, malnutrition and nutritional support among hospitalized patients in orthopedics/spinal surgery of a Hohhot teaching hospital.

The evolution of nutritional status (the prevalence of nutritional risk, malnutrition, overweight and obesity) and the nutritional support of the hospitalized patients from admission to discharge or over a two-week period in orthopedics/ spinal surgery of a teaching hospital in Hohhot were investigated. 432 patients from two wards of the orthopedics/spinal surgery from Jan to Dec 2013, the traditional spinal surgery and the minimally invasive spinal surgery, were selected and detected in this study. The Nutritional Risk Score 2002 (NRS 2002) was used to determine the patients' nutritional status within 48 h after admission and during their hospitalization. The overall prevalence of nutritional risk, malnutrition, overweight and obesity at admission was 11.6%, 12.7%, 35.9% and 7.41%, respectively. Overall, there were 88.0% of the patients who were at nutritional risk received nutritional support, while 14.1% of non-risk patients received a redundant nutritional support. The overall prevalence of nutritional risk changed from 11.6% at admission to 19.4% upon discharge (p<0.05), and the prevalence of malnutrition changed from 12.7% to 20.6% (p<0.05). The prevalence of overweight and obesity, which changed from 35.9% to 31.0% and from 7.41% to 5.79% respectively, didn't experience statistically significant evolution. NRS 2002 was a feasible nutritional risk screening tool for patients in spinal surgery of orthopedics department. Patients' prevalence of nutritional risk and malnutrition increased significantly in spinal surgery of this hospital. Some inappropriate uses of nutritional support were observed in orthopedics/spinal surgery, and nutritional support guidelines or protocols should be promoted by a professional committee.

The study of a 3D guider of percutaneous minimally invasive spine surgery

Objective To study the application of a novel three-dimensional (3D) guider of percutaneous minimally invasive spine surgery (MISS). Methods Between December 2012 and June 2014, percutaneous intervertebral foramen and disc puncture was performed on 6 cadavers (cadaveric experiment); percutaneous vertebroplasty (PVP) was performed on 56 patients with osteoporosis vertebral compression fracture (clinical trial). The 3D guider for percutaneous MISS was self-developed, and a national utility model patent was obtained; the device was randomly used on one side to aid the positioning of the puncture in the test group. The conventional manual puncture was used on the other side in the control group. Compared puncture positioning time, radiation dose of the C-arm X-ray fluoroscopy, and the incidence of surgical complications of two groups. Results The puncture times of the cadaveric experiment were 9.42±1.33 min in the experimental group and 13.59±1.26 min in the control group. The average puncture time of each vertebra of the clinical trial was 23.55±6.03 min in the test group and 29.86±8.96 min in the control group. The intraoperative fluoroscopy dose of each puncture in the cadaveric experiment was 0.40±0.10 mSv in test group and 0.65±0.11 mSv in control group. The intraoperative fluoroscopy dose of each vertebra in clinical trial was 1.04±0.37 mSv in test group and 1.33±0.40 mSv in control group. In cadaveric experiment, the test group had 2 cases of adverse punctures, while the control group had 8 cases of adverse punctures. In clinical trial, the incidence rates of bone cement leakage were 4.62% in test group and 10.78% in control group. In both cadaveric and clinical experiments, the puncture positioning time, radiation dose, and the incidence of surgical complications were statistically significant between the two groups. Conclusion The self-developed 3D guider for percutaneous MISS could personalize and precisely aid puncture positioning in PVP and percutaneous intervertebral foramen and disc puncture. Compared with the traditional manual method, 3D guider could significantly shorten surgical time, which could reduce the risk of surgical exposure; in addition, the device could also reduce radiation injury to both doctors and patients and reduce the incidence of complications, thus could increase surgical safety. Key words: Surgical procedures, minimally invasive; Spine; Surgical instruments