We share our experiences in designing a complete simulator prototype and provide the technological basis to determine whether an immersive medical training environment for vertebroplasty is successful. In our study, the following key research contributions were realised: (1) the effective combination of a virtual reality surgical simulator and a computerised mannequin in designing a novel training setup for medical education, and (2) based on a user-study, the quantitative evaluation through surgical workflow and crisis simulation in proving the face validity of our immersive medical training environment. Medical simulation platforms intend to assist and support surgical trainees by enhancing their skills in a virtual environment. This approach to training is consistent with an important paradigm shift in medical education that has occurred over the past decade. Surgical trainees have traditionally learned interventions on patients under the supervision of a senior physician in what is essentially an apprenticeship model. In addition to exposing patients to some risk, this tends to be a slow and inherently subjective process that lacks objective, quantitative assessment of performance. By proposing our immersive medical simulator we offer the first shared experimental platform for education researchers to design, implement, test, and compare vertebroplasty training methods. We collected feedback from two expert and two novice residents, on improving the teaching paradigm during vertebroplasty. In this way, this limits the risks of complications during the skill acquisition phase that all learners must pass through. The complete simulation environment was evaluated on a 5-pt Likert scale format: (1) strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, and (5) strongly agree. When assessing all aspects of the realism of the simulation environment, specifically on whether it is suitable for the training of technical skills team training, the participating surgeons gave an average score of 4.5. Additionally, we also simulated a crisis simulation. During training, the simulation instructor introduced a visualisation depicting cement extravasation into a perivertebral vein. Furthermore, the physiology of the computerised mannequin was influenced by the instructor simulating a lung embolism by gradually lowering the oxygen saturation from 98% to 80% beginning at a standardised point during the procedure. The simulation was stopped after the communication between the surgeon and the anaesthetist occurred which determined their acknowledgment that an adverse event occurred. The realism of this crisis simulation was ranked with an average score of 4.75. To our knowledge this is the first virtual reality simulator with the capacity to control the introduction of adverse events or complication yielding a wide spectrum of highly adjustable crisis simulation scenarios. Our conclusions validate the importance of incorporating surgical workflow analysis together with virtual reality, human multisensory responses, and the inclusion of real surgical instruments when considering the design of a simulation environment for medical education. The proposed training environment for individuals can be certainly extended to training medical teams

Aim. Infection after vertebroplasty (VP) is a rare but serious complication. Previous literatures showed most pathogens for infection after VP were bacteria; tuberculosis (TB) induced infection after VP was extremely rare. In this study, we reported our treatment experiences of 18 cases with infectious spondylitis after VP, and compared the differences between developed pyogenic and TB spondylitis. Method. From January 2001 to December 2015, 5749 patients underwent VP at our department were reviewed retrospectively. The causative organisms were obtained from tissue culture of revision surgery. Parameters including type of surgery, the interval between VP and revision surgery, neurologic status, and visual analog scale of back pain were recorded. Laboratory data at the time of VP and revision surgery were collected. Risk factors including the Charlson comorbidity index (CCI), preoperative bacteremia, urinary tract infection (UTI), pulmonary TB history were also analyzed. Results. 18 patients developed infectious spondylitis after VP (0.32%, 18/5749). Two were male and 16 were female. The median age at the time of VP was 73.4 years. The mean CCI score was 1.7. The causative organisms were TB in nine patients (Fig. 1), and bacteria in nine patients (Fig. 2). The interval between VP and revision surgery ranged from 7 to 1140 days (mean 123.2 days). C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were elevated in most patients especially at readmission. The most common type of revision surgery was anterior combined posterior surgery. Seven patients developed neurologic deficit before revision surgery. Three patients died within 6 months after revision surgery, with a mortality of 16.7%. Finally, VAS of back pain was improved from 7.4 to 3.1. 7 patients could walk normally, 5 patients needed walker support, 3 patients depended on wheelchair for ambulation (Table 1). Both pyogenic and TB group had similar age, sex, and CCI distribution. The interval between VP and revision surgery was shorter in the patients with pyogenic organisms (75.9 vs 170.6 days). At revision surgery, WBC and CRP were prominently elevated in the pyogenic group. Five in the pyogenic group had UTI or bacteremia; five in TB group had a history of lung TB (Table 2). Conclusions. VP is a minimal procedure but sustains possibility of postoperative infection, which required major surgery for salvage with a relevant part of residual disability. Before surgery, any bacteremia/ UTI or history of pulmonary TB should be reviewed rigorously; any elevation of infection parameters should be scrutinized strictly. For any figures and tables, please contact authors directly (click on ‘Info & Metrics’ tab above for contact details)

Introduction. Our clinic has started to use MAZOR's Spine-Assist(r) robotic device in routine spinal surgery practice since 2006. The use of this system is diverse and now applicable for Vertebroplasty, Biopsy procedures and different techniques of Spinal fusion. During this time our clinic performed near 150 robotic assisted surgeries. Amongst its benefits the system allows the reduction of the duration of fluoroscopic exposure in the OR, better accuracy due to computerized assisted planning and navigation, avoidance of human caused complications and a less traumatic procedure for the patient. On the other hand, the duration of the procedure is prolonged, the wound is subdued to a longer exposure in cases of the open surgery, and the operational cost is higher and requires a good trained medical staff. Materials and Methods. In the last 2 years we have performed 56 robotic assisted Vertebroplasty procedures (research group). At the same time we have performed 44 non assisted Vertebroplasty procedures. There was a significant difference in the fluoroscopic time and subsequent exposure time to radiation between the groups: in the research group we used only an average of 3 seconds of staff fluoroscopic exposure (an average of 5 fluoroscopic images) compared to an average of 11 seconds of exposure (an average of 24 fluoroscopic images). Furthermore, we have successfully inserted more than 400 pedical screws with less than 1mm accuracy from planning, out which only 8 were misplaced. Subsequently we have also performed 16 biopsies, which were effective as CT based biopsies. The average duration of a surgical procedure without the use of the system in 1 level fusion was 82 min. With the use of the system the average time was 106 min. The operational cost with the use of the system was about 1,000 ∊ more expensive. Furthermore, the use of the system required performing of an additional CT scan with 1 mm slices, which caused an additional exposure to patient radiation. Results. Robotic assisted spinal surgery is a new and safe approach aiming to dramatically shorten the duration of fluoroscopic exposure of the staff and surgeon thus reducing the exposure to radiogenic dose. This novel procedure, promotes a better accuracy with regard to Vertebroplasty, Spinal fusion, insertion of Pedical Screws and also for biopsies procedures. We continue to broaden the usage of the robotic assisted device to other fields of spinal surgery and to general orthopaedic surgery. However, we have to resolve some issues such as cost, operation time and less fluoroscopic exposure for the patient

Robotic assisted spine surgery was a breakthrough in the evolution of spinal surgery, gradually gaining its place as an alternative technique for conventional spinal procedures. As the general population's life expectancy increased so does the incidence of spinal pathology and with it emerged an urging need for a safer and more accurate means of treatment. In our institute we apply the “Spine Assist” platform for a variety of spinal procedures as Vertebroplasties, biopsies, Pedicular screws insertion and an inter-vertebral fusion – GOLIF procedures. This study is designed to analyze the learning curve of each procedure, regarding the amount of fluoro images (FI) taken, fluoro exposure (FE) time and net operation time. All spinal procedures using the “Spine Assist” platform were included in this study; all took place from 2006 until September 2010. Exclusion criteria were procedures with failed pre-op registration, and robotic assisted procedures that were converted to conventional fluoroscopic assisted during the operation. Every single surgery of all types of procedures was analyzed regarding the amount of FI taken, FE time and net operation time. Pedicular screws insertion was grouped into sets of four, where the same parameters were evaluated. Altogether we preformed 106 robotic assisted Vertebroplasty procedures. During this period a distinct learning curve was observed and analyzed. For the first ten Vertebroplasties an average of 12 FI were taken with a net operation time of 53.6 min per procedure. Analyzing the first 40 procedures has shown less FI per procedure (5 FI) and a net operation time of 48.6 min/procedure. Data drawn from the 51 following Vertebroplasties has set the standards of 4 FI with a net operation time of 25.6 min/procedure. Two Vertebroplasty procedures were not completed due to failure of software registration. Pedicular screws are a mean for stabilization of vertebral motion units. During a six years period 706 screws were inserted, out of whom 98 were inserted using percutaneous technique. Comparing the insertion of a set of 4 screws we found a significant improvement regarding the number of FI, FE time and the net operation time between the first ten procedures and the rest with a mean of 20 FI /4 FI and net screw insertion time of 82 min/ 25 min respectively. We found no difference in the parameters comparing percutaneous Vs open Pedicular screws insertion. The mean accuracy of all procedures was 0.3 mm compared to the pre planned screw trajectory. No false route was detected in any of the 506 procedures. This robotic assisted technique is a new and safe approach aiming to shorten the duration of the procedure, thus reducing the patient and surgeon exposure to radiogenic dose. The essence of robotic assisted surgery is a pre planned needle/screw trajectory aiming to reduce the possible intra-operative complication, inaccuracies and possible mishaps emerging during “free hand” procedures. Gaining more experience using the spine assist platform, as shown in this detailed learning curve, enabled us to leverage the platform for ultra-accurate procedures as the percutaneous intervertebral fusion – GOLIF, Vertebroplasty for burst fractures etc

The spine is a common site of metastasis. Complications include pathologic fracture, spinal cord compression, and neurological deficits. Vertebroplasty (VP) and Balloon Kyphoplasty (KP) are minimally invasive stabilization procedures used as a palliative treatment to improve mechanical stability, quality of life, and reduce pain. Photodynamic therapy (PDT) is a tumour-ablative modality that may complement mechanical stability afforded by VP/KP. This first-in-human study evaluates PDT safety when applied in conjunction with VP/KP. This dose escalation trial involved one light only control group and four light-drug doses (50,100,150,200J;n=6) delivered at 150mW from a 690nm diode laser by 800-micron optical fibers prior to KP/VP. Patients eligible for VP/KP in treating pathologic fracture or at-risk lesions at a single level were recruited. Exclusion criteria included spinal canal compromise or neurologic impairment. PDT is a two-step binary therapy of systemic drug followed by intravertebral light activation. Light was applied via bone trochar prior to cementation. This study used a benzoporphyrin derivative monoacid (BPD-MA), Verteporfin (VisudyneTm), as the photosensitizer drug in the therapy. Drug/light safety, neurologic safety, generic (SF-36), and disease-specific outcomes (VAS, EORTC-QLQ-BM22, EORTC-QLQ-C15-PAL) were recorded through six weeks. Phototoxicity and the side effects of the BPD-MA were also examined following PDT use. Thirty (10 male, 20 female) patients were treated (13 KP, 17 VP). The average age was 61 and significantly different between genders (Male 70yrs vs. Female 57yrs: p 0.05), and tumour status (lytic vs. mixed blastic/lytic: p>0.05). In most cases, fluence rates were similar throughout PDT treatment time, indicating a relatively stable treatment. Twelve (40%) of patients experienced complications during the study, none of which were attributed to PDT therapy. This included two kyphoplasty failures due to progression of disease, one case of shingles, one ankle fracture, one prominent suture, one case of constipation due to a lung lesion, one case of fatigue, and five patients experienced pain that was surgically related or preceded therapy. Vertebral PDT appears safe from pharmaceutical and neurologic perspectives. KP/VP failure rate is broadly in line with reported values and PDT did not compromise efficacy. The 50J group demonstrated an improved response. Ongoing study determining safe dose range and subsequent efficacy studies are necessary

In recent years internal fixation of the spine by using posterior approach with minimally invasive and percutaneous technique were increasingly used in trauma. The percutaneous surgery lose information and navigation is supposed to provide better data because the lost information is found again. We hypothesise that a percutaneous minimal invasive dorsal procedure by using 3D intra-operative imaging for vertebral fractures allows short operating times with correct screw positioning and does not increase radiation exposure. 59 patients were included in this prospective, monocentric and randomised study. 29 patients (108 implants) were operated on by using conventional surgical procedure (CP) and 30 patients (72 implants) were operated on by using a 3D fluoroscopy-based navigation system (3D fluo). In the two groups, a percutaneous approach was performed for transpedicular vertebroplasty or percutaneous pedicle screws insertion. In the two groups surgery was done from T4 level to L5 levels. Patients (54 years old on average) suffered trauma fractures, fragility fractures or degenerative instabilities. Evaluation of screw placement was done by using post-operative CT with two independent radiologists that used Youkilis criteria. Operative and radiation running time were also evaluated. With percutaneous surgery, the 3D fluo technique was less accurate with 13.88% of misplaced pedicle screws (10/72) compared with 11.11% (12/108) observed with CP. The radiation running time for each vertebra level (two screws) reached on average 0.56 mSv with 3D fluo group compared to 1.57 mSv with the CP group. The time required for instrumentation (one vertebra, two screws) with 3D fluo was 19.75 minutes compared with CP group 9.19 minutes. The results were statistically significant in terms of radiation dose and operative running time (p < 0.05), but not in terms of accuracy (p= 0.24). With percutaneous procedures, 3D fluoroscopy-based navigation (3D fluo) system has no superiority in terms of operative running time and to a lesser degree in terms of accuracy, as compared to 2D conventional procedure (CP), but the benefit in terms of radiation dose is important. Other advantages of the 3D fluo system are twofold: up-to-date image data of patient anatomy and immediate availability to assess the anatomical position of the implanted screws

Cementoplasty, like vertebroplasty, is a technique whereby Polymetylmethacrylate is placed into a bone lesion either percutaneouly or by surgery under image intensifier guidance. Although there have been few studies with regard to cementoplasty percutaneously, there is no series in the literature to support the open surgical technique as a palliative procedure. In our series we describe four patients (1male and 3 females, age range 63-83) with metastatic bone cancer who have benefited from an open surgical procedure. The four patients presented to our hospital between January 2004 and December 2006. They all had gradually worsening hip pain at the time of presentation and pelvic radiographs revealed osteolytic lesions in the acetabulum. A 5 centimetre longitudinal incision proximal to the greater trochanter was made and the malignant lesion identified using the image intensifier. The malignant tissue was curetted and sent for microscopy, culture, sensitivity and histopathology and the remaining void filled with bone cement (via a gun or by hand) under x-ray control. Radiographs were taken in all patients post-operatively and were referred for adjuvant radiotherapy. All patients had immediate relief of pain and were able to mobilise within 48 hours. Two patients died within 6 weeks post-operatively due to complications from their primary malignancy (lung). One patient died at three months due to unknown primary. One patient remained pain free and fully ambulatory at one and a half years post surgery (breast primary). This procedure can be recommended for patients with metastatic bone disease as it provides adequate pain control and improves the quality of life in this group of patients. These patients need a multi-disciplinary approach to their care, but as orthopaedic surgeons, we can make a significant impact to such patients and their families