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Fluoroscopy guided spinal biopsies were done by spine surgeons in the operation theatre using C-Arm fluoroscopy device (OECFluorostar7900Compact - GE®). C-arm image intensiﬁer was positioned until fluoroscopic beam was collinear with the corresponding vertebral body on AP view prior to insertion of biopsy needle

CT guided spinal biopsies were done by radiologist under guidance of 128-slice CT scanner (SOMATOM Definition AS+, Siemens Medical Solutions USA, Inc.). Preliminary axial CT scanning was done in bone window (window width, WW:2500; window level, WL:500) at the pre-selected levels decided from previous imaging to plan the needle access. Biopsy was then performed under sequential CT-fluoroscopy scan.

Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under fluoroscopic guidance.

Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis.

Fluoroscopy Guided Spinal Biopsy

Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under CT guidance.

Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis.

CT guided Spinal Biopsy

Chris Yin Wei Chan

Spinal biopsy is important to obtain culture and histopathological diagnosis in spine infection and tumors. To date, there is no prospective randomized study comparing both techniques. Therefore, the aim of this prospective randomized trial was to evaluate the accuracy, safety and diagnostic outcome of both these techniques.A prospective randomized trial was performed in 60 patients divided equally into fluoroscopic and CT guided spinal biopsy groups. Transpedicular approach was done with 8G core biopsy needle. Specimens were sent for histopathological examinations and cultures. Diagnosis were made based on biopsy results, clinical criteria and disease progression during 6 months follow up. Radiation expose to patients and doctors were measured with optically stimulated luminescence dosimeters (OSLDs).

This prospective randomized study was carried out in a single institution from November 2016 to June 2018.

Patients were recruited by three spine surgeons from the same institution after eligibility assessment. Sixty consecutive patients were randomized equally into fluoroscopic and CT guided spinal biopsy groups. Randomization procedure was performed using a computer generated random number sequence on www.random.org. Separate individuals completed the random allocation sequence, patient enrollment and outcome assessment. Outcome assessors were blinded to group assignment.

Data collection Clinical data collected were: patient demographics, comorbidities, infective parameters, tumor markers, Magnetic Resonance Imaging (MRI) findings and pre-biopsy pain score at rest using visual analogue scale (VAS). Intraoperative data included radiation exposure dosage, biopsy duration and complications encountered. Following biopsy, we recorded the biopsy result, 6-hourly pain score (VAS) at for 48 hours, additional analgesia requirement and complications.

Radiation measurement Commercial optically stimulated luminescence dosimeters, OSLDs (NanoDotTM Dosimeter, Landauer Inc, Glenwood, IL) were used to measure radiation dose. Ten OSLDs were placed on patients and doctors prior to all biopsies over selective areas representing radiosensitive organs. Placements of the OSLDs were done by a single observer. OSLDs were processed using MicroStar OSLD reader system (Landauer, Inc. Glenwood, IL). Each OSLD was processed 3 times during each reading to obtain a mean value to minimize error. The absorbed doses were measured in centigrays (cGy). Bleaching/zeroing of the OSLDs were done using optical annealing system containing fluorescent lamps (Osram lumilux, 24 W, 280 \~780 nm) in between each use of OSLDs.

Biopsy technique Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle (Argon Medical Devices, Athens, TX, USA) was used in both arms. 10cc 2% lignocaine was infiltrated prior to biopsy. Biopsy needle was tapped gently with mallet through the pedicle and into the lesion under imaging guidance. Trocar was then withdrawn once it reached the affected area. The cannula was rotated several times to disengage sample from surrounding tissue. Then, aspiration of samples was done using 10-ml syringe prior to retraction of the cannula. Tissue samples were retrieved from the cannula with the use of stylet.

Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis.

1. Fluoroscopy Guided Spinal Biopsy Arm: Fluoroscopy guided spinal biopsies were done by spine surgeons in the operation theatre using C-Arm fluoroscopy device (OECFluorostar7900Compact - GE®). C-arm image intensiﬁer was positioned until fluoroscopic beam was collinear with the corresponding vertebral body on AP view prior to insertion of biopsy needle.
2. CT guided Spinal Biopsy Arm: CT guided spinal biopsies were done by radiologist under guidance of 128-slice CT scanner (SOMATOM Definition AS+, Siemens Medical Solutions USA, Inc.). Preliminary axial CT scanning was done in bone window (window width, WW:2500; window level, WL:500) at the pre-selected levels decided from previous imaging to plan the needle access. Biopsy was then performed under sequential CT-fluoroscopy scan.

Post biopsy care Antimicrobials were commenced upon completion of biopsy for patients who were diagnosed to have spine infection. Disease progression was assessed based on clinical symptoms, ESR, CRP and/or MRI repeated during 6 months follow up for patients who were not treated for spinal infection.

For suspected spinal tumor cases, negative biopsies that were reported to have inadequate sample, were repeated with the other method or other investigation modalities will be resorted accordingly. Patients with negative biopsy that was reported to have adequate sample were follow up for 6 months for disease progression.

Sample size Sample size was determined based on accuracy of biopsy as outcome variable, in which the accuracy rate was 0.89. It was estimated using G\*Power software (version 3.1.9.2) based on 2 proportions formula (Fisher's exact test). With alpha level of 0.05, 95% confidence interval and power of study 0.8, a minimum number of 52 patients (26 patients for each arm) was required for this study.

Statistical analysis Data were analyzed with SPSS Inc., Chicago, IL (SPSS v 23). Continuous data were reported as mean ± standard deviation and compared using t test. Chi-squared testing was used for between-groups comparisons. Fisher-exact test was used for the comparison of diagnostic accuracy between fluoroscopic and CT guided spinal biopsy. A p-value of \<0.05 was considered significant.

Separate individuals completed the random allocation sequence, patient enrollment and outcome assessment. Outcome assessors were blinded to group assignment.

Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor

Accuracy, Safety and Diagnostic Outcome of Percutaneous Fluoroscopic vs. CT Guided Transpedicular Core Needle Biopsy for Spinal Infections and Tumors. A Prospective Randomized Trial

Diagnostic accuracy were determined based on true positive, true negative, false positive and false negative biopsy findings

Total of 10 commercial optically stimulated luminescence dosimeters (OSLDs) were placed on patients and doctors at different body areas prior to biopsy to measure radiation dose

Pre biopsy pain score and post biopsy pain score (6-hourly for 48 hours) were assessed base on visual analogue scale (VAS) and recorded. Pain score will be aggregated by mean and standard deviation and compared between both groups. Additional analgesia requirement was documented.

Complications of spinal biopsy were observed such as neurovascular injury and iatrogenic fracture.

University of Malaya

Orthopedic Registra

Recurrence

Intervertebral Disc Displacement

Hernia

Neoplasm Metastasis

Constriction, Pathologic

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Pathological Conditions, Anatomical

Spondylolysis

Spondylosis

This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).

This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).

This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.

Transpedicular screw placement and instrumentation

Transpedicular Instrumentation

Victor E Staartjes, BMed

Marc L Schröder, MD, PhD

Pierre-Pascal Girod, MD

Nikolaus Kögl, MD, MSc

Michel Lefranc, MD, PhD

Aymeric Amelot, MD

Yu-Mi Ryang, MD

Farman Hedayat, MD

Sophie Urbanski

Christoph Bettag, MD

Bawarjan Schatlo, MD

Sandro M Krieg, MD, MBA

Carsten G Schneekloth, MD

Mike Abu Saris, MD

Jasper FC Wolfs, MD

Enrico Tessitore, MD

Duccio Boscherini, MD

Paulien M van Kampen, PhD

In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.

Introduction A decade ago, minimally invasive surgery (MIS) was considered a promising development in spine surgery, yet the value of the pioneering technologies was questionable. With the growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss, length of stay, rehabilitation, cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever improving navigational systems have been developed. These systems allow a consistent level of safety and accuracy, on par with results achieved by very experienced free hand surgeons, with a reasonably short learning curve. Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery.

Designed to overcome some of the limitations of navigation-based technologies, robot-guided surgery has become commercially available to surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly challenging the gold standards. SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws, while accounting for changes in intervertebral relationships such as due to distraction, cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table. Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98% of screws placed within the pedicle or with a cortical encroachment of less than 2 mm.4 Although the reliability and accuracy of robot-guided spine surgery have been established, the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown. We have recently conducted cohort studies that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures, while achieving comparable clinical outcomes. We now want to assess these factors, among others, on a higher level of evidence. We aim to conduct a prospective, multicenter, multinational controlled trial comparing clinical and patient reported outcomes of robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle screw placement using pooled data from three centers.

Study Design The European Robotic Spinal Instrumentation (EUROSPIN) study is a prospective, international, multicentre, pragmatic, open-label, non-randomized controlled trial comparing the effectiveness of three techniques for pedicle screw instrumentation, namely RG, NV (CT-, O-Arm, or 3DFL-based), and FH. Following the baseline evaluation, patients will receive one of the three treatments, and will subsequently be followed up for 24 months (Figure 1). The primary analysis will be conducted using the 12-month data.

Sample Size Calculation It was determined that, to detect an intergroup difference of 5% in the primary endpoint, 205 patients are required per group to achieve a power of 1 - beta = 0.8 at alpha = 0.05. The incidence rates were based on the published literature, with an approximated incidence rate of the primary endpoint of 0% for the intervention and 5% for the control group. Because the study protocol is in line with the normal clinical follow-up of most centers, a low dropout rate is expected. This led to a minimum total sample size of 615 patients.

Monitoring An epidemiologist from the sponsor institution will organize an initiation monitor visit at every participating center before starting recruitment. This monitor visit will check whether all study staff are properly trained and the delegation of tasks are well documented (complete Investigator Site File, training and delegation logs). An additional audit will be carried out at 6 months after initiation of recruitment to check whether source documentation and eCRF documentation is similar. Throughout the entire study additional queries by the monitor are send to the investigator in the data capturing system to ensure proper data capturing.

The European Robotic Spinal Instrumentation (EUROSPIN) Study

The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation

Frequency of use of analgetics (daily/weekly/not regularly)

Satisfaction with symptoms (satisfied/neutral/dissatisfied)

Working status (able to work/unable to work)

We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.

Revision or redirection of a placed screw during the same general anesthesia session

Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

Radiation Dose as DAP (Dose Area Product, cGy cm2)

Need for blood transfusion during the hospital stay (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

EQ-5D-3L (Health-related quality of life) EuroQOL-five dimensions 3-level version measures health-related quality of life.

The scale is subdivided into an index, ranging from 0 to 1 and normalized to population-specific values, and a "thermometer" or visual analogue scale, ranging from 0 to 100.

The two subscores are not combined towards a single score. Higher values represent a better health-related quality of life in both subscores.

Numeric Rating Scale (NRS) of back pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.

Numeric Rating Scale (NRS) of leg pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.

Oswestry Disability Index (ODI) for functional impairment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Percutaneous Fluoroscopic vs CT Guided Core Needle Biopsy for Spinal Infection and Tumor	NCT03585699	Spondylodiskiti... Spinal Tumor	Fluoroscopy Gui... CT guided Spina...	18 Years -	University of Malaya
The European Robotic Spinal Instrumentation (EUROSPIN) Study	NCT03398915	Degenerative Di... Spondylolisthes... Spinal Stenosis Recurrent Disc ... Spondylodiskiti... Spinal Tumor Spinal Metastas...	Transpedicular ...	18 Years -	Bergman Clinics

Spots Global Cancer Trial Database for spondylodiskitis