The European Robotic Spinal Instrumentation (EUROSPIN) Study
The European Robotic Spinal Instrumentation (EUROSPIN) Study
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.
Inclusion Criteria

 -  Informed consent

 -  Thoracolumbar pedicle screw placement

 -  Indication for surgery: Degenerative pathologies (stenosis, spondylolisthesis,
 degenerative disc disease, recurrent disc herniation), infections, tumors, fractures,
 trauma

 -  Age ≥ 18

 Exclusion Criteria

 -  Deformity surgery

 -  >5 index levels