Degenerative Disc Disease Clinical Trial
Official title:
The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation
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.
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