The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion

Abstract

IntroductionRobotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the last decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared with conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high inherent costs. As a non-randomised, expertise-based study, the European Robotic Spinal Instrumentation Study aims to create prospective multicentre evidence on the potential comparative clinical benefits of RG, NV and FH in a real-world setting.Methods and analysisPatients are allocated in a non-randomised, non-blinded fashion to the RG, NV or FH arms. Adult patients that are to undergo thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumours or fractures are considered for inclusion. Deformity correction and surgery at more than five levels represent exclusion criteria. Follow-up takes place at 6 weeks, as well as 12 and 24 months. The primary endpoint is defined as the time to revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year. Secondary endpoints include patient-reported back and leg pain, as well as Oswestry Disability Index and EuroQOL 5-dimension questionnaires. Use of analgesic medication and work status are recorded. The primary analysis, conducted on the 12-month data, is carried out according to the intention-to-treat principle. The primary endpoint is analysed using crude and adjusted Cox proportional hazards models. Patient-reported outcomes are analysed using baseline-adjusted linear mixed models. The study is monitored according to a prespecified monitoring plan.Ethics and disseminationThe study protocol is approved by the appropriate national and local authorities. Written informed consent is obtained from all participants. The final results will be published in an international peer-reviewed journal.Trial registration numberClinical Trials.gov registryNCT03398915; Pre-results, recruiting stage.

Magnetic resonance imaging–based synthetic computed tomography of the lumbar spine for surgical planning: a clinical proof-of-concept

“…In spinal neurosurgery, CT imaging has particular importance in surgical navigation, for example, for the computerassisted insertion of pedicle screws. 22 Thus, high-fidelity sCT imaging combined with navigation systems or surgical robotics [22][23][24][25] could enable the concept of radiationless navigated surgery, enabling the use of computer assistance based on preoperative CT imaging without the need for additional radiation. Still, intraoperative fluoroscopy may be necessary for registration and instrumentation control, but these fluoroscopic doses are minor compared with those experienced by the patient during CT scanning.…”

Robot-Guided Transforaminal Versus Robot-Guided Posterior Lumbar Interbody Fusion for Lumbar Degenerative Disease

“…The promising trials MIS ReFRESH and EUROSPIN are researching this very issue to fill these remaining voids of evidence. The MIS ReFRESH trial is currently investigating the differences between robot-guided and freehand techniques and the EUROSPIN trial aims to produce evidence on the potential comparative clinical benefits of robot-guided, navigated, and freehand surgical approaches [ 13 , 14 ].…”

“…There is some evidence that robotic guidance can decrease the incidence of both radiological [ 11 , 12 ] as well as clinically relevant [ 10 ] pedicle screw malposition. If these benefits alone, particularly in light of the high acquisition and maintenance costs, warrant the use of these computer assistance systems, is currently unclear [ 13 , 14 ]. More importantly, data on the effect of using robotic guidance on clinical outcomes other than screw malposition, such as patient-reported outcome measures (PROMs) are lacking [ 15 ].…”

When Giants Talk; Robotic Dialog During Thoracolumbar and Sacral Surgery

“…Recently, initial results from a high-power multicenter prospective study from the U.S. MIS-ReFRESH compared 374 Mazor robotic-guided to 111 uoroscopic guided minimally invasive spinal fusions and found Mazor robotic-guided had 5.2 fold lower risk of surgical complications and 8.8 fold lower risk for revision surgery [23]. While a similar multi-center prospective comparative European Robotic Spinal Instrumentation study (EUROSPIN) is still ongoing [24].…”