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The European Robotic Spinal Instrumentation (EUROSPIN) study: design of a multicenter, pragmatic, controlled trial comparing robot-guided, navigated, and freehand thoracolumbar fusion surgery
EANS Academy. Staartjes V. 09/26/19; 275994; EP02068
Mr. Victor Staartjes
Mr. Victor Staartjes

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Abstract
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Background: Robotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the past decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared to conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high acquisition and maintenance costs often inherent to the use of these systems.
Methods: Patients will be allocated in a non-randomized, non-blinded fashion to the RG, NV, or FH groups, representing an 'expertise-based trial'. Inclusion criteria are thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumors, or fractures. Exclusion criteria include deformity correction and surgery at more than 5 levels. Follow-up will take place at 6 weeks, as well as 12 and 24 months. The primary endpoint was 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 and EQ5D scales. Use of analgesic medication, work status, as well as perioperative parameters will be recorded.
Results: Based on previously published data, a targeted recruitment of 615 patients was calculated. The primary analysis, conducted on the 12-month data, will be carried out according to the intention-to-treat principle. Crude and adjusted Cox proportional hazards models will be constructed. Patient-reported outcomes will be analysed using baseline-adjusted linear mixed models. Prespecified subgroup analyses of the primary outcome will be performed in the intention to-treat population to test for an interaction between study group indication for surgery, specific device used, type of exposure, as well as single-level or multi-level fusion.
Conclusions: The European Robotic Spinal Instrumentation (EUROSPIN) Study is aimed at creating high-level prospective multicenter evidence on the potential comparative benefits of RG, NV, and FH in a real-world setting.
Background: Robotic guidance (RG) and computer-assisted navigation (NV) have seen increased adoption in instrumented spine surgery over the past decade. Although there exists some evidence that these techniques increase radiological pedicle screw accuracy compared to conventional freehand (FH) surgery, this may not directly translate to any tangible clinical benefits, especially considering the relatively high acquisition and maintenance costs often inherent to the use of these systems.
Methods: Patients will be allocated in a non-randomized, non-blinded fashion to the RG, NV, or FH groups, representing an 'expertise-based trial'. Inclusion criteria are thoracolumbar pedicle screw instrumentation for degenerative pathologies, infections, vertebral tumors, or fractures. Exclusion criteria include deformity correction and surgery at more than 5 levels. Follow-up will take place at 6 weeks, as well as 12 and 24 months. The primary endpoint was 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 and EQ5D scales. Use of analgesic medication, work status, as well as perioperative parameters will be recorded.
Results: Based on previously published data, a targeted recruitment of 615 patients was calculated. The primary analysis, conducted on the 12-month data, will be carried out according to the intention-to-treat principle. Crude and adjusted Cox proportional hazards models will be constructed. Patient-reported outcomes will be analysed using baseline-adjusted linear mixed models. Prespecified subgroup analyses of the primary outcome will be performed in the intention to-treat population to test for an interaction between study group indication for surgery, specific device used, type of exposure, as well as single-level or multi-level fusion.
Conclusions: The European Robotic Spinal Instrumentation (EUROSPIN) Study is aimed at creating high-level prospective multicenter evidence on the potential comparative benefits of RG, NV, and FH in a real-world setting.
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