title: Risk-benefit analysis of navigation techniques for vertebral transpedicular instrumentation: a prospective study.
abstract: Pedicle screws in spinal surgery have allowed greater biomechanical stability and higher fusion rates. However, malposition is very common and may cause neurologic, vascular, and visceral injuries and compromise mechanical stability.
  
  
  
  The purpose of this study was to compare the malposition rate between intraoperative computed tomography (CT) scan assisted-navigation and free-hand fluoroscopy-guided techniques for placement of pedicle screw instrumentation.
  
  
  
  This is a prospective, randomized, observational study.
  
  
  
  A total of 114 patients were included: 58 in the assisted surgery group and 56 in the free-hand fluoroscopy-guided surgery group.
  
  
  
  Analysis of screw position was assessed using the Heary classification. Breach severity was defined according to the Gertzbein classification. Radiation doses were evaluated using thermoluminescent dosimeters, and estimates of effective and organ doses were made based on scan technical parameters.
  
  
  
  Consecutive patients with degenerative disease, who underwent surgical procedures using the free-hand, or intraoperative navigation technique for placement of transpedicular instrumentation, were included in the study.
  
  
  
  Forty-four out of 625 implanted screws were malpositioned: 11 (3.6%) in the navigated surgery group and 33 (10.3%) in the free-hand group (p<.001). Screw position according to the Heary scale was Grade II (4 navigated surgery, 6 fluoroscopy guided), Grade III (3 navigated surgery, 11 fluoroscopy guided), Grade IV (4 navigated surgery, 16 fluoroscopy guided), and Grade V (1 fluoroscopy guided). There was only one symptomatic case in the conventional surgery group. Breach severity was seven Grade A and four Grade B in the navigated surgery group, and eight Grade A, 24 Grade B, and one Grade C in free-hand fluoroscopy-guided surgery group. Radiation received per patient was 5.8 mSv (4.8-7.3). The median dose received in the free-hand fluoroscopy group was 1 mGy (0.8-1.1). There was no detectable radiation level in the navigation-assisted surgery group, whereas the effective dose was 10 µGy in the free-hand fluoroscopy-guided surgery group.
  
  
  
  Malposition rate, both symptomatic and asymptomatic, in spinal surgery is reduced when using CT-guided placement of transpedicular instrumentation compared with placement under fluoroscopic guidance, with radiation values within the safety limits for health. Larger studies are needed to determine risk-benefit in these patients.
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain. Electronic address: noriega1970@icloud.com.
authors: David C
authors: DC
authors: Noriega
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Rubén
authors: R
authors: Hernández-Ramajo
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Fiona
authors: F
authors: Rodríguez-Monsalve Milano
authors: Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Israel
authors: I
authors: Sanchez-Lite
authors: Servicio de Radiología, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Borja
authors: B
authors: Toribio
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Francisco
authors: F
authors: Ardura
authors: Servicio de Radiofísica y Protección Radiológica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Ricardo
authors: R
authors: Torres
authors: Unidad de Columna, Servicio Cirugía Ortopédica, Hospital Clínico Universitario de Valladolid, Calle Ramón y Cajal, 47008 Valladolid, Spain.
authors: Raul
authors: R
authors: Corredera
authors: Center for Orthopaedics and Trauma Surgery University Hospital Giessen and Marburg GmbH, Marburg, Germany.
authors: Antonio
authors: A
authors: Kruger
mesh_terms: D000368:Aged; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000009:adverse effects* / Q000379:methods; D065289:Pedicle Screws / Q000009:adverse effects*; D011183:Postoperative Complications; D011446:Prospective Studies; D011897:Random Allocation; D025321:Surgery, Computer-Assisted / Q000009:adverse effects* / Q000379:methods; D014057:Tomography, X-Ray Computed
keywords: Cone-beam computed tomography; Fluoroscopy; Guided surgery; Navigation; Pedicle screw; Spine surgery