Sébastien Ruatti1, C Dubois2, E Chipon3, G Kerschbaumer4, M Milaire4, A Moreau-Gaudry3, J Tonetti4, Ph Merloz4. 1. University Department of Orthopaedic Surgery and Traumatology, CHU A. Michallon, 38043, Grenoble Cedex, France. sruatti@chu-grenoble.fr. 2. University Department of Medical Imaging, CHU A. Michallon, 38043, Grenoble Cedex, France. 3. Clinical Investigation and Technological Innovation Center (CIC-IT), Joseph Fourier University, 38043, Grenoble Cedex, France. 4. University Department of Orthopaedic Surgery and Traumatology, CHU A. Michallon, 38043, Grenoble Cedex, France.
Abstract
PURPOSE: We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure. MATERIAL AND METHOD: We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan. RESULTS: 3D Fluoronavigation appeared less accurate in percutaneous procedures (24 % of misplaced pedicle screws vs 5 % in Group C) (p = 0.007), but more accurate in opened surgeries (5 % of misplaced pedicle screws vs 17 % in Group C) (p = 0.025). For one vertebra, the average surgical running time reached 8 min in Group C vs 21 min in Group N for percutaneous surgeries (p = 3.42 × 10(-9)), 7.33 min in Group C vs 16.33 min in Group N (p = 2.88 × 10(-7)) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62 mSv in Group C (p = 2.45 × 10(-9))]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1 mSv in Group C (p = 0.022). CONCLUSION: The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).
RCT Entities:
PURPOSE: We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure. MATERIAL AND METHOD: We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan. RESULTS: 3D Fluoronavigation appeared less accurate in percutaneous procedures (24 % of misplaced pedicle screws vs 5 % in Group C) (p = 0.007), but more accurate in opened surgeries (5 % of misplaced pedicle screws vs 17 % in Group C) (p = 0.025). For one vertebra, the average surgical running time reached 8 min in Group C vs 21 min in Group N for percutaneous surgeries (p = 3.42 × 10(-9)), 7.33 min in Group C vs 16.33 min in Group N (p = 2.88 × 10(-7)) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62 mSv in Group C (p = 2.45 × 10(-9))]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1 mSv in Group C (p = 0.022). CONCLUSION: The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).
Entities:
Keywords:
3D fluoroscope; 3D imaging; Computer-aided surgery; Navigation and spine surgery; Spine surgery
Authors: Nicholas Theocharopoulos; Kostas Perisinakis; John Damilakis; George Papadokostakis; Alexander Hadjipavlou; Nicholas Gourtsoyiannis Journal: J Bone Joint Surg Am Date: 2003-09 Impact factor: 5.284
Authors: Alexander Mason; Renee Paulsen; Jason M Babuska; Sharad Rajpal; Sigita Burneikiene; E Lee Nelson; Alan T Villavicencio Journal: J Neurosurg Spine Date: 2013-12-20
Authors: Jens Geerling; Thomas Gösling; Anna Gösling; Gil Ortega; Daniel Kendoff; Musa Citak; Christian Krettek; Tobias Hüfner Journal: Comput Aided Surg Date: 2008-05
Authors: Ioannis D Gelalis; Nikolaos K Paschos; Emilios E Pakos; Angelos N Politis; Christina M Arnaoutoglou; Athanasios C Karageorgos; Avraam Ploumis; Theodoros A Xenakis Journal: Eur Spine J Date: 2011-09-07 Impact factor: 3.134