Error rate of multi-level rapid prototyping trajectories for pedicle screw placement in lumbar and sacral spine.

OBJECTIVE Free-hand pedicle screw placement has a high incidence of pedicle perforation which can be reduced with fluoroscopy, navigation or an alternative rapid prototyping drill guide template. In our study the error rate of multi-level templates for pedicle screw placement in lumbar and sacral regions was evaluated. METHODS A case series study was performed on 11 patients. Seventy-two screws were implanted using multi-level drill guide templates manufactured with selective laser sintering. According to the optimal screw direction preoperatively defined, an analysis of screw misplacement was performed. Displacement, deviation and screw length difference were measured. The learning curve was also estimated. RESULTS Twelve screws (17%) were placed more than 3.125 mm out of its optimal position in the centre of pedicle. The tip of the 16 screws (22%) was misplaced more than 6.25 mm out of the predicted optimal position. According to our predefined goal, 19 screws (26%) were implanted inaccurately. In 10 cases the screw length was selected incorrectly: 1 (1%) screw was too long and 9 (13%) were too short. No clinical signs of neurovascular lesion were observed. Learning curve was insignificantly noticeable (P=0.129). CONCLUSION In our study, the procedure of manufacturing and applying multi-level drill guide templates has a 26% chance of screw misplacement. However, that rate does not coincide with pedicle perforation incidence and neurovascular injury. These facts along with a comparison to compatible studies make it possible to summarize that multi-level templates are satisfactorily accurate and allow precise screw placement with a clinically irrelevant mistake factor. Therefore templates could potentially represent a useful tool for routine pedicle screw placement.

[1]  K. Radermacher,et al.  Computer assisted orthopaedic surgery with image based individual templates. , 1998, Clinical orthopaedics and related research.

[2]  William W. Lu,et al.  A Novel Patient-Specific Navigational Template for Cervical Pedicle Screw Placement , 2009, Spine.

[3]  Le Xie,et al.  A novel computer-assisted drill guide template for placement of C2 laminar screws , 2009, European Spine Journal.

[4]  Branislav Jaramaz,et al.  Computer-Assisted Orthopaedic Surgery , 1998, Proceedings of the IEEE.

[5]  Le Xie,et al.  A novel computer-assisted drill guide template for thoracic pedicle screw placement: a cadaveric study , 2011, Archives of Orthopaedic and Trauma Surgery.

[6]  Di Lu,et al.  Efficacy and accuracy of a novel rapid prototyping drill template for cervical pedicle screw placement , 2011, Computer aided surgery : official journal of the International Society for Computer Aided Surgery.

[7]  Ricardo Ramina,et al.  "Free-hand" technique for thoracolumbar pedicle screw instrumentation: critical appraisal of current "state-of-art". , 2009, Neurology India.

[8]  Guy Fabry,et al.  A medical image based drill guide for pedicle screw insertion: a cadaver study , 1998 .

[9]  Wei Lei,et al.  Accuracy and Safety Assessment of Pedicle Screw Placement Using the Rapid Prototyping Technique in Severe Congenital Scoliosis , 2011, Journal of spinal disorders & techniques.

[10]  Igor Drstvenšek,et al.  Applications of Rapid Prototyping in Cranio- Maxilofacial Surgery Procedures , 2008 .

[11]  D J Quint,et al.  Stereotactic Navigation for Placement of Pedicle Screws in the Thoracic Spine , 2001, Neurosurgery.

[12]  A. Vaccaro,et al.  Posterior thoracic segmental pedicle screw instrumentation: evolving methods of safe and effective placement. , 2005, Neurology India.

[13]  Timothy C Ryken,et al.  Rapid prototype patient-specific drill template for cervical pedicle screw placement , 2007, Computer aided surgery : official journal of the International Society for Computer Aided Surgery.

[14]  Kai Zhang,et al.  Personalised modified osteotomy using computer-aided design–rapid prototyping to correct thoracic deformities , 2011, International Orthopaedics.

[15]  F. Langlotz,et al.  Computer-assisted Orthopaedic surgery (AOS): from pedicle screw insertion to further applications , 1997, Der Orthopäde.

[16]  D. E. Casey Jones,et al.  Accuracy of Pedicle Screw Placement in Lumbar Fusions by Plain Radiographs and Computed Tomography , 1995, Spine.

[17]  H. Sagi,et al.  Electromagnetic Field-Based Image-Guided Spine Surgery Part Two: Results of a Cadaveric Study Evaluating Thoracic Pedicle Screw Placement , 2003, Spine.

[18]  J Vander Sloten,et al.  Three-Dimensional Computed Tomography-Based, Personalized Drill Guide for Posterior Cervical Stabilization at C1–C2 , 2001, Spine.

[19]  A. Prescher,et al.  Computer-Assisted Orthopedic Surgery With Individual Templates and Comparison to Conventional Operation Method , 2001, Spine.

[20]  Yan Wang,et al.  Clinical application of computer-designed polystyrene models in complex severe spinal deformities: a pilot study , 2010, European Spine Journal.

[21]  Nikolaos K. Paschos,et al.  Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques , 2012, European Spine Journal.

[22]  E. L. Bradley,et al.  State of Art , 1994 .

[23]  Matjaz Merc,et al.  A multi-level rapid prototyping drill guide template reduces the perforation risk of pedicle screw placement in the lumbar and sacral spine , 2013, Archives of Orthopaedic and Trauma Surgery.

[24]  Le Xie,et al.  A novel computer‐assisted drill guide template for lumbar pedicle screw placement: a cadaveric and clinical study , 2009, The international journal of medical robotics + computer assisted surgery : MRCAS.

[25]  Zheng Wang,et al.  Accuracy and efficacy of thoracic pedicle screws in scoliosis with patient-specific drill template , 2012, Medical & Biological Engineering & Computing.

[26]  S P Hughes,et al.  Infection in the operating room. , 1999, The Journal of bone and joint surgery. British volume.

[27]  B B Seedhom,et al.  Personalised image-based templates for intra-operative guidance , 2005, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[28]  P. Richards,et al.  Assessment of CAOS as a training model in spinal surgery: a randomised study , 2007, European Spine Journal.

[29]  Moe R. Lim,et al.  Accuracy of Computerized Frameless Stereotactic Image-Guided Pedicle Screw Placement into Previously Fused Lumbar Spines , 2005, Spine.