Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial



Screw misplacement incidence can be as high as 15–30% in spine deformity surgery, with possible devastating consequences. Some technical solutions to prevent misplacement require expensive devices. MySpineTM comprises a low-dose CT scan of the patient’s spine to build a virtual model of the spine to plan the screw trajectories and a 3D-printed patient-specific guide system to prepare the screw trajectories and to implant the screws in the vertebrae in order to increase reproducibility and safety of the implants. The aim of this open-label, single-center, prospective randomized clinical trial with independent evaluation of outcomes was to compare the accuracy of free-hand insertion of pedicle screws to MySpineTM 3D-printed patient-specific guides.


Twenty-nine patients undergoing surgical correction for spinal deformity were randomized to Group A (pedicle screws implantation with MySpineTM) or Group B (free-hand implantation). Group A received 297 pedicle screws, and Group B 243 screws. Forty-three screws in Group A crossed over to free-hand implantation. Screw position was graded according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as “safe area.” Total fluoroscopy dose and time were compared in six patients of each group.


Comparing the two study groups, we observed a statistically significant difference between the two groups (p < 0.05), with 96.1% of screws in the “safe area” in Group A versus a 82.9% in Group B. Group-A patients had a mean effective dose of 0.23 mSv compared to 0.82 mSv in Group B. Patient-specific, 3D-printed pedicle screw guides increase safety in a wide spectrum of deformity conditions. In addition, the total radiation dose is reduced, even considering the need of a low-dose preoperative CT for surgical planning.

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  1. 1.

    Bhagat S, Vozar V, Lutchman L, Crawford RJ, Rai AS (2013) Morbidity and mortality in adult spinal deformity surgery: Norwich Spinal Unit experience. Eur Spine J 22(Suppl 1):S42–S46

    Article  PubMed  Google Scholar 

  2. 2.

    Sciubba DM, Yurter A, Smith JS, Kelly MP, Scheer JK, Goodwin CR, Lafage V, Hart RA, Bess S, Kebaish K, Schwab F, Shaffrey CI, Ames CP, International Spine Study Group (ISSG) (2015) A comprehensive review of complication rates after surgery for adult deformity: a reference for informed consent. Spine Deform 3(6):575–594

    Article  PubMed  Google Scholar 

  3. 3.

    Phillips JH, Knapp DR Jr, Herrera-Soto J (2013) Mortality and morbidity in early-onset scoliosis surgery. Spine (Phila Pa 1976) 38(4):324–327

    Article  Google Scholar 

  4. 4.

    Garbossa D, Pejrona M, Damilano M, Sansone V, Ducati A, Berjano P (2014) Pelvic parameters and global spine balance for spine degenerative disease: the importance of containing for the well being of content. Eur Spine J 23(Suppl 6):616–627

    Article  PubMed  Google Scholar 

  5. 5.

    Sarlak AY, Tosun B, Atmaca H, Sarisoy HT, Buluç L (2009) Evaluation of thoracic pedicle screw placement in adolescent idiopathic scoliosis. Eur Spine J 18:1892–1897

    Article  PubMed  PubMed Central  Google Scholar 

  6. 6.

    Wegener B, Birkenmaier C, Fottner A, Jansson V, Dürr HR (2008) Delayed perforation of the aorta by a thoracic pedicle screw. Eur Spine J 17(Suppl2):S351–S354

    Article  PubMed  Google Scholar 

  7. 7.

    Pitteloud N, Gamulin A, Barea C, Damet J, Racloz G, Sans-Merce M (2017) Radiation exposure using the O-arm® surgical imaging system. Eur Spine J 26(3):651–657. Epub 2016 Sep 21

    Article  PubMed  Google Scholar 

  8. 8.

    Zhu W, Sun W, Xu L, Sun X, Liu Z, Qiu Y, Zhu Z (2017) Minimally invasive scoliosis surgery assisted by O-arm navigation for Lenke Type 5C adolescent idiopathic scoliosis: a comparison with standard open approach spinal instrumentation. J Neurosurg Pediatr 19(4):472–478

    Article  Google Scholar 

  9. 9.

    Lange J, Karellas A, Street J, Eck JC, Lapinsky A, Connolly PJ, Dipaola CP (2013) Estimating the effective radiation dose imparted to patients by intraoperative cone-beam computed tomography in thoracolumbar spinal surgery. Spine (Phila Pa 1976) 38(5):E306–E312

    Article  Google Scholar 

  10. 10.

    Simony A, Hansen EJ, Christensen SB, Carreon LY, Andersen MO (2016) Incidence of cancer in adolescent idiopathic scoliosis patients treated 25 years previously. Eur Spine J 25:3366–3370

    Article  PubMed  Google Scholar 

  11. 11.

    Valone LC, Chambers M, Lattanza L, James MA (2016) Breast radiation exposure in female orthopaedic surgeons. JBJS Am 98(21):1808–1813

    Article  PubMed  Google Scholar 

  12. 12.

    Chou LB, Lerner LB, Harris AHS, Brandon AJ, Girod S, Butler LM (2015) Cancer prevalence among a cross-sectional survey of female orthopedic, urology, and plastic surgeons in the United States. Women’s Health Issues 25–5:476–481

    Article  Google Scholar 

  13. 13.

    Hu Y, Yuan ZS, Spiker WR, Dong WX, Sun XY, Yuan JB, Zhang J, Zhu B (2016) A comparative study on the accuracy of pedicle screw placement assisted by personalized rapid prototyping template between pre- and post-operation in patients with relatively normal mid-upper thoracic spine. Eur Spine J 25(6):1706–1715

    Article  PubMed  Google Scholar 

  14. 14.

    Berry E, Cuppone M, Porada S, Millner PA, Rao A, Chiverton N, Seedhom BB (2005) Personalised image-based templates for intra-operative guidance. Proc Inst Mech Eng H 219(2):111–118

    Article  CAS  PubMed  Google Scholar 

  15. 15.

    Gertzbein SD, Robbins SE (1990) Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976) 15(1):11–14

    Article  CAS  Google Scholar 

  16. 16.

    Amiot LP, Lang K, Putzier M, Zippel H, Labelle H (2000) Comparative results between conventional and computer-assisted pedicle screw installation in the thoracic, lumbar, and sacral spine. Spine (Phila Pa 1976) 25(5):606–614

    Article  CAS  Google Scholar 

  17. 17.

    Radermacher K, Bliem R, Hennecke C, Staudte HW, Rau G (1996) A desktop image processing system for computer-assisted orthopedic surgery (DISOS). Stud Health Technol Inform 29:675–680

    CAS  PubMed  Google Scholar 

  18. 18.

    Lamartina C, Cecchinato R, Fekete Z, Lipari A, Fiechter M, Berjano P (2015) Pedicle screw placement accuracy in thoracic and lumbar spinal surgery with a patient-matched targeting guide: a cadaveric study. Eur Spine J 24(Suppl 7):937–941

    Article  PubMed  Google Scholar 

  19. 19.

    Lamartina C, Capuzzo A, Cecchinato R, Zerbi A, Berjano P (2014) Adolescent idiopathic scoliosis surgery with patient-specific screw placement-guides. Eur Spine J 23(12):2765–2766

    Article  CAS  PubMed  Google Scholar 

  20. 20.

    Putzier M, Strube P, Cecchinato R, Lamartina C, Hoff EK (2017) A new navigational tool for pedicle screw placement in patients with severe scoliosis: a pilot study to prove feasibility, accuracy, and identify operative challenges. Clin Spine Surg 30(4):E430–E439

    Article  PubMed  Google Scholar 

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This study was financed with an unrestricted research Grant of 22,975 Euros from Medacta SA, CH.

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Correspondence to Riccardo Cecchinato.

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Authors RC, PB, AZ, MD and CL are consultants for Medacta SA.

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Cecchinato, R., Berjano, P., Zerbi, A. et al. Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial. Eur Spine J 28, 1712–1723 (2019).

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  • Scoliosis
  • Navigation
  • 3D printing
  • Accuracy
  • Spine deformity