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The investigators would like to investigate the fluoro-registered Mazor X Stealth in terms of pedicle screw accuracy and radiation exposure in comparison with the O-arm and navigation as the institutional gold standard.
Pedicle screw insertion for spinal fusion is a surgical procedure regularly performed around the world. Surgeons use free-hand, navigation or robotic techniques. The navigation began in 1995 in spine surgery. Surgical navigation systems provide pedicle screw insertion by projecting screw trajectories on a three-dimensional (3D) image acquisition, preoperatively or during the surgical procedure. Laine et al reported better accuracy and safety in pedicle screw insertion using the navigation system. Other authors reported less irradiation with the use of computer-assisted navigation. Robotic guidance was introduced in 2006 and assists the surgeon through a mechanical guidance according to a planning of screw trajectories on 3D imaging. This technique allows stable guidance for pedicle drilling and screw insertion, leading to greater screw positioning in lumbar fusion.
Medtronic (Medtronic, Minneapolis, MN, USA) introduced the Mazor X Stealth in Europa in 2019, including the Mazor robotic device with the navigation technology within the same system. The hypothesis would be a combination of the stability of the robot during screw insertion and the accuracy of the navigation with cumulative benefit from the two techniques.
The goal of this study is to compare radiological and clinical results of the use of the new Mazor Stealth with the surgical O-arm navigation during pedicle screw insertion for posterior lumbar fusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic group (RG) | Experimental | Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot |
|
| O-arm navigation group (NV) | Active Comparator | Patients in the NV group will be operated using the guidance of the Stealth navigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidance for pedicle screw insertion (Mazor Stealth) | Device | Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Pedicle screw accuracy | Usinge the Heary classification for thoracic screws and the Gertzbein classification for lumbar screws | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation exposure | Effective dose calculated with the PCXMC software for 2D (from dose area product) and with the ICRP 103 recommandations for 3D (from dose length product) | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duccio Boscherini, MD, PhD | Contact | +41216470525 | d.boscherini@lasource.ch | |
| Marc Prod'homme, MD | Contact | +41216470525 | marcprod86@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Duccio Boscherini, MD, PhD | Neuro Orthopedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Orthopedic Center | Recruiting | Lausanne | Canton of Vaud | 1004 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31501123 | Background | Staartjes VE, Molliqaj G, van Kampen PM, Eversdijk HAJ, Amelot A, Bettag C, Wolfs JFC, Urbanski S, Hedayat F, Schneekloth CG, Abu Saris M, Lefranc M, Peltier J, Boscherini D, Fiss I, Schatlo B, Rohde V, Ryang YM, Krieg SM, Meyer B, Kogl N, Girod PP, Thome C, Twisk JWR, Tessitore E, Schroder ML. The European Robotic Spinal Instrumentation (EUROSPIN) study: protocol for a multicentre prospective observational study of pedicle screw revision surgery after robot-guided, navigated and freehand thoracolumbar spinal fusion. BMJ Open. 2019 Sep 8;9(9):e030389. doi: 10.1136/bmjopen-2019-030389. | |
| 11415570 |
| Label | URL |
|---|---|
| \[Internet\]. Medtronic.com. 2019 \[cited 15 January 2020\]. | View source |
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All data will be available for the Investigators and for control from the ethical commission if asked
Data will be available from the beginning of the study, and until 10 years according to cantonal rules
Local professional computer
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
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Medical device compared with gold standard
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single-blind, only for the patient, after randomization
| Guidance for pedicle screw insertion (O-arm Navigation) | Device | Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion |
|
| Background |
| Nolte LP, Zamorano L, Visarius H, Berlemann U, Langlotz F, Arm E, Schwarzenbach O. Clinical evaluation of a system for precision enhancement in spine surgery. Clin Biomech (Bristol). 1995 Sep;10(6):293-303. doi: 10.1016/0268-0033(95)00004-5. |
| 29859354 | Background | Staartjes VE, Klukowska AM, Schroder ML. Pedicle Screw Revision in Robot-Guided, Navigated, and Freehand Thoracolumbar Instrumentation: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Aug;116:433-443.e8. doi: 10.1016/j.wneu.2018.05.159. Epub 2018 May 31. |
| 10905443 | Background | Laine T, Lund T, Ylikoski M, Lohikoski J, Schlenzka D. Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients. Eur Spine J. 2000 Jun;9(3):235-40. doi: 10.1007/s005860000146. |
| 22469525 | Background | Hartl R, Lam KS, Wang J, Korge A, Kandziora F, Audige L. Worldwide survey on the use of navigation in spine surgery. World Neurosurg. 2013 Jan;79(1):162-72. doi: 10.1016/j.wneu.2012.03.011. Epub 2012 Mar 30. |
| 16955046 | Background | Lieberman IH, Togawa D, Kayanja MM, Reinhardt MK, Friedlander A, Knoller N, Benzel EC. Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: Part I--Technical development and a test case result. Neurosurgery. 2006 Sep;59(3):641-50; discussion 641-50. doi: 10.1227/01.NEU.0000229055.00829.5B. |
| 17297375 | Background | Togawa D, Kayanja MM, Reinhardt MK, Shoham M, Balter A, Friedlander A, Knoller N, Benzel EC, Lieberman IH. Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: part 2--Evaluation of system accuracy. Neurosurgery. 2007 Feb;60(2 Suppl 1):ONS129-39; discussion ONS139. doi: 10.1227/01.NEU.0000249257.16912.AA. |
| 28463610 | Background | Schroder ML, Staartjes VE. Revisions for screw malposition and clinical outcomes after robot-guided lumbar fusion for spondylolisthesis. Neurosurg Focus. 2017 May;42(5):E12. doi: 10.3171/2017.3.FOCUS16534. |
| 15070139 | Background | Heary RF, Bono CM, Black M. Thoracic pedicle screws: postoperative computerized tomography scanning assessment. J Neurosurg. 2004 Apr;100(4 Suppl Spine):325-31. doi: 10.3171/spi.2004.100.4.0325. |
| 2326693 | Background | Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976). 1990 Jan;15(1):11-4. doi: 10.1097/00007632-199001000-00004. |
| 18082557 | Background | The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003. |
| Background | Servomaa A, Tapiovaara M. Organ dose calculation in medical x ray examinations by the program PCXMC. Radiation protection dosimetry. 1998 Nov 1;80(1-3):213-9 |
| Background | Nuclear Energy Agency Forum on Stakeholder ConfidenceChilton Seminar: Roger Cox -'Risks from low doses of low-LET radiation - the US National Academy of Sciences BEIR VII report'SRP Meeting on Source ManagementScientific Symposium to Mark the Past and Future Achievements of Richard Doll. Journal of Radiological Protection. 2006;26(1):119-123 |