The European Robotic Spinal Instrumentation (EUROSPIN) Study (EUROSPIN)

The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation

In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected. The three arms consist of robot-guided (RG), navigated (NV), or freehand (FH) screw insertion.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Disc Disease; Spinal Stenosis; Spondylolisthesis; Spinal Tumor; Spinal Metastases; Spondylodiskitis; Recurrent Disc Herniation
• Intervention / Treatment: Procedure: Transpedicular Instrumentation

Detailed Description

Introduction A decade ago, minimally invasive surgery (MIS) was considered a promising development in spine surgery, yet the value of the pioneering technologies was questionable. With the growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical benefits over open approaches in terms of blood loss, length of stay, rehabilitation, cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever improving navigational systems have been developed. These systems allow a consistent level of safety and accuracy, on par with results achieved by very experienced free hand surgeons, with a reasonably short learning curve. Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery.

Designed to overcome some of the limitations of navigation-based technologies, robot-guided surgery has become commercially available to surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly challenging the gold standards. SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on exact preoperative planning of pedicle screws, while accounting for changes in intervertebral relationships such as due to distraction, cage insertion or changes between the supine patient position in the preoperative CT and the prone patient on the operating table. Published evidence on robot-guided screw placement has demonstrated high levels of accuracy with most reports ranging around 98% of screws placed within the pedicle or with a cortical encroachment of less than 2 mm.4 Although the reliability and accuracy of robot-guided spine surgery have been established, the actual benefits for the patient in terms of clinical outcomes and revision surgeries remain unknown. We have recently conducted cohort studies that showed some evidence that robotic guidance lowers the rate of intraoperative screw revisions and implant related reoperations compared to free hand procedures, while achieving comparable clinical outcomes. We now want to assess these factors, among others, on a higher level of evidence. We aim to conduct a prospective, multicenter, multinational controlled trial comparing clinical and patient reported outcomes of robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle screw placement using pooled data from three centers.

Study Design The European Robotic Spinal Instrumentation (EUROSPIN) study is a prospective, international, multicentre, pragmatic, open-label, non-randomized controlled trial comparing the effectiveness of three techniques for pedicle screw instrumentation, namely RG, NV (CT-, O-Arm, or 3DFL-based), and FH. Following the baseline evaluation, patients will receive one of the three treatments, and will subsequently be followed up for 24 months (Figure 1). The primary analysis will be conducted using the 12-month data.

Sample Size Calculation It was determined that, to detect an intergroup difference of 5% in the primary endpoint, 205 patients are required per group to achieve a power of 1 - beta = 0.8 at alpha = 0.05. The incidence rates were based on the published literature, with an approximated incidence rate of the primary endpoint of 0% for the intervention and 5% for the control group. Because the study protocol is in line with the normal clinical follow-up of most centers, a low dropout rate is expected. This led to a minimum total sample size of 615 patients.

Monitoring An epidemiologist from the sponsor institution will organize an initiation monitor visit at every participating center before starting recruitment. This monitor visit will check whether all study staff are properly trained and the delegation of tasks are well documented (complete Investigator Site File, training and delegation logs). An additional audit will be carried out at 6 months after initiation of recruitment to check whether source documentation and eCRF documentation is similar. Throughout the entire study additional queries by the monitor are send to the investigator in the data capturing system to ensure proper data capturing.

• Study Type: Observational
• Enrollment (Anticipated): 615

Contacts and Locations

• Study Contact: Name: Victor E Staartjes, BMed; Phone Number: 0031 88 900 0500; Email: v.staartjes@bergmanclinics.nl
• Study Contact Backup: Name: Marc L Schröder, MD, PhD; Phone Number: 0031 88 900 0500; Email: m.schroder@bergmanclinics.nl

Study Locations

• Austria
  • Innsbruck, Austria
    • Not yet recruiting
    • Medical University of Innsbruck
    • Contact: Pierre-Pascal Girod, MD
    • Contact: Nikolaus Kögl, MD, MSc
• France
  • Amiens, France
    • Not yet recruiting
    • Amiens University Hospital
    • Contact: Michel Lefranc, MD, PhD
  • Paris, France
    • Recruiting
    • La Pitié Salpêtrière Hospital
    • Contact: Aymeric Amelot, MD
• Germany
  • Berlin, Germany
    • Not yet recruiting
    • Helios Klinikum Berlin-Buch
    • Contact: Yu-Mi Ryang, MD
  • Dortmund, Germany
    • Not yet recruiting
    • Ortho-Klinik Dortmund
    • Contact: Farman Hedayat, MD
    • Contact: Sophie Urbanski
  • Göttingen, Germany
    • Not yet recruiting
    • Universitatsmedizin Gottingen
    • Contact: Christoph Bettag, MD
    • Contact: Bawarjan Schatlo, MD
  • Munich, Germany
    • Not yet recruiting
    • Klinikum rechts der Isar
    • Contact: Sandro M Krieg, MD, MBA
  • Paderborn, Germany
    • Not yet recruiting
    • St Josef Brothers Hospital
    • Contact: Carsten G Schneekloth, MD
• Netherlands
  • Groningen, Netherlands
    • Not yet recruiting
    • Martini Hospital
    • Contact: Mike Abu Saris, MD
  • Naarden, Netherlands, GE
    • Recruiting
    • Bergman Clinics
    • Contact: Marc L Schröder, MD, PhD; Email: m.schroder@bergmanclinics.nl
    • Contact: Victor E Staartjes, BMed
  • the Hague, Netherlands
    • Not yet recruiting
    • MC Haaglanden
    • Contact: Jasper FC Wolfs, MD
• Switzerland
  • Geneva, Switzerland
    • Not yet recruiting
    • HUG Geneva
    • Contact: Enrico Tessitore, MD
  • Lausanne, Switzerland
    • Not yet recruiting
    • Clinique de la Source
    • Contact: Duccio Boscherini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving thoracolumbar transpedicular screw placement for degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, fractures, trauma, or tumors.

Description

Inclusion Criteria

• Informed consent
• Thoracolumbar pedicle screw placement
• Indication for surgery: Degenerative pathologies (stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation), infections, tumors, fractures, trauma
• Age ≥ 18

Exclusion Criteria

• Deformity surgery
• >5 index levels

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robot-Guided Transpedicular Instrumentation; This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).	Procedure: Transpedicular Instrumentation; Transpedicular screw placement and instrumentation
Navigated Transpedicular Instrumentation; This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).	Procedure: Transpedicular Instrumentation; Transpedicular screw placement and instrumentation
Freehand Transpedicular Instrumentation; This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.	Procedure: Transpedicular Instrumentation; Transpedicular screw placement and instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision surgery for a malpositioned pedicle screw	We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative screw revision	Revision or redirection of a placed screw during the same general anesthesia session	Intraoperative
Duration of Surgery	Duration of Surgery in minutes	Intraoperative
Length of Hospital Stay	Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)	Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
Radiation Dose (DAP)	Radiation Dose as DAP (Dose Area Product, cGy cm2)	Intraoperative
Estimated Blood Loss	Estimated Blood Loss (ml)	Intraoperative
Need for blood transfusion	Need for blood transfusion during the hospital stay (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)	Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
Intraoperative Complications	Intraoperative Complications	0 weeks
Postoperative Complications	Postoperative Complications	6 weeks
EQ-5D-3L	EQ-5D-3L (Health-related quality of life) EuroQOL-five dimensions 3-level version measures health-related quality of life. The scale is subdivided into an index, ranging from 0 to 1 and normalized to population-specific values, and a "thermometer" or visual analogue scale, ranging from 0 to 100. The two subscores are not combined towards a single score. Higher values represent a better health-related quality of life in both subscores.	2 years
NRS back pain severity	Numeric Rating Scale (NRS) of back pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.	2 years
NRS leg pain severity	Numeric Rating Scale (NRS) of leg pain severity The scale ranges from 0 to 10. Only integers are available to choose from. Higher values represent a higher amount of pain. There are no subscales.	2 years
Oswestry Disability Index	Oswestry Disability Index (ODI) for functional impairment	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of use of analgetics	Frequency of use of analgetics (daily/weekly/not regularly)	2 years
Satisfaction with symptoms	Satisfaction with symptoms (satisfied/neutral/dissatisfied)	2 years
Smoking status	Smoking status (active/ceased/never)	2 years
Working status	Working status (able to work/unable to work)	2 years
Return to work	Return to work (number of weeks/not yet)	2 years
Overall rate of reoperations	Overall rate of reoperations	2 weeks

Collaborators and Investigators

• Sponsor: Marc Schröder
• Investigators: Study Director: Victor E Staartjes, BMed, Department of Neurosurgery, Bergman Clinics; Principal Investigator: Marc L Schröder, MD, PhD, Department of Neurosurgery, Bergman Clinics; Study Director: Paulien M van Kampen, PhD, Department of Epidemiology, Bergman Clinics

Publications and helpful links

General Publications

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
• Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
• Goldstein CL, Phillips FM, Rampersaud YR. Comparative Effectiveness and Economic Evaluations of Open Versus Minimally Invasive Posterior or Transforaminal Lumbar Interbody Fusion: A Systematic Review. Spine (Phila Pa 1976). 2016 Apr;41 Suppl 8:S74-89. doi: 10.1097/BRS.0000000000001462.
• Hu X, Lieberman IH. What is the learning curve for robotic-assisted pedicle screw placement in spine surgery? Clin Orthop Relat Res. 2014 Jun;472(6):1839-44. doi: 10.1007/s11999-013-3291-1.
• Schatlo B, Martinez R, Alaid A, von Eckardstein K, Akhavan-Sigari R, Hahn A, Stockhammer F, Rohde V. Unskilled unawareness and the learning curve in robotic spine surgery. Acta Neurochir (Wien). 2015 Oct;157(10):1819-23; discussion 1823. doi: 10.1007/s00701-015-2535-0. Epub 2015 Aug 19.
• Marcus HJ, Cundy TP, Nandi D, Yang GZ, Darzi A. Robot-assisted and fluoroscopy-guided pedicle screw placement: a systematic review. Eur Spine J. 2014 Feb;23(2):291-7. doi: 10.1007/s00586-013-2879-1. Epub 2013 Jun 26.
• 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.
• Molliqaj G, Schatlo B, Alaid A, Solomiichuk V, Rohde V, Schaller K, Tessitore E. Accuracy of robot-guided versus freehand fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery. Neurosurg Focus. 2017 May;42(5):E14. doi: 10.3171/2017.3.FOCUS179.
• Schatlo B, Molliqaj G, Cuvinciuc V, Kotowski M, Schaller K, Tessitore E. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. J Neurosurg Spine. 2014 Jun;20(6):636-43. doi: 10.3171/2014.3.SPINE13714. Epub 2014 Apr 11.
• R Core Team. R: A Language and Environment for Statistical Computing. (R Foundation for Statistical Computing, 2017).
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 7, 2018
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: robotic; pedicle screw; instrumentation; computer-assisted; robot-guided; navigated; thoracolumbar
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Cord Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Diseases; Bone Diseases; Spondylitis; Hernia; Bone Diseases, Infectious; Bone Neoplasms; Spondylolysis; Spondylosis; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylolisthesis; Spinal Cord Neoplasms; Spinal Neoplasms; Discitis
• Other Study ID Numbers: EUROSPIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No