Clinical trial NCT03398915: The European Robotic Spinal Instrumentation (EUROSPIN) Study
Official title: The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Spondylolisthesis
Spinal Stenosis
Recurrent Disc Herniation
Spondylodiskitis
Spinal Tumor
Spinal Metastases
Keywords: robotic
robot-guided
navigated
computer-assisted
pedicle screw
instrumentation
thoracolumbar
Lead sponsor: Bergman Clinics
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Revision surgery for a malpositioned pedicle screw
timeFrame: 12 months
Secondary outcomes:
measure: Intraoperative screw revision
timeFrame: Intraoperative
measure: Duration of Surgery
timeFrame: Intraoperative
measure: Length of Hospital Stay
timeFrame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
measure: Radiation Dose (DAP)
timeFrame: Intraoperative
measure: Estimated Blood Loss
timeFrame: Intraoperative
measure: Need for blood transfusion
timeFrame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out)
measure: Intraoperative Complications
timeFrame: 0 weeks
measure: Postoperative Complications
timeFrame: 6 weeks
measure: EQ-5D-3L
timeFrame: 2 years
measure: NRS back pain severity
timeFrame: 2 years
measure: NRS leg pain severity
timeFrame: 2 years
measure: Oswestry Disability Index
timeFrame: 2 years
Other outcomes:
measure: Frequency of use of analgetics
timeFrame: 2 years
measure: Satisfaction with symptoms
timeFrame: 2 years
measure: Smoking status
timeFrame: 2 years
measure: Working status
timeFrame: 2 years
measure: Return to work
timeFrame: 2 years
measure: Overall rate of reoperations
timeFrame: 2 weeks
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Amiens
country: France
facility: Amiens University Hospital
city: Paris
country: France
facility: La Pitié Salpetrière Hospital
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Dortmund
country: Germany
facility: Ortho-Klinik Dortmund
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Munich
country: Germany
facility: Klinikum Rechts der Isar
city: Paderborn
country: Germany
facility: St Josef Brothers Hospital
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Naarden
country: Netherlands
facility: Bergman Clinics
city: the Hague
country: Netherlands
facility: MC Haaglanden
city: Geneva
country: Switzerland
facility: HUG Geneva
city: Lausanne
country: Switzerland
facility: Clinique de La Source
Study officials:
affiliation: Department of Neurosurgery, Bergman Clinics
name: Victor E Staartjes, BMed
role: STUDY_DIRECTOR
affiliation: Department of Neurosurgery, Bergman Clinics
name: Marc L Schröder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Epidemiology, Bergman Clinics
name: Paulien M van Kampen, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: R Core Team. R: A Language and Environment for Statistical Computing. (R Foundation for Statistical Computing, 2017).
citation: 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.
citation: 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.