The European Robotic Spinal Instrumentation (EUROSPIN) Study

Degenerative Disc Disease Clinical Trial

— EUROSPIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398915
• Other study ID #: EUROSPIN
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2020
• Source: Bergman Clinics
• Contact: Victor E Staartjes, BMed
• Phone: 0031 88 900 0500
• Email: v.staartjes[@]bergmanclinics.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 615
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Discitis
• Intervertebral Disc Degeneration
• Recurrent Disc Herniation
• Spinal Metastases
• Spinal Stenosis
• Spinal Tumor
• Spondylodiskitis
• Spondylolisthesis

Intervention

Procedure:
• Transpedicular Instrumentation
Transpedicular screw placement and instrumentation

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
France	Amiens University Hospital	Amiens
France	La Pitié Salpetrière Hospital	Paris
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Ortho-Klinik Dortmund	Dortmund
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Klinikum Rechts der Isar	Munich
Germany	St Josef Brothers Hospital	Paderborn
Netherlands	Martini Hospital	Groningen
Netherlands	Bergman Clinics	Naarden
Netherlands	MC Haaglanden	the Hague
Switzerland	HUG Geneva	Geneva
Switzerland	Clinique de La Source	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Marc Schröder

Countries where clinical trial is conducted

Austria,  France,  Germany,  Netherlands,  Switzerland, 

References & Publications (13)

Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

R Core Team. R: A Language and Environment for Statistical Computing. (R Foundation for Statistical Computing, 2017).

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. Review. — View 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. — View 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. — View 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. — View Citation

Schröder 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. — View Citation

Staartjes VE, Klukowska AM, Schröder 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of use of analgetics	Frequency of use of analgetics (daily/weekly/not regularly)	2 years
Other	Satisfaction with symptoms	Satisfaction with symptoms (satisfied/neutral/dissatisfied)	2 years
Other	Smoking status	Smoking status (active/ceased/never)	2 years
Other	Working status	Working status (able to work/unable to work)	2 years
Other	Return to work	Return to work (number of weeks/not yet)	2 years
Other	Overall rate of reoperations	Overall rate of reoperations	2 weeks
Primary	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	Intraoperative screw revision	Revision or redirection of a placed screw during the same general anesthesia session	Intraoperative
Secondary	Duration of Surgery	Duration of Surgery in minutes	Intraoperative
Secondary	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)
Secondary	Radiation Dose (DAP)	Radiation Dose as DAP (Dose Area Product, cGy cm2)	Intraoperative
Secondary	Estimated Blood Loss	Estimated Blood Loss (ml)	Intraoperative
Secondary	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)
Secondary	Intraoperative Complications	Intraoperative Complications	0 weeks
Secondary	Postoperative Complications	Postoperative Complications	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Oswestry Disability Index	Oswestry Disability Index (ODI) for functional impairment	2 years