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

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ClinicalTrials.gov Identifier: NCT03398915
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Schröder, Bergman Clinics

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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Spondylolisthesis Spinal Stenosis Recurrent Disc Herniation Spondylodiskitis Spinal Tumor Spinal Metastases Procedure: Transpedicular Instrumentation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 615 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Revision surgery for a malpositioned pedicle screw [ Time Frame: 12 months ]
    We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.


Secondary Outcome Measures :
  1. Intraoperative screw revision [ Time Frame: Intraoperative ]
    Revision or redirection of a placed screw during the same general anesthesia session

  2. Duration of Surgery [ Time Frame: Intraoperative ]
    Duration of Surgery in minutes

  3. Length of Hospital Stay [ Time Frame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out) ]
    Length of Hospital Stay in days (Defined as from admission to discharge, during the hospital stay in which the primary surgery was carried out)

  4. Radiation Dose (DAP) [ Time Frame: Intraoperative ]
    Radiation Dose as DAP (Dose Area Product, cGy cm2)

  5. Estimated Blood Loss [ Time Frame: Intraoperative ]
    Estimated Blood Loss (ml)

  6. Need for blood transfusion [ Time Frame: Through hospital stay (From admission to discharge of the hospital stay in which the primary surgery was carried out) ]
    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)

  7. Intraoperative Complications [ Time Frame: 0 weeks ]
    Intraoperative Complications

  8. Postoperative Complications [ Time Frame: 6 weeks ]
    Postoperative Complications

  9. EQ-5D-3L [ Time Frame: 2 years ]

    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.


  10. NRS back pain severity [ Time Frame: 2 years ]
    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.

  11. NRS leg pain severity [ Time Frame: 2 years ]
    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.

  12. Oswestry Disability Index [ Time Frame: 2 years ]
    Oswestry Disability Index (ODI) for functional impairment


Other Outcome Measures:
  1. Frequency of use of analgetics [ Time Frame: 2 years ]
    Frequency of use of analgetics (daily/weekly/not regularly)

  2. Satisfaction with symptoms [ Time Frame: 2 years ]
    Satisfaction with symptoms (satisfied/neutral/dissatisfied)

  3. Smoking status [ Time Frame: 2 years ]
    Smoking status (active/ceased/never)

  4. Working status [ Time Frame: 2 years ]
    Working status (able to work/unable to work)

  5. Return to work [ Time Frame: 2 years ]
    Return to work (number of weeks/not yet)

  6. Overall rate of reoperations [ Time Frame: 2 weeks ]
    Overall rate of reoperations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398915


Contacts
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Contact: Victor E Staartjes, BMed 0031 88 900 0500 v.staartjes@bergmanclinics.nl
Contact: Marc L Schröder, MD, PhD 0031 88 900 0500 m.schroder@bergmanclinics.nl

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marc Schröder, Head of Department, Bergman Clinics
ClinicalTrials.gov Identifier: NCT03398915    
Other Study ID Numbers: EUROSPIN
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marc Schröder, Bergman Clinics:
robotic
robot-guided
navigated
computer-assisted
pedicle screw
instrumentation
thoracolumbar
Additional relevant MeSH terms:
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Discitis
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis
Spondylitis
Bone Diseases, Infectious
Infection