<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02998060</url>
  </required_header>
  <id_info>
    <org_study_id>ABR-59636</org_study_id>
    <nct_id>NCT02998060</nct_id>
  </id_info>
  <brief_title>Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion</brief_title>
  <official_title>Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marc Schröder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bergman Clinics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Computer-based navigation systems were first introduced to spine surgery in 1995 and while&#xD;
      they have been long established as standards in certain cranial procedures, they have not&#xD;
      been similarly adopted in spine surgery. Designed to overcome some of the limitations of&#xD;
      navigation-based technologies, robot-guided surgical systems have become commercially&#xD;
      available to surgeons worldwide.These systems are rapidly challenging the gold standards.&#xD;
&#xD;
      The aim is to conduct a prospective randomized controlled trial. The randomized variable will&#xD;
      be the screw placement technique used. One arm will be treated with lumbar fusion using&#xD;
      robotic guidance (RG), one arm will receive the same procedure but with a free hand technique&#xD;
      (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted). Intraoperative&#xD;
      screw revisions and revision surgery for screw malposition as well as clinical&#xD;
      patient-reported outcomes to identify any such differences between these methods of screw&#xD;
      insertion will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A decade ago, minimally invasive surgery (MIS) was considered a promising development in&#xD;
      spine surgery, yet the value of the pioneering technologies was questionable. With the&#xD;
      growing number of experienced MIS surgeons, the influx of evidence in favour of MIS is&#xD;
      rapidly increasing. This makes a compelling argument towards MIS offering distinct clinical&#xD;
      benefits over open approaches in terms of blood loss, length of stay, rehabilitation,&#xD;
      cost-effectiveness and perioperative patient comfort. Due to the limited or inexistent&#xD;
      line-of-sight in MIS procedures, surgeons need to rely on imaging, navigation, and guidance&#xD;
      technologies to operate in a safe and efficient manner. Therefore, a plethora of new and ever&#xD;
      improving navigational systems have been developed. These systems allow a consistent level of&#xD;
      safety and accuracy, on par with results achieved by very experienced free hand surgeons,&#xD;
      with a reasonably short learning curve.&#xD;
&#xD;
      Computer-based navigation systems were first introduced to spine surgery in 1995 and while&#xD;
      they have been long established as standards in certain cranial procedures, they have not&#xD;
      been similarly adopted in spine surgery. Designed to overcome some of the limitations of&#xD;
      navigation-based technologies, robot-guided surgery has become commercially available to&#xD;
      surgeons worldwide, like SpineAssist® (Mazor Robotics Ltd. Caesarea, Israel) and the recently&#xD;
      launched ROSA™ Spine (Zimmer-Biomet, Warsaw, Indiana, USA). These systems are rapidly&#xD;
      challenging the gold standards.&#xD;
&#xD;
      SpineAssist®, and its upgraded version, the Renaissance®, provides a stable drilling platform&#xD;
      and restricts the surgeon's natural full range of motion to 2 degrees of freedom (up/down&#xD;
      motion and yaw in the cannula). The system's guidance unit moves into the trajectory based on&#xD;
      exact preoperative planning of pedicle screws, while accounting for changes in intervertebral&#xD;
      relationships such as due to distraction, cage insertion or changes between the supine&#xD;
      patient position in the preoperative CT and the prone patient on the operating table.&#xD;
      Published evidence on robot-guided screw placement has demonstrated high levels of accuracy&#xD;
      with most reports ranging around 98% of screws placed within the pedicle or with a cortical&#xD;
      encroachment of less than 2 mm.&#xD;
&#xD;
      Although the reliability and accuracy of robot-guided spine surgery have been established,&#xD;
      the actual benefits for the patient in terms of clinical outcomes and revision surgeries&#xD;
      remain unknown.&#xD;
&#xD;
      The investigators recently conducted a cohort study that showed some evidence that robotic&#xD;
      guidance lowers the rate of intraoperative screw revisions and implant related reoperations&#xD;
      compared to free hand procedures, while achieving comparable clinical outcomes. Now, these&#xD;
      factors, among others, have to be assessed on a higher level of evidence. This would be, to&#xD;
      date, the first randomized controlled trial comparing clinical patient reported outcomes of&#xD;
      robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle&#xD;
      screw placement.&#xD;
&#xD;
      The investigator's aim is to conduct a prospective randomized controlled trial. The&#xD;
      randomized variable will be the screw placement technique used. One arm will be treated with&#xD;
      lumbar fusion using robotic guidance (RG), one arm will receive the same procedure but with a&#xD;
      free hand technique (FH) and the third arm will use navigation (NV) (CT or&#xD;
      Fluoroscopy-assisted).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in study design [Randomization not feasible]&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life after Spinal Fusion as assessed using the Euroqol EQ-5D questionnaire</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Back Pain after Spinal Fusion as assessed using the Oswestry Disability Index (ODI)</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Back and Leg pain after Spinal Fusion as assessed using a Virtual Analogue Scale (VAS)</measure>
    <time_frame>12 months after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Pedicle Screws that needed intraoperative Revision</measure>
    <time_frame>Intraoperatively (From induction until end of anesthesia)</time_frame>
    <description>If a pedicle screw is malpositioned and this is noticed intraoperatively, the screw can be removed and revised.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Revision Surgeries for malpositioned Screws</measure>
    <time_frame>Through study completion, an average of 12 months</time_frame>
    <description>If a screw malposition is not detected intraoperatively and neurological deficits or other complaints secondary to the malpositioned screw arise, the screw needs to be surgically revised.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Spondylolisthesis</condition>
  <condition>Intervertebral Disc Degeneration</condition>
  <arm_group>
    <arm_group_label>Robot-guided</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Robotic guidance (SpineAssist®or Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) will be used for navigation and insertion of pedicle screws.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Navigated</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A computer-assisted method of navigation (CT- or 3D-Fluoroscopy-based) will be used for navigation and insertion of pedicle screws.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Freehand</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pedicle screws will be inserted using the freehand technique under fluoroscopic control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pedicle Screw Placement</intervention_name>
    <description>As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.</description>
    <arm_group_label>Freehand</arm_group_label>
    <arm_group_label>Navigated</arm_group_label>
    <arm_group_label>Robot-guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)</intervention_name>
    <description>This robot will be used to guide pedicle screws into their trajectories.</description>
    <arm_group_label>Robot-guided</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D C-Arm (Ziehm Imaging, Nuremberg, Germany)</intervention_name>
    <description>This 3D Fluoroscope will be used to navigate pedicle screws into their trajectories.</description>
    <arm_group_label>Navigated</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
          -  Lumbar single level discopathy or Spondylolisthesis of Meyerding Grade 1 or 2&#xD;
&#xD;
          -  Body Mass Index &gt;19 and &lt;33&#xD;
&#xD;
          -  American Society of Anesthesiologists Scale 1 or 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Scoliosis (Coronal Cobb's &gt;30 degrees / Schwab classification sagittal modifier&#xD;
             + or ++)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victor E Staartjes, Stud. Med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsmedizin Göttingen Georg-August</name>
      <address>
        <city>Gottingen</city>
        <state>Niedersachsen</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bergman Clinics</investigator_affiliation>
    <investigator_full_name>Marc Schröder</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Robot</keyword>
  <keyword>Spinal Fusion</keyword>
  <keyword>Spine</keyword>
  <keyword>Navigation</keyword>
  <keyword>Freehand</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998060
org study id: ABR-59636
nct id: NCT02998060
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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 surgical systems have become commercially
      available to surgeons worldwide.These systems are rapidly challenging the gold standards.

      The aim is to conduct a prospective randomized controlled trial. The randomized variable will
      be the screw placement technique used. One arm will be treated with lumbar fusion using
      robotic guidance (RG), one arm will receive the same procedure but with a free hand technique
      (FH) and the third arm will use navigation (NV) (CT or Fluoroscopy-assisted). Intraoperative
      screw revisions and revision surgery for screw malposition as well as clinical
      patient-reported outcomes to identify any such differences between these methods of screw
      insertion will be assessed.
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.

      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.

      The investigators recently conducted a cohort study 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. Now, these
      factors, among others, have to be assessed on a higher level of evidence. This would be, to
      date, the first randomized controlled trial comparing clinical patient reported outcomes of
      robotic guided (RG) pedicle screw placement vs. navigated (NV) vs. free hand (FH) pedicle
      screw placement.

      The investigator's aim is to conduct a prospective randomized controlled trial. The
      randomized variable will be the screw placement technique used. One arm will be treated with
      lumbar fusion using robotic guidance (RG), one arm will receive the same procedure but with a
      free hand technique (FH) and the third arm will use navigation (NV) (CT or
      Fluoroscopy-assisted).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of Life after Spinal Fusion as assessed using the Euroqol EQ-5D questionnaire
time frame: 12 months after surgery
measure: Back Pain after Spinal Fusion as assessed using the Oswestry Disability Index (ODI)
time frame: 12 months after surgery
measure: Back and Leg pain after Spinal Fusion as assessed using a Virtual Analogue Scale (VAS)
time frame: 12 months after surgery
measure: Number of Pedicle Screws that needed intraoperative Revision
time frame: Intraoperatively (From induction until end of anesthesia)
description: If a pedicle screw is malpositioned and this is noticed intraoperatively, the screw can be removed and revised.
measure: Number of Revision Surgeries for malpositioned Screws
time frame: Through study completion, an average of 12 months
description: If a screw malposition is not detected intraoperatively and neurological deficits or other complaints secondary to the malpositioned screw arise, the screw needs to be surgically revised.
arm group label: Robot-guided
arm group type: Active Comparator
description: Robotic guidance (SpineAssist®or Renaissance® (Mazor Robotics Ltd. Caesarea, Israel) will be used for navigation and insertion of pedicle screws.
arm group label: Navigated
arm group type: Active Comparator
description: A computer-assisted method of navigation (CT- or 3D-Fluoroscopy-based) will be used for navigation and insertion of pedicle screws.
arm group label: Freehand
arm group type: Active Comparator
description: Pedicle screws will be inserted using the freehand technique under fluoroscopic control.
intervention type: Procedure
intervention name: Pedicle Screw Placement
description: As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.
arm group label: Freehand
arm group label: Navigated
arm group label: Robot-guided
intervention type: Device
intervention name: SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)
description: This robot will be used to guide pedicle screws into their trajectories.
arm group label: Robot-guided
intervention type: Device
intervention name: 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)
description: This 3D Fluoroscope will be used to navigate pedicle screws into their trajectories.
arm group label: Navigated
criteria: 
gender: All
minimum age: 17 Years
maximum age: 79 Years
healthy volunteers: No
last name: Victor E Staartjes, Stud. Med.
role: Principal Investigator
affiliation: University of Zurich
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Bergman Clinics
investigator full name: Marc Schröder
investigator title: MD, PhD
mesh term: Spondylolisthesis
mesh term: Intervertebral Disc Degeneration
sharing ipd: No