<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/NCT02212899</url>
  </required_header>
  <id_info>
    <org_study_id>CLN111</org_study_id>
    <nct_id>NCT02212899</nct_id>
  </id_info>
  <brief_title>Prospective, Observational Registry of Renaissance-guided Spine Surgeries</brief_title>
  <official_title>Prospective, Observational Registry of Renaissance-guided Spine Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mazor Robotics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mazor Robotics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish an observational registry for systematic collection of clinical data from&#xD;
      Renaissance-guided spine surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The key objective of this observational registry is to prospectively collect data to&#xD;
      facilitate the quantification of potential short- and long-term benefits of&#xD;
      Renaissance-guided spine surgery. It establishes a common framework for collaboration between&#xD;
      surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or&#xD;
      open surgical approaches.&#xD;
&#xD;
      The main endpoints that will be collected are surgical endpoints (e.g. complication rates),&#xD;
      patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal&#xD;
      alignment, mainly in reconstructive surgeries for spinal deformities) and technical&#xD;
      parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor Decision&#xD;
  </why_stopped>
  <start_date type="Actual">February 18, 2015</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Clinical outcomes as measured on plain radiographs</measure>
    <time_frame>Within 10 years of surgery</time_frame>
    <description>sagittal and coronal alignment in reconstructive surgeries for spinal deformities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>Within 10 years of surgery</time_frame>
    <description>new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reoperation rates</measure>
    <time_frame>Within 10 years of surgery</time_frame>
    <description>Any revision surgery on the segment of interest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation exposure</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical performance of instrumentation technique</measure>
    <time_frame>Day of surgery</time_frame>
    <description>implant instrumentation time, total surgery time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of executed vs. planned screws</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of abandoned screws</measure>
    <time_frame>Day of surgery</time_frame>
    <description>the number of screws not instrumented and the reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuromonitoring events</measure>
    <time_frame>Day of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of convalescence</measure>
    <time_frame>within 2 years of surgery</time_frame>
    <description>Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in health-related quality of life metrics</measure>
    <time_frame>up to 10 years post-operative</time_frame>
    <description>back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fusion rates/pseudoarthrosis</measure>
    <time_frame>Within 1 year of surgery</time_frame>
    <description>The rate of fusion as determined within one year of surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant placement accuracy</measure>
    <time_frame>Within one year post-surgery</time_frame>
    <description>Accuracy of implants as measured on a post-operative CT scan (when available)</description>
  </secondary_outcome>
  <enrollment type="Actual">93</enrollment>
  <condition>Degenerative Spine Disease</condition>
  <condition>Spinal Deformity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Any pediatric, adolescent or adult patient undergoing open or MIS Renaissance-guided spine&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients undergoing spinal surgery in a posterior approach where the surgeon used&#xD;
        Renaissance surgical guidance system.&#xD;
&#xD;
        Patient capable of complying with study requirements. Signed informed consent by patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any significant disease or disorder which, in the opinion of the Investigator, may either&#xD;
        put the participant at risk because of participation in the study, or may influence the&#xD;
        result of the study.&#xD;
&#xD;
        Patient cannot follow study protocol, for any reason. Patient cannot or will not sign&#xD;
        informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doron Dinstein, MD, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Mazor Robotics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lyerly Baptist/ Lyerly Neurosurgery</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tabor Orthopedics</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spine Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Virginia Spine Institute</name>
      <address>
        <city>Reston</city>
        <state>Virginia</state>
        <zip>20190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lieberman IH, Hardenbrook MA, Wang JC, Guyer RD. Assessment of pedicle screw placement accuracy, procedure time, and radiation exposure using a miniature robotic guidance system. J Spinal Disord Tech. 2012 Jul;25(5):241-8. doi: 10.1097/BSD.0b013e318218a5ef.</citation>
    <PMID>21602728</PMID>
  </reference>
  <reference>
    <citation>Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].</citation>
    <PMID>21079498</PMID>
  </reference>
  <reference>
    <citation>Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.</citation>
    <PMID>21384205</PMID>
  </reference>
  <reference>
    <citation>Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.</citation>
    <PMID>22975723</PMID>
  </reference>
  <reference>
    <citation>Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. doi: 10.1097/01.brs.0000254048.79024.8b.</citation>
    <PMID>17268254</PMID>
  </reference>
  <reference>
    <citation>Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. doi: 10.1097/01.brs.0000252094.64857.ab.</citation>
    <PMID>17224800</PMID>
  </reference>
  <reference>
    <citation>Tian NF, Huang QS, Zhou P, Zhou Y, Wu RK, Lou Y, Xu HZ. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J. 2011 Jun;20(6):846-59. doi: 10.1007/s00586-010-1577-5. Epub 2010 Sep 23.</citation>
    <PMID>20862593</PMID>
  </reference>
  <reference>
    <citation>Hamilton DK, Smith JS, Sansur CA, Glassman SD, Ames CP, Berven SH, Polly DW Jr, Perra JH, Knapp DR, Boachie-Adjei O, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Rates of new neurological deficit associated with spine surgery based on 108,419 procedures: a report of the scoliosis research society morbidity and mortality committee. Spine (Phila Pa 1976). 2011 Jul 1;36(15):1218-28. doi: 10.1097/BRS.0b013e3181ec5fd9.</citation>
    <PMID>21217448</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Surgery</keyword>
  <keyword>Spinal Fusion</keyword>
  <keyword>Deformity Correction</keyword>
  <keyword>Spinal Instrumentation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <!-- 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/NCT02212899
org study id: CLN111
nct id: NCT02212899
lead sponsor: 
has dmc: No
To establish an observational registry for systematic collection of clinical data from
      Renaissance-guided spine surgeries.
The key objective of this observational registry is to prospectively collect data to
      facilitate the quantification of potential short- and long-term benefits of
      Renaissance-guided spine surgery. It establishes a common framework for collaboration between
      surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or
      open surgical approaches.

      The main endpoints that will be collected are surgical endpoints (e.g. complication rates),
      patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal
      alignment, mainly in reconstructive surgeries for spinal deformities) and technical
      parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).
observational model: Case-Only
time perspective: Prospective
measure: Clinical outcomes as measured on plain radiographs
time frame: Within 10 years of surgery
description: sagittal and coronal alignment in reconstructive surgeries for spinal deformities
measure: Surgical complications
time frame: Within 10 years of surgery
description: new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss
measure: Reoperation rates
time frame: Within 10 years of surgery
description: Any revision surgery on the segment of interest
measure: Radiation exposure
time frame: Day of surgery
description: Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room
measure: Clinical performance of instrumentation technique
time frame: Day of surgery
description: implant instrumentation time, total surgery time
measure: Ratio of executed vs. planned screws
time frame: Day of surgery
description: Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause
measure: Number of abandoned screws
time frame: Day of surgery
description: the number of screws not instrumented and the reason
measure: Neuromonitoring events
time frame: Day of surgery
measure: Length of convalescence
time frame: within 2 years of surgery
description: Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities
measure: Improvement in health-related quality of life metrics
time frame: up to 10 years post-operative
description: back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices
measure: Fusion rates/pseudoarthrosis
time frame: Within 1 year of surgery
description: The rate of fusion as determined within one year of surgical procedure.
measure: Implant placement accuracy
time frame: Within one year post-surgery
description: Accuracy of implants as measured on a post-operative CT scan (when available)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 90 Years
healthy volunteers: No
last name: Doron Dinstein, MD, MBA
role: Study Director
affiliation: Mazor Robotics
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Lieberman IH, Hardenbrook MA, Wang JC, Guyer RD. Assessment of pedicle screw placement accuracy, procedure time, and radiation exposure using a miniature robotic guidance system. J Spinal Disord Tech. 2012 Jul;25(5):241-8. doi: 10.1097/BSD.0b013e318218a5ef.
PMID: 21602728
citation: Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].
PMID: 21079498
citation: Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
PMID: 21384205
citation: Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.
PMID: 22975723
citation: Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. doi: 10.1097/01.brs.0000254048.79024.8b.
PMID: 17268254
citation: Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. doi: 10.1097/01.brs.0000252094.64857.ab.
PMID: 17224800
citation: Tian NF, Huang QS, Zhou P, Zhou Y, Wu RK, Lou Y, Xu HZ. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J. 2011 Jun;20(6):846-59. doi: 10.1007/s00586-010-1577-5. Epub 2010 Sep 23.
PMID: 20862593
citation: Hamilton DK, Smith JS, Sansur CA, Glassman SD, Ames CP, Berven SH, Polly DW Jr, Perra JH, Knapp DR, Boachie-Adjei O, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Rates of new neurological deficit associated with spine surgery based on 108,419 procedures: a report of the scoliosis research society morbidity and mortality committee. Spine (Phila Pa 1976). 2011 Jul 1;36(15):1218-28. doi: 10.1097/BRS.0b013e3181ec5fd9.
PMID: 21217448
responsible party type: Sponsor
mesh term: Spinal Diseases
mesh term: Congenital Abnormalities