xml: <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/NCT06020417</url>
    </required_header>
    <id_info>
      <org_study_id>FUPiaui_No-HARM</org_study_id>
      <nct_id>NCT06020417</nct_id>
    </id_info>
    <brief_title>Pedicle Screw Malposition in Spine Arthrodesis Surgeries With O-ARM-guided Navigation</brief_title>
    <acronym>NoHARM</acronym>
    <official_title>Occurrence of Pedicle Screw Malposition in Spine Arthrodesis Surgeries Performed With O-ARM-guided Navigation at a University Hospital: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federal University of Piaui</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federal University of Piaui</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: Throughout the history of spinal deformity there have been continuous advances in&#xD;
        the surgical treatment. Although many techniques have been successfully developed despite the&#xD;
        anatomy complex, screw placement still remains difficult with a significant risk of misplaced&#xD;
        implants. The O-ARM guided Navigation is a scanner that allows imaging of screws&#xD;
        intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence&#xD;
        of misplaced implants. Methods: This is a prospective and randomized clinical study that will&#xD;
        be carried out at the University Hospital of the Federal University of Piaui, which provides&#xD;
        exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design: This is a prospective and randomized clinical study. Local: The study will be&#xD;
        carried out at the University Hospital of the Federal University of Piauí (UH-FUPI), which&#xD;
        provides exclusive assistance to patients of the Unified Health System (UHS), in the&#xD;
        municipality of Teresina (PI), in northeastern Brazil, in the surgical center sector,&#xD;
        involving patients undergoing neurosurgical procedures. Data collection will begin after&#xD;
        approval by the UH-FUPI research ethics committee. Population and sample: The study&#xD;
        population will consist of patients hospitalized for spinal deformities in the wards of the&#xD;
        University Hospital of the Federal University of Piauí (UH-FUPI).&#xD;
  &#xD;
        Patients aged 18 years or older with surgical indication for spine arthrodesis will be&#xD;
        included in the study and will be randomized for corrective neurological or orthopedic spine&#xD;
        surgeries performed with O-Arm technology (Intervention Group) and without O-arm (Group&#xD;
        control). The surgeries performed electively in the three segments of the spine will be&#xD;
        included in this study. Patients who do not sign the informed consent form and those without&#xD;
        adequate records in medical records that do not allow the analysis of the data provided for&#xD;
        this research will be excluded. Sample size: The sample size of the present study was&#xD;
        calculated with the aim of comparing the incidence of misplacement of screws between two&#xD;
        approaches, the first using a navigator and the other without. Setting the power of the test&#xD;
        at 80% and the confidence level at 95%, the incidence of misplacement of screws known in the&#xD;
        literature with the use of a navigator is = 9.8% and without use = 15%. Thus, at least 496&#xD;
        screws would be needed in each arm of the study. Using data from the study by Jin, Liu, Qiu&#xD;
        et al. (2017), we noticed that 1145 screws were inserted in 144 patients, generating an&#xD;
        average of approximately 8 screws per patient. Thus, at least 62 patients would be needed in&#xD;
        each arm. The calculations necessary to determine the sample size were performed by the&#xD;
        formula where, is the order percentile of the standard normal distribution, is the order&#xD;
        percentile of the standard normal distribution, is the proportion of screw misplacement&#xD;
        without using the navigator, is proportion of screw misplacement using the navigator and is&#xD;
        the midpoint of the proportions. Data collect: Data will be collected through medical&#xD;
        records, which will be completed in the data collection form, after the procedure. The&#xD;
        variables analyzed will be: type of surgery performed, technique used, which vertebrae&#xD;
        underwent surgical intervention with the implantation of screws, number of screws in each&#xD;
        vertebra, presence or not of invasion of the pedicle cortex after analysis with CT, in&#xD;
        addition to the description of the affected vertebra , which screws invaded, measurement of&#xD;
        invasion, in millimeters, and whether the position was medial or lateral. Statistical&#xD;
        analysis: The collected data will be organized in tables and graphs. The program used to&#xD;
        carry out the statistical tests will be SPSS Statistics. The method used to jointly analyze&#xD;
        the relationship between the studied variables and the presence or absence of expected&#xD;
        outcomes will be the Pearson chi-square test method. The admitted confidence interval is 95%&#xD;
        and the p-value less than 0.05.&#xD;
  &#xD;
        Ethical and legal aspects: All patients included will sign the informed consent form. Data&#xD;
        collection will begin after approval of the study by the research ethics committee. All&#xD;
        research ethics regulations will be followed according to the resolution of the National&#xD;
        Health Council n° 466/12. Risks and benefits: The research risks involve the exposure of&#xD;
        personal data and embarrassment to the participants. To work around such problems, patients&#xD;
        will be identified by numbering, where only the researchers will have direct access to the&#xD;
        patients' records, without photos or any record that could cause the dissemination of&#xD;
        personal information. In addition, questions to participants will be asked with caution and&#xD;
        empathy, in order to avoid any embarrassment to the patient. If it is demonstrated that the&#xD;
        studied neurovagegation system significantly reduces the need for surgical repositioning of&#xD;
        the pedicle screws, in addition to the benefit for the sample patient in the intervention&#xD;
        group, who will not have to face yet another surgical approach, the FUPI may also be&#xD;
        benefited, since the hospital will have, within its list, the option of a neuronavigation&#xD;
        technology that brings real results to the hospital's patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</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>
      <intervention_model_description>Comparison between the use or not of neuronavigation for corrective surgery of spinal deformity</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>misplaced implant</measure>
      <time_frame>30 days</time_frame>
      <description>medial and/or lateral deviations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>recurrent pain</measure>
      <time_frame>30 days</time_frame>
      <description>ocurrence of posoperative pain and persistence of symptoms after surgery</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">124</enrollment>
    <condition>Spinal Fusion</condition>
    <condition>Spinal Deformity</condition>
    <condition>Spine Injury</condition>
    <arm_group>
      <arm_group_label>O-Arm neuronavigator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods. Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper. Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused. This is done precisely to create space for the bone graft that will be placed later. Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion. Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together. This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor. Then, in the spinal column fixation step, rods, screws and/or plates are used to fix the vertebrae that will be fused.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>O-ARM (Medtronic, Inc, Louisville, CO)</intervention_name>
      <description>scanner that allows imaging of screws intraoperatively</description>
      <arm_group_label>O-Arm neuronavigator</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional corrective surgery for arthrodesis</intervention_name>
      <description>Conventional procedure without neuronavigation guide</description>
      <arm_group_label>Conventional</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  spine deformities (spinal cord trauma, osteoarthritis, intervertebral disc&#xD;
               degeneration, degenerative or isthmic spondylolisthesis, intervertebral disc&#xD;
               degeneration, spinal stenosis and degenerative scoliosis).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  anatomical abnormalities that can not be used the neuronavigation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carlos Eduardo B Lima, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Federal University of Piaui</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Denilson G Italiano, Sr.</last_name>
      <role>Study Chair</role>
      <affiliation>Federal University of Piaui</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Paulo M Sousa Nunes, MD</last_name>
      <role>Study Director</role>
      <affiliation>Federal University of Piaui</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mauricio Giraldi, MD, MSc</last_name>
      <role>Study Chair</role>
      <affiliation>University Hospital of Federal University of Piaui</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carlos E Lima, MD, PhD</last_name>
      <phone>+5586981805000</phone>
      <email>carlos.lima@ufpi.edu.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Denilson G Italiano, Sr.</last_name>
      <phone>+5586994804115</phone>
      <email>denilsonitaliano@ufpi.edu.br</email>
    </overall_contact_backup>
    <reference>
      <citation>Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. The accuracy of intraoperative O-arm images for the assessment of pedicle screw postion. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E119-25. doi: 10.1097/BRS.0b013e3182257cae.</citation>
      <PMID>21673628</PMID>
    </reference>
    <reference>
      <citation>Perdomo-Pantoja A, Ishida W, Zygourakis C, Holmes C, Iyer RR, Cottrill E, Theodore N, Witham TF, Lo SL. Accuracy of Current Techniques for Placement of Pedicle Screws in the Spine: A Comprehensive Systematic Review and Meta-Analysis of 51,161 Screws. World Neurosurg. 2019 Jun;126:664-678.e3. doi: 10.1016/j.wneu.2019.02.217. Epub 2019 Mar 15.</citation>
      <PMID>30880208</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Federal University of Piaui</investigator_affiliation>
      <investigator_full_name>Carlos Eduardo Batista de Lima, MD, PhD</investigator_full_name>
      <investigator_title>Associate Professor, MD, PhD</investigator_title>
    </responsible_party>
    <keyword>neuronavigation</keyword>
    <keyword>spinal deformity</keyword>
    <keyword>Spine injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Congenital Abnormalities</mesh_term>
      <mesh_term>Spinal Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020417
  org study id: FUPiaui_No-HARM
  nct id: NCT06020417
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Background: Throughout the history of spinal deformity there have been continuous advances in
        the surgical treatment. Although many techniques have been successfully developed despite the
        anatomy complex, screw placement still remains difficult with a significant risk of misplaced
        implants. The O-ARM guided Navigation is a scanner that allows imaging of screws
        intraoperatively and could be a tool to facilitate screw revision and reduce the occurrence
        of misplaced implants. Methods: This is a prospective and randomized clinical study that will
        be carried out at the University Hospital of the Federal University of Piaui, which provides
        exclusive assistance to patients of the Unified Health System (UHS), in northeastern Brazil.
  Study design: This is a prospective and randomized clinical study. Local: The study will be
        carried out at the University Hospital of the Federal University of Piauí (UH-FUPI), which
        provides exclusive assistance to patients of the Unified Health System (UHS), in the
        municipality of Teresina (PI), in northeastern Brazil, in the surgical center sector,
        involving patients undergoing neurosurgical procedures. Data collection will begin after
        approval by the UH-FUPI research ethics committee. Population and sample: The study
        population will consist of patients hospitalized for spinal deformities in the wards of the
        University Hospital of the Federal University of Piauí (UH-FUPI).
  
        Patients aged 18 years or older with surgical indication for spine arthrodesis will be
        included in the study and will be randomized for corrective neurological or orthopedic spine
        surgeries performed with O-Arm technology (Intervention Group) and without O-arm (Group
        control). The surgeries performed electively in the three segments of the spine will be
        included in this study. Patients who do not sign the informed consent form and those without
        adequate records in medical records that do not allow the analysis of the data provided for
        this research will be excluded. Sample size: The sample size of the present study was
        calculated with the aim of comparing the incidence of misplacement of screws between two
        approaches, the first using a navigator and the other without. Setting the power of the test
        at 80% and the confidence level at 95%, the incidence of misplacement of screws known in the
        literature with the use of a navigator is = 9.8% and without use = 15%. Thus, at least 496
        screws would be needed in each arm of the study. Using data from the study by Jin, Liu, Qiu
        et al. (2017), we noticed that 1145 screws were inserted in 144 patients, generating an
        average of approximately 8 screws per patient. Thus, at least 62 patients would be needed in
        each arm. The calculations necessary to determine the sample size were performed by the
        formula where, is the order percentile of the standard normal distribution, is the order
        percentile of the standard normal distribution, is the proportion of screw misplacement
        without using the navigator, is proportion of screw misplacement using the navigator and is
        the midpoint of the proportions. Data collect: Data will be collected through medical
        records, which will be completed in the data collection form, after the procedure. The
        variables analyzed will be: type of surgery performed, technique used, which vertebrae
        underwent surgical intervention with the implantation of screws, number of screws in each
        vertebra, presence or not of invasion of the pedicle cortex after analysis with CT, in
        addition to the description of the affected vertebra , which screws invaded, measurement of
        invasion, in millimeters, and whether the position was medial or lateral. Statistical
        analysis: The collected data will be organized in tables and graphs. The program used to
        carry out the statistical tests will be SPSS Statistics. The method used to jointly analyze
        the relationship between the studied variables and the presence or absence of expected
        outcomes will be the Pearson chi-square test method. The admitted confidence interval is 95%
        and the p-value less than 0.05.
  
        Ethical and legal aspects: All patients included will sign the informed consent form. Data
        collection will begin after approval of the study by the research ethics committee. All
        research ethics regulations will be followed according to the resolution of the National
        Health Council n° 466/12. Risks and benefits: The research risks involve the exposure of
        personal data and embarrassment to the participants. To work around such problems, patients
        will be identified by numbering, where only the researchers will have direct access to the
        patients' records, without photos or any record that could cause the dissemination of
        personal information. In addition, questions to participants will be asked with caution and
        empathy, in order to avoid any embarrassment to the patient. If it is demonstrated that the
        studied neurovagegation system significantly reduces the need for surgical repositioning of
        the pedicle screws, in addition to the benefit for the sample patient in the intervention
        group, who will not have to face yet another surgical approach, the FUPI may also be
        benefited, since the hospital will have, within its list, the option of a neuronavigation
        technology that brings real results to the hospital's patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Comparison between the use or not of neuronavigation for corrective surgery of spinal deformity
  primary purpose: Treatment
  masking: None (Open Label)
  measure: misplaced implant
  time frame: 30 days
  description: medial and/or lateral deviations
  measure: recurrent pain
  time frame: 30 days
  description: ocurrence of posoperative pain and persistence of symptoms after surgery
  arm group label: O-Arm neuronavigator
  arm group type: Active Comparator
  description: The O-ARM imaging system can help surgeons to view the spine in real time and verify the placement of implants such as screws or rods. Primarily, therefore, in image acquisition, during surgery, the O-ARM is activated and generates real-time images of the patient's spine, so that these images are displayed on a screen, allowing the surgeon to visualize the anatomical structures and check that implant placement is proper. Therefore, when analyzing these images, the surgeon can, for example, analyze and verify the placement of the implants and ensure that the arthrodesis is performed correctly, in such a way that, if necessary, the surgeon can make adjustments and then acquire new images for verification.
  arm group label: Conventional
  arm group type: Placebo Comparator
  description: The conventional procedure for spinal arthrodesis will involve the intervertebral disc removal step between the vertebrae that will be fused. This is done precisely to create space for the bone graft that will be placed later. Then, there is bone surface preparation, where you prepare the bone surfaces of the vertebrae that will be fused, removing any soft tissue that might interfere with bone fusion. Then, there is bone graft placement, where the surgeon places a bone graft between the vertebrae that will be fused together. This graft can be obtained from another part of the patient's body (such as the pelvis) or from a deceased donor. Then, in the spinal column fixation step, rods, screws and/or plates are used to fix the vertebrae that will be fused.
  intervention type: Device
  intervention name: O-ARM (Medtronic, Inc, Louisville, CO)
  description: scanner that allows imaging of screws intraoperatively
  arm group label: O-Arm neuronavigator
  intervention type: Procedure
  intervention name: Conventional corrective surgery for arthrodesis
  description: Conventional procedure without neuronavigation guide
  arm group label: Conventional
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Carlos Eduardo B Lima, MD, PhD
  role: Principal Investigator
  affiliation: Federal University of Piaui
  last name: Denilson G Italiano, Sr.
  role: Study Chair
  affiliation: Federal University of Piaui
  last name: Paulo M Sousa Nunes, MD
  role: Study Director
  affiliation: Federal University of Piaui
  last name: Mauricio Giraldi, MD, MSc
  role: Study Chair
  affiliation: University Hospital of Federal University of Piaui
  last name: Carlos E Lima, MD, PhD
  phone: +5586981805000
  email: carlos.lima@ufpi.edu.br
  last name: Denilson G Italiano, Sr.
  phone: +5586994804115
  email: denilsonitaliano@ufpi.edu.br
  citation: Santos ER, Ledonio CG, Castro CA, Truong WH, Sembrano JN. The accuracy of intraoperative O-arm images for the assessment of pedicle screw postion. Spine (Phila Pa 1976). 2012 Jan 15;37(2):E119-25. doi: 10.1097/BRS.0b013e3182257cae.
  PMID: 21673628
  citation: Perdomo-Pantoja A, Ishida W, Zygourakis C, Holmes C, Iyer RR, Cottrill E, Theodore N, Witham TF, Lo SL. Accuracy of Current Techniques for Placement of Pedicle Screws in the Spine: A Comprehensive Systematic Review and Meta-Analysis of 51,161 Screws. World Neurosurg. 2019 Jun;126:664-678.e3. doi: 10.1016/j.wneu.2019.02.217. Epub 2019 Mar 15.
  PMID: 30880208
  responsible party type: Principal Investigator
  investigator affiliation: Federal University of Piaui
  investigator full name: Carlos Eduardo Batista de Lima, MD, PhD
  investigator title: Associate Professor, MD, PhD
  mesh term: Congenital Abnormalities
  mesh term: Spinal Injuries
  sharing ipd: No