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/NCT05963815</url>
    </required_header>
    <id_info>
      <org_study_id>0000090</org_study_id>
      <nct_id>NCT05963815</nct_id>
    </id_info>
    <brief_title>The Spine PROMCO Study: a Cohort Observational Study</brief_title>
    <acronym>Spine PROMCO</acronym>
    <official_title>Spine Patient Reported Outcome Measures: a Cohort Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Park Medical centrum</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Park Medical centrum</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>
        Our primary objective is to design a cohort to determine the treatment outcome of different&#xD;
        surgical interventions of the degenerative lumbar spine highlighting the expediency and value&#xD;
        of the current surgical treatment program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This observational prospective unicenter cohort study includes patients who are eligible for&#xD;
        elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk,&#xD;
        spinal canal stenosis, discopathy and spondylolisthesis). We pursue an enrolment rate of at&#xD;
        least 80% within 1.5 years of inclusion. A digital survey is used including self-reporting&#xD;
        questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back),&#xD;
        health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is&#xD;
        sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery&#xD;
        and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis,&#xD;
        an economic evaluation will be performed from a societal perspective.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 13, 2023</start_date>
    <completion_date type="Anticipated">January 13, 2030</completion_date>
    <primary_completion_date type="Anticipated">January 13, 2030</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Patient related outcome Measures</measure>
      <time_frame>Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery</time_frame>
      <description>PROMs will be collected using validated questionnaires that pertain to different domains: (1) pain intensity, (2) functionality, (3) disability, (4) health related quality of life, and (5) patient satisfaction.&#xD;
  This prospective cohort study uses a set of outcome metrics in accordance with the ICHOMs recommendations for low back pain (cite).&#xD;
  Including: COMI BACK, EQ5D5L</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical outcome</measure>
      <time_frame>post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery</time_frame>
      <description>Re-operation and complications are systematically assessed by self-reported questionnaires (e.g. liquor leakage, sensomotoric deficits, incontinence, infections, etc).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">4000</enrollment>
    <condition>Lumbar Disc Herniation</condition>
    <condition>Spondylolisthesis</condition>
    <condition>Spinal Stenosis</condition>
    <arm_group>
      <arm_group_label>Degenerative spine disorder</arm_group_label>
      <description>Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Spine surgery</intervention_name>
      <description>Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.</description>
      <arm_group_label>Degenerative spine disorder</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are eligible for surgical treatment of the spine, including a lumbar herniated&#xD;
          disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients who are eligible for elective surgery of the lumbar spine.&#xD;
  &#xD;
            -  All patients with degenerative disorder of the lumbar spine including: herniated disk,&#xD;
               stenosis, discopathy and spondylolisthesis.&#xD;
  &#xD;
            -  Patients must be able to fill in the questionnaire online&#xD;
  &#xD;
            -  Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc&#xD;
               herniation, stenosis, discopathy, or listhesis.&#xD;
  &#xD;
            -  Elective cases&#xD;
  &#xD;
            -  Patients operated with laminectomy, microscopic discectomy, percutaneous&#xD;
               transforaminal endoscopic discectomy, and spondylodesis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who cannot speak nor read the Dutch language&#xD;
  &#xD;
            -  Patients who are not able to complete the digital questionnaires, according to the&#xD;
               including doctor&#xD;
  &#xD;
            -  Patients with fractures, primary infections of the spine, or with spinal malignant-&#xD;
               cies.&#xD;
  &#xD;
            -  Patients in a traumatic setting.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Park Medical Center</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>30677 GH</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Annegien Boeykens, MD</last_name>
        <phone>010 436 1537</phone>
        <email>a.boeykens@parkmc.nl</email>
      </contact>
      <investigator>
        <last_name>B.Sanjay Harhangi, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Annegien GM Boeykens, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.</citation>
      <PMID>29573870</PMID>
    </reference>
    <reference>
      <citation>Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.</citation>
      <PMID>24665116</PMID>
    </reference>
    <reference>
      <citation>Parenteau CS, Lau EC, Campbell IC, Courtney A. Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using Medicare data. Sci Rep. 2021 Mar 8;11(1):5389. doi: 10.1038/s41598-021-84724-6.</citation>
      <PMID>33686128</PMID>
    </reference>
    <reference>
      <citation>Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.</citation>
      <PMID>18923325</PMID>
    </reference>
    <reference>
      <citation>Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.</citation>
      <PMID>31375617</PMID>
    </reference>
    <reference>
      <citation>Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.</citation>
      <PMID>26571179</PMID>
    </reference>
    <reference>
      <citation>Asher AL, Knightly J, Mummaneni PV, Alvi MA, McGirt MJ, Yolcu YU, Chan AK, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Haid RW, Fu KM, Wang MY, Park P, Bisson EF, Harbaugh RE, Bydon M. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus. 2020 May 1;48(5):E2. doi: 10.3171/2020.2.FOCUS207.</citation>
      <PMID>32357320</PMID>
    </reference>
    <reference>
      <citation>van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86(5):534-44. doi: 10.3109/17453674.2015.1043174.</citation>
      <PMID>25909475</PMID>
    </reference>
    <reference>
      <citation>Gadjradj PS, Chin-See-Chong TC, Donk D, Depauw P, Tulder MWV, Harhangi BS. Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine. Neurospine. 2021 Dec;18(4):798-805. doi: 10.14245/ns.2142682.341. Epub 2021 Dec 31.</citation>
      <PMID>35000334</PMID>
    </reference>
    <reference>
      <citation>Mannion AF, Vila-Casademunt A, Domingo-Sabat M, Wunderlin S, Pellise F, Bago J, Acaroglu E, Alanay A, Perez-Grueso FS, Obeid I, Kleinstuck FS; European Spine Study Group (ESSG). The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.</citation>
      <PMID>26519374</PMID>
    </reference>
    <reference>
      <citation>Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.</citation>
      <PMID>28194657</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Patient related outcome measures</keyword>
    <keyword>Prognosis</keyword>
    <keyword>Degenerative Spine disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Stenosis</mesh_term>
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Spondylolisthesis</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/NCT05963815
  org study id: 0000090
  nct id: NCT05963815
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Our primary objective is to design a cohort to determine the treatment outcome of different
        surgical interventions of the degenerative lumbar spine highlighting the expediency and value
        of the current surgical treatment program.
  This observational prospective unicenter cohort study includes patients who are eligible for
        elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk,
        spinal canal stenosis, discopathy and spondylolisthesis). We pursue an enrolment rate of at
        least 80% within 1.5 years of inclusion. A digital survey is used including self-reporting
        questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back),
        health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is
        sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery
        and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis,
        an economic evaluation will be performed from a societal perspective.
  observational model: Cohort
  time perspective: Prospective
  measure: Patient related outcome Measures
  time frame: Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
  description: PROMs will be collected using validated questionnaires that pertain to different domains: (1) pain intensity, (2) functionality, (3) disability, (4) health related quality of life, and (5) patient satisfaction.
  This prospective cohort study uses a set of outcome metrics in accordance with the ICHOMs recommendations for low back pain (cite).
  Including: COMI BACK, EQ5D5L
  measure: Clinical outcome
  time frame: post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery
  description: Re-operation and complications are systematically assessed by self-reported questionnaires (e.g. liquor leakage, sensomotoric deficits, incontinence, infections, etc).
  arm group label: Degenerative spine disorder
  description: Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.
  intervention type: Other
  intervention name: Spine surgery
  description: Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.
  arm group label: Degenerative spine disorder
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Netherlands
  citation: Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.
  PMID: 29573870
  citation: Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
  PMID: 24665116
  citation: Parenteau CS, Lau EC, Campbell IC, Courtney A. Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using Medicare data. Sci Rep. 2021 Mar 8;11(1):5389. doi: 10.1038/s41598-021-84724-6.
  PMID: 33686128
  citation: Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.
  PMID: 18923325
  citation: Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.
  PMID: 31375617
  citation: Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
  PMID: 26571179
  citation: Asher AL, Knightly J, Mummaneni PV, Alvi MA, McGirt MJ, Yolcu YU, Chan AK, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Haid RW, Fu KM, Wang MY, Park P, Bisson EF, Harbaugh RE, Bydon M. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus. 2020 May 1;48(5):E2. doi: 10.3171/2020.2.FOCUS207.
  PMID: 32357320
  citation: van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86(5):534-44. doi: 10.3109/17453674.2015.1043174.
  PMID: 25909475
  citation: Gadjradj PS, Chin-See-Chong TC, Donk D, Depauw P, Tulder MWV, Harhangi BS. Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine. Neurospine. 2021 Dec;18(4):798-805. doi: 10.14245/ns.2142682.341. Epub 2021 Dec 31.
  PMID: 35000334
  citation: Mannion AF, Vila-Casademunt A, Domingo-Sabat M, Wunderlin S, Pellise F, Bago J, Acaroglu E, Alanay A, Perez-Grueso FS, Obeid I, Kleinstuck FS; European Spine Study Group (ESSG). The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.
  PMID: 26519374
  citation: Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.
  PMID: 28194657
  responsible party type: Sponsor
  mesh term: Spinal Stenosis
  mesh term: Intervertebral Disc Displacement
  mesh term: Spondylolisthesis
  sharing ipd: No