<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/NCT04406987</url>
  </required_header>
  <id_info>
    <org_study_id>20/7176</org_study_id>
    <secondary_id>20202000-22</secondary_id>
    <nct_id>NCT04406987</nct_id>
  </id_info>
  <brief_title>Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)</brief_title>
  <official_title>Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spine Centre of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spine Centre of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Age related changes in the lumbar spine can lead to narrowing of the spinal canal (spinal&#xD;
      stenosis) causing leg and back pain. Spinal stenosis can be associated with a misalignment of&#xD;
      the spine caused by forward slippage of a vertebrae over another. This instability is&#xD;
      diagnosed using diagnostic imaging. With signs of instability the spine surgeon might choose&#xD;
      a fusion of the vertebrae. This is a more complex procedure in relation to the simple&#xD;
      decompression preformed without instability for spinal stenosis.&#xD;
&#xD;
      The purpose of this study is to identify characteristics of instability of the lumbar spine&#xD;
      on diagnostic imaging, and investigate associations with surgical data and patient reported&#xD;
      outcomes from the National Spine databases from Denmark and Sweden.&#xD;
&#xD;
      This will support spine surgeons in providing evidence-based surgical treatment for spinal&#xD;
      stenosis with or without signs of instability&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multicenter retrospective cohort study of prospectively collected data from national spine&#xD;
      surgery databases in Denmark and Sweden. This project is a collaboration between sector for&#xD;
      spine surgery and research Middelfart Hospital and spine surgeons at Orebro Hospital and Lund&#xD;
      Hospital in Sweden.&#xD;
&#xD;
      Data subtracted from Danish national spine surgery database, DaneSpine, from Middelfart&#xD;
      Hospital, and Swedish Spinal Register, SweSpine, from hospitals in Malmö, Lund, Trelleborg&#xD;
      and Karlskroga.&#xD;
&#xD;
      Both databases are clinical quality databases with a high response-rate. DaneSpine is&#xD;
      administered by Danish Society of Spine Surgeons and is managed by secretary of DaneSpine.&#xD;
      SweSpine is administered by Swedish Society of Spinal Surgeons and managed&#xD;
&#xD;
      Patients are invited to register when scheduled for surgery. Patients signs informed consent&#xD;
      and receives follow-up questionaires 3 and 6 months, one, two, 5 and 10 years post-surgery.&#xD;
      Questionaires are validated PROM (patient reported outcome measures) and PREM (patient&#xD;
      reported experience measures).&#xD;
&#xD;
      The surgeon is responsible for registering surgical data, including complications and&#xD;
      reoperations.&#xD;
&#xD;
      Data relevant for present study will be applied for at the respective societies and managed&#xD;
      and stored in compliance with General Data Protection Regulation.&#xD;
&#xD;
      The EasyWiz software (Medical Insight, Chicago, IL, USA) is used for analysis of all MRIs and&#xD;
      radiographs.&#xD;
&#xD;
      All imaging will be analyzed by 2 independent examiners. The interobserver reliability will&#xD;
      be calculated.&#xD;
&#xD;
      Missing data such as variables reported as missing or non-reported will not be included in&#xD;
      statistical analysis.&#xD;
&#xD;
      Statistics: significance of difference in mean values between groups for continuous normally&#xD;
      distributed data unpaired t-test. Categorical variables normally distributed:&#xD;
      Chi-squared/Fishers exact test. Multivariable regression analysis. Kappa statistics for&#xD;
      interobserver reliability presented in the article.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2021</start_date>
  <completion_date type="Actual">December 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 5, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>facet joint gap</measure>
    <time_frame>pre-surgery</time_frame>
    <description>MRI proxies 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>facet angel</measure>
    <time_frame>pre-surgery</time_frame>
    <description>MRI proxies 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disc height</measure>
    <time_frame>pre-surgery</time_frame>
    <description>MRI proxies 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anterior translation</measure>
    <time_frame>pre-surgery</time_frame>
    <description>MRI proxies 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intradiscal vacuum</measure>
    <time_frame>pre-surgery</time_frame>
    <description>MRI proxies 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiographic slip</measure>
    <time_frame>pre-surgery</time_frame>
    <description>anterior translation on lateral radiograph</description>
  </secondary_outcome>
  <other_outcome>
    <measure>VAS leg</measure>
    <time_frame>pre-surgery and 3 months, 12 months and 2 years post-surgery</time_frame>
    <description>Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale</description>
  </other_outcome>
  <other_outcome>
    <measure>VAS back</measure>
    <time_frame>pre-surgery and 3 months, 12 months and 2 years post-surgery</time_frame>
    <description>Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ-5D</measure>
    <time_frame>pre-surgery and 3 months, 12 months and 2 years post-surgery</time_frame>
    <description>EuroQol (EQ-5D) measures health-related quality of life on a scale where 0.0 equal's death and 1.0 equals perfect health</description>
  </other_outcome>
  <other_outcome>
    <measure>ODI</measure>
    <time_frame>pre-surgery and 3 months, 12 months and 2 years post-surgery</time_frame>
    <description>Oswestry Disability Index (ODI) questionnaire scores range from 0 (no disability) to 100 (total disability)</description>
  </other_outcome>
  <other_outcome>
    <measure>patient characteristics</measure>
    <time_frame>pre-surgery and 3 months, 12 months and 2 years post-surgery</time_frame>
    <description>age, gender, BMI, smoking, diabetes</description>
  </other_outcome>
  <other_outcome>
    <measure>reoperation</measure>
    <time_frame>3 months, 12 months and 2 years post-surgery</time_frame>
    <description>operation on index level after primary operation and discharge within follow-up period</description>
  </other_outcome>
  <other_outcome>
    <measure>complication</measure>
    <time_frame>during surgery or during admission</time_frame>
    <description>perisurgical complication within admission.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">235</enrollment>
  <condition>Degenerative Lumbar Spinal Stenosis</condition>
  <condition>Degenerative Spondylolisthesis</condition>
  <arm_group>
    <arm_group_label>decompression</arm_group_label>
    <description>patients treated with decompression for lumbar spinal stenosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fusion</arm_group_label>
    <description>patients treated with decompression with fusion for lumbar spinal stenosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>decompression</intervention_name>
    <description>surgical technique for neural decompression varied based on surgeon's preference, but always with preservation for spinous processes. Either open with or without microscope or using tubular retractors.</description>
    <arm_group_label>decompression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fusion</intervention_name>
    <description>fusion techniques consisted besides decompression of additional implantation of pedicle screws with rods, with or without intervertebral fusion and cage(s). Non-instrumented technique with allograft bone. Fusion technique on surgeon's discretion.</description>
    <arm_group_label>fusion</arm_group_label>
    <other_name>arthrodese</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients with symptomatic, MRI-verifeis lumbar spinal stenosis referred to&#xD;
        Spine Center of Southern Denmark between 2010-2017. And same study population referred to&#xD;
        Spine Centers at hospitals in Malmö, Lund, Trelleborg and Karlskroga Sweden between&#xD;
        2010-2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - MRI verified spinal stenosis patients with or with out degenerative spondylolisthesis (&gt;&#xD;
        3mm anterior translation in lumbar MRI), who underwent surgery at L4/L5 level with either&#xD;
        decompression alone or decompression with fusion between 2010 and 2017. Included ICD-10&#xD;
        diagnostic groups DM480 and DM431. Must have standing lateral radiographs preoperatively.&#xD;
        Completed 2 year follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous surgery at the same level,&#xD;
&#xD;
          -  malignancy or undergoing treatment for malignancy&#xD;
&#xD;
          -  scoliosis Cobb angel &gt;20 degrees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Signe Forbech Elmose, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for spine surgery and research, Spine Center of Southern Denmark</name>
      <address>
        <city>Middelfart</city>
        <zip>5500</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>December 11, 2021</last_update_submitted>
  <last_update_submitted_qc>December 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>instability</keyword>
  <keyword>anterior translation</keyword>
  <keyword>slip</keyword>
  <keyword>segmental motion</keyword>
  <keyword>radiologic assesment</keyword>
  <keyword>lumbar MRI</keyword>
  <keyword>MRI characteristics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT04406987
org study id: 20/7176
secondary id: 20202000-22
nct id: NCT04406987
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Age related changes in the lumbar spine can lead to narrowing of the spinal canal (spinal
      stenosis) causing leg and back pain. Spinal stenosis can be associated with a misalignment of
      the spine caused by forward slippage of a vertebrae over another. This instability is
      diagnosed using diagnostic imaging. With signs of instability the spine surgeon might choose
      a fusion of the vertebrae. This is a more complex procedure in relation to the simple
      decompression preformed without instability for spinal stenosis.

      The purpose of this study is to identify characteristics of instability of the lumbar spine
      on diagnostic imaging, and investigate associations with surgical data and patient reported
      outcomes from the National Spine databases from Denmark and Sweden.

      This will support spine surgeons in providing evidence-based surgical treatment for spinal
      stenosis with or without signs of instability
A multicenter retrospective cohort study of prospectively collected data from national spine
      surgery databases in Denmark and Sweden. This project is a collaboration between sector for
      spine surgery and research Middelfart Hospital and spine surgeons at Orebro Hospital and Lund
      Hospital in Sweden.

      Data subtracted from Danish national spine surgery database, DaneSpine, from Middelfart
      Hospital, and Swedish Spinal Register, SweSpine, from hospitals in Malmö, Lund, Trelleborg
      and Karlskroga.

      Both databases are clinical quality databases with a high response-rate. DaneSpine is
      administered by Danish Society of Spine Surgeons and is managed by secretary of DaneSpine.
      SweSpine is administered by Swedish Society of Spinal Surgeons and managed

      Patients are invited to register when scheduled for surgery. Patients signs informed consent
      and receives follow-up questionaires 3 and 6 months, one, two, 5 and 10 years post-surgery.
      Questionaires are validated PROM (patient reported outcome measures) and PREM (patient
      reported experience measures).

      The surgeon is responsible for registering surgical data, including complications and
      reoperations.

      Data relevant for present study will be applied for at the respective societies and managed
      and stored in compliance with General Data Protection Regulation.

      The EasyWiz software (Medical Insight, Chicago, IL, USA) is used for analysis of all MRIs and
      radiographs.

      All imaging will be analyzed by 2 independent examiners. The interobserver reliability will
      be calculated.

      Missing data such as variables reported as missing or non-reported will not be included in
      statistical analysis.

      Statistics: significance of difference in mean values between groups for continuous normally
      distributed data unpaired t-test. Categorical variables normally distributed:
      Chi-squared/Fishers exact test. Multivariable regression analysis. Kappa statistics for
      interobserver reliability presented in the article.
observational model: Cohort
time perspective: Prospective
measure: facet joint gap
time frame: pre-surgery
description: MRI proxies 1
measure: facet angel
time frame: pre-surgery
description: MRI proxies 2
measure: disc height
time frame: pre-surgery
description: MRI proxies 3
measure: anterior translation
time frame: pre-surgery
description: MRI proxies 4
measure: intradiscal vacuum
time frame: pre-surgery
description: MRI proxies 5
measure: radiographic slip
time frame: pre-surgery
description: anterior translation on lateral radiograph
measure: VAS leg
time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery
description: Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale
measure: VAS back
time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery
description: Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale
measure: EQ-5D
time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery
description: EuroQol (EQ-5D) measures health-related quality of life on a scale where 0.0 equal's death and 1.0 equals perfect health
measure: ODI
time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery
description: Oswestry Disability Index (ODI) questionnaire scores range from 0 (no disability) to 100 (total disability)
measure: patient characteristics
time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery
description: age, gender, BMI, smoking, diabetes
measure: reoperation
time frame: 3 months, 12 months and 2 years post-surgery
description: operation on index level after primary operation and discharge within follow-up period
measure: complication
time frame: during surgery or during admission
description: perisurgical complication within admission.
arm group label: decompression
description: patients treated with decompression for lumbar spinal stenosis
arm group label: fusion
description: patients treated with decompression with fusion for lumbar spinal stenosis
intervention type: Procedure
intervention name: decompression
description: surgical technique for neural decompression varied based on surgeon's preference, but always with preservation for spinous processes. Either open with or without microscope or using tubular retractors.
arm group label: decompression
intervention type: Procedure
intervention name: fusion
description: fusion techniques consisted besides decompression of additional implantation of pedicle screws with rods, with or without intervertebral fusion and cage(s). Non-instrumented technique with allograft bone. Fusion technique on surgeon's discretion.
arm group label: fusion
other name: arthrodese
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
last name: Signe Forbech Elmose, M.D.
role: Principal Investigator
affiliation: Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Spondylolisthesis
mesh term: Constriction, Pathologic
sharing ipd: No