<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/NCT04444739</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00150; ch20Muendermann4</org_study_id>
    <nct_id>NCT04444739</nct_id>
  </id_info>
  <brief_title>Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis</brief_title>
  <acronym>AtrophyLSS</acronym>
  <official_title>AtrophyLSS - Association Between Lumbar Muscle Atrophy, Sagittal Pelvic Alignment and Stenosis Grade in Patients With Degenerative Lumbar Spinal Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment,&#xD;
      and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological&#xD;
      images, specific radiographic parameters will be extracted. General Information (Age, sex,&#xD;
      levels of stenosis, duration of symptoms) will be extracted from patient files.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Muscle atrophy stage will be observed using Goutallier classification&#xD;
Stage 0: No fatty infiltration&#xD;
Stage 1: Few fatty streaks within the muscle&#xD;
Stage 2: Less than 50% fat within the muscle&#xD;
Stage 3: 50% of fat within the muscle&#xD;
Stage 4: more than 50% fat with in the muscle. The MA stage will be observed in MRI of 5 lumbar disc levels (L1-S1). The MA stage of patients will be calculated as average stage of five lumbar segments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Pelvic incidence (PI): The angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of stenosis from supine MRI of lumbar spine</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Stenosis grade will be observed using Schizas classification (Schizas et al., 2010)&#xD;
Grade 1: Dural sac party occupied by the rootlets; Cerebrospinal fluid clearly visible; No stenosis&#xD;
Grade 2: Rootlets occupy whole dural sac; Some cerebrospinal fluid visible; Moderate stenosis.&#xD;
Grade 3: Rootlets not visible; No cerebrospinal fluid visible; Epidural fat posteriorly; Severe stenosis.&#xD;
Grade 4: Rootlets not visible; No cerebrospinal fluid; No epidural fat; Extreme Stenosis. The most severe level will be regarded as the stenosis grade of the patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic tilt (PT): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Pelvic tilt (PT): The angle formed by a vertical line through the center of the femoral heads and the line from the center of the femoral axis and the midpoint of the sacral end plate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sacral slope (SS): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Sacral slope (SS): The angle formed between the horizontal and the sacral end plate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar lordosis (LL): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads</measure>
    <time_frame>single time-point at baseline</time_frame>
    <description>Lumbar lordosis (LL): The sagittal angle formed between the superior end plate of L1 and the sacral end plate</description>
  </primary_outcome>
  <enrollment type="Actual">165</enrollment>
  <condition>Lumbar Spinal Stenosis (LSS)</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>radiographic data collection</intervention_name>
    <description>From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who visited Orthopaedics and Traumatology outpatient clinic at University&#xD;
        Hospital Basel for clinical and radiological consultation regarding their lumbar spine&#xD;
        between 01.01.2018 and 31.12.2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of degenerative lumbar spinal stenosis&#xD;
&#xD;
          -  Upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis&#xD;
             sacrum and femoral head&#xD;
&#xD;
          -  MRI of the lumbar region with clear visibility of different muscle atrophy grade&#xD;
&#xD;
          -  Consent that health related information can be used for research was signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other spinal disease such as severe scoliosis, fracture, spondylolisthesis and&#xD;
             ankylosing spondylitis.&#xD;
&#xD;
          -  Neuromuscular diseases such as M.Parkinson or multiple sclerosis&#xD;
&#xD;
          -  Previous surgery of the spine&#xD;
&#xD;
          -  Infection and/or malignancy tumor with involvement of the bony or soft tissue&#xD;
             structures of the spine&#xD;
&#xD;
          -  Presence of a documented consent dissent.&#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>Annegret Muendermann, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopaedics and Traumatology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedics and Traumatology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>paraspinal muscle atrophy (MA)</keyword>
  <keyword>sagittal pelvic alignment</keyword>
  <keyword>degenerative spine diseases</keyword>
  <keyword>stenosis grade (SG)</keyword>
  <keyword>degenerative LSS</keyword>
  <keyword>Goutallier classification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
    <mesh_term>Atrophy</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/NCT04444739
org study id: 2020-00150; ch20Muendermann4
nct id: NCT04444739
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the correlation between muscle atrophy (MA), sagittal alignment,
      and stenosis degree in patients with lumbar spinal Stenosis (LSS). From existing radiological
      images, specific radiographic parameters will be extracted. General Information (Age, sex,
      levels of stenosis, duration of symptoms) will be extracted from patient files.
observational model: Cohort
time perspective: Retrospective
measure: Severity of muscle atrophy (MA) from supine Magnetic Resonance Imaging (MRI) of lumbar spine
time frame: single time-point at baseline
description: Muscle atrophy stage will be observed using Goutallier classification
Stage 0: No fatty infiltration
Stage 1: Few fatty streaks within the muscle
Stage 2: Less than 50% fat within the muscle
Stage 3: 50% of fat within the muscle
Stage 4: more than 50% fat with in the muscle. The MA stage will be observed in MRI of 5 lumbar disc levels (L1-S1). The MA stage of patients will be calculated as average stage of five lumbar segments.
measure: Pelvic incidence (PI): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
time frame: single time-point at baseline
description: Pelvic incidence (PI): The angle between the line perpendicular to the sacral endplate at its midpoint and a line connecting this point to the axis of the femoral head.
measure: Severity of stenosis from supine MRI of lumbar spine
time frame: single time-point at baseline
description: Stenosis grade will be observed using Schizas classification (Schizas et al., 2010)
Grade 1: Dural sac party occupied by the rootlets; Cerebrospinal fluid clearly visible; No stenosis
Grade 2: Rootlets occupy whole dural sac; Some cerebrospinal fluid visible; Moderate stenosis.
Grade 3: Rootlets not visible; No cerebrospinal fluid visible; Epidural fat posteriorly; Severe stenosis.
Grade 4: Rootlets not visible; No cerebrospinal fluid; No epidural fat; Extreme Stenosis. The most severe level will be regarded as the stenosis grade of the patients.
measure: Pelvic tilt (PT): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
time frame: single time-point at baseline
description: Pelvic tilt (PT): The angle formed by a vertical line through the center of the femoral heads and the line from the center of the femoral axis and the midpoint of the sacral end plate.
measure: Sacral slope (SS): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
time frame: single time-point at baseline
description: Sacral slope (SS): The angle formed between the horizontal and the sacral end plate.
measure: Lumbar lordosis (LL): Pelvic alignment from standard upright standing sagittal plane X-ray of lumbar spine with clear visibility of pelvis sacrum and femoral heads
time frame: single time-point at baseline
description: Lumbar lordosis (LL): The sagittal angle formed between the superior end plate of L1 and the sacral end plate
intervention type: Other
intervention name: radiographic data collection
description: From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annegret Muendermann, Prof. Dr. med.
role: Principal Investigator
affiliation: Orthopaedics and Traumatology, University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Spinal Stenosis
mesh term: Muscular Atrophy
mesh term: Constriction, Pathologic
mesh term: Atrophy