<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/NCT03237039</url>
  </required_header>
  <id_info>
    <org_study_id>EOS60</org_study_id>
    <nct_id>NCT03237039</nct_id>
  </id_info>
  <brief_title>Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects</brief_title>
  <acronym>EOS60</acronym>
  <official_title>Classification of the Sagittal Profile of the Spine in Asymptomatic Elderly Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Galeazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Galeazzi</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>
      Principal aim The main purpose of the study is to describe the distribution of the sagittal&#xD;
      profile in elderly subjects in order to bridge the gap present in this type of screening,&#xD;
      evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al.&#xD;
      in 2005). This classification assigns an integer value from 1 to 4 in relation to the&#xD;
      evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population&#xD;
      description is therefore divided into four categories. The extension of this classification&#xD;
      to elderly can provide useful support for the clinical evaluation and the specific treatment&#xD;
      of the elderly patients.&#xD;
&#xD;
      Secondary aims The study aims in addition to evaluate the relation between the spine sagittal&#xD;
      profile and the objective indexes obtained from the assessment of fall-risk and gait cycle&#xD;
      analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This&#xD;
      subgroup will consider the subjects older than or equal to 74 years, where the risk of&#xD;
      falling is most likely to be expected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      The classification of spine sagittal profile can be an essential prediction factor for the&#xD;
      specific prevention and treatment of patient's pathologies. Despite high variability,&#xD;
      sagittal alignment can be accurately measured by radiographic examination and is fully&#xD;
      replicable. To this regard, a classification of the lumbar profile and pelvis in the sagittal&#xD;
      plane was proposed by Roussouly et al. Specifically, four different typologies can be&#xD;
      recognized. These typologies classify the profile of the lumbar curve and are directly&#xD;
      related to the quantification of the pelvic inclination. The study by Roussouly et al.&#xD;
      examined 160 asymptomatic subjects aged between 18 and 45 years and confirmed the high&#xD;
      inter-individual variability of the sagittal profile. Unfortunately, this classification has&#xD;
      not been extended to elderly. In this regard, it has been shown that peculiar changes in the&#xD;
      sagittal profile are particularly evident in aging, such as the advancement of the average&#xD;
      sagittal axis and the tendency to decrease of the degree of lumbar lordosis.&#xD;
&#xD;
      According to that, extending the classification of the spine sagittal alignment in elderly&#xD;
      results of prime importance. Furthermore, extending this classification will also provide&#xD;
      useful information supporting the clinical evaluation and the specific treatment of elderly&#xD;
      patients (e.g. better understanding the association between spine alignment and the&#xD;
      development of degenerative alterations). In addition to this primary objective, this study&#xD;
      aims to assess the relation between postural imbalance (due to alterations of the sagittal&#xD;
      profile) and motor functionality in elderly. A subgroup of the enrolled subjects, equal to&#xD;
      one quarter of the total size, will undergo fall-risk assessment and gait cycle analysis.&#xD;
      This subgroup will account subjects older than or equal to 74 years, where the risk of&#xD;
      falling is more likely to occur. The objective indices obtained from these analyses will be&#xD;
      put in relation with the classification of the spine sagittal profile.&#xD;
&#xD;
      Aims of the study:&#xD;
&#xD;
      The primary aim of this study is to classify the spine sagittal profile in elderly&#xD;
      asymptomatic subjects (older than or equal to 60 years) through the semi-automatic analysis&#xD;
      of low dose radiographic images obtained through a validated radiographic system (EOS Imaging&#xD;
      System, France). The study will evaluate 160 subjects, at least 40 of whom will have an age&#xD;
      greater than or equal to 74 years. According to Roussouly et al., the classification of the&#xD;
      spine alignment will assign an integer value ranging from 1 to 4, in relation to the&#xD;
      evaluation of the lumbar spine and pelvis in the sagittal plane. Secondary aim of the study&#xD;
      will be to investigate the relation between the classification of spine sagittal profile and&#xD;
      the objective indexes characterizing the fall-risk and the gait cycle analysis. This&#xD;
      assessment will take into account the subgroup of 40 subjects aged 74 years or more.&#xD;
&#xD;
      Radiographic examination:&#xD;
&#xD;
      The radiographic examination will be performed with the EOS low-dose X-ray radiation system&#xD;
      by a radiology technician. The examination, which will take about 10 seconds, will allow the&#xD;
      simultaneous acquisition in upright position of two full-body radiographic images, one in the&#xD;
      coronal plane and one in the sagittal plane. The evaluation of the radiographic images will&#xD;
      be performed by an orthopedic physician. Image processing will be performed by a biomedical&#xD;
      engineer through sterEOS proprietary software and will provide the anatomical parameters&#xD;
      needed to classify the sagittal profile.&#xD;
&#xD;
      Assessment of fall-risk:&#xD;
&#xD;
      This evaluation will be performed after the radiographic examination, in the same session.&#xD;
      The fall-risk assessment test will be performed by a biomedical engineer through OAK device&#xD;
      (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps&#xD;
      applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts&#xD;
      eight consecutive postural equilibrium exercises and provide the automatic detection of&#xD;
      subject's postural parameters. At the end of the test, the fall-risk rating is automatically&#xD;
      assigned.&#xD;
&#xD;
      Gait cycle analysis:&#xD;
&#xD;
      This assessment will be performed in the same session of fall-risk evaluation. The gait cycle&#xD;
      analysis, which takes approximately forty minutes, will be executed by a biomedical engineer.&#xD;
      Adhesive passive reflective markers will be placed on the skin according to a protocol&#xD;
      suitable to characterize the alignment of lower limbs and trunk. The markers trajectories&#xD;
      during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy).&#xD;
      A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the&#xD;
      forces exchanged with the ground. The data analysis will provide the kinematic and kinetic&#xD;
      descriptive parameters of gait cycle.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The total sample size was chosen considering the classificatory purpose of the present study&#xD;
      and its descriptive and non-comparative intent. It was therefore considered as appropriate to&#xD;
      match the number of 160 subjects evaluated in previous study to classify the spine sagittal&#xD;
      alignment in adult subjects. Concerning the secondary aim of the study, the correlation&#xD;
      between the Roussouly type (identifying the spine sagittal alignment) and the indexes&#xD;
      characterizing fall-risk and gait cycle will be assessed. The significance of the Pearson&#xD;
      correlation coefficient or of Spearman correlation coefficient, in case of non-Gaussian data,&#xD;
      will be tested according to two-tailed t-test or permutation distribution test, respectively.&#xD;
      Statistical significance will be considered at p &lt;0.05 level. To this regard, the sample size&#xD;
      requested to guarantee the significance (with α = 0.05 and statistical power = 95%) of a&#xD;
      correlation value defined as 'strong' (not less than 0.6, in absolute value), is equal to 30.&#xD;
      The number of 40 subjects planned for the secondary aim thus fulfills the requirements for&#xD;
      the correlation analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Anticipated">April 3, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>symptomatic elderly subjects</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Classification of Roussouly type</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>This classification assigns an integer value ranging from 1 to 4, in relation to the evaluation of lumbar spine and pelvis alignment in the sagittal plane. It will be acquired to describe subjects' population, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject's weight</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Subject's weight (kg) will be acquired to describe subjects' population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject's height</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Subject's height (cm) will be acquired to describe subjects' population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thoracic kyphosis</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Thoracic kyphosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumbar lordosis</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Lumbar lordosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic incidence</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Pelvic incidence (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sacral slope</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Sacral slope (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic tilt</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Pelvic tilt (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lateral pelvic inclination</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Lateral pelvic inclination (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic torsion</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Pelvic torsion (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fall-risk score</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Evaluation of the fall-risk with the OAK device (OAK, Khymeia, Italy). The device automatically evaluates the fall-risk score, an integer value ranging from 0 to 24, where 0 indicates maximum risk and 24 the minimum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional forward flexion</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Functional forward flexion (cm) will be automatically computed by the OAK device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CoP sway area</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Sway area of the center of pressure (cm2) will be automatically computed by the OAK device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: stance phase</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Stance phase (% of total gait cycle time) will be evaluated for both the right and left legs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: swing phase</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Swing phase (% of total gait cycle time) will be evaluated for both the right and left legs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: stride length</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Stride length (m) will be evaluated for both the right and left legs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: average walking speed</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Average walking speed (m/s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: average step cadence</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Average step cadence (steps/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: maximum hip flexion</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Maximum hip flexion (°) will be evaluated for both the right and left hips.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: maximum hip extension</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Maximum hip extension (°) will be evaluated for both the right and left hips.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: maximum hip flexion moment</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Maximum hip flexion moment (Nm) will be evaluated for both the right and left hips.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait analysis: maximum hip extension moment</measure>
    <time_frame>Through study completion, an average of 18 months</time_frame>
    <description>Maximum hip extension moment (Nm) will be evaluated for both the right and left hips.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Aged</condition>
  <condition>Asymptomatic Condition</condition>
  <arm_group>
    <arm_group_label>X-ray examination, fall-risk and gait</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>X-ray examination</intervention_name>
    <description>Radiological examination of frontal and lateral planes, simultaneously acquired with low dose X-ray system (EOS system, France) in one single exposition. The evaluation of the radiographic images will be performed by an orthopedic physician.Image processing will be performed by a biomedical engineer through sterEOS proprietary software and will provide the anatomical parameters needed to classify the sagittal profile.</description>
    <arm_group_label>X-ray examination, fall-risk and gait</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fall-risk assessment</intervention_name>
    <description>This evaluation will be performed after the radiographic scan, in the same day. The fall-risk assessment test will be performed by a biomedical engineer through OAK device (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts eight consecutive postural equilibrium exercises and provide the automatic detection of subject's postural parameters. At the end of the test, the fall-risk rating is automatically assigned.</description>
    <arm_group_label>X-ray examination, fall-risk and gait</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gait cycle analysis</intervention_name>
    <description>This assessment will be performed in the same session of fall-risk evaluation. The gait cycle analysis, which takes approximately forty minutes, will be executed by a biomedical engineer. Adhesive passive reflective markers will be placed on the skin according to a protocol suitable to characterize the alignment of lower limbs and trunk. The markers trajectories during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy). A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the forces exchanged with the ground. The data analysis will provide the kinematic and kinetic descriptive parameters of gait cycle.</description>
    <arm_group_label>X-ray examination, fall-risk and gait</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than or equal to 60 years&#xD;
&#xD;
          -  subscription of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant painful episodes linked to the spine in the last 2 years&#xD;
&#xD;
          -  Early surgical interventions involving the spine&#xD;
&#xD;
          -  scoliosis or other spine pathologies (vertebral, neurological, muscular)&#xD;
&#xD;
          -  Obesity (BMI&gt; 30 kg / m2)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Brayda-Bruno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Ortopedico Galeazzi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tito Bassani, PhD</last_name>
    <phone>+390266214939</phone>
    <email>tito.bassani@grupposandonato.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Marco Brayda-Bruno, MD</name>
      <address>
        <city>Milano</city>
        <state>Milan</state>
        <zip>20161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Brayda-Bruno, MD</last_name>
      <phone>+390266214939</phone>
      <email>marco.brayda@spinecaregroup.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Dietrich TJ, Pfirrmann CW, Schwab A, Pankalla K, Buck FM. Comparison of radiation dose, workflow, patient comfort and financial break-even of standard digital radiography and a novel biplanar low-dose X-ray system for upright full-length lower limb and whole spine radiography. Skeletal Radiol. 2013 Jul;42(7):959-67. doi: 10.1007/s00256-013-1600-0. Epub 2013 Mar 28.</citation>
    <PMID>23536038</PMID>
  </reference>
  <reference>
    <citation>Dreischarf M, Albiol L, Rohlmann A, Pries E, Bashkuev M, Zander T, Duda G, Druschel C, Strube P, Putzier M, Schmidt H. Age-related loss of lumbar spinal lordosis and mobility--a study of 323 asymptomatic volunteers. PLoS One. 2014 Dec 30;9(12):e116186. doi: 10.1371/journal.pone.0116186. eCollection 2014.</citation>
    <PMID>25549085</PMID>
  </reference>
  <reference>
    <citation>Gelb DE, Lenke LG, Bridwell KH, Blanke K, McEnery KW. An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1351-8.</citation>
    <PMID>7676332</PMID>
  </reference>
  <reference>
    <citation>Hammerberg EM, Wood KB. Sagittal profile of the elderly. J Spinal Disord Tech. 2003 Feb;16(1):44-50. doi: 10.1097/00024720-200302000-00008.</citation>
    <PMID>12571484</PMID>
  </reference>
  <reference>
    <citation>Jackson RP, Peterson MD, McManus AC, Hales C. Compensatory spinopelvic balance over the hip axis and better reliability in measuring lordosis to the pelvic radius on standing lateral radiographs of adult volunteers and patients. Spine (Phila Pa 1976). 1998 Aug 15;23(16):1750-67. doi: 10.1097/00007632-199808150-00008.</citation>
    <PMID>9728376</PMID>
  </reference>
  <reference>
    <citation>Jackson RP, Hales C. Congruent spinopelvic alignment on standing lateral radiographs of adult volunteers. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2808-15. doi: 10.1097/00007632-200011010-00014.</citation>
    <PMID>11064527</PMID>
  </reference>
  <reference>
    <citation>Pellet N, Aunoble S, Meyrat R, Rigal J, Le Huec JC. Sagittal balance parameters influence indications for lumbar disc arthroplasty or ALIF. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):647-62. doi: 10.1007/s00586-011-1933-0. Epub 2011 Aug 16.</citation>
    <PMID>21845396</PMID>
  </reference>
  <reference>
    <citation>Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53. doi: 10.1097/01.brs.0000152379.54463.65.</citation>
    <PMID>15682018</PMID>
  </reference>
  <reference>
    <citation>Shah DJ, Sachs RK, Wilson DJ. Radiation-induced cancer: a modern view. Br J Radiol. 2012 Dec;85(1020):e1166-73. doi: 10.1259/bjr/25026140.</citation>
    <PMID>23175483</PMID>
  </reference>
  <reference>
    <citation>Stagnara P, De Mauroy JC, Dran G, Gonon GP, Costanzo G, Dimnet J, Pasquet A. Reciprocal angulation of vertebral bodies in a sagittal plane: approach to references for the evaluation of kyphosis and lordosis. Spine (Phila Pa 1976). 1982 Jul-Aug;7(4):335-42. doi: 10.1097/00007632-198207000-00003.</citation>
    <PMID>7135066</PMID>
  </reference>
  <reference>
    <citation>Vedantam R, Lenke LG, Keeney JA, Bridwell KH. Comparison of standing sagittal spinal alignment in asymptomatic adolescents and adults. Spine (Phila Pa 1976). 1998 Jan 15;23(2):211-5. doi: 10.1097/00007632-199801150-00012.</citation>
    <PMID>9474728</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Roussouly type</keyword>
  <keyword>spine alignment</keyword>
  <keyword>fall-risk</keyword>
  <keyword>gait cycle analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asymptomatic Diseases</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/NCT03237039
org study id: EOS60
nct id: NCT03237039
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Principal aim The main purpose of the study is to describe the distribution of the sagittal
      profile in elderly subjects in order to bridge the gap present in this type of screening,
      evaluated in the literature for adults only (i.e. 160 subjects considered by Roussouly et al.
      in 2005). This classification assigns an integer value from 1 to 4 in relation to the
      evaluation of alignment of the lumbar spine and pelvis in the sagittal plane. The population
      description is therefore divided into four categories. The extension of this classification
      to elderly can provide useful support for the clinical evaluation and the specific treatment
      of the elderly patients.

      Secondary aims The study aims in addition to evaluate the relation between the spine sagittal
      profile and the objective indexes obtained from the assessment of fall-risk and gait cycle
      analysis. Accordingly, a subgroup of 40 subjects out of the 160 will be evaluated. This
      subgroup will consider the subjects older than or equal to 74 years, where the risk of
      falling is most likely to be expected.
Introduction:

      The classification of spine sagittal profile can be an essential prediction factor for the
      specific prevention and treatment of patient's pathologies. Despite high variability,
      sagittal alignment can be accurately measured by radiographic examination and is fully
      replicable. To this regard, a classification of the lumbar profile and pelvis in the sagittal
      plane was proposed by Roussouly et al. Specifically, four different typologies can be
      recognized. These typologies classify the profile of the lumbar curve and are directly
      related to the quantification of the pelvic inclination. The study by Roussouly et al.
      examined 160 asymptomatic subjects aged between 18 and 45 years and confirmed the high
      inter-individual variability of the sagittal profile. Unfortunately, this classification has
      not been extended to elderly. In this regard, it has been shown that peculiar changes in the
      sagittal profile are particularly evident in aging, such as the advancement of the average
      sagittal axis and the tendency to decrease of the degree of lumbar lordosis.

      According to that, extending the classification of the spine sagittal alignment in elderly
      results of prime importance. Furthermore, extending this classification will also provide
      useful information supporting the clinical evaluation and the specific treatment of elderly
      patients (e.g. better understanding the association between spine alignment and the
      development of degenerative alterations). In addition to this primary objective, this study
      aims to assess the relation between postural imbalance (due to alterations of the sagittal
      profile) and motor functionality in elderly. A subgroup of the enrolled subjects, equal to
      one quarter of the total size, will undergo fall-risk assessment and gait cycle analysis.
      This subgroup will account subjects older than or equal to 74 years, where the risk of
      falling is more likely to occur. The objective indices obtained from these analyses will be
      put in relation with the classification of the spine sagittal profile.

      Aims of the study:

      The primary aim of this study is to classify the spine sagittal profile in elderly
      asymptomatic subjects (older than or equal to 60 years) through the semi-automatic analysis
      of low dose radiographic images obtained through a validated radiographic system (EOS Imaging
      System, France). The study will evaluate 160 subjects, at least 40 of whom will have an age
      greater than or equal to 74 years. According to Roussouly et al., the classification of the
      spine alignment will assign an integer value ranging from 1 to 4, in relation to the
      evaluation of the lumbar spine and pelvis in the sagittal plane. Secondary aim of the study
      will be to investigate the relation between the classification of spine sagittal profile and
      the objective indexes characterizing the fall-risk and the gait cycle analysis. This
      assessment will take into account the subgroup of 40 subjects aged 74 years or more.

      Radiographic examination:

      The radiographic examination will be performed with the EOS low-dose X-ray radiation system
      by a radiology technician. The examination, which will take about 10 seconds, will allow the
      simultaneous acquisition in upright position of two full-body radiographic images, one in the
      coronal plane and one in the sagittal plane. The evaluation of the radiographic images will
      be performed by an orthopedic physician. Image processing will be performed by a biomedical
      engineer through sterEOS proprietary software and will provide the anatomical parameters
      needed to classify the sagittal profile.

      Assessment of fall-risk:

      This evaluation will be performed after the radiographic examination, in the same session.
      The fall-risk assessment test will be performed by a biomedical engineer through OAK device
      (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps
      applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts
      eight consecutive postural equilibrium exercises and provide the automatic detection of
      subject's postural parameters. At the end of the test, the fall-risk rating is automatically
      assigned.

      Gait cycle analysis:

      This assessment will be performed in the same session of fall-risk evaluation. The gait cycle
      analysis, which takes approximately forty minutes, will be executed by a biomedical engineer.
      Adhesive passive reflective markers will be placed on the skin according to a protocol
      suitable to characterize the alignment of lower limbs and trunk. The markers trajectories
      during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy).
      A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the
      forces exchanged with the ground. The data analysis will provide the kinematic and kinetic
      descriptive parameters of gait cycle.

      Statistical analysis:

      The total sample size was chosen considering the classificatory purpose of the present study
      and its descriptive and non-comparative intent. It was therefore considered as appropriate to
      match the number of 160 subjects evaluated in previous study to classify the spine sagittal
      alignment in adult subjects. Concerning the secondary aim of the study, the correlation
      between the Roussouly type (identifying the spine sagittal alignment) and the indexes
      characterizing fall-risk and gait cycle will be assessed. The significance of the Pearson
      correlation coefficient or of Spearman correlation coefficient, in case of non-Gaussian data,
      will be tested according to two-tailed t-test or permutation distribution test, respectively.
      Statistical significance will be considered at p <0.05 level. To this regard, the sample size
      requested to guarantee the significance (with α = 0.05 and statistical power = 95%) of a
      correlation value defined as 'strong' (not less than 0.6, in absolute value), is equal to 30.
      The number of 40 subjects planned for the secondary aim thus fulfills the requirements for
      the correlation analysis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: symptomatic elderly subjects
primary purpose: Screening
masking: None (Open Label)
measure: Classification of Roussouly type
time frame: Through study completion, an average of 18 months
description: This classification assigns an integer value ranging from 1 to 4, in relation to the evaluation of lumbar spine and pelvis alignment in the sagittal plane. It will be acquired to describe subjects' population, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Subject's weight
time frame: Through study completion, an average of 18 months
description: Subject's weight (kg) will be acquired to describe subjects' population
measure: Subject's height
time frame: Through study completion, an average of 18 months
description: Subject's height (cm) will be acquired to describe subjects' population
measure: Thoracic kyphosis
time frame: Through study completion, an average of 18 months
description: Thoracic kyphosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Lumbar lordosis
time frame: Through study completion, an average of 18 months
description: Lumbar lordosis (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Pelvic incidence
time frame: Through study completion, an average of 18 months
description: Pelvic incidence (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Sacral slope
time frame: Through study completion, an average of 18 months
description: Sacral slope (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Pelvic tilt
time frame: Through study completion, an average of 18 months
description: Pelvic tilt (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Lateral pelvic inclination
time frame: Through study completion, an average of 18 months
description: Lateral pelvic inclination (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Pelvic torsion
time frame: Through study completion, an average of 18 months
description: Pelvic torsion (°) will be accounted for the spine alignment classification, and correlations with fall-risk and gait cycle indexes will be checked for.
measure: Fall-risk score
time frame: Through study completion, an average of 18 months
description: Evaluation of the fall-risk with the OAK device (OAK, Khymeia, Italy). The device automatically evaluates the fall-risk score, an integer value ranging from 0 to 24, where 0 indicates maximum risk and 24 the minimum.
measure: Functional forward flexion
time frame: Through study completion, an average of 18 months
description: Functional forward flexion (cm) will be automatically computed by the OAK device.
measure: CoP sway area
time frame: Through study completion, an average of 18 months
description: Sway area of the center of pressure (cm2) will be automatically computed by the OAK device.
measure: Gait analysis: stance phase
time frame: Through study completion, an average of 18 months
description: Stance phase (% of total gait cycle time) will be evaluated for both the right and left legs.
measure: Gait analysis: swing phase
time frame: Through study completion, an average of 18 months
description: Swing phase (% of total gait cycle time) will be evaluated for both the right and left legs.
measure: Gait analysis: stride length
time frame: Through study completion, an average of 18 months
description: Stride length (m) will be evaluated for both the right and left legs.
measure: Gait analysis: average walking speed
time frame: Through study completion, an average of 18 months
description: Average walking speed (m/s).
measure: Gait analysis: average step cadence
time frame: Through study completion, an average of 18 months
description: Average step cadence (steps/min)
measure: Gait analysis: maximum hip flexion
time frame: Through study completion, an average of 18 months
description: Maximum hip flexion (°) will be evaluated for both the right and left hips.
measure: Gait analysis: maximum hip extension
time frame: Through study completion, an average of 18 months
description: Maximum hip extension (°) will be evaluated for both the right and left hips.
measure: Gait analysis: maximum hip flexion moment
time frame: Through study completion, an average of 18 months
description: Maximum hip flexion moment (Nm) will be evaluated for both the right and left hips.
measure: Gait analysis: maximum hip extension moment
time frame: Through study completion, an average of 18 months
description: Maximum hip extension moment (Nm) will be evaluated for both the right and left hips.
arm group label: X-ray examination, fall-risk and gait
arm group type: Other
description: simultaneous acquisition in upright position of two full-body radiographic images, one in the coronal plane and one in the sagittal plane. In addition, 40 out of 160 subjects will undergo fall-risk assessment and gait cycle analysis evaluation.
intervention type: Radiation
intervention name: X-ray examination
description: Radiological examination of frontal and lateral planes, simultaneously acquired with low dose X-ray system (EOS system, France) in one single exposition. The evaluation of the radiographic images will be performed by an orthopedic physician.Image processing will be performed by a biomedical engineer through sterEOS proprietary software and will provide the anatomical parameters needed to classify the sagittal profile.
arm group label: X-ray examination, fall-risk and gait
intervention type: Other
intervention name: fall-risk assessment
description: This evaluation will be performed after the radiographic scan, in the same day. The fall-risk assessment test will be performed by a biomedical engineer through OAK device (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts eight consecutive postural equilibrium exercises and provide the automatic detection of subject's postural parameters. At the end of the test, the fall-risk rating is automatically assigned.
arm group label: X-ray examination, fall-risk and gait
intervention type: Other
intervention name: gait cycle analysis
description: This assessment will be performed in the same session of fall-risk evaluation. The gait cycle analysis, which takes approximately forty minutes, will be executed by a biomedical engineer. Adhesive passive reflective markers will be placed on the skin according to a protocol suitable to characterize the alignment of lower limbs and trunk. The markers trajectories during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy). A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the forces exchanged with the ground. The data analysis will provide the kinematic and kinetic descriptive parameters of gait cycle.
arm group label: X-ray examination, fall-risk and gait
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marco Brayda-Bruno, MD
role: Principal Investigator
affiliation: IRCCS Istituto Ortopedico Galeazzi
last name: Tito Bassani, PhD
phone: +390266214939
email: tito.bassani@grupposandonato.it
facility: 
status: Recruiting
contact: 
country: Italy
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PMID: 23536038
citation: Dreischarf M, Albiol L, Rohlmann A, Pries E, Bashkuev M, Zander T, Duda G, Druschel C, Strube P, Putzier M, Schmidt H. Age-related loss of lumbar spinal lordosis and mobility--a study of 323 asymptomatic volunteers. PLoS One. 2014 Dec 30;9(12):e116186. doi: 10.1371/journal.pone.0116186. eCollection 2014.
PMID: 25549085
citation: Gelb DE, Lenke LG, Bridwell KH, Blanke K, McEnery KW. An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1351-8.
PMID: 7676332
citation: Hammerberg EM, Wood KB. Sagittal profile of the elderly. J Spinal Disord Tech. 2003 Feb;16(1):44-50. doi: 10.1097/00024720-200302000-00008.
PMID: 12571484
citation: Jackson RP, Peterson MD, McManus AC, Hales C. Compensatory spinopelvic balance over the hip axis and better reliability in measuring lordosis to the pelvic radius on standing lateral radiographs of adult volunteers and patients. Spine (Phila Pa 1976). 1998 Aug 15;23(16):1750-67. doi: 10.1097/00007632-199808150-00008.
PMID: 9728376
citation: Jackson RP, Hales C. Congruent spinopelvic alignment on standing lateral radiographs of adult volunteers. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2808-15. doi: 10.1097/00007632-200011010-00014.
PMID: 11064527
citation: Pellet N, Aunoble S, Meyrat R, Rigal J, Le Huec JC. Sagittal balance parameters influence indications for lumbar disc arthroplasty or ALIF. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):647-62. doi: 10.1007/s00586-011-1933-0. Epub 2011 Aug 16.
PMID: 21845396
citation: Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53. doi: 10.1097/01.brs.0000152379.54463.65.
PMID: 15682018
citation: Shah DJ, Sachs RK, Wilson DJ. Radiation-induced cancer: a modern view. Br J Radiol. 2012 Dec;85(1020):e1166-73. doi: 10.1259/bjr/25026140.
PMID: 23175483
citation: Stagnara P, De Mauroy JC, Dran G, Gonon GP, Costanzo G, Dimnet J, Pasquet A. Reciprocal angulation of vertebral bodies in a sagittal plane: approach to references for the evaluation of kyphosis and lordosis. Spine (Phila Pa 1976). 1982 Jul-Aug;7(4):335-42. doi: 10.1097/00007632-198207000-00003.
PMID: 7135066
citation: Vedantam R, Lenke LG, Keeney JA, Bridwell KH. Comparison of standing sagittal spinal alignment in asymptomatic adolescents and adults. Spine (Phila Pa 1976). 1998 Jan 15;23(2):211-5. doi: 10.1097/00007632-199801150-00012.
PMID: 9474728
responsible party type: Sponsor
mesh term: Asymptomatic Diseases
sharing ipd: No