<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/NCT03251534</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC-1550</org_study_id>
    <nct_id>NCT03251534</nct_id>
  </id_info>
  <brief_title>Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.</brief_title>
  <acronym>FEOS</acronym>
  <official_title>Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Investigation Centre for Innovative Technology Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</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 observational study is a collection of clinical and imaging data of patients with a&#xD;
      femoral shaft fracture treated by nails. The aim of this research is the contribution of the&#xD;
      EOS imaging system in the quantification of malunions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is based on the collection of clinical and imaging data (using EOS imaging system)&#xD;
      necessary for the follow-up of patients who have benefited, most often in the emergency, of a&#xD;
      centromedullary nailing of the femoral shaft. The study does not lead to any further&#xD;
      examination for the patient since they are followed until the removal of the material, which&#xD;
      usually takes place 24 months after the fracture episode. This observational and pilot study&#xD;
      is monocentric, prospective on a continuous series of 40 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Quantitative evaluation of rotational disturbances</measure>
    <time_frame>24 months</time_frame>
    <description>Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of the rotation disorder with the clinical condition of the patient.</measure>
    <time_frame>24 months</time_frame>
    <description>Rotation disorder (angle in degree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).</measure>
    <time_frame>24 months</time_frame>
    <description>Shortening or lengthening of the entire operative limb and of the femur alone (measured in mm), recorded in a standardized and comparative way compared to the healthy side, by the EOS © software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of shortening or limb lengthening with the clinical condition of the patient.</measure>
    <time_frame>24 months</time_frame>
    <description>Shortening or lengthening of limb (measured in mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative evaluation of the varus-valgus (lateral-medial plane).</measure>
    <time_frame>24 months</time_frame>
    <description>Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the varus-valgus with the clinical condition of the patient</measure>
    <time_frame>24 months</time_frame>
    <description>Varus-valgus (angle in degree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative evaluation of the flessum-recurvatum</measure>
    <time_frame>24 months</time_frame>
    <description>Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the flessum-recurvatum with the clinical condition of the patient.</measure>
    <time_frame>24 months</time_frame>
    <description>Flessum-recurvatum (angle in degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures</measure>
    <time_frame>24 months</time_frame>
    <description>Rotational disturbance (angle in degree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.</measure>
    <time_frame>24 months</time_frame>
    <description>Shortening or limb lengthening (measured in mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures</measure>
    <time_frame>24 months</time_frame>
    <description>Varus-valgus (angle in degree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures</measure>
    <time_frame>24 months</time_frame>
    <description>Flessum-recurvatum (angle in degree).</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Femoral Shaft Fracture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Centromedullary nailing</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with surgery of femoral shaft fracture treated by nails&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged at least 16 years (parental agreement signed for minors) or adults at&#xD;
             the time of data collection&#xD;
&#xD;
          -  Patients with a femoral shaft fractures since january 2014&#xD;
&#xD;
          -  Patients with a post-nailing femoral shaft fracture&#xD;
&#xD;
          -  Patients with unilateral fracture&#xD;
&#xD;
          -  Patients with regional origin allowing a follow-up in Grenoble center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to sign a non-objective form&#xD;
&#xD;
          -  Patients with femoral shaft fracture untreted with nails&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tonetti Jerôme, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic and Trauma department, University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopedic and Trauma Department, University Hospital, Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.cic-it.fr/cic-it-grenoble.php</url>
    <description>Clinical Investigation Centre for Innovative Technology Network</description>
  </link>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eos imaging stereography</keyword>
  <keyword>Centromedullary nailing</keyword>
  <keyword>Quantification of malunions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</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/NCT03251534
org study id: DCIC-1550
nct id: NCT03251534
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study is a collection of clinical and imaging data of patients with a
      femoral shaft fracture treated by nails. The aim of this research is the contribution of the
      EOS imaging system in the quantification of malunions.
The study is based on the collection of clinical and imaging data (using EOS imaging system)
      necessary for the follow-up of patients who have benefited, most often in the emergency, of a
      centromedullary nailing of the femoral shaft. The study does not lead to any further
      examination for the patient since they are followed until the removal of the material, which
      usually takes place 24 months after the fracture episode. This observational and pilot study
      is monocentric, prospective on a continuous series of 40 patients.
observational model: Cohort
time perspective: Prospective
measure: Quantitative evaluation of rotational disturbances
time frame: 24 months
description: Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.
measure: Correlation of the rotation disorder with the clinical condition of the patient.
time frame: 24 months
description: Rotation disorder (angle in degree).
measure: Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).
time frame: 24 months
description: Shortening or lengthening of the entire operative limb and of the femur alone (measured in mm), recorded in a standardized and comparative way compared to the healthy side, by the EOS © software
measure: Correlation of shortening or limb lengthening with the clinical condition of the patient.
time frame: 24 months
description: Shortening or lengthening of limb (measured in mm).
measure: Quantitative evaluation of the varus-valgus (lateral-medial plane).
time frame: 24 months
description: Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.
measure: Correlation of the varus-valgus with the clinical condition of the patient
time frame: 24 months
description: Varus-valgus (angle in degree).
measure: Quantitative evaluation of the flessum-recurvatum
time frame: 24 months
description: Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.
measure: Correlation of the flessum-recurvatum with the clinical condition of the patient.
time frame: 24 months
description: Flessum-recurvatum (angle in degree)
measure: Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures
time frame: 24 months
description: Rotational disturbance (angle in degree)
measure: Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.
time frame: 24 months
description: Shortening or limb lengthening (measured in mm).
measure: Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures
time frame: 24 months
description: Varus-valgus (angle in degree).
measure: Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures
time frame: 24 months
description: Flessum-recurvatum (angle in degree).
intervention type: Procedure
intervention name: Centromedullary nailing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
last name: Tonetti Jerôme, MD, PhD
role: Principal Investigator
affiliation: Orthopedic and Trauma department, University Hospital, Grenoble
facility: 
country: France
url: http://www.cic-it.fr/cic-it-grenoble.php
description: Clinical Investigation Centre for Innovative Technology Network
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: No