<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/NCT03835000</url>
  </required_header>
  <id_info>
    <org_study_id>CNIL 2168319 v 0</org_study_id>
    <nct_id>NCT03835000</nct_id>
  </id_info>
  <brief_title>Customized Biomechanical Models of the Musculoskeletal System Before and After Surgery</brief_title>
  <acronym>ORTHOSIMV1</acronym>
  <official_title>Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation pour la Recherche Médicale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Garches</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TIMC-IMAG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</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>
      The objective of this study is to design a library of biomechanical musculoskeletal models of&#xD;
      patients before and after surgery. These models will be evaluated to analyze the support they&#xD;
      can provide for virtual surgical planning in orthopedics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While there are multiple surgical options for the treatment of a specific orthopaedic&#xD;
      pathology, the patient is most often operated on according to the preferred method used&#xD;
      within a team and not necessarily according to the method that would optimize the functional&#xD;
      result. In addition, the variability of morphologies means that some patients, due to their&#xD;
      anatomical characteristics, cannot benefit from an intervention that is necessary&#xD;
      (incorrectly sized implant, unsuitable equipment). As the orthopaedic surgical procedure is&#xD;
      definitive, the investigators believe that it may be useful to perform surgical simulations&#xD;
      on a digital clone before performing on the real patient. This would be relevant for the&#xD;
      patient, the caregiver, but also the community, as many surgical reopenings or treatment&#xD;
      failures can be attributed to the difficulty of properly planning surgery for a functional&#xD;
      objective in the long term.&#xD;
&#xD;
      This is a Retrospective study based on patient's record and medical imaging files.&#xD;
&#xD;
      50 patients For 3D medical imaging, the data will be obtained from the examinations performed&#xD;
      by the patient before and after his surgery, they will be anonymized. The investigators will&#xD;
      use the so-called &quot;DICOM&quot; sequences allowing the reconstruction of 3D models The personal&#xD;
      data collected will be taken from the Surgical Report and the pre-surgical check-up (age,&#xD;
      sex, height, weight) The patient identifier will be assigned for each subject with the centre&#xD;
      number, initials (Surname / First name of the patient) and its inclusion number per centre.&#xD;
&#xD;
      Personal data will be obtained from the department's computerized or paper patient file&#xD;
      Medical imaging data will be anonymized by the medical imaging department staff who will be&#xD;
      assigned the patient identifier.&#xD;
&#xD;
      The database will be centralized and hosted on a laboratory computer on an encrypted and&#xD;
      password-protected session.&#xD;
&#xD;
      The usable patient records will be recruited according to the database of surgical procedures&#xD;
      performed in the various departments. If the file meets the inclusion and non-inclusion&#xD;
      criteria, patients will then be contacted (telephone) to discuss their participation in the&#xD;
      study, and verbally obtain their non-opposition.&#xD;
&#xD;
      Patients will be informed in a complete and fair manner, in understandable terms, of the&#xD;
      objectives of the study, their right to refuse to participate in the study or the possibility&#xD;
      of withdrawing at any time. All this information will be included on an information form&#xD;
      given to the patient by email or post.&#xD;
&#xD;
      Once the authorization has been obtained, the data will be anonymized and downloaded to an&#xD;
      encrypted hard disk for processing for model reconstruction.&#xD;
&#xD;
      Clinical data will be retrieved from the operative report and the pre-surgical file and then&#xD;
      integrated into the database.&#xD;
&#xD;
      The models resulting from this procedure will bear the name of the surgical procedure&#xD;
      associated with a patient identification number.&#xD;
&#xD;
      Morphological comparison of individual bone structures and the outer envelope including&#xD;
      internal soft tissues (measurement of distances and volumes) Comparison of radiological&#xD;
      parameters used in routine pre-surgery routine (measurement of angles, segment lengths,&#xD;
      tissue thickness) Between February 2019 and June 2021, the three surgical teams will search&#xD;
      for patients who have benefited from the surgeries and who meet the inclusion criteria.&#xD;
&#xD;
      The distribution will be as follows:&#xD;
&#xD;
      Grenoble University Hospital (12 cases):&#xD;
&#xD;
        -  5 patients Knee&#xD;
&#xD;
        -  5 patients Rachis&#xD;
&#xD;
        -  2 patients Hip&#xD;
&#xD;
      Raymond Poincaré University Hospital (19 cases):&#xD;
&#xD;
      2 patients for tendon transfer procedures&#xD;
&#xD;
        -  1 patient for muscle stretching&#xD;
&#xD;
        -  2 patients for lower limb amputations&#xD;
&#xD;
        -  5 patients Rachis&#xD;
&#xD;
        -  6 patients Foot / Ankle&#xD;
&#xD;
        -  1 patient Shoulder&#xD;
&#xD;
        -  2 patients Elbow / Hand&#xD;
&#xD;
      Groupe Hospitalier Croix saint Simon (19 cases):&#xD;
&#xD;
        -  3 patients Knee&#xD;
&#xD;
        -  2 Patients Hip&#xD;
&#xD;
        -  9 patients Foot / Ankle&#xD;
&#xD;
        -  2 patients Shoulder&#xD;
&#xD;
        -  3 patients Elbow / Hand&#xD;
&#xD;
      From April 2019, the models will begin to be developed by the TIMC IMAG laboratory team.&#xD;
&#xD;
      Once the biomechanical models are developed, the investigators will virtually apply the&#xD;
      surgery performed on the pre-surgical models. Then the investigators will compare the virtual&#xD;
      post surgery models with the post surgical models. A description of the limitations of the&#xD;
      virtual procedures will be established in order to analyze the scientific locks to be removed&#xD;
      and move towards biomechanical simulation-based surgical planning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 19, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bones volume assessment</measure>
    <time_frame>20 days</time_frame>
    <description>Comparison of volume of bone pieces in mm3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Soft tissue volume assessment</measure>
    <time_frame>20 days</time_frame>
    <description>Volume comparison of soft tissue envelope in mm3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative positions of bones</measure>
    <time_frame>10 days</time_frame>
    <description>Comparison of the relative positions of bones relative to each other in degrees</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomechanical response</measure>
    <time_frame>2 days</time_frame>
    <description>the convergence of the numerical simulation performed from the reconstructed model.&#xD;
measurement of the Stress in Nm-2 and the strains (Strain has no units because it is a ratio of lengths)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Joint Disease</condition>
  <condition>Joint Instability</condition>
  <condition>Osteoarthritis</condition>
  <condition>Bone Malalignment</condition>
  <arm_group>
    <arm_group_label>Pre operative patient</arm_group_label>
    <description>Patients who will require orthopedic surgery for corrective, replacement or repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Orthopedic surgery</intervention_name>
    <description>before and after surgery, patient will need medical imaging to asses their conditions</description>
    <arm_group_label>Pre operative patient</arm_group_label>
    <other_name>Medical imaging</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 20 to 65 years who require orthopaedic surgery as described in the literature&#xD;
        and for which 3D medical imaging will be performed before and after the surgical procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Men or women aged 20 to 65 years&#xD;
&#xD;
          -  Patients who have had orthopaedic surgery&#xD;
&#xD;
          -  Presence in the file of a preoperative CT scan and/or magnetic resonance imaging (MRI)&#xD;
&#xD;
          -  Presence in the file of a CT scan and/or MRI postoperatively at a distance from the&#xD;
             operation (at least 4 weeks)&#xD;
&#xD;
          -  Presence in the file of an operating report describing the procedure in detail with&#xD;
             access routes, operating times, type of equipment and possible complications.&#xD;
&#xD;
          -  Patient who has authorized the anonymous use of data from his pre and post surgical&#xD;
             examinations&#xD;
&#xD;
          -  Patient who is a member of a social security organisation&#xD;
&#xD;
        Criteria for non-inclusion:&#xD;
&#xD;
          -  Patient who has expressed his refusal to use his medical data&#xD;
&#xD;
          -  Minor, patient under guardianship, inability to receive information and express&#xD;
             consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Non-affiliation to a social security scheme (beneficiary or beneficiary)&#xD;
&#xD;
          -  Examinations of images that do not allow 3D reconstruction of structures (poor&#xD;
             resolution or type of sequence)&#xD;
&#xD;
          -  Incomplete operating report not allowing the understanding of the steps of the&#xD;
             surgery.&#xD;
&#xD;
          -  Surgical report describing surgery that does not represent the usual procedures&#xD;
             performed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Perrier Antoine, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CIC 1429</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Perrier Antoine, Dr</last_name>
    <phone>+33 (1)44 74 10 19</phone>
    <email>perrier.antoine@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Izedaren Fatima, CRA</last_name>
    <phone>+33 (1)47 10 44 49</phone>
    <email>fatima.izedaren@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laboratoire CNRS TIMC IMAG</name>
      <address>
        <city>La Tronche</city>
        <state>Grenoble Alpes University - CNRS UMR</state>
        <zip>38706</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Perrier Antoine</last_name>
      <phone>+ 33 (0)144741019</phone>
      <email>perrier.antoine@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>virtual patient</keyword>
  <keyword>joint modeling</keyword>
  <keyword>biomechanical simulation</keyword>
  <keyword>surgery mechanical results</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Joint Instability</mesh_term>
    <mesh_term>Bone Malalignment</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/NCT03835000
org study id: CNIL 2168319 v 0
nct id: NCT03835000
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to design a library of biomechanical musculoskeletal models of
      patients before and after surgery. These models will be evaluated to analyze the support they
      can provide for virtual surgical planning in orthopedics.
While there are multiple surgical options for the treatment of a specific orthopaedic
      pathology, the patient is most often operated on according to the preferred method used
      within a team and not necessarily according to the method that would optimize the functional
      result. In addition, the variability of morphologies means that some patients, due to their
      anatomical characteristics, cannot benefit from an intervention that is necessary
      (incorrectly sized implant, unsuitable equipment). As the orthopaedic surgical procedure is
      definitive, the investigators believe that it may be useful to perform surgical simulations
      on a digital clone before performing on the real patient. This would be relevant for the
      patient, the caregiver, but also the community, as many surgical reopenings or treatment
      failures can be attributed to the difficulty of properly planning surgery for a functional
      objective in the long term.

      This is a Retrospective study based on patient's record and medical imaging files.

      50 patients For 3D medical imaging, the data will be obtained from the examinations performed
      by the patient before and after his surgery, they will be anonymized. The investigators will
      use the so-called "DICOM" sequences allowing the reconstruction of 3D models The personal
      data collected will be taken from the Surgical Report and the pre-surgical check-up (age,
      sex, height, weight) The patient identifier will be assigned for each subject with the centre
      number, initials (Surname / First name of the patient) and its inclusion number per centre.

      Personal data will be obtained from the department's computerized or paper patient file
      Medical imaging data will be anonymized by the medical imaging department staff who will be
      assigned the patient identifier.

      The database will be centralized and hosted on a laboratory computer on an encrypted and
      password-protected session.

      The usable patient records will be recruited according to the database of surgical procedures
      performed in the various departments. If the file meets the inclusion and non-inclusion
      criteria, patients will then be contacted (telephone) to discuss their participation in the
      study, and verbally obtain their non-opposition.

      Patients will be informed in a complete and fair manner, in understandable terms, of the
      objectives of the study, their right to refuse to participate in the study or the possibility
      of withdrawing at any time. All this information will be included on an information form
      given to the patient by email or post.

      Once the authorization has been obtained, the data will be anonymized and downloaded to an
      encrypted hard disk for processing for model reconstruction.

      Clinical data will be retrieved from the operative report and the pre-surgical file and then
      integrated into the database.

      The models resulting from this procedure will bear the name of the surgical procedure
      associated with a patient identification number.

      Morphological comparison of individual bone structures and the outer envelope including
      internal soft tissues (measurement of distances and volumes) Comparison of radiological
      parameters used in routine pre-surgery routine (measurement of angles, segment lengths,
      tissue thickness) Between February 2019 and June 2021, the three surgical teams will search
      for patients who have benefited from the surgeries and who meet the inclusion criteria.

      The distribution will be as follows:

      Grenoble University Hospital (12 cases):

        -  5 patients Knee

        -  5 patients Rachis

        -  2 patients Hip

      Raymond Poincaré University Hospital (19 cases):

      2 patients for tendon transfer procedures

        -  1 patient for muscle stretching

        -  2 patients for lower limb amputations

        -  5 patients Rachis

        -  6 patients Foot / Ankle

        -  1 patient Shoulder

        -  2 patients Elbow / Hand

      Groupe Hospitalier Croix saint Simon (19 cases):

        -  3 patients Knee

        -  2 Patients Hip

        -  9 patients Foot / Ankle

        -  2 patients Shoulder

        -  3 patients Elbow / Hand

      From April 2019, the models will begin to be developed by the TIMC IMAG laboratory team.

      Once the biomechanical models are developed, the investigators will virtually apply the
      surgery performed on the pre-surgical models. Then the investigators will compare the virtual
      post surgery models with the post surgical models. A description of the limitations of the
      virtual procedures will be established in order to analyze the scientific locks to be removed
      and move towards biomechanical simulation-based surgical planning.
observational model: Other
time perspective: Retrospective
measure: Bones volume assessment
time frame: 20 days
description: Comparison of volume of bone pieces in mm3
measure: Soft tissue volume assessment
time frame: 20 days
description: Volume comparison of soft tissue envelope in mm3
measure: Relative positions of bones
time frame: 10 days
description: Comparison of the relative positions of bones relative to each other in degrees
measure: Biomechanical response
time frame: 2 days
description: the convergence of the numerical simulation performed from the reconstructed model.
measurement of the Stress in Nm-2 and the strains (Strain has no units because it is a ratio of lengths)
arm group label: Pre operative patient
description: Patients who will require orthopedic surgery for corrective, replacement or repair
intervention type: Procedure
intervention name: Orthopedic surgery
description: before and after surgery, patient will need medical imaging to asses their conditions
arm group label: Pre operative patient
other name: Medical imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
last name: Perrier Antoine, Dr
role: Principal Investigator
affiliation: CIC 1429
last name: Perrier Antoine, Dr
phone: +33 (1)44 74 10 19
email: perrier.antoine@gmail.com
last name: Izedaren Fatima, CRA
phone: +33 (1)47 10 44 49
email: fatima.izedaren@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Joint Instability
mesh term: Bone Malalignment
sharing ipd: No