<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/NCT03823755</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC18.0214</org_study_id>
    <nct_id>NCT03823755</nct_id>
  </id_info>
  <brief_title>Evaluation of the Mobility of the Digital Flexor Tendons</brief_title>
  <acronym>DynamicMRI</acronym>
  <official_title>Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      To study flexor tendon excursion in the hand after surgery by dynamic MRI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study of the movement of the digital flexor tendon operated on MRI could lead to a better&#xD;
      understanding of the biomechanics of this tendon after surgery, to objectively assess the&#xD;
      repair of the tendon and the recovery of its mobility. The visualization of the aspect and&#xD;
      the movement of this operated tendon would make it possible to adapt the rehabilitation for&#xD;
      each patient and to prevent the occurrence of complications which limit functional recovery&#xD;
      and source of handicap.&#xD;
&#xD;
      The analysis of the imaging in patients evolving would establish useful criteria the surgeon&#xD;
      to judge the evolution of the operated tendon.&#xD;
&#xD;
      The first step consists in evaluating the feasibility of the acquisition of dynamic sequences&#xD;
      in MRI and the possibility of observing the movement of the flexor tendon operated during the&#xD;
      mobilization of the finger, and comparing the biomechanical data obtained with those of the&#xD;
      nonoperated tendons and experimental models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2019</start_date>
  <completion_date type="Actual">December 8, 2020</completion_date>
  <primary_completion_date type="Actual">December 8, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Flexor tendon excursion</measure>
    <time_frame>1 year</time_frame>
    <description>Imaging of flexor tendon excursion in the hand after surgery during motion with MRI</description>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Flexor Digitorum Longus on the Right</condition>
  <condition>Flexor Digitorum Longus on the Left</condition>
  <condition>Tendon Rupture</condition>
  <condition>Tendon Injury - Hand</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient with flexor tendon injury in zone 2 and insufficient functional after surgery&#xD;
        with MRI requested for exploration&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  flexor tendon injury in zone 2&#xD;
&#xD;
          -  treatment by surgery&#xD;
&#xD;
          -  insufficient functional outcome after surgery&#xD;
&#xD;
          -  MRI requested by surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  MRI contraindications&#xD;
&#xD;
          -  previous surgery on the hand&#xD;
&#xD;
          -  rheumatic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Keraudren</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HIA</name>
      <address>
        <city>Brest</city>
        <zip>29240</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Tendon Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available after the publication of result and ending three years maximum following the last visit of the last patient</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement</ipd_access_criteria>
  </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/NCT03823755
org study id: 29BRC18.0214
nct id: NCT03823755
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study flexor tendon excursion in the hand after surgery by dynamic MRI
The study of the movement of the digital flexor tendon operated on MRI could lead to a better
      understanding of the biomechanics of this tendon after surgery, to objectively assess the
      repair of the tendon and the recovery of its mobility. The visualization of the aspect and
      the movement of this operated tendon would make it possible to adapt the rehabilitation for
      each patient and to prevent the occurrence of complications which limit functional recovery
      and source of handicap.

      The analysis of the imaging in patients evolving would establish useful criteria the surgeon
      to judge the evolution of the operated tendon.

      The first step consists in evaluating the feasibility of the acquisition of dynamic sequences
      in MRI and the possibility of observing the movement of the flexor tendon operated during the
      mobilization of the finger, and comparing the biomechanical data obtained with those of the
      nonoperated tendons and experimental models.
observational model: Cohort
time perspective: Prospective
measure: Flexor tendon excursion
time frame: 1 year
description: Imaging of flexor tendon excursion in the hand after surgery during motion with MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Rupture
mesh term: Tendon Injuries
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement