<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/NCT03771144</url>
  </required_header>
  <id_info>
    <org_study_id>UF7640</org_study_id>
    <nct_id>NCT03771144</nct_id>
  </id_info>
  <brief_title>Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis</brief_title>
  <acronym>POPB</acronym>
  <official_title>Anatomopathology of the Subscapularis and Infraspinatus Muscles in Children With Brachial Plexus Obstetric Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PhyMedExp Inserm U1046</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      POPB is a consequence of the stretching of the nerve roots (C5, C6 + / C7, C8 or T1) of the&#xD;
      brachial plexus at birth. One third of patients will have sequelae. The most common is the&#xD;
      appearance of a deficit of passive and active mobilities in the movements in external&#xD;
      rotation of the shoulder especially in external rotation (RE) elbow to the body, despite&#xD;
      daily rehabilitation. At present, this stiffness is attributed to an imbalance between the&#xD;
      external rotator muscles (mainly infraspinatus) that would be atrophied and the internal&#xD;
      rotator muscles (subscapularis, pectoralis major, latissimus dorsi) that would be slightly&#xD;
      affected In case of no or negative RE from the age of 1 year, there is a surgical indication&#xD;
      to operate these children. At present, surgery to lift internal retractions is the only&#xD;
      therapy used, but despite this surgery and intensive rehabilitation, in some patients&#xD;
      mobility deficits re-occur in a few years. Thus, some teams systematically perform a muscle&#xD;
      transfer to strengthen the outer rotator muscles deficit during the initial operation. Other&#xD;
      teams (of which principal investigator is part) do this transfer only secondarily and in some&#xD;
      patients. Investigators lack objective and scientific criteria for the indication of this&#xD;
      second muscle transfer surgery and the etiology of retractions is not clearly defined.&#xD;
&#xD;
      In humans, subscapularis is innervated by the C5 and C6 roots, which are constantly affected&#xD;
      in POPB. It can be assumed that subscapularis may have an atrophy in POPB patients. To date,&#xD;
      no anatomopathological study has been performed on the internal / external rotator muscles of&#xD;
      patients with POPB that can give indications on recurrences.&#xD;
&#xD;
      Based on our clinical observations and literature data, the main hypothese is there is&#xD;
      amyotrophy of subscapularis and / or infraspinatus in POPB patients with shoulder stiffness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator's decision&#xD;
  </why_stopped>
  <start_date type="Actual">June 11, 2019</start_date>
  <completion_date type="Actual">June 23, 2020</completion_date>
  <primary_completion_date type="Actual">June 23, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quantity of fibrosis on tissue muscle</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>quantity of satellit cells (Pax7, MyoD,Actine) on the muscle detected by PCR</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Brachial Obstetrical Palsy</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthrolysis</intervention_name>
    <description>Surgery is performed under general anesthesia. The usual duration of this surgery is on average 1h30. This surgery requires an anterior approach and a posterior approach. The patient is placed in lateral decubitus. The arthroscope of 2.7 is introduced by a posterior route. An anterior instrumental track is made from inside out through the rotator interval.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child with POPB presenting a stiffness in external shoulder rotation after the age of&#xD;
             1 year with a surgical indication of anterior release of shoulder is asked&#xD;
&#xD;
          -  Obligation to obtain written informed consent from parents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with another neuromuscular pathology&#xD;
&#xD;
          -  Significant traumatic history of the upper limb (fracture or surgical intervention) or&#xD;
             any other pathology affecting the mobility of the joints of the upper limb (either on&#xD;
             the pathological side or on the healthy side)&#xD;
&#xD;
          -  Patient with a contraindication to surgery (precarious general condition, major&#xD;
             coagulation disorders, anesthetic contraindication)&#xD;
&#xD;
          -  Child over 10 years old&#xD;
&#xD;
          -  Refusal of the patient or family&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brachial obstetrical palsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Paralysis, Obstetric</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/NCT03771144
org study id: UF7640
nct id: NCT03771144
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
POPB is a consequence of the stretching of the nerve roots (C5, C6 + / C7, C8 or T1) of the
      brachial plexus at birth. One third of patients will have sequelae. The most common is the
      appearance of a deficit of passive and active mobilities in the movements in external
      rotation of the shoulder especially in external rotation (RE) elbow to the body, despite
      daily rehabilitation. At present, this stiffness is attributed to an imbalance between the
      external rotator muscles (mainly infraspinatus) that would be atrophied and the internal
      rotator muscles (subscapularis, pectoralis major, latissimus dorsi) that would be slightly
      affected In case of no or negative RE from the age of 1 year, there is a surgical indication
      to operate these children. At present, surgery to lift internal retractions is the only
      therapy used, but despite this surgery and intensive rehabilitation, in some patients
      mobility deficits re-occur in a few years. Thus, some teams systematically perform a muscle
      transfer to strengthen the outer rotator muscles deficit during the initial operation. Other
      teams (of which principal investigator is part) do this transfer only secondarily and in some
      patients. Investigators lack objective and scientific criteria for the indication of this
      second muscle transfer surgery and the etiology of retractions is not clearly defined.

      In humans, subscapularis is innervated by the C5 and C6 roots, which are constantly affected
      in POPB. It can be assumed that subscapularis may have an atrophy in POPB patients. To date,
      no anatomopathological study has been performed on the internal / external rotator muscles of
      patients with POPB that can give indications on recurrences.

      Based on our clinical observations and literature data, the main hypothese is there is
      amyotrophy of subscapularis and / or infraspinatus in POPB patients with shoulder stiffness.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: quantity of fibrosis on tissue muscle
time frame: 1 day
measure: quantity of satellit cells (Pax7, MyoD,Actine) on the muscle detected by PCR
time frame: 1 day
arm group label: Experimental
arm group type: Experimental
intervention type: Procedure
intervention name: arthrolysis
description: Surgery is performed under general anesthesia. The usual duration of this surgery is on average 1h30. This surgery requires an anterior approach and a posterior approach. The patient is placed in lateral decubitus. The arthroscope of 2.7 is introduced by a posterior route. An anterior instrumental track is made from inside out through the rotator interval.
arm group label: Experimental
criteria: 
gender: All
minimum age: 12 Months
maximum age: 11 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Paralysis
mesh term: Paralysis, Obstetric
sharing ipd: No