xml: <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/NCT05995795</url>
    </required_header>
    <id_info>
      <org_study_id>Arthroscopy in OBBP</org_study_id>
      <nct_id>NCT05995795</nct_id>
    </id_info>
    <brief_title>Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy</brief_title>
    <official_title>Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous&#xD;
        arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy&#xD;
        without any further intervention as tendon transfer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the&#xD;
        brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical&#xD;
        roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the&#xD;
        shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a&#xD;
        remaining imbalance causing severe functional impairment . In addition to diminished&#xD;
        function, prolonged muscle contractures result in bony deformities in both the glenoid and&#xD;
        proximal humerus. Internal rotation contractures due to external rotational weakness are the&#xD;
        most common deformity in OBPP. Contracture release, tendon transfers, and rotational&#xD;
        osteotomies are surgical methods used, depending on the level of deformity and the patient's&#xD;
        age. To achieve functional external rotation of the arm, contracted structures should be&#xD;
        released first. Currently, there is a lack of consensus on which procedures over the best&#xD;
        outcome for mobility and function, and what are the precise indications for each type of&#xD;
        surgery. There is also a large variation of practice between centers&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Number of participants with failure of initial intervention</measure>
      <time_frame>1 year</time_frame>
      <description>change of improvement of passive and active external rotation of operated shoulder using mallet score</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Arthroscopy</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ARTHROSCOY</intervention_name>
      <description>arthroscopy</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          children with brachial plexus injury operated or not with internal rotation contracture&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  children from 1 year to 15years of age.&#xD;
  &#xD;
            -  all genders&#xD;
  &#xD;
            -  patients with brachial plexus injury operated or not with internal rotation&#xD;
               contracture&#xD;
  &#xD;
            -  patient with traumatic brachial plexus injury have residual internal rotation&#xD;
               contracture&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of septic shoulder&#xD;
  &#xD;
            -  Flail anaethetic limb&#xD;
  &#xD;
            -  glenohumeral posterior sublaxation or dislocation in CT&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Koteb, phD</last_name>
      <role>Study Chair</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>MOHAMED HAMED, MASTER</last_name>
      <phone>01146962067</phone>
      <email>dr.mohamedelhamed@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.</citation>
      <PMID>20141905</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mohamed Hamed Mohamed</investigator_full_name>
      <investigator_title>DR.mohamed hamed</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Contracture</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995795
  org study id: Arthroscopy in OBBP
  nct id: NCT05995795
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous
        arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy
        without any further intervention as tendon transfer.
  Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the
        brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical
        roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the
        shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a
        remaining imbalance causing severe functional impairment . In addition to diminished
        function, prolonged muscle contractures result in bony deformities in both the glenoid and
        proximal humerus. Internal rotation contractures due to external rotational weakness are the
        most common deformity in OBPP. Contracture release, tendon transfers, and rotational
        osteotomies are surgical methods used, depending on the level of deformity and the patient's
        age. To achieve functional external rotation of the arm, contracted structures should be
        released first. Currently, there is a lack of consensus on which procedures over the best
        outcome for mobility and function, and what are the precise indications for each type of
        surgery. There is also a large variation of practice between centers
  observational model: Cohort
  time perspective: Prospective
  measure: Number of participants with failure of initial intervention
  time frame: 1 year
  description: change of improvement of passive and active external rotation of operated shoulder using mallet score
  intervention type: Device
  intervention name: ARTHROSCOY
  description: arthroscopy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 15 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohamed Koteb, phD
  role: Study Chair
  affiliation: Assiut University
  last name: MOHAMED HAMED, MASTER
  phone: 01146962067
  email: dr.mohamedelhamed@gmail.com
  citation: Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.
  PMID: 20141905
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mohamed Hamed Mohamed
  investigator title: DR.mohamed hamed
  mesh term: Contracture
  sharing ipd: No