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/NCT05982327</url>
    </required_header>
    <id_info>
      <org_study_id>Scapular fractures</org_study_id>
      <nct_id>NCT05982327</nct_id>
    </id_info>
    <brief_title>Operative Management of Scapular Fractures</brief_title>
    <official_title>Assessment of Operative Management of Scapular Fractures in Level 1 Trauma Center</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>
        Assessment of functional outcome of operative management of scapular fractures through Arabic&#xD;
        version DASH score&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Scapular fractures are rare, accounting less than1% all fractures. 3-5%all fractures of&#xD;
        shoulder girdle, however very serious because 80-90% due to high energy trauma such as Motor&#xD;
        car accidents or Fall from height. It can be associated with life-threatening injuries such&#xD;
        as thoraco-scapular dissociation and vascular injury as subclavian and axillary vessels and&#xD;
        brachial plexus injuries.So morbidity and mortality reports are relatively high.It can be&#xD;
        diagnosed by X ray and computed tomography scan (CT scan) that play important role to&#xD;
        discover scapular fractures and associated injuries ,and to guide clinical decision such as&#xD;
        approaches and other surgical interventions.Most of scapular fractures are managed&#xD;
        conservatively by Immbolization in sling .literature stated that conservative management of&#xD;
        scapular body fractures and scapular neck fractures displaced less than 10 mm have&#xD;
        satisfactory outcome and operative management suitable for displaced glenoid fossa fractures&#xD;
        and scapular neck fractures more than 10 mm and associated with better functional&#xD;
        outcome.Others stated that conservative management with highly displaced scapular body and&#xD;
        neck fractures are associated with satisfactory long -term functional outcome with minor loss&#xD;
        of motion and strength.&#xD;
  &#xD;
        So standard treatment of scapular fracture is still controversial and there is no clear&#xD;
        guidelines about management of scapular fractures.&#xD;
  &#xD;
        In Investigators hypothesis, Operative management of scapular fractures is better choice due&#xD;
        to better functional outcome, early rehabilitation ,high union rate and less complications.&#xD;
        Investigators will try to answer this question ''What is the effect of operative management&#xD;
        of scapular fractures on functional outcome?''&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of functional outcome</measure>
      <time_frame>6 week</time_frame>
      <description>Arabic version DASH score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>Six months</time_frame>
      <description>Goniometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Strength of shoulder muscle</measure>
      <time_frame>Six months</time_frame>
      <description>Handheld dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Union rate</measure>
      <time_frame>Six months</time_frame>
      <description>X ray-CT</description>
    </secondary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Scapular Fracture</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ORIF</intervention_name>
      <description>fixation of scapular fractures by plate and screws</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any patients who meets the inclusion criteria and agrees to be involved in our study will&#xD;
          do:&#xD;
  &#xD;
            1. Preoperative assessment:&#xD;
  &#xD;
                 1. Examination : Neurological and Vascular examination&#xD;
  &#xD;
                 2. Imaging:&#xD;
  &#xD;
                      -  Plain X- ray (True AP - Scapula Y view ) and Plain X-ray (True AP )of&#xD;
                         contralateral side Measurement of Glenopolar angle (GPA)&#xD;
  &#xD;
                      -  CT scan&#xD;
  &#xD;
            2. Intra-operative assessment:&#xD;
  &#xD;
               a. Selection of approach. b.Postion C.Type of osteosynthesis d. Blood loss e.&#xD;
               Radiation exposure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1.All patient presented with scapular fractures more than 18 years old involving body,&#xD;
               neck and glenoid 2.Intraarticular glenoid fractures with step-off &gt;4 mm 3.&gt;20% of the&#xD;
               joint is involved and Fragment large enough to be hold by lag screw.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1- Low demanded patients:Age &gt;65 yrs . 2.Scapular fractures of acromion and coracoid&#xD;
          process and Osteoporotic fractures .&#xD;
  &#xD;
          3.Scapular fractures associated with brain injuries cervical spine injuries and brachial&#xD;
          plexus injuries.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ahmed Elbadry Mahmoud, Resident</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Aly Mohamadean, Prof Dr</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mahmoud Badran, Ass.prof</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed Elbadry Mahmoud, Resident</last_name>
      <phone>+201551176565</phone>
      <email>ahmedelbadry@med.aun.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mahmoud Badran, Ass prof</last_name>
      <phone>+201000341878</phone>
      <email>mahmoud.badran@aun.edu.eg</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Ideberg R, Grevsten S, Larsson S. Epidemiology of scapular fractures. Incidence and classification of 338 fractures. Acta Orthop Scand. 1995 Oct;66(5):395-7. doi: 10.3109/17453679508995571.</citation>
      <PMID>7484114</PMID>
    </results_reference>
    <results_reference>
      <citation>Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:903850. doi: 10.1155/2012/903850. Epub 2012 Nov 20.</citation>
      <PMID>23209916</PMID>
    </results_reference>
    <results_reference>
      <citation>McGahan JP, Rab GT, Dublin A. Fractures of the scapula. J Trauma. 1980 Oct;20(10):880-3. doi: 10.1097/00005373-198010000-00011.</citation>
      <PMID>6252325</PMID>
    </results_reference>
    <results_reference>
      <citation>Zelle BA, Pape HC, Gerich TG, Garapati R, Ceylan B, Krettek C. Functional outcome following scapulothoracic dissociation. J Bone Joint Surg Am. 2004 Jan;86(1):2-8. doi: 10.2106/00004623-200401000-00002.</citation>
      <PMID>14711938</PMID>
    </results_reference>
    <results_reference>
      <citation>Brown CV, Velmahos G, Wang D, Kennedy S, Demetriades D, Rhee P. Association of scapular fractures and blunt thoracic aortic injury: fact or fiction? Am Surg. 2005 Jan;71(1):54-7.</citation>
      <PMID>15757058</PMID>
    </results_reference>
    <results_reference>
      <citation>Lantry JM, Roberts CS, Giannoudis PV. Operative treatment of scapular fractures: a systematic review. Injury. 2008 Mar;39(3):271-83. doi: 10.1016/j.injury.2007.06.018. Epub 2007 Oct 4.</citation>
      <PMID>17919636</PMID>
    </results_reference>
    <results_reference>
      <citation>Kannan S, Singh HP, Pandey R. A systematic review of management of scapular fractures. Acta Orthop Belg. 2018 Dec;84(4):497-508.</citation>
      <PMID>30879456</PMID>
    </results_reference>
    <results_reference>
      <citation>Mayo KA, Benirschke SK, Mast JW. Displaced fractures of the glenoid fossa. Results of open reduction and internal fixation. Clin Orthop Relat Res. 1998 Feb;(347):122-30.</citation>
      <PMID>9520882</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Ahmed Elbadry Mahmoud Ahmed</investigator_full_name>
      <investigator_title>Assuit lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</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/NCT05982327
  org study id: Scapular fractures
  nct id: NCT05982327
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Assessment of functional outcome of operative management of scapular fractures through Arabic
        version DASH score
  Scapular fractures are rare, accounting less than1% all fractures. 3-5%all fractures of
        shoulder girdle, however very serious because 80-90% due to high energy trauma such as Motor
        car accidents or Fall from height. It can be associated with life-threatening injuries such
        as thoraco-scapular dissociation and vascular injury as subclavian and axillary vessels and
        brachial plexus injuries.So morbidity and mortality reports are relatively high.It can be
        diagnosed by X ray and computed tomography scan (CT scan) that play important role to
        discover scapular fractures and associated injuries ,and to guide clinical decision such as
        approaches and other surgical interventions.Most of scapular fractures are managed
        conservatively by Immbolization in sling .literature stated that conservative management of
        scapular body fractures and scapular neck fractures displaced less than 10 mm have
        satisfactory outcome and operative management suitable for displaced glenoid fossa fractures
        and scapular neck fractures more than 10 mm and associated with better functional
        outcome.Others stated that conservative management with highly displaced scapular body and
        neck fractures are associated with satisfactory long -term functional outcome with minor loss
        of motion and strength.
  
        So standard treatment of scapular fracture is still controversial and there is no clear
        guidelines about management of scapular fractures.
  
        In Investigators hypothesis, Operative management of scapular fractures is better choice due
        to better functional outcome, early rehabilitation ,high union rate and less complications.
        Investigators will try to answer this question ''What is the effect of operative management
        of scapular fractures on functional outcome?''
  observational model: Case-Only
  time perspective: Prospective
  measure: Assessment of functional outcome
  time frame: 6 week
  description: Arabic version DASH score
  measure: Range of motion
  time frame: Six months
  description: Goniometer
  measure: Strength of shoulder muscle
  time frame: Six months
  description: Handheld dynamometer
  measure: Union rate
  time frame: Six months
  description: X ray-CT
  intervention type: Procedure
  intervention name: ORIF
  description: fixation of scapular fractures by plate and screws
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Ahmed Elbadry Mahmoud, Resident
  role: Principal Investigator
  affiliation: Assiut University
  last name: Aly Mohamadean, Prof Dr
  role: Study Director
  affiliation: Assiut University
  last name: Mahmoud Badran, Ass.prof
  role: Study Director
  affiliation: Assiut University
  last name: Ahmed Elbadry Mahmoud, Resident
  phone: +201551176565
  email: ahmedelbadry@med.aun.edu.eg
  last name: Mahmoud Badran, Ass prof
  phone: +201000341878
  email: mahmoud.badran@aun.edu.eg
  citation: Ideberg R, Grevsten S, Larsson S. Epidemiology of scapular fractures. Incidence and classification of 338 fractures. Acta Orthop Scand. 1995 Oct;66(5):395-7. doi: 10.3109/17453679508995571.
  PMID: 7484114
  citation: Voleti PB, Namdari S, Mehta S. Fractures of the scapula. Adv Orthop. 2012;2012:903850. doi: 10.1155/2012/903850. Epub 2012 Nov 20.
  PMID: 23209916
  citation: McGahan JP, Rab GT, Dublin A. Fractures of the scapula. J Trauma. 1980 Oct;20(10):880-3. doi: 10.1097/00005373-198010000-00011.
  PMID: 6252325
  citation: Zelle BA, Pape HC, Gerich TG, Garapati R, Ceylan B, Krettek C. Functional outcome following scapulothoracic dissociation. J Bone Joint Surg Am. 2004 Jan;86(1):2-8. doi: 10.2106/00004623-200401000-00002.
  PMID: 14711938
  citation: Brown CV, Velmahos G, Wang D, Kennedy S, Demetriades D, Rhee P. Association of scapular fractures and blunt thoracic aortic injury: fact or fiction? Am Surg. 2005 Jan;71(1):54-7.
  PMID: 15757058
  citation: Lantry JM, Roberts CS, Giannoudis PV. Operative treatment of scapular fractures: a systematic review. Injury. 2008 Mar;39(3):271-83. doi: 10.1016/j.injury.2007.06.018. Epub 2007 Oct 4.
  PMID: 17919636
  citation: Kannan S, Singh HP, Pandey R. A systematic review of management of scapular fractures. Acta Orthop Belg. 2018 Dec;84(4):497-508.
  PMID: 30879456
  citation: Mayo KA, Benirschke SK, Mast JW. Displaced fractures of the glenoid fossa. Results of open reduction and internal fixation. Clin Orthop Relat Res. 1998 Feb;(347):122-30.
  PMID: 9520882
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Ahmed Elbadry Mahmoud Ahmed
  investigator title: Assuit lecturer
  mesh term: Fractures, Bone
  sharing ipd: No