<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/NCT03023956</url>
  </required_header>
  <id_info>
    <org_study_id>ZhouXuANFSNF</org_study_id>
    <nct_id>NCT03023956</nct_id>
  </id_info>
  <brief_title>Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiaoxiao Zhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhoupu Hospital, Pudong New Area, Shanghai, China</source>
  <brief_summary>
    <textblock>
      From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were&#xD;
      treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck&#xD;
      fractures (SNF), we divided the patients into two groups. All the patients were followed at&#xD;
      least 1 year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">January 3, 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change of head-shaft angle at 12months from 6months in two groups</measure>
    <time_frame>12months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of Offset at 12months from 6months in two groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant-Murly scores at 3 months, 12 months and last follow-up</measure>
    <time_frame>3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Humeral Fracture, Proximal</condition>
  <condition>Internal Fixation; Complications, Mechanical, Bones of Limb</condition>
  <arm_group>
    <arm_group_label>ANF</arm_group_label>
    <description>anatomic neck fractures of proximal humerus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SNF</arm_group_label>
    <description>surgical neck fractures of proximal humerus</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Locking plates were used for proximal humeral fractures.</intervention_name>
    <arm_group_label>ANF</arm_group_label>
    <arm_group_label>SNF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        From May ,2013 to April 2015, patients with fractures of the proximal humerus who were&#xD;
        treated with locking plate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -From May ,2013 to April 2015, patients with fractures of the proximal humerus who were&#xD;
        treated with locking plate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients had pathologic fractures,&#xD;
&#xD;
          -  Patients had previous surgery on the affected shoulder,&#xD;
&#xD;
          -  Patients were treated with shoulder arthroplasty.&#xD;
&#xD;
          -  Patients were treated with intramedullary nail.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 22, 2017</last_update_submitted>
  <last_update_submitted_qc>January 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhoupu Hospital, Pudong New Area, Shanghai, China</investigator_affiliation>
    <investigator_full_name>Xiaoxiao Zhou</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Humeral Fractures</mesh_term>
    <mesh_term>Shoulder Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT03023956
org study id: ZhouXuANFSNF
nct id: NCT03023956
lead sponsor: 
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were
      treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck
      fractures (SNF), we divided the patients into two groups. All the patients were followed at
      least 1 year.
observational model: Cohort
time perspective: Retrospective
measure: change of head-shaft angle at 12months from 6months in two groups
time frame: 12months
measure: change of Offset at 12months from 6months in two groups
time frame: 12 months
measure: Constant-Murly scores at 3 months, 12 months and last follow-up
time frame: 3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months )
measure: change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups
time frame: 12 months
arm group label: ANF
description: anatomic neck fractures of proximal humerus
arm group label: SNF
description: surgical neck fractures of proximal humerus
intervention type: Procedure
intervention name: Locking plates were used for proximal humeral fractures.
arm group label: ANF
arm group label: SNF
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Zhoupu Hospital, Pudong New Area, Shanghai, China
investigator full name: Xiaoxiao Zhou
investigator title: Professor
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Shoulder Fractures