<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/NCT02212600</url>
  </required_header>
  <id_info>
    <org_study_id>DECIPHER</org_study_id>
    <nct_id>NCT02212600</nct_id>
  </id_info>
  <brief_title>Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures</brief_title>
  <official_title>The DECIPHER Study: Determinants of Function and Clinically Important Outcomes in Proximal Humerus Fractures in the Elder Population: A National Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>London Health Sciences Centre</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>
      The proposed project will be a multi-centre, prospective observational study to determine the&#xD;
      prognosis and determinants of functional outcomes of patients with proximal humerus&#xD;
      fractures. Approximately 10 centres will participate in this observational cohort, each&#xD;
      enrolling at least 50 patients over the course of 2 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Disabilities of the Arm, Shoulder, and Hand (DASH)</measure>
    <time_frame>2 years</time_frame>
    <description>The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complications</measure>
    <time_frame>2 years</time_frame>
    <description>Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Humeral Fractures, Proximal</condition>
  <arm_group>
    <arm_group_label>Population</arm_group_label>
    <description>We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>observational cohort of proximal humerus fractures</description>
    <arm_group_label>Population</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will include male and female patients who are over 50 years of age and who have an&#xD;
        acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma and&#xD;
        who provide written informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        males and females age 50 years or older (no uper age limit) presenting with an acute&#xD;
        displaced or undisplaced proximal humerus fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        pathologic fractures patients likely to be lost before completing follow-up patients who do&#xD;
        not provide consent patients who do not speak English and who do not have a translator that&#xD;
        will be available during consent discussion and at each follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emil Schemitsch, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Scieneces Centre and St. Michael's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melanie MacNevin</last_name>
    <phone>602-284-8105</phone>
    <email>melanie.macnevin@lhsc.on.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melanie MacNevin</last_name>
      <phone>602-284-8105</phone>
      <email>mealnie.macnevin@lhsc.on.ca</email>
    </contact>
    <investigator>
      <last_name>Emil Schemitsch, MD. FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Sanders, MD, FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abdel Lawendy, MD, FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 1R6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Milena Vicente</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>2608</phone_ext>
      <email>milena.vicente@unityhealth.to</email>
    </contact>
    <investigator>
      <last_name>Jeremy Hall, MD, FRCSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aaron Nauth, MD, FRCSC</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>London Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Emil Schemitsch</investigator_full_name>
    <investigator_title>MD, FRCSC</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/NCT02212600
org study id: DECIPHER
nct id: NCT02212600
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed project will be a multi-centre, prospective observational study to determine the
      prognosis and determinants of functional outcomes of patients with proximal humerus
      fractures. Approximately 10 centres will participate in this observational cohort, each
      enrolling at least 50 patients over the course of 2 years.
observational model: Cohort
time perspective: Prospective
measure: Disabilities of the Arm, Shoulder, and Hand (DASH)
time frame: 2 years
description: The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb.
measure: Rate of complications
time frame: 2 years
description: Clinical outcomes will include range of motion measurements, standardized radiographic evaluation, assessment of complications, rate of re-operation, infections, osteonecrosis.
arm group label: Population
description: We will include male and female patients who are over 50 years of age and who have an acute, displaced or undisplaced proximal humerus fracture caused by low energy trauma
intervention type: Other
intervention name: Observational
description: observational cohort of proximal humerus fractures
arm group label: Population
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Emil Schemitsch, MD, FRCSC
role: Principal Investigator
affiliation: London Health Scieneces Centre and St. Michael's Hospital
last name: Melanie MacNevin
phone: 602-284-8105
email: melanie.macnevin@lhsc.on.ca
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: London Health Sciences Centre
investigator full name: Emil Schemitsch
investigator title: MD, FRCSC
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Shoulder Fractures