<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/NCT03833414</url>
  </required_header>
  <id_info>
    <org_study_id>3799-Sur-ERC-15</org_study_id>
    <nct_id>NCT03833414</nct_id>
  </id_info>
  <brief_title>Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?</brief_title>
  <official_title>Surgical Approach for Distal Humerus Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</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>
      observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate&#xD;
      the difference between two common surgical approaches to distal humerus fracture fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fractures around the distal humerus fractures make up to 2% of all fractures. Complex&#xD;
      intra-articular distal humerus fractures present as challenge to restore of painless, stable&#xD;
      and mobile elbow joint. Surgical exposure to all critical structures is of paramount&#xD;
      importance to achieve anatomic reduction. Conflict still persists regarding the choice of&#xD;
      ideal approach between triceps-sparing approach compared with olecranon osteotomy approach.&#xD;
      In this study investigators compare the effect of surgical approach triceps lifting vs&#xD;
      olecranon osteotomy on the functional outcome after fixation of distal humerus&#xD;
      intra-articular fractures. Investigators conducted a non-funded, non-commercial,&#xD;
      retrospective cohort study on participants with closed distal humerus intra-articular&#xD;
      fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital.&#xD;
      Participants &gt;18 years of age with closed complex intra-articular distal humerus fracture&#xD;
      were operated using two different surgical approaches, either triceps lifting approach&#xD;
      (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is&#xD;
      carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded&#xD;
      that triceps lifting approach can be used equally efficiently for exposure of these complex&#xD;
      distal humerus injuries with no comprise in visibility of articular fragments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2010</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Functional outcome using Quick DASH Score</measure>
    <time_frame>1 years followup</time_frame>
    <description>Disabilities of Arm, Shoulder &amp; Hand</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Distal Humerus Fracture</condition>
  <arm_group>
    <arm_group_label>(Group1)</arm_group_label>
    <description>Triceps lifting approach .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(Group 2)</arm_group_label>
    <description>olecranon osteotomy approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>triceps lifting and olecranon osteotomy approaches</intervention_name>
    <description>two different surgical approaches for distal humerus fracture</description>
    <arm_group_label>(Group 2)</arm_group_label>
    <arm_group_label>(Group1)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all adult patients males and females who met the eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt;18 years of age with closed complex intra-articular distal humerus&#xD;
             fracture (Intercondylar Fracture Riseborough Radin Classification type lll and lV)&#xD;
             were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with CVA (Cerebero-Vascular Accident), dementia and associated with&#xD;
             neurovascular injuries which may impede with rehabilitation are excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Aziz Hayder</investigator_full_name>
    <investigator_title>admin assistant</investigator_title>
  </responsible_party>
  <keyword>intra-articular fractures; distal humerus; osteotomy; elbow joint</keyword>
  <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>Intra-Articular Fractures</mesh_term>
    <mesh_term>Humeral Fractures, Distal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not allowed according to hospital policy</ipd_description>
  </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/NCT03833414
org study id: 3799-Sur-ERC-15
nct id: NCT03833414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate
      the difference between two common surgical approaches to distal humerus fracture fixation.
Fractures around the distal humerus fractures make up to 2% of all fractures. Complex
      intra-articular distal humerus fractures present as challenge to restore of painless, stable
      and mobile elbow joint. Surgical exposure to all critical structures is of paramount
      importance to achieve anatomic reduction. Conflict still persists regarding the choice of
      ideal approach between triceps-sparing approach compared with olecranon osteotomy approach.
      In this study investigators compare the effect of surgical approach triceps lifting vs
      olecranon osteotomy on the functional outcome after fixation of distal humerus
      intra-articular fractures. Investigators conducted a non-funded, non-commercial,
      retrospective cohort study on participants with closed distal humerus intra-articular
      fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital.
      Participants >18 years of age with closed complex intra-articular distal humerus fracture
      were operated using two different surgical approaches, either triceps lifting approach
      (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is
      carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded
      that triceps lifting approach can be used equally efficiently for exposure of these complex
      distal humerus injuries with no comprise in visibility of articular fragments.
observational model: Cohort
time perspective: Retrospective
measure: Functional outcome using Quick DASH Score
time frame: 1 years followup
description: Disabilities of Arm, Shoulder & Hand
arm group label: (Group1)
description: Triceps lifting approach .
arm group label: (Group 2)
description: olecranon osteotomy approach
intervention type: Procedure
intervention name: triceps lifting and olecranon osteotomy approaches
description: two different surgical approaches for distal humerus fracture
arm group label: (Group 2)
arm group label: (Group1)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Aziz Hayder
investigator title: admin assistant
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Intra-Articular Fractures
mesh term: Humeral Fractures, Distal
sharing ipd: No
ipd description: not allowed according to hospital policy