<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/NCT02246335</url>
  </required_header>
  <id_info>
    <org_study_id>HOPE</org_study_id>
    <nct_id>NCT02246335</nct_id>
  </id_info>
  <brief_title>Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly</brief_title>
  <acronym>HOPE</acronym>
  <official_title>Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danderyd Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of&#xD;
      displaced femoral neck fractures in the elderly-elderly&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment&#xD;
      of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2009</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>2 years</time_frame>
    <description>The hip specific outcome score Harris hip score at 2 years will be the main outcome variable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>2 years</time_frame>
    <description>Health-related quality of life at 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>4 years</time_frame>
    <description>Health-related quality of life at 4 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>6 years</time_frame>
    <description>Health-related quality of life at 6 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>10 years</time_frame>
    <description>Health-related quality of life at 10 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>All hip related adverse events at 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>4 years</time_frame>
    <description>All hip related adverse events at 4 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 years</time_frame>
    <description>All hip related adverse events at 6 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>10 years</time_frame>
    <description>All hip related adverse events at 10 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>4 years</time_frame>
    <description>Harris hip score at 4 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>6 years</time_frame>
    <description>Harris hip score at 6 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Harris hip score</measure>
    <time_frame>10 years</time_frame>
    <description>Harris hip score at 10 years</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Femoral Neck Fractures</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hemiarthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total hip arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cemented total hip arthroplasty</intervention_name>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cemented hemiarthroplasty</intervention_name>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute displaced femoral neck fracture of hip (Garden classification 3-4)&#xD;
&#xD;
          -  Independent walker with or without walking aides&#xD;
&#xD;
          -  Patient willing to participate in the study and give written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fracture older than 36 hours before admission&#xD;
&#xD;
          -  Osteoarthritis in the fractured hip&#xD;
&#xD;
          -  Rheumatoid arthritis in the fractured hip&#xD;
&#xD;
          -  Pathological fractures&#xD;
&#xD;
          -  Contraindication for hip arthroplasty surgery&#xD;
&#xD;
          -  Not suitable for inclusion for other reasons e.g. substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>80 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopaedic department, Danderyd Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>18288</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danderyd Hospital</investigator_affiliation>
    <investigator_full_name>Olof Skoldenberg</investigator_full_name>
    <investigator_title>Medical Doctor, Ph D</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>Femoral Neck 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/NCT02246335
org study id: HOPE
nct id: NCT02246335
lead sponsor: 
has dmc: No
Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of
      displaced femoral neck fractures in the elderly-elderly
Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment
      of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Harris hip score
time frame: 2 years
description: The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
measure: EQ-5D
time frame: 2 years
description: Health-related quality of life at 2 years
measure: EQ-5D
time frame: 4 years
description: Health-related quality of life at 4 years
measure: EQ-5D
time frame: 6 years
description: Health-related quality of life at 6 years
measure: EQ-5D
time frame: 10 years
description: Health-related quality of life at 10 years
measure: Adverse events
time frame: 2 years
description: All hip related adverse events at 2 years
measure: Adverse events
time frame: 4 years
description: All hip related adverse events at 4 years
measure: Adverse events
time frame: 6 years
description: All hip related adverse events at 6 years
measure: Adverse events
time frame: 10 years
description: All hip related adverse events at 10 years
measure: Harris hip score
time frame: 4 years
description: Harris hip score at 4 years
measure: Harris hip score
time frame: 6 years
description: Harris hip score at 6 years
measure: Harris hip score
time frame: 10 years
description: Harris hip score at 10 years
arm group label: Control group
arm group type: Active Comparator
description: Hemiarthroplasty
arm group label: Treatment group
arm group type: Active Comparator
description: Total hip arthroplasty
intervention type: Device
intervention name: Cemented total hip arthroplasty
arm group label: Treatment group
intervention type: Device
intervention name: Cemented hemiarthroplasty
arm group label: Control group
criteria: 
gender: All
minimum age: 80 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: Olof Skoldenberg
investigator title: Medical Doctor, Ph D
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures