<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/NCT02247791</url>
  </required_header>
  <id_info>
    <org_study_id>CHANCE</org_study_id>
    <nct_id>NCT02247791</nct_id>
  </id_info>
  <brief_title>Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty</brief_title>
  <acronym>CHANCE</acronym>
  <official_title>Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danderyd Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as&#xD;
      an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a&#xD;
      displaced femoral neck fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will randomize patients between an uncemented and cemented stem&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 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>Hip related complication rate</measure>
    <time_frame>2 years</time_frame>
    <description>All hip-related complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>2 years</time_frame>
    <description>Health related quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative bleeding</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip function</measure>
    <time_frame>2 years</time_frame>
    <description>Measured with Harris hip score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Cemented femoral stem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient undergoing total hip arthroplasty surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Uncemented femoral stem</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing total hip arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uncemented femoral stem</intervention_name>
    <description>All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem</description>
    <arm_group_label>Uncemented femoral stem</arm_group_label>
    <other_name>BiMetric uncemented femoral stem</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cemented femoral stem</intervention_name>
    <description>All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem</description>
    <arm_group_label>Cemented femoral stem</arm_group_label>
    <other_name>CPT cemented femoral stem</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Displaced femoral neck fracture&#xD;
&#xD;
          -  Subject is aged between 65-79 years&#xD;
&#xD;
          -  Independent walker with or without walking aides&#xD;
&#xD;
          -  Subject is able and capable of providing consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Rheumatoid Arthritis&#xD;
&#xD;
          -  Patients with an impaired cognitive dysfunction&#xD;
&#xD;
          -  Patients with Pathological fractures&#xD;
&#xD;
          -  Patients with substance abuse&#xD;
&#xD;
          -  Patients with fracture older than 36-hours on arrival at the A&amp;E&#xD;
&#xD;
          -  Patients suffering from cancer&#xD;
&#xD;
          -  Patients determined by principal investigator to be unsuitable for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ghazi Chammout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>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>January 2016</verification_date>
  <study_first_submitted>October 21, 2013</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 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>Director of research, Orthopaedic dept</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip 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/NCT02247791
org study id: CHANCE
nct id: NCT02247791
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as
      an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a
      displaced femoral neck fracture.
The study will randomize patients between an uncemented and cemented stem
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hip related complication rate
time frame: 2 years
description: All hip-related complications
measure: Health-related Quality of Life
time frame: 2 years
description: Health related quality of life
measure: Duration of surgery
time frame: 2 years
measure: Intraoperative bleeding
time frame: 2 years
measure: Hip function
time frame: 2 years
description: Measured with Harris hip score
arm group label: Cemented femoral stem
arm group type: Active Comparator
description: Patient undergoing total hip arthroplasty surgery
arm group label: Uncemented femoral stem
arm group type: Active Comparator
description: Patients undergoing total hip arthroplasty
intervention type: Procedure
intervention name: Uncemented femoral stem
description: All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
arm group label: Uncemented femoral stem
other name: BiMetric uncemented femoral stem
intervention type: Procedure
intervention name: Cemented femoral stem
description: All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
arm group label: Cemented femoral stem
other name: CPT cemented femoral stem
criteria: 
gender: All
minimum age: 65 Years
maximum age: 79 Years
healthy volunteers: No
last name: Ghazi Chammout, MD
role: Principal Investigator
affiliation: Dept of Orthopaedics, Danderyd Hospital, Stockholm, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: Olof Skoldenberg
investigator title: Director of research, Orthopaedic dept
mesh term: Hip Fractures