<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/NCT04401462</url>
  </required_header>
  <id_info>
    <org_study_id>SCORE</org_study_id>
    <nct_id>NCT04401462</nct_id>
  </id_info>
  <brief_title>Scandinavian Olecranon Research in the Elderly</brief_title>
  <official_title>SCORE Trial - Scandinavian Olecranon Research in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Satakunta Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jyväskylä Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Copenhagen University Hospital at Herlev</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku University Hospital</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>
      This study is designed to study the difference between operative treatment, either with&#xD;
      tension band wiring or plate fixation, and conservative treatment of traumatic, displaced&#xD;
      olecranon fractures in elderly population in a non-inferiority study setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Disabilities of Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>1 year</time_frame>
    <description>Minimum value 0, maximum value 100. Higher scores mean worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Disabilities of Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>3 months</time_frame>
    <description>Minimum value 0, maximum value 100. Higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, visual analogue scale (VAS)</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction, visual analogue scale (VAS)</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elbow X-rays</measure>
    <time_frame>post-operatively, 2 weeks, 3 and 12 months</time_frame>
    <description>AP and lateral view.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of elbow motion.</measure>
    <time_frame>3 and 12 months</time_frame>
    <description>The results are reported in degrees. Measurement is performed to the injured arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of extension strength between injured and healthy elbow.</measure>
    <time_frame>12 months</time_frame>
    <description>Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Olecranon Fracture</condition>
  <arm_group>
    <arm_group_label>Operative group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>tension band wiring or plate fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operative group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conservative treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tension band wiring or plate fixation</intervention_name>
    <description>Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name</description>
    <arm_group_label>Operative group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sling or a long-arm plaster</intervention_name>
    <description>Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.</description>
    <arm_group_label>Non-operative group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm&#xD;
             dislocation of the joint surface) fracture of the olecranon&#xD;
&#xD;
          -  Age of patient is 75 years or over at the time of the injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A delay more than 2 weeks after traumatic event to the day of intervention&#xD;
&#xD;
          -  Mayo type 3 fracture&#xD;
&#xD;
          -  Fracture continuation distal to coronoideus&#xD;
&#xD;
          -  Other acute fracture or nerve damage of the ipsilateral upper limb&#xD;
&#xD;
          -  Old fracture (&lt;6 months) or pseudoarthrosis or unhealed nerve injury of the&#xD;
             ipsilateral upper limb&#xD;
&#xD;
          -  Open fracture&#xD;
&#xD;
          -  Pathological fracture&#xD;
&#xD;
          -  History of alcoholism, drug abuse, psychological or other emotional problems likely to&#xD;
             jeopardize informed consent&#xD;
&#xD;
          -  Patient's inability to understand written and spoken Finnish or Swedish or Danish&#xD;
&#xD;
          -  Patient's denial for participation or cognitive incapability to provide consent&#xD;
&#xD;
          -  Patient physically unfit for surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ida Rantalaiho, MD</last_name>
    <phone>+35823135040</phone>
    <email>ida.rantalaiho@tyks.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inari Laaksonen, PhD</last_name>
    <email>inari.laaksonen@tyks.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Turku Central University Hospital</name>
      <address>
        <city>Turku</city>
        <state>Varsinais-Suomi</state>
        <zip>20700</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ida Rantalaiho</last_name>
      <phone>+35823135040</phone>
      <email>ida.rantalaiho@tyks.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olecranon Fracture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04401462
org study id: SCORE
nct id: NCT04401462
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to study the difference between operative treatment, either with
      tension band wiring or plate fixation, and conservative treatment of traumatic, displaced
      olecranon fractures in elderly population in a non-inferiority study setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: the Disabilities of Arm, Shoulder and Hand (DASH)
time frame: 1 year
description: Minimum value 0, maximum value 100. Higher scores mean worse outcome.
measure: the Disabilities of Arm, Shoulder and Hand (DASH)
time frame: 3 months
description: Minimum value 0, maximum value 100. Higher scores mean worse outcome.
measure: Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
time frame: 3 and 12 months
description: Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.
measure: Pain, visual analogue scale (VAS)
time frame: 3 and 12 months
description: Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.
measure: Satisfaction, visual analogue scale (VAS)
time frame: 3 and 12 months
description: Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.
measure: Elbow X-rays
time frame: post-operatively, 2 weeks, 3 and 12 months
description: AP and lateral view.
measure: Range of elbow motion.
time frame: 3 and 12 months
description: The results are reported in degrees. Measurement is performed to the injured arm.
measure: Comparison of extension strength between injured and healthy elbow.
time frame: 12 months
description: Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.
measure: Adverse events
time frame: up to 12 months
arm group label: Operative group
arm group type: Active Comparator
description: tension band wiring or plate fixation
arm group label: Non-operative group
arm group type: Active Comparator
description: conservative treatment
intervention type: Procedure
intervention name: Tension band wiring or plate fixation
description: Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
arm group label: Operative group
intervention type: Behavioral
intervention name: Sling or a long-arm plaster
description: Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.
arm group label: Non-operative group
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ida Rantalaiho, MD
phone: +35823135040
email: ida.rantalaiho@tyks.fi
last name: Inari Laaksonen, PhD
email: inari.laaksonen@tyks.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Sponsor
mesh term: Olecranon Fracture
sharing ipd: No