xml: <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/NCT06029374</url>
    </required_header>
    <id_info>
      <org_study_id>1529/2023</org_study_id>
      <nct_id>NCT06029374</nct_id>
    </id_info>
    <brief_title>Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting</brief_title>
    <acronym>BoxerFx</acronym>
    <official_title>Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this prospective randomized controlled clinical trial is to evaluate if&#xD;
        functional treatment leads to a better functional outcome than a forearm cast and a finger&#xD;
        splint in patients with fifth metacarpal neck fracture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study represents a prospective randomized clinical trial comparing two different&#xD;
        conservative treatment options in patients with fifth metacarpal neck fracture.&#xD;
  &#xD;
        Patients meeting the inclusion criteria will be enrolled in the present study provided they&#xD;
        give their consent. Informed written consent will be obtained. Randomization will be&#xD;
        performed according to the CONSORT Guidelines of Prospective Randomized Trials using the&#xD;
        software &quot;Randomizer&quot; by the Medical University of Graz. Patients allocated to the control&#xD;
        group will receive a forearm cast with a finger splint in terms of an immobilizing treatment,&#xD;
        while patients in the study group will receive buddy taping for fingers IV and V and an&#xD;
        elastic bandage in terms of a functional treatment. Both groups will receive the allocated&#xD;
        bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Brief Michigan-Hand-Outcome-Questionnaire</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Loss/Gain of Reduction</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Failure</measure>
      <time_frame>at 1, 2, 4 and 12 weeks</time_frame>
      <description>Occurrence of indication for surgery (malrotation, palmar angulation &gt;50°) after primary reposition</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>at 0, 1, 2, 4 and 12 weeks</time_frame>
      <description>Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)</description>
    </other_outcome>
    <other_outcome>
      <measure>Strength Measurement</measure>
      <time_frame>at 4 and 12 weeks</time_frame>
      <description>dynamometer-based strength evaluation</description>
    </other_outcome>
    <other_outcome>
      <measure>Range of Motion (ROM) Assessment</measure>
      <time_frame>at 4 and 12 weeks</time_frame>
      <description>goniometer-based ROM evaluation of hand and wrist</description>
    </other_outcome>
    <other_outcome>
      <measure>Delayed Bone Healing</measure>
      <time_frame>at 12 weeks</time_frame>
      <description>number of participants with bone non-union at end of study</description>
    </other_outcome>
    <other_outcome>
      <measure>Radiological Outcome</measure>
      <time_frame>at 0, 1, 2, 4 and 12 weeks</time_frame>
      <description>x-ray based outcome of fracture healing in terms of axial deviation (measured in °)</description>
    </other_outcome>
    <other_outcome>
      <measure>Radiological Outcome</measure>
      <time_frame>at 0, 1, 2, 4 and 12 weeks</time_frame>
      <description>x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)</description>
    </other_outcome>
    <other_outcome>
      <measure>Quick DASH-Score</measure>
      <time_frame>at 0, 1, 2, 4 and 12 weeks</time_frame>
      <description>patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)</description>
    </other_outcome>
    <other_outcome>
      <measure>Brief Michigan-Hand-Outcome-Questionnaire</measure>
      <time_frame>at 0, 1, 2 and 4 weeks</time_frame>
      <description>patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)</description>
    </other_outcome>
    <other_outcome>
      <measure>Occurrence of Complications</measure>
      <time_frame>at 0, 1, 2, 4 and 12 weeks</time_frame>
      <description>occurence of complications due to treatment</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Boxer's Fracture</condition>
    <arm_group>
      <arm_group_label>Functional Treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Forearm Cast and Finger Splint</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Functional Treatment</intervention_name>
      <description>Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.</description>
      <arm_group_label>Functional Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Forearm Cast and Finger Splint</intervention_name>
      <description>Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.</description>
      <arm_group_label>Forearm Cast and Finger Splint</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Fifth Metacarpal Neck Fractures&#xD;
  &#xD;
            -  Patient age between 18 and 70 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Palmar angulation &gt;50° in first lateral x-ray&#xD;
  &#xD;
            -  Pathologic fracture&#xD;
  &#xD;
            -  Intraarticular fracture&#xD;
  &#xD;
            -  Patients unable to consent&#xD;
  &#xD;
            -  Polytraumatized patients&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Compound fractures&#xD;
  &#xD;
            -  Multiple hand injuries&#xD;
  &#xD;
            -  Patients initially presenting more than 7 days after injury&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gerhild Thalhammer, M.D.</last_name>
      <role>Study Director</role>
      <affiliation>Medical University of Vienna</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paul L Hoppe, M.D.</last_name>
      <phone>0043 1 40400 59160</phone>
      <email>paul.hoppe@meduniwien.ac.at</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Paul L Hoppe</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029374
  org study id: 1529/2023
  nct id: NCT06029374
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this prospective randomized controlled clinical trial is to evaluate if
        functional treatment leads to a better functional outcome than a forearm cast and a finger
        splint in patients with fifth metacarpal neck fracture.
  This study represents a prospective randomized clinical trial comparing two different
        conservative treatment options in patients with fifth metacarpal neck fracture.
  
        Patients meeting the inclusion criteria will be enrolled in the present study provided they
        give their consent. Informed written consent will be obtained. Randomization will be
        performed according to the CONSORT Guidelines of Prospective Randomized Trials using the
        software "Randomizer" by the Medical University of Graz. Patients allocated to the control
        group will receive a forearm cast with a finger splint in terms of an immobilizing treatment,
        while patients in the study group will receive buddy taping for fingers IV and V and an
        elastic bandage in terms of a functional treatment. Both groups will receive the allocated
        bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Brief Michigan-Hand-Outcome-Questionnaire
  time frame: at 12 weeks
  description: patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
  measure: Loss/Gain of Reduction
  time frame: at 12 weeks
  description: changes in palmar angulation of the fracture at end of treatment, compared to first x-ray (in degrees)
  measure: Treatment Failure
  time frame: at 1, 2, 4 and 12 weeks
  description: Occurrence of indication for surgery (malrotation, palmar angulation >50°) after primary reposition
  measure: Visual Analogue Scale (VAS)
  time frame: at 0, 1, 2, 4 and 12 weeks
  description: Pain evaluation on a psychometric response scale (range 0-10, 0=no pain, 10=maximum pain)
  measure: Strength Measurement
  time frame: at 4 and 12 weeks
  description: dynamometer-based strength evaluation
  measure: Range of Motion (ROM) Assessment
  time frame: at 4 and 12 weeks
  description: goniometer-based ROM evaluation of hand and wrist
  measure: Delayed Bone Healing
  time frame: at 12 weeks
  description: number of participants with bone non-union at end of study
  measure: Radiological Outcome
  time frame: at 0, 1, 2, 4 and 12 weeks
  description: x-ray based outcome of fracture healing in terms of axial deviation (measured in °)
  measure: Radiological Outcome
  time frame: at 0, 1, 2, 4 and 12 weeks
  description: x-ray based outcome of fracture healing in terms of length deviation and dislocation (measured in mm)
  measure: Quick DASH-Score
  time frame: at 0, 1, 2, 4 and 12 weeks
  description: patient-based standardised questionnaire (11 items, range 0-100, 100=ideal function, 0=poorest function)
  measure: Brief Michigan-Hand-Outcome-Questionnaire
  time frame: at 0, 1, 2 and 4 weeks
  description: patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
  measure: Occurrence of Complications
  time frame: at 0, 1, 2, 4 and 12 weeks
  description: occurence of complications due to treatment
  arm group label: Functional Treatment
  arm group type: Active Comparator
  arm group label: Forearm Cast and Finger Splint
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Functional Treatment
  description: Patients receiving buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Duration of bandage treatment is determined with 4 weeks.
  arm group label: Functional Treatment
  intervention type: Procedure
  intervention name: Forearm Cast and Finger Splint
  description: Patients receiving reduction of fractured finger and subsequent customization of a forearm cast with a finger splint. Duration of cast treatment is determined with 4 weeks.
  arm group label: Forearm Cast and Finger Splint
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Gerhild Thalhammer, M.D.
  role: Study Director
  affiliation: Medical University of Vienna
  last name: Paul L Hoppe, M.D.
  phone: 0043 1 40400 59160
  email: paul.hoppe@meduniwien.ac.at
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Paul L Hoppe
  investigator title: M.D.
  mesh term: Fractures, Bone
  sharing ipd: No