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/NCT06022419</url>
    </required_header>
    <id_info>
      <org_study_id>1526/2023</org_study_id>
      <nct_id>NCT06022419</nct_id>
    </id_info>
    <brief_title>Conservative Therapy of Proximal Phalanx Fractures - Comparing the Lucerne Cast With Finger Splinting</brief_title>
    <acronym>LuCa</acronym>
    <official_title>Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With 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 the&#xD;
        lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in&#xD;
        patients with a proximal phalanx fracture.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study represents a prospective randomized controlled clinical trial comparing two&#xD;
        different conservative treatment options in patients with proximal phalanx fractures.&#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, while patients in the study group&#xD;
        will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks.&#xD;
        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>Treatment Failure</measure>
      <time_frame>at 1, 2, 4 and 12 weeks</time_frame>
      <description>Occurrence of indication for surgery (malrotation, axial deviation &gt;10°, dorsal angulation &gt;20°) 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>Occurrence of complications due to treatment</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">86</enrollment>
    <condition>Proximal Phalanx Fracture</condition>
    <arm_group>
      <arm_group_label>Lucerne Cast</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>Lucerne Cast</intervention_name>
      <description>Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.</description>
      <arm_group_label>Lucerne Cast</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;
            -  Proximal phalanx fracture in the fingers (II - V)&#xD;
  &#xD;
            -  Patient age between 18 and 70 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Condylar fracture&#xD;
  &#xD;
            -  Avulsions of the collateral ligament&#xD;
  &#xD;
            -  Pathologic fracture&#xD;
  &#xD;
            -  Intraarticular fracture&#xD;
  &#xD;
            -  Patients unable to consent&#xD;
  &#xD;
            -  Polytraumatized patients&#xD;
  &#xD;
            -  Patients initially presenting more than 7 days after injury&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Compound fractures&#xD;
  &#xD;
            -  Multiple hand injuries&#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 1, 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 1, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Calpastatin</mesh_term>
    </intervention_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/NCT06022419
  org study id: 1526/2023
  nct id: NCT06022419
  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 the
        lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in
        patients with a proximal phalanx fracture.
  This study represents a prospective randomized controlled clinical trial comparing two
        different conservative treatment options in patients with proximal phalanx fractures.
  
        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, while patients in the study group
        will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks.
        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: Treatment Failure
  time frame: at 1, 2, 4 and 12 weeks
  description: Occurrence of indication for surgery (malrotation, axial deviation >10°, dorsal angulation >20°) 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: Occurrence of complications due to treatment
  arm group label: Lucerne Cast
  arm group type: Active Comparator
  arm group label: Forearm Cast and Finger Splint
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Lucerne Cast
  description: Patients receiving reduction of fractured finger and subsequent customization of a lucerne cast. Duration of cast treatment is determined with 4 weeks.
  arm group label: Lucerne Cast
  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
  mesh term: Calpastatin
  sharing ipd: No