<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/NCT04470349</url>
  </required_header>
  <id_info>
    <org_study_id>2020.1</org_study_id>
    <nct_id>NCT04470349</nct_id>
  </id_info>
  <brief_title>Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures</brief_title>
  <acronym>DYNAFIX</acronym>
  <official_title>Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Waldfriede Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Waldfriede Hospital</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>
      Fractures of the proximal interphalangeal joints continue to pose significant management&#xD;
      challenges. Thus the aim of our study is to compare two dynamic finger joint distractors&#xD;
      (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination&#xD;
      and functional assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disabilities of Arm, Shoulder and Hand (DASH) score</measure>
    <time_frame>3 months after explantation</time_frame>
    <description>Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) pain</measure>
    <time_frame>3 months after explantation</time_frame>
    <description>From 0mm (no pain) to 100mm (maximum pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional assessment: Goniometry</measure>
    <time_frame>3 months after explantation</time_frame>
    <description>ROM of each joint of the injured fingert with a goniometer.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Proximal Interphalangeal Joint Fracture of the Hand</condition>
  <arm_group>
    <arm_group_label>LITOS</arm_group_label>
    <description>Patients who received a LITOS dynamic distraction system after 31.12.2017</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ligamentotaxor</arm_group_label>
    <description>Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LITOS</intervention_name>
    <description>Patients who received a LITOS dynamic distraction system after 31.12.2017</description>
    <arm_group_label>LITOS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ligamentotaxor</intervention_name>
    <description>Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017</description>
    <arm_group_label>Ligamentotaxor</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People who have sustained a proximal interphalangeal fracture treated with external dynamic&#xD;
        fixator&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  proximal interphalangeal fracture treated with external dynamic fixator&#xD;
&#xD;
          -  Operative care &lt;21 days from trauma&#xD;
&#xD;
          -  Age between 18 and 90 years.&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - additional fractures or disabilities of the hand&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Bock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Waldfriede Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Lautenbach, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Waldfriede Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Markus Bock, MD</last_name>
    <phone>00493081810201</phone>
    <email>m.bock@waldfriede.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthias Url, MD</last_name>
    <phone>00493081810201</phone>
    <email>m.url@waldfriede.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Waldfriede Hospital</name>
      <address>
        <city>Berlin</city>
        <zip>14163</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Bock, MD</last_name>
      <phone>00493081810201</phone>
      <email>m.bock@waldfriede.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</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>Fractures, Bone</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/NCT04470349
org study id: 2020.1
nct id: NCT04470349
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Fractures of the proximal interphalangeal joints continue to pose significant management
      challenges. Thus the aim of our study is to compare two dynamic finger joint distractors
      (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination
      and functional assessments.
observational model: Cohort
time perspective: Retrospective
measure: Disabilities of Arm, Shoulder and Hand (DASH) score
time frame: 3 months after explantation
description: Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
measure: Visual analogue scale (VAS) pain
time frame: 3 months after explantation
description: From 0mm (no pain) to 100mm (maximum pain imaginable)
measure: Functional assessment: Goniometry
time frame: 3 months after explantation
description: ROM of each joint of the injured fingert with a goniometer.
arm group label: LITOS
description: Patients who received a LITOS dynamic distraction system after 31.12.2017
arm group label: Ligamentotaxor
description: Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017
intervention type: Device
intervention name: LITOS
description: Patients who received a LITOS dynamic distraction system after 31.12.2017
arm group label: LITOS
intervention type: Device
intervention name: Ligamentotaxor
description: Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017
arm group label: Ligamentotaxor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Markus Bock, MD
role: Principal Investigator
affiliation: Waldfriede Hospital
last name: Martin Lautenbach, MD
role: Study Chair
affiliation: Waldfriede Hospital
last name: Markus Bock, MD
phone: 00493081810201
email: m.bock@waldfriede.de
last name: Matthias Url, MD
phone: 00493081810201
email: m.url@waldfriede.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Fractures, Bone