<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/NCT03038581</url>
  </required_header>
  <id_info>
    <org_study_id>13-054</org_study_id>
    <secondary_id>U1111-1176-0115</secondary_id>
    <nct_id>NCT03038581</nct_id>
  </id_info>
  <brief_title>Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries</brief_title>
  <official_title>Comparison of Self-inflicted Deep Wrist Injuries to Traumatic Deep Wrist Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Psychiatry, University of Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</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>
      Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills.&#xD;
      There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and&#xD;
      compare them to traumatic wrist injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries&#xD;
      involve risks that require special psychiatric knowledge and tactical skills. There is no&#xD;
      protocol for treating such injuries. Therefore, the investigators analyze self-inflicted&#xD;
      wrist injuries and compare them to traumatic wrist injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Hand function</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychiatric history</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Assessment of quality of life</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">183</enrollment>
  <condition>Deep Wound</condition>
  <condition>Wrist Injuries</condition>
  <arm_group>
    <arm_group_label>Self-inflicted wrist injury</arm_group_label>
    <description>Wrist injury by self-infliction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traumatic wrist injury</arm_group_label>
    <description>Wrist injury by not self-inflicted trauma</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with deep wrist injuries that were treated 2008-2018 in University Hospital&#xD;
        Schleswig-Holstein&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Deep wrist injury from 2008-2018&#xD;
&#xD;
          -  Treated in University Hospital Schleswig-Holstein&#xD;
&#xD;
          -  Agreed to retrospective analysis, questionnaires and hand function assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Kisch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Schleswig-Holstein, Campus Lübeck, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 29, 2015</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 1, 2019</last_update_submitted>
  <last_update_submitted_qc>December 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>Tobias Kisch</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Deep wrist injury</keyword>
  <keyword>Self inflicted</keyword>
  <keyword>Traumatic wrist injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Wrist Injuries</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/NCT03038581
org study id: 13-054
secondary id: U1111-1176-0115
nct id: NCT03038581
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Self-inflicted wrist injuries require special psychiatric knowledge and tactical skills.
      There is no protocol for treating such injuries. We analyze self-inflicted wrist injuries and
      compare them to traumatic wrist injuries.
Self-inflicted wrist injuries are regularly treated in hand surgery centers. These injuries
      involve risks that require special psychiatric knowledge and tactical skills. There is no
      protocol for treating such injuries. Therefore, the investigators analyze self-inflicted
      wrist injuries and compare them to traumatic wrist injuries.
observational model: Cohort
time perspective: Retrospective
measure: Hand function
time frame: Up to 10 years
description: Assessment of hand function by measuring sensibility (2-point-discrimination) and motoric (degree joints)
measure: Psychiatric history
time frame: Up to 10 years
description: Assessment of quality of life
arm group label: Self-inflicted wrist injury
description: Wrist injury by self-infliction
arm group label: Traumatic wrist injury
description: Wrist injury by not self-inflicted trauma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Kisch, MD
role: Principal Investigator
affiliation: University of Schleswig-Holstein, Campus Lübeck, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: Tobias Kisch
investigator title: MD
mesh term: Wounds and Injuries
mesh term: Wrist Injuries
sharing ipd: No