<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/NCT02247778</url>
  </required_header>
  <id_info>
    <org_study_id>Beiromat_02</org_study_id>
    <nct_id>NCT02247778</nct_id>
  </id_info>
  <brief_title>Surgical Innovations in Treatment of Clavicle Fractures</brief_title>
  <acronym>ClavFrac</acronym>
  <official_title>Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7&#xD;
      to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of&#xD;
      this incision secondary problems like prolonged fracture healing, paresthesia of&#xD;
      supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a&#xD;
      mini-incision technique using an average incision length of 4cm.&#xD;
&#xD;
      The aim of this study is to analyzed whether secondary problems following plate&#xD;
      osteosynthesis of the clavicle correlate mit the length of the surgical access.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7&#xD;
      to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of&#xD;
      this incision secondary problems like prolonged fracture healing, paresthesia of&#xD;
      supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a&#xD;
      mini-incision technique using an average incision length of 4cm.&#xD;
&#xD;
      The aim of this study is to analyzed whether secondary problems following plate&#xD;
      osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a&#xD;
      prospective observational protocol was chosen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>area of paresthetic skin</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to fracture healing</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative shoulder function</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Complication</condition>
  <arm_group>
    <arm_group_label>conventional plate osteosynthesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mini-incision-type osteosynthesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mini-incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional plate osteosynthesis</intervention_name>
    <description>Standard incision</description>
    <arm_group_label>conventional plate osteosynthesis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mini-incision-type osteosynthesis</intervention_name>
    <description>Mini-incision</description>
    <arm_group_label>mini-incision-type osteosynthesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        all patients with fractures of the clavicle and indication for operative intervention using&#xD;
        plate osteosynthesis ability to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        all other patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chlodwig Kirchhoff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chlodwig Kirchhoff, MD</last_name>
    <email>chlodwig.kirchhoff@mri.tum.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marc Beirer, MD</last_name>
    <email>marc.beirer@mri.tum.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Biberthaler, MD</last_name>
      <phone>0049-(0)89-41402126</phone>
      <email>peter.biberthaler@mri.tum.de</email>
    </contact>
    <investigator>
      <last_name>Chlodwig Kirchhoff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 28, 2014</last_update_submitted>
  <last_update_submitted_qc>September 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Technical University of Munich</investigator_affiliation>
    <investigator_full_name>Dr. Chlodwig Kirchhoff</investigator_full_name>
    <investigator_title>PD DR. med. Chlodwig Kirchhoff</investigator_title>
  </responsible_party>
  <keyword>clavicle</keyword>
  <keyword>surgical intervention</keyword>
  <keyword>mini-incision</keyword>
  <keyword>plate osteosynthesis</keyword>
  <!-- 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/NCT02247778
org study id: Beiromat_02
nct id: NCT02247778
lead sponsor: 
has dmc: No
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7
      to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of
      this incision secondary problems like prolonged fracture healing, paresthesia of
      supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a
      mini-incision technique using an average incision length of 4cm.

      The aim of this study is to analyzed whether secondary problems following plate
      osteosynthesis of the clavicle correlate mit the length of the surgical access.
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7
      to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of
      this incision secondary problems like prolonged fracture healing, paresthesia of
      supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a
      mini-incision technique using an average incision length of 4cm.

      The aim of this study is to analyzed whether secondary problems following plate
      osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a
      prospective observational protocol was chosen.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: area of paresthetic skin
time frame: 12 month
measure: Time to fracture healing
time frame: 12 month
measure: Postoperative shoulder function
time frame: 12 month
arm group label: conventional plate osteosynthesis
arm group type: Active Comparator
description: Standard procedure
arm group label: mini-incision-type osteosynthesis
arm group type: Active Comparator
description: mini-incision
intervention type: Procedure
intervention name: conventional plate osteosynthesis
description: Standard incision
arm group label: conventional plate osteosynthesis
intervention type: Procedure
intervention name: mini-incision-type osteosynthesis
description: Mini-incision
arm group label: mini-incision-type osteosynthesis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chlodwig Kirchhoff, MD
role: Principal Investigator
affiliation: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
last name: Chlodwig Kirchhoff, MD
email: chlodwig.kirchhoff@mri.tum.de
last name: Marc Beirer, MD
email: marc.beirer@mri.tum.de
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Dr. Chlodwig Kirchhoff
investigator title: PD DR. med. Chlodwig Kirchhoff