<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/NCT02256059</url>
  </required_header>
  <id_info>
    <org_study_id>Beiromat_03</org_study_id>
    <nct_id>NCT02256059</nct_id>
  </id_info>
  <brief_title>Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension</brief_title>
  <acronym>LatClav</acronym>
  <official_title>Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study</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>
      Treatment of lateral fractures of the clavicle is challenging and has been controversially&#xD;
      discussed for a long time due to high non-union rates in non-operative treatment and high&#xD;
      complication rates in surgical treatment. A recently developed implant was proven to ensure a&#xD;
      biomechanically sufficient fixation of fractures leading to bony union and promising&#xD;
      functional outcome in a small collective of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment of lateral fractures of the clavicle is challenging and has been controversially&#xD;
      discussed for a long time due to high non-union rates in non-operative treatment and high&#xD;
      complication rates in surgical treatment. A recently developed implant was proven to ensure a&#xD;
      biomechanically sufficient fixation of fractures leading to bony union and promising&#xD;
      functional outcome in a small collective of patients.&#xD;
&#xD;
      In this prospective study patients with dislocated fractures of the lateral clavicle&#xD;
      (Jäger&amp;Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using&#xD;
      the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional&#xD;
      outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative&#xD;
      self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the&#xD;
      Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint&#xD;
      stability is evaluated using the Taft-Score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>bone healing</measure>
    <time_frame>12 month</time_frame>
    <description>time until bone healing, visualized using conventional x-ray in two planes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>shoulder function</measure>
    <time_frame>12 month</time_frame>
    <description>shoulder function assessed using Munich Shoulder Questionnaire [MSQ]</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Fracture, Closed, Comminuted, Healing</condition>
  <arm_group>
    <arm_group_label>Plate osteosynthesis</arm_group_label>
    <description>Patients with fracture of the lateral clavicle and indication for surgical treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Plate osteosynthesis</intervention_name>
    <description>Plate osteosynthesis using LCP plate (Synthes)</description>
    <arm_group_label>Plate osteosynthesis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from a dislocated fracture of the lateral clavicle presenting at our&#xD;
        emergency department.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dislocated fracture of the lateral clavicle&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of any other pathology such as preexisting rotator cuff tear,&#xD;
             gleno-humeral instability, glenohumeral osteoarthritis (&gt; Samilson I),&#xD;
             Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying&#xD;
             tendonitis, biceps pathology or signs of cervical root symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>
  <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>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 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>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Fractures, Closed</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/NCT02256059
org study id: Beiromat_03
nct id: NCT02256059
lead sponsor: 
has dmc: No
Treatment of lateral fractures of the clavicle is challenging and has been controversially
      discussed for a long time due to high non-union rates in non-operative treatment and high
      complication rates in surgical treatment. A recently developed implant was proven to ensure a
      biomechanically sufficient fixation of fractures leading to bony union and promising
      functional outcome in a small collective of patients.
Treatment of lateral fractures of the clavicle is challenging and has been controversially
      discussed for a long time due to high non-union rates in non-operative treatment and high
      complication rates in surgical treatment. A recently developed implant was proven to ensure a
      biomechanically sufficient fixation of fractures leading to bony union and promising
      functional outcome in a small collective of patients.

      In this prospective study patients with dislocated fractures of the lateral clavicle
      (Jäger&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using
      the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional
      outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative
      self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the
      Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint
      stability is evaluated using the Taft-Score.
observational model: Cohort
time perspective: Prospective
measure: bone healing
time frame: 12 month
description: time until bone healing, visualized using conventional x-ray in two planes
measure: shoulder function
time frame: 12 month
description: shoulder function assessed using Munich Shoulder Questionnaire [MSQ]
arm group label: Plate osteosynthesis
description: Patients with fracture of the lateral clavicle and indication for surgical treatment
intervention type: Procedure
intervention name: Plate osteosynthesis
description: Plate osteosynthesis using LCP plate (Synthes)
arm group label: Plate osteosynthesis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 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
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Technical University of Munich
investigator full name: Dr. Chlodwig Kirchhoff
investigator title: MD
mesh term: Fractures, Bone
mesh term: Fractures, Closed